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1.
Journal of Clinical Epidemiology ; 2022.
Article in English | ScienceDirect | ID: covidwho-1814651

ABSTRACT

Objective To develop a digital communication tool to improve the implementation of up-to-date COVID-19 recommendations. Specifically, to improve patient, caregiver and public understanding of healthcare recommendations on prevention, diagnoses and treatment. Study Design and Setting Multi-stakeholder engagement design. In conjunction with the COVID-19 Recommendations and Gateway to Contextualization RecMap, we co-developed a stakeholder prioritization, drafting and editing process to enhance guideline communication and understanding. Results This paper presents the multi-stakeholder development process with three distinct plain language recommendation formats: formal recommendation, good practice statement and additional guidance. Our case study of COVID-19 PLRs addresses both public health interventions (e.g., vaccination, face masks) and clinical interventions (e.g., home pulse oximetry) Conclusion This paper presents a novel approach to engaging stakeholders in improving the communication and understanding of published guidelines during the COVID-19 pandemic.

2.
BMJ Evid Based Med ; 2022 Apr 15.
Article in English | MEDLINE | ID: covidwho-1794512

ABSTRACT

OBJECTIVES: To evaluate the development and quality of actionable statements that qualify as good practice statements (GPS) reported in COVID-19 guidelines. DESIGN AND SETTING: Systematic review . We searched MEDLINE, MedSci, China National Knowledge Infrastructure (CNKI), databases of Grading of Recommendations Assessment, Development and Evaluation (GRADE) Guidelines, NICE, WHO and Guidelines International Network (GIN) from March 2020 to September 2021. We included original or adapted recommendations addressing any COVID-19 topic. MAIN OUTCOME MEASURES: We used GRADE Working Group criteria for assessing the appropriateness of issuing a GPS: (1) clear and actionable; (2) rationale necessitating the message for healthcare practice; (3) practicality of systematically searching for evidence; (4) likely net positive consequences from implementing the GPS and (5) clear link to the indirect evidence. We assessed guideline quality using the Appraisal of Guidelines for Research and Evaluation II tool. RESULTS: 253 guidelines from 44 professional societies issued 3726 actionable statements. We classified 2375 (64%) as GPS; of which 27 (1%) were labelled as GPS by guideline developers. 5 (19%) were labelled as GPS by their authors but did not meet GPS criteria. Of the 2375 GPS, 85% were clear and actionable; 59% provided a rationale necessitating the message for healthcare practice, 24% reported the net positive consequences from implementing the GPS. Systematic collection of evidence was deemed impractical for 13% of the GPS, and 39% explained the chain of indirect evidence supporting GPS development. 173/2375 (7.3%) statements explicitly satisfied all five criteria. The guidelines' overall quality was poor regardless of the appropriateness of GPS development and labelling. CONCLUSIONS: Statements that qualify as GPS are common in COVID-19 guidelines but are characterised by unclear designation and development processes, and methodological weaknesses.

3.
BMJ Evid Based Med ; 2022 Apr 15.
Article in English | MEDLINE | ID: covidwho-1794511

ABSTRACT

An evidence-based approach is considered the gold standard for health decision-making. Sometimes, a guideline panel might judge the certainty that the desirable effects of an intervention clearly outweigh its undesirable effects as high, but the body of supportive evidence is indirect. In such cases, the application of the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach for grading the strength of recommendations is inappropriate. Instead, the GRADE Working Group has recommended developing ungraded best or good practice statement (GPS) and developed guidance under which circumsances they would be appropriate.Through an evaluation of COVID-1- related recommendations on the eCOVID Recommendation Map (COVID-19.recmap.org), we found that recommendations qualifying a GPS were widespread. However, guideline developers failed to label them as GPS or transparently report justifications for their development. We identified ways to improve and facilitate the operationalisation and implementation of the GRADE guidance for GPS.Herein, we propose a structured process for the development of GPSs that includes applying a sequential order for the GRADE guidance for developing GPS. This operationalisation considers relevant evidence-to-decision criteria when assessing the net consequences of implementing the statement, and reporting information supporting judgments for each criterion. We also propose a standardised table to facilitate the identification of GPS and reporting of their development. This operationalised guidance, if endorsed by guideline developers, may palliate some of the shortcomings identified. Our proposal may also inform future updates of the GRADE guidance for GPS.

4.
J Clin Epidemiol ; 2022 Mar 23.
Article in English | MEDLINE | ID: covidwho-1757507

ABSTRACT

OBJECTIVE: To describe divergence between actionable statements issued by COVID-19 guideline developers catalogued on the "COVID-19 Recommendations and Gateway to Contextualization" platform. STUDY DESIGN AND SETTING: We defined divergence as at least two comparable actionable statements with different explicit judgements of strength, direction or subgroup consideration of the population or intervention. We applied content analysis to compare guideline development methods for a sample of diverging statements and to evaluate factors associated with divergence. RESULTS: Of the 138 guidelines evaluated, 85 (62%) contained at least one statement that diverged from another guideline. We identified 223 diverging statements in these 85 guidelines. We grouped statements into 66 clusters. Each cluster addressed the same population, intervention, and comparator group or just similar interventions. Clinical practice statements were more likely to diverge in explicit judgment of strength or direction compared to public health statements (Cramer's V = 0.7, Fisher's exact test; P <0.001). Statements were more likely to diverge in strength than direction. Date of publication, utilized evidence, interpretation of evidence, and contextualization considerations were associated with divergence. CONCLUSION: More than half of the assessed guidelines issued at least one diverging statement. This study helps understanding the types of differences between guidelines issuing comparable statements and factors associated with their divergence.

6.
Ann Intern Med ; 2022 Jan 25.
Article in English | MEDLINE | ID: covidwho-1702163

ABSTRACT

DESCRIPTION: The Scientific Medical Policy Committee (SMPC) of the American College of Physicians (ACP) developed these living, rapid practice points to summarize the current best available evidence on the antibody response to SARS-CoV-2 infection and protection against reinfection with SARS-CoV-2. This is version 2 of the ACP practice points, which serves to update version 1, published on 16 March 2021. These practice points do not evaluate vaccine-acquired immunity or cellular immunity. METHODS: The SMPC developed this version of the living, rapid practice points based on an updated living, rapid, systematic review conducted by the Portland VA Research Foundation and funded by the Agency for Healthcare Research and Quality. PRACTICE POINT 1: Do not use SARS-CoV-2 antibody tests for the diagnosis of SARS-CoV-2 infection. PRACTICE POINT 2: Do not use SARS-CoV-2 antibody tests to predict the degree or duration of natural immunity conferred by antibodies against reinfection, including natural immunity against different variants. RETIREMENT FROM LIVING STATUS: Although natural immunity remains a topic of scientific interest, this topic is being retired from living status given the availability of effective vaccines for SARS-CoV-2 and widespread recommendations for and prevalence of their use. Currently, vaccination is the best clinical recommendation for preventing infection, reinfection, and serious illness from SARS-CoV-2 and its variants.

9.
J Clin Epidemiol ; 141: 161-171, 2022 01.
Article in English | MEDLINE | ID: covidwho-1433469

ABSTRACT

OBJECTIVE: To propose a taxonomy and framework that identifies and presents actionable statements in guidelines. STUDY DESIGN AND SETTING: We took an iterative approach reviewing case studies of guidelines produced by the World Health Organization and the American Society of Hematology to develop an initial conceptual framework. We then tested it using randomly selected recommendations from published guidelines addressing COVID-19 from different organizations, evaluated its results, and refined it before retesting. The urgency and availability of evidence for development of these recommendations varied. We consulted with experts in research methodology and guideline developers to improve the final framework. RESULTS: The resulting taxonomy and framework distinguishes five types of actional statements: formal recommendations; research recommendations; good practice statements; implementation considerations, tools and tips; and informal recommendations. These statements should respond to a priori established criteria and require a clear structure and recognizable presentation in a guideline. Most importantly, this framework identifies informal recommendations that differ from formal recommendations by how they consider evidence and in their development process. CONCLUSION: The identification, standardization and explicit labelling of actionable statements according to the framework may support guideline developers to create actionable statements with clear intent, avoid informal recommendations and improve their understanding and implementation by users.


Subject(s)
COVID-19 , COVID-19/epidemiology , Humans , Publications , Research Design , World Health Organization
10.
Ann Intern Med ; 174(8): 1126-1132, 2021 08.
Article in English | MEDLINE | ID: covidwho-1360869

ABSTRACT

In response to the COVID-19 pandemic, the Scientific Medical Policy Committee (SMPC) of the American College of Physicians (ACP) began developing "practice points" to provide clinical advice based on the best available evidence for the public, patients, clinicians, and public health professionals. As one of the first organizations in the United States to develop evidence-based clinical guidelines, ACP continues to lead and advance the science of evidence-based medicine by implementing new methods to rapidly publish practice points and maintain them as living advice that regularly assesses and incorporates new evidence. The overarching aim of practice points is to answer targeted key questions for which there is a timely need to synthesize evidence for decision making. The SMPC believes these methods can potentially be adapted to address various clinical and public health topics beyond the COVID-19 pandemic. This article presents an overview of the SMPC's living, rapid practice points development process, which includes a rapid systematic review, use of the GRADE (Grading of Recommendations Assessment, Development and Evaluation) method, use of stringent policies on the disclosure of interests and management of conflicts of interest, incorporating a public (nonclinician) perspective, and maintenance of the documents as living through ongoing surveillance and synthesis of new evidence as it emerges.


Subject(s)
COVID-19/diagnosis , COVID-19/therapy , Evidence-Based Medicine/methods , Practice Guidelines as Topic , COVID-19 Testing , Clinical Decision-Making , Conflict of Interest , Humans , Pandemics , Systematic Reviews as Topic/methods , United States
11.
Int J Environ Res Public Health ; 18(15)2021 07 25.
Article in English | MEDLINE | ID: covidwho-1325669

ABSTRACT

BACKGROUND: Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. METHODS: A multi-country, three-phase study including a cross-sectional survey to test for the short-term side effects of COVID-19 vaccines among target population groups. In the second phase, we will monitor the booster doses' side effects, while in the third phase, the long-term safety and effectiveness will be investigated. A validated, self-administered questionnaire will be used to collect data from the target population; Results: The study protocol has been registered at ClinicalTrials.gov, with the identifier NCT04834869. CONCLUSIONS: CoVaST is the first independent study aiming to monitor the side effects of COVID-19 vaccines following booster doses, and the long-term safety and effectiveness of said vaccines.


Subject(s)
COVID-19 , Vaccines , COVID-19 Vaccines , Cross-Sectional Studies , Humans , Prospective Studies , SARS-CoV-2 , Vaccines/adverse effects , Watchful Waiting
13.
Ann Intern Med ; 174(6): 828-835, 2021 06.
Article in English | MEDLINE | ID: covidwho-1136617

ABSTRACT

DESCRIPTION: The widespread availability of SARS-CoV-2 antibody tests raises important questions for clinicians, patients, and public health professionals related to the appropriate use and interpretation of these tests. The Scientific Medical Policy Committee (SMPC) of the American College of Physicians developed these rapid, living practice points to summarize the current and best available evidence on the antibody response to SARS-CoV-2 infection, antibody durability after initial infection with SARS-CoV-2, and antibody protection against reinfection with SARS-CoV-2. METHODS: The SMPC developed these rapid, living practice points based on a rapid and living systematic evidence review done by the Portland VA Research Foundation and funded by the Agency for Healthcare Research and Quality. Ongoing literature surveillance is planned through December 2021. When new studies are identified and a full update of the evidence review is published, the SMPC will assess the new evidence and any effect on the practice points. PRACTICE POINT 1: Do not use SARS-CoV-2 antibody tests for the diagnosis of SARS-CoV-2 infection. PRACTICE POINT 2: Antibody tests can be useful for the purpose of estimating community prevalence of SARS-CoV-2 infection. PRACTICE POINT 3: Current evidence is uncertain to predict presence, level, or durability of natural immunity conferred by SARS-CoV-2 antibodies against reinfection (after SARS-CoV-2 infection).


Subject(s)
Antibodies, Viral/immunology , Antibody Formation , COVID-19 Testing/standards , COVID-19/immunology , Immunity, Innate/immunology , SARS-CoV-2/immunology , Humans
15.
J Clin Epidemiol ; 129: 1-11, 2021 01.
Article in English | MEDLINE | ID: covidwho-1012425

ABSTRACT

OBJECTIVES: The aim of this study is to propose an approach for developing trustworthy recommendations as part of urgent responses (1-2 week) in the clinical, public health, and health systems fields. STUDY DESIGN AND SETTING: We conducted a review of the literature, outlined a draft approach, refined the concept through iterative discussions, a workshop by the Grading of Recommendations Assessment, Development and Evaluation Rapid Guidelines project group, and obtained feedback from the larger Grading of Recommendations Assessment, Development and Evaluation working group. RESULTS: A request for developing recommendations within 2 week is the usual trigger for an urgent response. Although the approach builds on the general principles of trustworthy guideline development, we highlight the following steps: (1) assess the level of urgency; (2) assess feasibility; (3) set up the organizational logistics; (4) specify the question(s); (5) collect the information needed; (6) assess the adequacy of identified information; (7) develop the recommendations using one of the 4 potential approaches: adopt existing recommendations, adapt existing recommendations, develop new recommendations using existing adequate systematic review, or develop new recommendations using expert panel input; and (8) consider an updating plan. CONCLUSION: An urgent response for developing recommendations requires building a cohesive, skilled, and highly motivated multidisciplinary team with the necessary clinical, scientific, and methodological expertise; adapting to shifting needs; complying with the principles of transparency; and properly managing conflicts of interest.


Subject(s)
Information Management , Practice Guidelines as Topic/standards , Consensus , Evidence-Based Medicine/standards , Evidence-Based Medicine/trends , Humans , Information Management/methods , Information Management/organization & administration , Outcome Assessment, Health Care/methods , Outcome Assessment, Health Care/organization & administration , Systematic Reviews as Topic
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