The methodological quality is insufficient in clinical practice guidelines in the context of COVID-19: systematic review.
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ABSTRACT: Objectives
The number of published clinical practice guidelines related to COVID-19 has rapidly increased. This study explored if basic methodological standards of guideline development have been met in the published clinical practice guidelines related to COVID-19.Study design and setting
Rapid systematic review from February 1 until April 27, 2020 using MEDLINE [PubMed], CINAHL [Ebsco], Trip and manual search, including all types of healthcare workers providing any kind of healthcare to any patient population in any setting.Results
There were 1342 titles screened and 188 guidelines included. The highest average AGREE II domain score was 89% for scope and purpose, the lowest for rigor of development (25%). Only eight guidelines (4%) were based on a systematic literature search and a structured consensus process by representative experts (classified as the highest methodological quality). The majority (156; 83%) was solely built on an informal expert consensus. A process for regular updates was described in 27 guidelines (14%). Patients were included in the development of only one guideline.Conclusion
Despite clear scope, most publications fell short of basic methodological standards of guideline development. Clinicians should use guidelines that include up-to-date information, were informed by stakeholder involvement, and employed rigorous methodologies.
SUBMITTER: Stamm TA
PROVIDER: S-EPMC7937325 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundAnnually, non-communicable diseases (NCDs) kill 38 million people worldwide, with low and middle-income countries accounting for three-quarters of these deaths. High-quality clinical practice guidelines (CPGs) are fundamental to improving NCD management. The present study evaluated the methodological rigor and transparency of Brazilian CPGs that recommend pharmacological treatment for the most prevalent NCDs.MethodsWe conducted a systematic search for CPGs of the following NCDs: asthma, atrial fibrillation, benign prostatic hyperplasia, chronic obstructive pulmonary disease, congestive heart failure, coronary artery disease and/or stable angina, dementia, depression, diabetes, gastroesophageal reflux disease, hypercholesterolemia, hypertension, osteoarthritis, and osteoporosis. CPGs comprising pharmacological treatment recommendations were included. No language or year restrictions were applied. CPGs were excluded if they were merely for local use and referred to NCDs not listed above. CPG quality was independently assessed by two reviewers using the Appraisal of Guidelines Research and Evaluation instrument, version II (AGREE II).Main findings"Scope and purpose" and "clarity and presentation" domains received the highest scores. Sixteen of 26 CPGs were classified as low quality, and none were classified as high overall quality. No CPG was recommended without modification (77% were not recommended at all). After 2009, 2 domain scores ("rigor of development" and "clarity and presentation") increased (61% and 73%, respectively). However, "rigor of development" was still rated < 30%.ConclusionBrazilian healthcare professionals should be concerned with CPG quality for the treatment of selected NCDs. Features that undermined AGREE II scores included the lack of a multidisciplinary team for the development group, no consideration of patients' preferences, insufficient information regarding literature searches, lack of selection criteria, formulating recommendations, authors' conflict of interest disclosures, and funding body influence.
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Project description:With efforts to combat opioid use disorder, there is an increased interest in clinical practice guidelines (CPGs) for opioid use disorder treatments. No literature exists examining the quality of systematic reviews used in opioid use disorder CPGs. This study aims to describe the methodological quality and reporting clarity of systematic reviews (SRs) used to create CPGs for opioid use disorder.From June to July 2016 guideline clearinghouses and medical literature databases were searched for relevant CPGs used in the treatment of opioid use disorder. Included CPGs must have been recognized by a national organization. SRs from the reference section of each CPG was scored by using AMSTAR (a measurement tool to assess the methodological quality of systematic reviews) tool and PRISMA (preferred reporting items for systematic reviews and meta-analyses) checklist.Seventeen CPGs from 2006-2016 were included in the review. From these, 57 unique SRs were extracted. SRS comprised 0.28% to 17.92% of all references found in the CPGs. All SRs obtained moderate or high methodological quality score on the AMSTAR tool. All reviews met at least 70% of PRISMA criteria. In PRISMA, underperforming areas included accurate title labeling, protocol registration, and risk of bias. Underperforming areas in AMSTAR included conflicts of interest, funding, and publication bias. A positive correlation was found between AMSTAR and PRISMA scores (r = .79).Although the SRs in the CPGs were of good quality, there are still areas for improvement. Systematic reviewers should consult PRISMA and AMSTAR when conducting and reporting reviews. It is important for CPG developers to consider methodological quality as a factor when developing CPG recommendations, recognizing that the quality of systematic reviews underpinning guidelines does not necessarily correspond to the quality of the guideline itself.
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Project description:INTRODUCTION:Since the beginning of the new pandemic, COVID-19 health services have had to face a new scenario. Voice therapy faces a double challenge, interventions using telepractice, and delivering rehabilitation services to a growing population of patients at risk of functional impairment related to the COVID-19 disease. Moreover, as COVID-19 is transmitted through droplets, it is critical to understand how to mitigate these risks during assessment and treatment. OBJECTIVE:To promote safety, and effective clinical practice to voice assessment and rehabilitation in the pandemic COVID-19 context for speech-language pathologists. METHODS:A group of 11 experts in voice and swallowing disorders from five different countries conducted a consensus recommendation following the American Academy of Otolaryngology-Head and Neck Surgery rules building a clinical guide for speech-language pathologists during this pandemic context. RESULTS:The clinical guide provides 65 recommendations for clinicians in the management of voice disorders during the pandemic and includes advice from assessment, direct treatment, telepractice, and teamwork. The consensus was reached 95% for all topics. CONCLUSION:This guideline should be taken only as recommendation; each clinician must attempt to mitigate the risk of infection and achieve the best therapeutic results taking into account the patient's particular reality.
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Project description:BACKGROUND: Updating clinical practice guidelines (CPGs) is a crucial process for maintaining the validity of recommendations. Methodological handbooks should provide guidance on both developing and updating CPGs. However, little is known about the updating guidance provided by these handbooks. METHODS: We conducted a systematic review to identify and describe the updating guidance provided by CPG methodological handbooks and included handbooks that provide updating guidance for CPGs. We searched in the Guidelines International Network library, US National Guidelines Clearinghouse and MEDLINE (PubMed) from 1966 to September 2013. Two authors independently selected the handbooks and extracted the data. We used descriptive statistics to analyze the extracted data and conducted a narrative synthesis. RESULTS: We included 35 handbooks. Most handbooks (97.1%) focus mainly on developing CPGs, including variable degrees of information about updating. Guidance on identifying new evidence and the methodology of assessing the need for an update is described in 11 (31.4%) and eight handbooks (22.8%), respectively. The period of time between two updates is described in 25 handbooks (71.4%), two to three years being the most frequent (40.0%). The majority of handbooks do not provide guidance for the literature search, evidence selection, assessment, synthesis, and external review of the updating process. CONCLUSIONS: Guidance for updating CPGs is poorly described in methodological handbooks. This guidance should be more rigorous and explicit. This could lead to a more optimal updating process, and, ultimately to valid trustworthy guidelines.
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Project description:BackgroundClinical practice guidelines (CPG) are statements that provide recommendations regarding the approach to different diseases and aim to increase quality while decreasing the risk of complications in health care. Numerous guidelines in the field of perioperative care have been published in the previous decade but their methodological quality and transparency are relatively unknown.ObjectiveTo critically evaluate the transparency and methodological quality of published CPG in the preoperative assessment and management of adult patients undergoing elective surgery.DesignSystematic review and methodological appraisal study.Data sourcesWe searched for eligible CPG published in English or Spanish between January 1, 2010, and June 30, 2022, in Pubmed MEDLINE, TRIP Database, Embase, the Cochrane Library, as well as in representatives' medical societies of Anaesthesiology and developers of CPG.Eligibility criteriaCPG dedicated on preoperative fasting, cardiac assessment for non-cardiac surgery, and the use of routine preoperative tests were included. Methodological quality and transparency of CPG were assessed by 3 evaluators using the 6 domains of the AGREE-II tool.ResultsWe included 20 CPG of which 14 were classified as recommended guidelines. The domain of "applicability" scored the lowest (44%), while the domains "scope and objective" and "editorial interdependence" received the highest median scores of 93% and 97% respectively. The remaining domains received scores ranging from 44% to 84%. The top mean scored CPG in preoperative fasting was ASA 2017 (93%); among cardiac evaluation, CPG for non-cardiac surgery were CCS 2017 (91%), ESC-ESA 2014 (90%), and AHA-ACC 2014 (89%); in preoperative testing ICSI 2020 (97%).ConclusionsIn the last ten years, most published CPG in the preoperative assessment or management of adult patients undergoing elective surgery focused on preoperative fasting, cardiac assessment for non-cardiac surgery, and use of routine preoperative tests, present moderate to high methodological quality and can be recommended for their use or adaptation. Applicability and stakeholder involvement domains must be improved in the development of future guidelines.
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Project description:OBJECTIVE:To determine the accessibility and currency of delirium guidelines, guideline summary papers and evaluation studies, and critically appraise guideline quality. DESIGN:Systematic literature search for formal guidelines (in English or French) with focus on delirium assessment and/or management in adults (≥18 years), guideline summary papers and evaluation studies.Full appraisal of delirium guidelines published between 2008 and 2013 and obtaining a 'Rigour of Development' domain screening score cut-off of >40% using the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument. DATA SOURCES:Multiple bibliographic databases, guideline organisation databases, complemented by a grey literature search. RESULTS:3327 database citations and 83 grey literature links were identified. A total of 118 retrieved delirium guidelines and related documents underwent full-text screening. A final 21 delirium guidelines (with 10 being >5 years old), 12 guideline summary papers and 3 evaluation studies were included. For 11 delirium guidelines published between 2008 and 2013, the screening AGREE II 'Rigour' scores ranged from 3% to 91%, with seven meeting the cut-off score of >40%. Overall, the highest rating AGREE II domains were 'Scope and Purpose' (mean 80.1%, range 64-100%) and 'Clarity and Presentation' (mean 76.7%, range 38-97%). The lowest rating domains were 'Applicability' (mean 48.7%, range 8-81%) and 'Editorial Independence' (mean 53%, range 2-90%). The three highest rating guidelines in the 'Applicability' domain incorporated monitoring criteria or audit and costing templates, and/or implementation strategies. CONCLUSIONS:Delirium guidelines are best sourced by a systematic grey literature search. Delirium guideline quality varied across all six AGREE II domains, demonstrating the importance of using a formal appraisal tool prior to guideline adaptation and implementation into clinical settings. Adding more knowledge translation resources to guidelines may improve their practical application and effective monitoring. More delirium guideline evaluation studies are needed to determine their effect on clinical practice.
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Project description:Background: The Appraisal of Guidelines Research and Evaluation (AGREE) II instrument has been widely used in the methodological quality assessment of clinical practice guidelines (CPG). Chinese medicine CPGs have unique characteristics which distinguish them from those of Western medicine, e.g. syndrome differentiation, on which treatments are based. As such, certain domains and items in AGREE II are unsuitable for assessing TCM CPGs. Therefore, it is necessary to adjust and supplement the description and rating section of some items of the AGREE Ⅱinstrument. Purpose: To adjust and expand AGREE II according to characteristics of TCM clinical practice guidelines. Methods: A research working group was established, consisting of a core working group and an expert consensus group, before a systematic literature search performed to screen for TCM guidelines. Two researchers evaluated the quality of the included guidelines using AGREE Ⅱ and later proposed adjustments to some items of AGREE Ⅱ and supplementary comments, which were applicable to TCM CPGs, and drafted an initial version of AGREE Ⅱ for TCM. Suggestions from literature on development and evaluation of TCM CPGs were solicited and integrated into the revised version, which 16 experts were then invited to advise on. When the experts reached a consensus, their comments to the draft were adopted by the core group into the final version. Results: After evaluating the included TCM guidelines, the two researchers offered adjustments and supplementary comments for AGREE Ⅱ Items 1, 7, 10, 11, 12, 15, and 18, and drafted an initial version of AGREE Ⅱ for TCM. Combining suggestions from the literature on development and quality evaluation of TCM clinical guidelines, the core working group modified AGREE Ⅱ items 2, 4, 5, 8, 9, 13, 20, and 21, then proposed the revised version of AGREE Ⅱ for TCM, on which was advised by a group of experts, before consensus on improvements was reached. The results of the first round of expert surveys showed strong agreement, and experts' opinions were adopted into the final version of AGREE Ⅱ for TCM. Conclusion: Based on the characteristics of the TCM CPGs, we adjustment and expansion were made to create AGREE II for TCM. This version is suitable for the assessment of methodological quality of TCM CPGs, capable of providing content support for the standardization of procedures and methods of formulating TCM CPGs.
| S-EPMC9877221 | biostudies-literature
Project description:BackgroundThe coronavirus disease 2019 (COVID-19) pandemic has presented as a therapeutic challenge for clinicians worldwide due to its rapid spread along with evolving evidence and understanding of the disease. Internationally, recommendations to guide the management of COVID-19 have been created and updated continuously by the WHO and CDC, which have been locally adapted by different countries. Similarly, Pakistan's National Command Operation Center (NCOC), in its national COVID-19 management strategy, generated guidelines for national implementation. Keeping the guidelines updated has proved challenging globally and locally. Here, we present a summary of the process to assess the evidence, including a time-restricted systematic review based on NCOC Clinical Management Guidelines for COVID-19 Infections v4 published on 11th December 2020 version, correlating it with current recommendations and with input one of the guidelines authors, particularly noting the methodological challenges.MethodsWe conducted a systematic review synthesizing global research on treatment options for COVID-19 hospitalized patients, limiting it to pharmacological interventions for hospitalized COVID-19 patients included in Pakistan's NCOC's national guidelines v4 published on 11th December 2020. Each treatment recommendation's strength and quality of evidence was assessed based on the grading of recommendations assessment, development, and evaluation (GRADE) methodology. These were then compared to the most current living WHO COVID-19 pharmacological treatment guidelines v7.1. One of the authors of the NCOC guidelines reviewed and commented on the findings as well.ResultsWe note that the data from our systematic review strongly supports corticosteroids use in treating severe and critically ill COVID-19 hospitalized patients correlating with WHO v7.1 guidelines 24 September 2021. However, evidence from our review and WHO v7.1 for the use of tocilizumab had some conflicting evidence, with data from our review until December 2020 supporting only a weak recommendation for its use, compared to the strong recommendation by the WHO for the use of tocilizumab in patients with severe or critical COVID-19 infection. Regarding the use of antibiotics and ivermectin use in treating COVID-19 hospitalized patients, data from our review and WHO v 7.1 recommend against their use.ConclusionResearch data about the efficacy and safety of pharmacological interventions to treat hospitalized patients with COVID-19 are rapidly evolving, and based on it, the evidence for or against recommendations changes accordingly. Our study illustrates the challenges of keeping up with the evidence; the recommendations were based on studies up till December 2021, and we have compared our recommendations with the WHO v7.1, which showed some significant changes in the use of pharmacological treatment options.
| S-EPMC9020141 | biostudies-literature
Project description:Background: The morbidity and mortality of coronavirus disease 2019 (COVID-19) are still increasing. This study aimed to assess the quality of relevant COVID-19 clinical practice guidelines (CPGs) and to compare the similarities and differences between recommendations. Methods: A comprehensive search was conducted using electronic databases (PubMed, Embase, and Web of Science) and representative guidelines repositories from December 1, 2019, to August 11, 2020 (updated to April 5, 2021), to obtain eligible CPGs. The Appraisal of Guidelines for Research and Evaluation (AGREE II) tool was used to evaluate the quality of CPGs. Four authors extracted relevant information and completed data extraction forms. All data were analyzed using R version 3.6.0 software. Results: In total, 39 CPGs were identified and the quality was not encouragingly high. The median score (interquartile range, IQR) of every domain from AGREE II for evidence-based CPGs (EB-CPGs) versus (vs.) consensus-based CPG (CB-CPGs) was 81.94% (75.00-84.72) vs. 58.33% (52.78-68.06) in scope and purpose, 59.72% (38.89-75.00) vs. 36.11% (33.33-36.11) in stakeholder involvement, 64.58% (32.29-71.88) vs. 22.92% (16.67-26.56) in rigor of development, 75.00% (52.78-86.81) vs. 52.78% (50.00-63.89) in clarity of presentation, 40.63% (22.40-62.50) vs. 20.83% (13.54-25.00) in applicability, and 58.33% (50.00-100.00) vs. 50.00% (50.00-77.08) in editorial independence, respectively. The methodological quality of EB-CPGs were significantly superior to the CB-CPGs in the majority of domains (P < 0.05). There was no agreement on diagnosis criteria of COVID-19. But a few guidelines show Remdesivir may be beneficial for the patients, hydroxychloroquine +/- azithromycin may not, and there were more consistent suggestions regarding discharge management. For instance, after discharge, isolation management and health status monitoring may be continued. Conclusions: In general, the methodological quality of EB-CPGs is greater than CB-CPGs. However, it is still required to be further improved. Besides, the consistency of COVID-19 recommendations on topics such as diagnosis criteria is different. Of them, hydroxychloroquine +/- azithromycin may be not beneficial to treat patients with COVID-19, but remdesivir may be a favorable risk-benefit in severe COVID-19 infection; isolation management and health status monitoring after discharge may be still necessary. Chemoprophylaxis, including SARS-CoV 2 vaccines and antiviral drugs of COVID-19, still require more trials to confirm this.
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