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1.
J Clin Epidemiol ; 165: 111219, 2024 Jan.
Article in English | MEDLINE | ID: mdl-38008266

ABSTRACT

OBJECTIVES: To make informed decisions, the general population should have access to accessible and understandable health recommendations. To compare understanding, accessibility, usability, satisfaction, intention to implement, and preference of adults provided with a digital "Plain Language Recommendation" (PLR) format vs. the original "Standard Language Version" (SLV). STUDY DESIGN AND SETTING: An allocation-concealed, blinded, controlled superiority trial and a qualitative study to understand participant preferences. An international on-line survey. 488 adults with some English proficiency. 67.8% of participants identified as female, 62.3% were from the Americas, 70.1% identified as white, 32.2% had a bachelor's degree as their highest completed education, and 42% said they were very comfortable reading health information. In collaboration with patient partners, advisors, and the Cochrane Consumer Network, we developed a plain language format of guideline recommendations (PLRs) to compare their effectiveness vs. the original standard language versions (SLVs) as published in the source guideline. We selected two recommendations about COVID-19 vaccine, similar in their content, to compare our versions, one from the World Health Organization (WHO) and one from Centers for Disease Control and Prevention (CDC). The primary outcome was understanding, measured as the proportion of correct responses to seven comprehension questions. Secondary outcomes were accessibility, usability, satisfaction, preference, and intended behavior, measured on a 1-7 scale. RESULTS: Participants randomized to the PLR group had a higher proportion of correct responses to the understanding questions for the WHO recommendation (mean difference [MD] of 19.8%, 95% confidence interval [CI] 14.7-24.9%; P < 0.001) but this difference was smaller and not statistically significant for the CDC recommendation (MD of 3.9%, 95% CI -0.7% to 8.3%; P = 0.096). However, regardless of the recommendation, participants found the PLRs more accessible, (MD of 1.2 on the seven-point scale, 95% CI 0.9-1.4%; P < 0.001) and more satisfying (MD of 1.2, 95% CI 0.9-1.4%; P < 0.001). They were also more likely to follow the recommendation if they had not already followed it (MD of 1.2, 95% CI 0.7-1.8%; P < 0.001) and share it with other people they know (MD of 1.9, 95% CI 0.5-1.2%; P < 0.001). There was no significant difference in the preference between the two formats (MD of -0.3, 95% CI -0.5% to 0.03%; P = 0.078). The qualitative interviews supported and contextualized these findings. CONCLUSION: Health information provided in a PLR format improved understanding, accessibility, usability, and satisfaction and thereby has the potential to shape public decision-making behavior.


Subject(s)
Comprehension , Consumer Health Information , Health Knowledge, Attitudes, Practice , Patient Education as Topic , Adult , Female , Humans , COVID-19 Vaccines , United States , Male , Language
2.
JAMA Pediatr ; 177(9): 956-965, 2023 09 01.
Article in English | MEDLINE | ID: mdl-37548983

ABSTRACT

Importance: To ensure that youths can make informed decisions about their health, it is important that health recommendations be presented for understanding by youths. Objective: To compare understanding, accessibility, usability, satisfaction, intention to implement, and preference of youths provided with a digital plain language recommendation (PLR) format vs the original standard language version (SLV) of a health recommendation. Design, Setting, and Participants: This pragmatic, allocation-concealed, blinded, superiority randomized clinical trial included individuals from any country who were 15 to 24 years of age, had internet access, and could read and understand English. The trial was conducted from May 27 to July 6, 2022, and included a qualitative component. Interventions: An online platform was used to randomize youths in a 1:1 ratio to an optimized digital PLR or SLV format of 1 of 2 health recommendations related to the COVID-19 vaccine; youth-friendly PLRs were developed in collaboration with youth partners and advisors. Main Outcomes and Measures: The primary outcome was understanding, measured as the proportion of correct responses to 7 comprehension questions. Secondary outcomes were accessibility, usability, satisfaction, preference, and intended behavior. After completion of the survey, participants indicated their interest in completing a 1-on-1 semistructured interview to reflect on their preferred digital format (PLR or SLV) and their outcome assessment survey response. Results: Of the 268 participants included in the final analysis, 137 were in the PLR group (48.4% female) and 131 were in the SLV group (53.4% female). Most participants (233 [86.9%]) were from North and South America. No significant difference was found in understanding scores between the PLR and SLV groups (mean difference, 5.2%; 95% CI, -1.2% to 11.6%; P = .11). Participants found the PLR to be more accessible and usable (mean difference, 0.34; 95% CI, 0.05-0.63) and satisfying (mean difference, 0.39; 95% CI, 0.06-0.73) and had a stronger preference toward the PLR (mean difference, 4.8; 95% CI, 4.5-5.1 [4.0 indicated a neutral response]) compared with the SLV. No significant difference was found in intended behavior (mean difference, 0.22 (95% CI, -0.20 to 0.74). Interviewees (n = 14) agreed that the PLR was easier to understand and generated constructive feedback to further improve the digital PLR. Conclusions and Relevance: In this randomized clinical trial, compared with the SLV, the PLR did not produce statistically significant findings in terms of understanding scores. Youths ranked it higher in terms of accessibility, usability, and satisfaction, suggesting that the PLR may be preferred for communicating health recommendations to youths. The interviews provided suggestions for further improving PLR formats. Trial Registration: ClinicalTrials.gov Identifier: NCT05358990.


Subject(s)
COVID-19 , Humans , Adolescent , Female , Male , COVID-19/prevention & control , COVID-19 Vaccines , Outcome Assessment, Health Care , Surveys and Questionnaires , Formative Feedback
3.
J Clin Epidemiol ; 161: 8-19, 2023 09.
Article in English | MEDLINE | ID: mdl-37421995

ABSTRACT

OBJECTIVES: To assess the effectiveness of plain language compared with standard language versions of COVID-19 recommendations specific to child health. STUDY DESIGN AND SETTING: Pragmatic, allocation-concealed, blinded, superiority randomized controlled trial with nested qualitative component. Trial was conducted online, internationally. Parents or legal guardians (≥18 years) of a child (<18 years) were eligible. Participants were randomized to receive a plain language recommendation (PLR) or standard (SLV) verison of a COVID-19 recommendation specific to child health. Primary outcome was understanding. Secondary outcomes included: preference, accessibility, usability, satisfaction, and intended behavior. Interviews explored perceptions and preferences for each format. RESULTS: Between July and August 2022, 295 parents were randomized; 241 (81.7%) completed the study (intervention n = 121, control n = 120). Mean understanding scores were significantly different between groups (PLR 3.96 [standard deviation (SD) 2.02], SLV 3.33 [SD 1.88], P = 0.014). Overall participants preferred the PLR version: mean rating 5.05/7.00 (95% CI 4.81, 5.29). Interviews (n = 12 parents) highlighted their preference for the PLR and provided insight on elements to enhance future knowledge mobilization of health recommendations. CONCLUSION: Compared to SLVs, parents preferred PLRs and better understood the recommendation. Guideline developers should strive to use plain language to increase understanding, uptake, and implementation of evidence by the public.


Subject(s)
COVID-19 , Parents , Child , Humans , Data Collection , Language , Adolescent , Adult
4.
BMC Health Serv Res ; 23(1): 282, 2023 Mar 25.
Article in English | MEDLINE | ID: mdl-36966293

ABSTRACT

BACKGROUND: There is a clear need for research evidence to drive policymaking and emergency responses so that lives are saved and resources are not wasted. The need for evidence support for health and humanitarian crisis is even more pertinent because of the time and practical constraints that decision-makers in these settings face. To improve the use of research evidence in policy and practice, it is important to provide evidence resources tailored to the target audience. This study aims to gain real-world insights from decision-makers about how they use evidence summaries to inform real-time decision-making in crisis-settings, and to use our findings to improve the format of evidence summaries. METHODS: This study used an explanatory sequential mixed method study design. First, we used a survey to identify the views and experiences of those who were directly involved in crisis response in different contexts, and who may or may not have used evidence summaries. Second, we used the insights generated from the survey to help inform qualitative interviews with decision-makers in crisis-settings to derive an in-depth understanding of how they use evidence summaries and their desired format for evidence summaries. RESULTS: We interviewed 26 decision-makers working in health and humanitarian emergencies. The study identified challenges decision-makers face when trying to find and use research evidence in crises, including insufficient time and increased burden of responsibilities during crises, limited access to reliable internet connection, large volume of data not translated into user friendly summaries, and little information available on preparedness and response measures. Decision-makers preferred the following components in evidence summaries: title, target audience, presentation of key findings in an actionable checklist or infographic format, implementation considerations, assessment of the quality of evidence presented, citation and hyperlink to the full review, funding sources, language of full review, and other sources of information on the topic. Our study developed an evidence summary template with accompanying training material to inform real-time decision-making in crisis-settings. CONCLUSIONS: Our study provided a deeper understanding of the preferences of decision-makers working in health and humanitarian emergencies about the format of evidence summaries to enable real-time evidence informed decision-making.


Subject(s)
Emergencies , Evidence-Based Medicine , Humans , Policy Making , Research Design , Decision Making
5.
Trials ; 24(1): 27, 2023 Jan 14.
Article in English | MEDLINE | ID: mdl-36641457

ABSTRACT

INTRODUCTION: The COVID-19 pandemic underlined that guidelines and recommendations must be made more accessible and more understandable to the general public to improve health outcomes. The objective of this study is to evaluate, quantify, and compare the public's understanding, usability, satisfaction, intention to implement, and preference for different ways of presenting COVID-19 health recommendations derived from the COVID-19 Living Map of Recommendations and Gateway to Contextualization (RecMap). METHODS AND ANALYSIS: This is a protocol for a multi-method study. Through an online survey, we will conduct pragmatic allocation-concealed, blinded superiority randomized controlled trials (RCTs) in three populations to test alternative formats of presenting health recommendations: adults, parents, and youth, with at least 240 participants in each population. Prior to initiating the RCT, our interventions will have been refined with relevant stakeholder input. The intervention arm will receive a plain language recommendation (PLR) format while the control arm will receive the corresponding original recommendation format as originally published by the guideline organizations (standard language version). Our primary outcome is understanding, and our secondary outcomes are accessibility and usability, satisfaction, intended behavior, and preference for the recommendation formats. Each population's results will be analyzed separately. However, we are planning a meta-analysis of the results across populations. At the end of each survey, participants will be invited to participate in an optional one-on-one, virtual semi-structured interview to explore their user experience. All interviews will be transcribed and analyzed using the principles of thematic analysis and a hybrid inductive and deductive approach. ETHICS AND DISSEMINATION: Through Clinical Trials Ontario, the Hamilton Integrated Research Ethics Board has reviewed and approved this protocol (Project ID: 3856). The University of Alberta has approved the parent portion of the trial (Project ID:00114894). Findings from this study will be disseminated through open-access publications in peer-reviewed journals and using social media. TRIAL REGISTRATION: Clinicaltrials.gov NCT05358990 . Registered on May 3, 2022.


Subject(s)
COVID-19 , Humans , Adult , Adolescent , SARS-CoV-2 , Randomized Controlled Trials as Topic , Surveys and Questionnaires , Ontario , Meta-Analysis as Topic
6.
J Clin Epidemiol ; 149: 206-216, 2022 09.
Article in English | MEDLINE | ID: mdl-35724863

ABSTRACT

OBJECTIVES: Analytical frameworks are graphical representation of the key questions answered by a systematic review and can support the development of guideline recommendations. Our objectives were to a) conduct a systematic review to identify, describe and compare all analytical frameworks published as part of a systematic and guideline development process related to colorectal cancer (CRC), and b) to use this case study to develop guidance on how to conduct systematic reviews of analytical frameworks. METHODS: We developed a search strategy to identify eligible studies in Medline and Embase from 1996 until December 2020. We also manually searched guideline databases and websites to identify all guidelines and systematic reviews in CRC that used an analytical framework. We assessed the quality of the guidelines using the Appraisal of Guidelines for Research and Evaluation II tool. The systematic review was registered in International Prospective Register of Systematic Reviews, registration CRD42020172117. RESULTS: We screened 34,505 records and identified 1,166 guidelines and 3,127 systematic reviews on CRC of which five met our inclusion criteria. These five publications included four analytical frameworks in colorectal cancer (one update). We also describe our methodological approach to systematic reviews for analytical frameworks and underlying concepts for developing analytical framework using a bottom-up or top-down approach. CONCLUSION: Few guidelines and systematic reviews are utilizing analytical frameworks in the development of recommendations. Development of analytical frameworks should begin with a systematic search for existing analytical frameworks and follow a structured conceptual approach for their development to support guideline recommendations. Our methods may be helpful in achieving these objectives.


Subject(s)
Colorectal Neoplasms , Humans , Systematic Reviews as Topic , MEDLINE , Databases, Factual , Colorectal Neoplasms/therapy
7.
Blood Adv ; 6(17): 4975-4982, 2022 09 13.
Article in English | MEDLINE | ID: mdl-35748885

ABSTRACT

BACKGROUND: COVID-19-related critical illness is associated with an increased 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 patients with COVID-19. METHODS: ASH formed a multidisciplinary guideline panel, including 3 patient representatives, and applied strategies to minimize potential bias from conflicts of interest. The McMaster University Grading of Recommendations Assessment, Development and Evaluation (GRADE) Centre supported the guideline development process, including performing systematic evidence reviews (up to January 2022). The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The panel used the GRADE approach to assess evidence and make recommendations, which were subject to public comment. This is an update to guidelines published in February 2021 and May 2021 as part of the living phase of these guidelines. RESULTS: The panel made 1 additional recommendation: a conditional recommendation for the use of prophylactic-intensity over therapeutic-intensity anticoagulation for patients with COVID-19-related critical illness who do not have suspected or confirmed VTE. The panel emphasized the need for an individualized assessment of thrombotic and bleeding risk. CONCLUSIONS: This conditional recommendation was based on very low certainty in the evidence, underscoring the need for additional, high-quality, randomized controlled trials comparing different intensities of anticoagulation for patients with COVID-19-related critical illness.


Subject(s)
COVID-19 , Hematology , Venous Thromboembolism , Anticoagulants/therapeutic use , Critical Illness/therapy , Humans , United States , Venous Thromboembolism/drug therapy , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control
8.
Blood Adv ; 6(17): 4915-4923, 2022 09 13.
Article in English | MEDLINE | ID: mdl-35503027

ABSTRACT

BACKGROUND: COVID-19-related acute illness is associated with an increased risk of venous thromboembolism (VTE). OBJECTIVE: These evidence-based guidelines from the American Society of Hematology (ASH) are intended to support patients, clinicians, and other health care professionals in making decisions about the use of anticoagulation in patients with COVID-19. METHODS: ASH formed a multidisciplinary guideline panel that included patient representatives and applied strategies to minimize potential bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline development process and performed systematic evidence reviews (through November 2021). 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 to assess evidence and make recommendations, which were subject to public comment. This is an update to guidelines published in February 2021 as part of the living phase of these guidelines. RESULTS: The panel made one additional recommendation. The panel issued a conditional recommendation in favor of therapeutic-intensity over prophylactic-intensity anticoagulation in patients with COVID-19-related acute illness who do not have suspected or confirmed VTE. The panel emphasized the need for an individualized assessment of risk of thrombosis and bleeding. The panel also noted that heparin (unfractionated or low molecular weight) may be preferred because of a preponderance of evidence with this class of anticoagulants. CONCLUSION: This conditional recommendation was based on very low certainty in the evidence, underscoring the need for additional, high-quality, randomized controlled trials comparing different intensities of anticoagulation in patients with COVID-19-related acute illness.


Subject(s)
COVID-19 , Hematology , Venous Thromboembolism , Acute Disease , Anticoagulants/therapeutic use , Humans , United States , Venous Thromboembolism/drug therapy , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control
9.
Blood Adv ; 6(2): 664-671, 2022 01 25.
Article in English | MEDLINE | ID: mdl-34727173

ABSTRACT

BACKGROUND: COVID-19-related acute illness is associated with an increased 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 in patients with COVID-19 who do not have confirmed or suspected VTE. METHODS: ASH formed a multidisciplinary guideline panel, including 3 patient representatives, and applied strategies to minimize potential bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline development process, including performing systematic evidence reviews (up to March 2021). 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 to assess evidence and make recommendations, which were subject to public comment. RESULTS: The panel agreed on 1 additional recommendation. The panel issued a conditional recommendation against the use of outpatient anticoagulant prophylaxis in patients with COVID-19 who are discharged from the hospital and who do not have suspected or confirmed VTE or another indication for anticoagulation. CONCLUSIONS: This recommendation was based on very low certainty in the evidence, underscoring the need for high-quality randomized controlled trials assessing the role of postdischarge thromboprophylaxis. Other key research priorities include better evidence on assessing risk of thrombosis and bleeding outcomes in patients with COVID-19 after hospital discharge.


Subject(s)
COVID-19 , Hematology , Venous Thromboembolism , Aftercare , Anticoagulants/adverse effects , Evidence-Based Medicine , Humans , Patient Discharge , SARS-CoV-2 , United States , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control
10.
Blood Adv ; 5(20): 3951-3959, 2021 10 26.
Article in English | MEDLINE | ID: mdl-34474482

ABSTRACT

BACKGROUND: COVID-19-related critical illness is associated with an increased 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 making decisions about the use of anticoagulation for thromboprophylaxis in patients with COVID-19-related critical illness who do not have confirmed or suspected VTE. METHODS: ASH formed a multidisciplinary guideline panel that included 3 patient representatives and applied strategies to minimize potential bias from conflicts of interest. The McMaster University Grading of Recommendations Assessment, Development and Evaluation (GRADE) Centre supported the guideline development process by performing systematic evidence reviews (up to 5 March 2021). The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The panel used the GRADE approach to assess evidence and make recommendations, which were subject to public comment. This is an update on guidelines published in February 2021. RESULTS: The panel agreed on 1 additional recommendation. The panel issued a conditional recommendation in favor of prophylactic-intensity over intermediate-intensity anticoagulation in patients with COVID-19-related critical illness who do not have confirmed or suspected VTE. CONCLUSIONS: This recommendation was based on low certainty in the evidence, which underscores the need for additional high-quality, randomized, controlled trials comparing different intensities of anticoagulation in critically ill patients. Other key research priorities include better evidence regarding predictors of thrombosis and bleeding risk in critically ill patients with COVID-19 and the impact of nonanticoagulant therapies (eg, antiviral agents, corticosteroids) on thrombotic risk.


Subject(s)
COVID-19 , Hematology , Venous Thromboembolism , Anticoagulants/adverse effects , Critical Illness , Evidence-Based Medicine , Humans , SARS-CoV-2 , United States , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control
11.
Lancet ; 398 Suppl 1: S22, 2021 Jul.
Article in English | MEDLINE | ID: mdl-34227954

ABSTRACT

BACKGROUND: As of Feb 14, 2014, UNRWA had registered almost 53 000 Palestinian refugees from Syria (PRS) who had fled to Lebanon as the result of the conflict in Syria. Half of the PRS had gone to one of the 12 Palestinian camps, which are overcrowded and of poor infrastructure. Consequently, there is concern for the wellbeing of PRS; in particular, their health status and access to medical care. Little attention has been given to non-communicable diseases (NCDs) in the acute phases of emergencies. Therefore, an assessment of the prevalence of NCDs among PRS, as well as the patterns of use of available health care services by PRS, is warranted. METHODS: A cross-sectional study was conducted in April, 2018, with 1100 PRS residing inside and outside refugee camps across all governorates of Lebanon. A listing of all PRS families was the sampling frame. A random sample of families was selected and contacted, and then one adult randomly selected from each family was approached for data collection. Pregnant women and participants who were too ill to participate were excluded. After obtaining informed verbal consent, we did face-to-face interviews to collect data on household details (such as type of settlement, source of income) and sociodemographic information, major NCDs (for the household representative), lifestyle behaviours, and health-care use. We invited all participants to UNRWA clinics for physical and biochemical measurements. The study protocol was approved by the Institutional Review Board of the American University of Beirut. FINDINGS: We surveyed 959 PRS (59% male [465], 82% married [785], mean age 43 years [SD 12]). A quarter of those interviewed had at least one NCD; the most prevalent were hypertension (23%; 221 of 959), rheumatic diseases (17%; 166), cardiovascular diseases (CVDs, 13%; 126), diabetes (13%; 124), and chronic respiratory diseases (CRDs) (10%; 100). All these NCDs were more prevalent among PRS inside camps than in those residing outside camps, except for diabetes. Most participants who had been diagnosed with NCDs were adhering to their prescribed medications (90-98%). However, of those reporting CVDs, only 56% (71 of 126) had attended at least one follow-up appointment, and of those reporting rheumatic diseases, only 33% (55 of 166) had attended at least one follow-up appointment. About half of participants reported that they checked their blood pressure (55%; 528 of 959) or blood glucose (45%; 430). 111 of 221 (50%) participants with hypertension monitored their blood pressure, and 78 of 124 (63%) participants with diabetes monitored their blood glucose. 133 participants attended UNRWA clinics for measurements; 40% (54) had obesity (>30 kg/cm2), 10% (13) had elevated blood pressure, 12% (16) had stage 1 hypertension, and 8% (10) had stage 2 hypertension. Most participants had normal glucose (67%; 89 of 133), cholesterol (65%; 87), triglyceride (58%; 77), and glycosylated haemoglobin levels (64; 85). A substantial proportion of participants who were tested had undiagnosed diabetes (14%; 33 of 108 reporting no diabetes), undiagnosed hypertension (23%; 19 of 81), uncontrolled diabetes (79% of participants with diabetes; 19 of 24), or uncontrolled hypertension (64% of participants with hypertension; 29 of 45). INTERPRETATION: Further study is needed to understand why the prevalence of NCDs among PRS residing in Palestinian camps is higher than among those living outside, and to understand whether and why access to medicines is a problem, particularly outside camps. The burden of NCDs among PRS is high and their access to services is not optimal; therefore UNRWA should pay special attention to NCD services in this population. UNRWA should invest in efforts to increase awareness of free blood pressure and blood glucose monitoring services in its clinics, and could actively offer free testing in public areas inside camps. Doctors at UNRWA clinics should recommend that patients monitor their disease more frequently and educate them on how to do so. A limitation of the study was the low percentage of participants who attended UNRWA clinics for physical and biochemical measurements. FUNDING: UNRWA.

12.
J Clin Epidemiol ; 134: 138-149, 2021 06.
Article in English | MEDLINE | ID: mdl-33762142

ABSTRACT

OBJECTIVE: Having up-to-date health policy recommendations accessible in one location is in high demand by guideline users. We developed an easy to navigate interactive approach to organize recommendations and applied it to tuberculosis (TB) guidelines of the World Health Organization (WHO). STUDY DESIGN: We used a mixed-methods study design to develop a framework for recommendation mapping with seven key methodological considerations. We define a recommendation map as an online repository of recommendations from several guidelines on a condition, providing links to the underlying evidence and expert judgments that inform them, allowing users to filter and cross-tabulate the search results. We engaged guideline developers, users, and health software engineers in an iterative process to elaborate the WHO eTB recommendation map. RESULTS: Applying the seven-step framework, we included 228 recommendations, linked to 103 guideline questions and organized the recommendation map according to key components of the health question, including the original recommendations and rationale (https://who.tuberculosis.recmap.org/). CONCLUSION: The recommendation mapping framework provides the entire continuum of evidence mapping by framing recommendations within a guideline questions' population, interventions, and comparators domains. Recommendation maps should allow guideline developers to organize their work meaningfully, standardize the automated publication of guidelines through links to the GRADEpro guideline development tool, and increase their accessibility and usability.


Subject(s)
Evidence-Based Medicine/organization & administration , Tuberculosis , Humans , Research Design , Software , World Health Organization
13.
Blood Adv ; 5(3): 872-888, 2021 02 09.
Article in English | MEDLINE | ID: mdl-33560401

ABSTRACT

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.


Subject(s)
Anticoagulants/therapeutic use , COVID-19/pathology , Venous Thromboembolism/drug therapy , COVID-19/complications , COVID-19/virology , Enoxaparin/therapeutic use , Evidence-Based Medicine , Guidelines as Topic , Humans , SARS-CoV-2/isolation & purification , Societies, Medical , Venous Thromboembolism/complications
14.
Blood Adv ; 4(19): 4929-4944, 2020 10 13.
Article in English | MEDLINE | ID: mdl-33049056

ABSTRACT

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.


Subject(s)
Venous Thromboembolism , Hemorrhage/diagnosis , Humans , Risk Assessment , Risk Factors , Systematic Reviews as Topic , Venous Thromboembolism/diagnosis , Venous Thromboembolism/drug therapy , Venous Thromboembolism/epidemiology
15.
Blood Adv ; 4(12): 2557-2566, 2020 06 23.
Article in English | MEDLINE | ID: mdl-32542391

ABSTRACT

Risk assessment models (RAMs) for venous thromboembolism (VTE) and bleeding in hospitalized medical patients inform appropriate use of thromboprophylaxis. Our aim was to use a novel approach for selecting risk factors for VTE and bleeding to be included in RAMs. First, we used the results of a systematic review of all candidate factors. Second, we used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to assess the certainty of the evidence for the identified factors. Third, we using a structured approach to select factors to develop the RAMs, by building on clinical and methodological expertise. The expert panel made judgments on whether to include, potentially include, or exclude risk factors, according to domains of the GRADE approach and the Delphi method. The VTE RAM included age >60 years, previous VTE, acute infections, immobility, acute paresis, active malignancy, critical illness, and known thrombophilia. The bleeding RAM included age ≥65 years, renal failure, thrombocytopenia, active gastroduodenal ulcers, hepatic disease, recent bleeding, and critical illness. We identified acute infection as a factor that was not considered in widely used RAMs. Also, we identified factors that require further research to confirm or refute their importance in a VTE RAM (eg, D-dimer). We excluded autoimmune disease which is included in the IMPROVE (International Medical Prevention Registry on Venous Thromboembolism) bleeding RAM. Our results also suggest that sex, malignancy, and use of central venous catheters (factors in the IMPROVE bleeding RAM) require further research. In conclusion, our study presents a novel approach to systematically identifying and assessing risk factors to be included or further explored during RAM development.


Subject(s)
Venous Thromboembolism , Aged , Anticoagulants , Hemorrhage/epidemiology , Hemorrhage/etiology , Humans , Inpatients , Middle Aged , Risk Assessment , Venous Thromboembolism/diagnosis , Venous Thromboembolism/epidemiology
16.
PLoS One ; 15(5): e0233757, 2020.
Article in English | MEDLINE | ID: mdl-32470071

ABSTRACT

BACKGROUND: Health care workers (HCWs) are essential for the delivery of health care services in conflict areas and in rebuilding health systems post-conflict. OBJECTIVE: The aim of this study was to systematically identify and map the published evidence on HCWs in conflict and post-conflict settings. Our ultimate aim is to inform researchers and funders on research gap on this subject and support relevant stakeholders by providing them with a comprehensive resource of evidence about HCWs in conflict and post-conflict settings on a global scale. METHODS: We conducted a systematic mapping of the literature. We included a wide range of study designs, addressing any type of personnel providing health services in either conflict or post-conflict settings. We conducted a descriptive analysis of the general characteristics of the included papers and built two interactive systematic maps organized by country, study design and theme. RESULTS: Out of 13,863 identified citations, we included a total of 474 studies: 304 on conflict settings, 149 on post-conflict settings, and 21 on both conflict and post-conflict settings. For conflict settings, the most studied counties were Iraq (15%), Syria (15%), Israel (10%), and the State of Palestine (9%). The most common types of publication were opinion pieces in conflict settings (39%), and primary studies (33%) in post-conflict settings. In addition, most of the first and corresponding authors were affiliated with countries different from the country focus of the paper. Violence against health workers was the most tackled theme of papers reporting on conflict settings, while workforce performance was the most addressed theme by papers reporting on post-conflict settings. The majority of papers in both conflict and post-conflict settings did not report funding sources (81% and 53%) or conflicts of interest of authors (73% and 62%), and around half of primary studies did not report on ethical approvals (45% and 41%). CONCLUSIONS: This systematic mapping provides a comprehensive database of evidence about HCWs in conflict and post-conflict settings on a global scale that is often needed to inform policies and strategies on effective workforce planning and management and in reducing emigration. It can also be used to identify evidence for policy-relevant questions, knowledge gaps to direct future primary research, and knowledge clusters.


Subject(s)
Health Personnel , Health Workforce , Warfare and Armed Conflicts , Africa , Americas , Databases, Factual , Delivery of Health Care , Geographic Mapping , Government Programs/economics , Humans , Middle East
17.
Blood Adv ; 4(5): 953-968, 2020 03 10.
Article in English | MEDLINE | ID: mdl-32150612

ABSTRACT

Values and preferences relate to the importance that patients place on health outcomes (eg, bleeding, having a deep venous thrombosis) and are essential when weighing benefits and harms in guideline recommendations. To inform the American Society of Hematology guidelines for management of venous thromboembolism (VTE) disease, we conducted a systematic review of patients' values and preferences related to VTE. We searched Medline, Embase, Cochrane Central Register of Controlled Trials, PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature from inception to April of 2018 (PROSPERO-CRD42018094003). We included quantitative and qualitative studies. We followed Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidance for rating the certainty and presenting findings for quantitative research about the relative importance of health outcomes and a grounded theory approach for qualitative thematic synthesis. We identified 14 quantitative studies (2465 participants) describing the relative importance of VTE-related health states in a widely diverse population of patients, showing overall small to important impact on patients' lives (certainty of the evidence from low to moderate). Additionally, evidence from 34 quantitative studies (6424 participants) and 15 qualitative studies (570 participants) revealed that patients put higher value on VTE risk reduction than on the potential harms of the treatment (certainty of evidence from low to moderate). Studies also suggested a clear preference for oral medication over subcutaneous medication (moderate certainty). The observed variability in health state values may be a result of differences in the approaches used to elicit them and the diversity of included populations rather than true variability in values. This finding highlights the necessity to explore the variability induced by different approaches to ascertain values.


Subject(s)
Hematology , Neoplasms , Venous Thromboembolism , Anticoagulants/therapeutic use , Heparin, Low-Molecular-Weight , Humans , United States , Venous Thromboembolism/drug therapy
18.
Blood ; 135(20): 1788-1810, 2020 05 14.
Article in English | MEDLINE | ID: mdl-32092132

ABSTRACT

There may be many predictors of venous thromboembolism (VTE) and bleeding in hospitalized medical patients, but until now, systematic reviews and assessments of the certainty of the evidence have not been published. We conducted a systematic review to identify prognostic factors for VTE and bleeding in hospitalized medical patients and searched Medline and EMBASE from inception through May 2018. We considered studies that identified potential prognostic factors for VTE and bleeding in hospitalized adult medical patients. Reviewers extracted data in duplicate and independently and assessed the certainty of the evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach. Of 69 410 citations, we included 17 studies in our analysis: 14 that reported on VTE, and 3 that reported on bleeding. For VTE, moderate-certainty evidence showed a probable association with older age; elevated C-reactive protein (CRP), D-dimer, and fibrinogen levels; tachycardia; thrombocytosis; leukocytosis; fever; leg edema; lower Barthel Index (BI) score; immobility; paresis; previous history of VTE; thrombophilia; malignancy; critical illness; and infections. For bleeding, moderate-certainty evidence showed a probable association with older age, sex, anemia, obesity, low hemoglobin, gastroduodenal ulcers, rehospitalization, critical illness, thrombocytopenia, blood dyscrasias, hepatic disease, renal failure, antithrombotic medication, and presence of a central venous catheter. Elevated CRP, a lower BI, a history of malignancy, and elevated heart rate are not included in most VTE risk assessment models. This study informs risk prediction in the management of hospitalized medical patients for VTE and bleeding; it also informs guidelines for VTE prevention and future research.


Subject(s)
Hemorrhage/diagnosis , Hospitalization , Venous Thromboembolism/diagnosis , Adult , Age Factors , Aged , Aged, 80 and over , Comorbidity , Female , Hemorrhage/epidemiology , Hemorrhage/etiology , Hospitalization/statistics & numerical data , Humans , Male , Middle Aged , Prognosis , Risk Factors , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiology
19.
PLoS One ; 13(2): e0192191, 2018.
Article in English | MEDLINE | ID: mdl-29425207

ABSTRACT

INTRODUCTION: Waterpipe tobacco smoking is harmful to health however its prevalence estimates remain uncertain. We aimed to systematically review the medical literature on waterpipe tobacco prevalence and trends. METHODS: We searched Medline, Embase and ISI Web of Science for 'waterpipe' and its synonyms, without using language or date restrictions. We included any measure of waterpipe tobacco smoking prevalence in jurisdictionally representative populations. We stratified findings by prevalence measure (past 30 day, ever, regular or occasional, daily, other or unspecified) and age (adults or youth). RESULTS: We included 129 studies reporting 355 estimates for 68 countries. In general, prevalence estimates among adults were highest in the Eastern Mediterranean, and among youth were about equal between Eastern Mediterranean and European regions. Past 30 day use was highest among Lebanese youth (37.2% in 2008), ever use was highest among Lebanese youth in 2002 and Lebanese university students in 2005 (both 65.3%), regular or occasional use was highest in among Iranian university students (16.3% in 2005), and daily use was highest among Egyptian youth (10.4% in 2005). Trend data were limited but most studies reported increased use over time, ranging from 0.3-1.0% per year among youth in the US to 2.9% per year among youth in Jordan (both for past 30 day use). Results were similar for ever use trends. Turkey (2.3% in 2008 to 0.8% in 2010) and Iraq (6.3% in 2008 and 4.8% in 2012) both witnessed decreased waterpipe use. CONCLUSION: Waterpipe tobacco smoking is most prevalent in Eastern Mediterranean and European countries, and appears higher among youth than adults. Continued surveillance will be important to assess and inform policy measures to control waterpipe tobacco use.


Subject(s)
Tobacco Smoking , Adolescent , Female , Humans , Male , Mediterranean Region/epidemiology , Prevalence , Surveys and Questionnaires , Young Adult
20.
Virol J ; 14(1): 220, 2017 11 10.
Article in English | MEDLINE | ID: mdl-29126448

ABSTRACT

Norovirus (NoV) is considered the second leading cause of viral acute gastroenteritis (AGE). To our knowledge, there are no systematic reviews assessing the role of NoV in AGE in the Middle East and North Africa (MENA) region. Consequently, we conducted an extensive systematic literature review on articles studying NoV in the 24 countries of the MENA region during the past 15 years (2000-2015). The methods and reporting were set according to the 2015 PRISMA-P and based on the elements from the international prospective register of systematic reviews (PROSPERO). We retrieved 38 studies meeting our predefined inclusion criteria and were used to extract full data. Studies reporting on NoV were conducted in 15 out of the 24 countries of the region. The reported NoV infection rates in MENA countries ranged between 0.82% and 36.84%. The majority of studies were clinical observational studies assessing NoV rates mainly among children. Participants were recruited from in- and outpatient clinics. NoV infection was reported all year round with with peaks observed mainly during cold months. GII.4 was the predominant genotype detected in stool of participants as reported by 16 out of 25 studies (64%). Overall, there is an increasing recognition of NoV as an important causative agent of AGE across all age groups in the MENA region. Further studies are needed to assess the national and the regional burden of NoV among different age groups, its molecular diversity and seasonal variability.


Subject(s)
Caliciviridae Infections/epidemiology , Norovirus , Acute Disease , Africa, Northern/epidemiology , Age Factors , Caliciviridae Infections/virology , Gastroenteritis/epidemiology , Gastroenteritis/virology , Genotype , Humans , Middle East/epidemiology , Norovirus/genetics , Prevalence , Seasons
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