GRADE Working Group*
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BACKGROUND AND OBJECTIVE: This article explores the need for conceptual advances and practical guidance in the application of the GRADE approach within public health contexts. METHODS: We convened an expert workshop and conducted a scoping review to identify challenges experienced by GRADE users in public health contexts. We developed this concept article through thematic analysis and an iterative process of consultation and discussion conducted with members electronically and at three GRADE Working Group meetings. RESULTS: Five priority issues can pose challenges for public health guideline developers and systematic reviewers when applying GRADE: (1) incorporating the perspectives of diverse stakeholders; (2) selecting and prioritizing health and "nonhealth" outcomes; (3) interpreting outcomes and identifying a threshold for decision-making; (4) assessing certainty of evidence from diverse sources, including nonrandomized studies; and (5) addressing implications for decision makers, including concerns about conditional recommendations. We illustrate these challenges with examples from public health guidelines and systematic reviews, identifying gaps where conceptual advances may facilitate the consistent application or further development of the methodology and provide solutions. CONCLUSION: The GRADE Public Health Group will respond to these challenges with solutions that are coherent with existing guidance and can be consistently implemented across public health decision-making contexts.
BACKGROUND AND OBJECTIVE: The Grading of Recommendations, Assessment, Development and Evaluations (GRADE)-ADOLOPMENT methodology has been widely used to adopt, adapt, or de novo develop recommendations from existing or new guideline and evidence synthesis efforts. The objective of this guidance is to refine the operationalization for applying GRADE-ADOLOPMENT. METHODS: Through iterative discussions, online meetings, and email communications, the GRADE-ADOLOPMENT project group drafted the updated guidance. We then conducted a review of handbooks of guideline-producing organizations, and a scoping review of published and planned adolopment guideline projects. The lead authors refined the existing approach based on the scoping review findings and feedback from members of the GRADE working group. We presented the revised approach to the group in November 2022 (approximately 115 people), in May 2023 (approximately 100 people), and twice in September 2023 (approximately 60 and 90 people) for approval. RESULTS: This GRADE guidance shows how to effectively and efficiently contextualize recommendations using the GRADE-ADOLOPMENT approach by doing the following: (1) showcasing alternative pathways for starting an adolopment effort; (2) elaborating on the different essential steps of this approach, such as building on existing evidence-to-decision (EtDs), when available or developing new EtDs, if necessary; and (3) providing examples from adolopment case studies to facilitate the application of the approach. We demonstrate how to use contextual evidence to make judgments about EtD criteria, and highlight the importance of making the resulting EtDs available to facilitate adolopment efforts by others. CONCLUSION: This updated GRADE guidance further operationalizes the application of GRADE-ADOLOPMENT based on over 6 years of experience. It serves to support uptake and application by end users interested in contextualizing recommendations to a local setting or specific reality in a short period of time or with limited resources.
- MeSH
- lidé MeSH
- medicína založená na důkazech normy MeSH
- směrnice pro lékařskou praxi jako téma * normy MeSH
- systém GRADE normy MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
PURPOSE: Nuclear grade is an important indicator of the biological behaviour of ductal carcinoma in situ (DCIS). De-escalation of treatment has been suggested for low-grade DCIS. Our aim is to estimate the relative rate of progression of DCIS by nuclear grade by analysing the distribution of nuclear grade by detection at initial or subsequent screening. METHODS: We asked International Cancer Screening Network sites to complete, based on their screening and clinical databases, an aggregated data file on DCIS detection, diagnosis and treatment. RESULTS: Eleven screening programs reported 5068 screen-detected pure DCIS in nearly 7 million screening tests in women 50-69 years of age. For all programs combined, low-grade DCIS were 20.1% (range 11.4-31.8%) of graded DCIS, intermediate grade 31.0% and high grade 48.9%. Detection rates decreased more steeply from initial to subsequent screening in low compared to high-grade DCIS: the ratios of subsequent to initial detection rates were 0.39 for low grade, 0.51 for intermediate grade, and 0.75 for high grade (p < 0.001). CONCLUSIONS: These results suggest that the duration of the preclinical detectable phase is longer for low than for high-grade DCIS. The findings from this large multi-centre, international study emphasize that the management of low-grade DCIS should be carefully scrutinized in order to minimize overtreatment of screen-detected slow-growing or indolent lesions. The high variation by site in the proportion of low grade suggests that further pathology standardization and training would be beneficial.
- MeSH
- časná detekce nádoru MeSH
- intraduktální neinfiltrující karcinom diagnóza epidemiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory prsu diagnóza epidemiologie MeSH
- plošný screening MeSH
- progrese nemoci MeSH
- senioři MeSH
- staging nádorů MeSH
- stupeň nádoru MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- Geografické názvy
- Spojené státy americké MeSH
IARC monographs on the evaluation of carcinogenic risks to humans, ISSN 1017-1606 vol. 90
viii, 670 s. : il.
- MeSH
- infekce papilomavirem MeSH
- karcinogeny MeSH
- papilární karcinom MeSH
- Papillomaviridae MeSH
- Publikační typ
- sborníky MeSH
- Konspekt
- Lékařské vědy. Lékařství
- NLK Obory
- onkologie
- gynekologie a porodnictví
The selection of pharmacotherapy for patients with allergic rhinitis aims to control the disease and depends on many factors. Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines have considerably improved the treatment of allergic rhinitis. However, there is an increasing trend toward use of real-world evidence to inform clinical practice, especially because randomized controlled trials are often limited with regard to the applicability of results. The Contre les Maladies Chroniques pour un Vieillissement Actif (MACVIA) algorithm has proposed an allergic rhinitis treatment by a consensus group. This simple algorithm can be used to step up or step down allergic rhinitis treatment. Next-generation guidelines for the pharmacologic treatment of allergic rhinitis were developed by using existing GRADE-based guidelines for the disease, real-world evidence provided by mobile technology, and additive studies (allergen chamber studies) to refine the MACVIA algorithm.
OBJECTIVE: The objective of this paper is to propose an approach to visual unification of adapted guidelines and transformation of classifications of certainty of evidence (CoE) and strength of recommendations (SoR) into the approach suggested by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group. STUDY DESIGN AND SETTING: We carried out a literature search in MEDLINE and Epistemonikos, an analysis of selected guidelines, and an iterative discussion to decide on a consistent visual presentation and CoE and SoR depictions. RESULTS: The results of the literature search suggested this issue had not been addressed yet. The analysis of the chosen eight guidelines showed significant heterogeneity in the visual presentation of recommendations. Recommendations were often worded similarly to whether or not they were strong or conditional. Many guidelines contained "statements," almost all of which did not fulfill the good practice statement (GPS) criteria. We proposed an approach for transforming recommendations that are being adapted and which use various classification systems for CoE and SoR into GRADE and a consistent visual style. CONCLUSION: Guideline developers should aim for unification in the formulation of recommendations to improve transferability.
- MeSH
- lidé MeSH
- medicína založená na důkazech * MeSH
- publikace MeSH
- systém GRADE * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
Ig gene (IG) clonality analysis has an important role in the distinction of benign and malignant B-cell lymphoid proliferations and is mostly performed with the conventional EuroClonality/BIOMED-2 multiplex PCR protocol and GeneScan fragment size analysis. Recently, the EuroClonality-NGS Working Group developed a method for next-generation sequencing (NGS)-based IG clonality analysis. Herein, we report the results of an international multicenter biological validation of this novel method compared with the gold standard EuroClonality/BIOMED-2 protocol, based on 209 specimens of reactive and neoplastic lymphoproliferations. NGS-based IG clonality analysis showed a high interlaboratory concordance (99%) and high concordance with conventional clonality analysis (98%) for the molecular conclusion. Detailed analysis of the individual IG heavy chain and kappa light chain targets showed that NGS-based clonality analysis was more often able to detect a clonal rearrangement or yield an interpretable result. NGS-based and conventional clonality analysis detected a clone in 96% and 95% of B-cell neoplasms, respectively, and all but one of the reactive cases were scored polyclonal. We conclude that NGS-based IG clonality analysis performs comparable to conventional clonality analysis. We provide critical parameters for interpretation and discuss a first step toward a quantitative scoring approach for NGS clonality results. Considering the advantages of NGS-based clonality analysis, including its high sensitivity and possibilities for accurate clonal comparison, this supports implementation in diagnostic practice.
- MeSH
- B-buněčný lymfom genetika MeSH
- B-lymfocyty imunologie MeSH
- buněčné klony imunologie MeSH
- fenotyp MeSH
- folikulární lymfom genetika MeSH
- genová přestavba * MeSH
- geny pro imunoglobuliny * MeSH
- imunoglobuliny - kappa-řetězce genetika MeSH
- lidé MeSH
- multiplexová polymerázová řetězová reakce metody MeSH
- senzitivita a specificita MeSH
- správnost dat MeSH
- těžké řetězce imunoglobulinů genetika MeSH
- vysoce účinné nukleotidové sekvenování metody MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- validační studie MeSH
Bariatrická chirurgie je v současnosti nejúčinnější léčbou těžké obezity. Jejím výsledkem je dlouhodobý úbytek hmotnosti a prokázaný pozitivní vliv na komorbidity spojené s obezitou. V posledních dvaceti letech celosvětově prudce narůstá počet bariatrických operací. Proto je patrná snaha o konsenzus v perioperační péči v této oblasti chirurgie na základě ověřených důkazů. Metody: Pracovní skupina Společné sekce bariatricko-metabolické chirurgie České chirurgické společnosti (ČCHS) a České obezitologické společnosti (ČOS) zpracovala text praktického doporučení pro koncepci ERAS (Enhanced Recovery After Surgery) pro perioperační péči v bariatrické chirurgii. Vycházela z doporučení společnosti ERAS aktualizované v roce 2021. Původní text originálního doporučení pracovní skupina adoptovala, následně adaptovala a případně připojila ke konkrétním položkám svůj komentář. Závěrečnou fází tvorby bylo elektronické hlasování všech členů pracovní skupiny, kterým byla vyjádřena míra konsenzu nad jednotlivými elementy doporučení. Výsledky: Ve většině bodů se česká pracovní skupina shodla s doporučeními ERABS (Enhanced Recovery After Bariatric Surgery). Pro některé intervence z protokolu ERAS pro bariatrickou operativu neexistují kvalitní důkazy. Proto je nutné pro praxi založenou na důkazech extrapolovat z jiných chirurgických výkonů a oblastí. Závěr: Doporučení je určeno pro klinickou praxi v bariatrické operativě s protokolem ERAS vycházející ze současných poznatků a doporučení. Je založeno na recentním a zevrubném doporučení společnosti ERAS, které bylo českou pracovní skupinou společné sekce bariatrické a metabolické chirurgie adoptováno a adaptováno. Česká verze v komentářích odráží případné doplnění a upřesnění. Originální článek byl publikován v Rozhledech v chirurgii (Satinský et al., 2023, doi:10.33699/ PIS2023.102.7.283-297).
Introduction: Bariatric surgery is the most effective treatment for the morbid obesity. It results in sustained weight loss as well as pronounced effects on obesity-related comorbidities. In the last twenty years the number of procedures performed worldwide increased. Therefore, the effort to establish a consensus in perioperative care based on best evidence in this issue is evident. Methods: Working Group of Joint Section of Bariatric and Metabolic Surgery of Czech Surgery Society and Czech Obesitology Society reached practical recommendations for ERAS (Enhanced Recovery After Surgery) in perioperative care in bariatric surgery. It issued from ERAS recommendations published in 2021. Working group adopted the original text, consequently adapted and in particular cases affixed its commentary. The electronic voting of all members of working group was the final phase, by which the strenght of consensus of particular elements was expressed. Results: The Czech working group reached the consensus with recommendations ERABS (Enhanced Recovery After Bariatric Surgery) in the most elements. For some interventions of ERAS protocol for bariatric surgery the quality of evidence is low. Therefore, the evidence-based practices may need to be extrapolated from other surgeries. Conclusion: The recommendation is appointed for clinical practice in bariatric surgery with protocol ERAS based on updated evidence and recommendations. It is based on recent and comprehensive ERAS recommendation, which was adopted and adapted by the Czech working group of Joint Section of Bariatric and Metabolic Surgery of Czech Surgery Society and Czech Obesitology Society. The Czech version contents some supplementations and specifications in commentaries. Original article was published in Rozhledy v chirurgii (Satinský et al., 2023, doi:10.33699/PIS2023.102.7.283-297).
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.
- MeSH
- COVID-19 * MeSH
- lidé MeSH
- medicína založená na důkazech * MeSH
- výzkumný projekt MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
OBJECTIVES: This Grading of Recommendations Assessment, Development and Evaluation (GRADE) concept article offers systematic reviewers, guideline authors, and other users of evidence assistance in addressing randomized trial situations in which interventions or comparators differ from those in the target people, interventions, comparators, and outcomes. To clarify what GRADE considers under indirectness of interventions and comparators, we focus on a particular example: when comparator arm participants receive some or all aspects of the intervention management strategy (treatment switching). STUDY DESIGN AND SETTING: An interdisciplinary panel of the GRADE working group members developed this concept article through an iterative review of examples in multiple teleconferences, small group sessions, and e-mail correspondence. After presentation at a GRADE working group meeting in November 2022, attendees approved the final concept paper, which we support with examples from systematic reviews and individual trials. RESULTS: In the presence of safeguards against risk of bias, trials provide unbiased estimates of the effect of an intervention on the people as enrolled, the interventions as implemented, the comparators as implemented, and the outcomes as measured. Within the GRADE framework, differences in the people, interventions, comparators, and outcomes elements between the review or guideline recommendation targets and the trials as implemented constitute issues of indirectness. The intervention or comparator group management strategy as implemented, when it differs from the target comparator, constitutes one potential source of indirectness: Indirectness of interventions and comparators-comparator group receipt of the intervention constitutes a specific subcategory of said indirectness. The proportion of comparator arm participants that received the intervention and the apparent magnitude of effect bear on whether one should rate down, and if one does, to what extent. CONCLUSION: Treatment switching and other differences between review or guideline recommendation target interventions and comparators vs. interventions and comparators as implemented in otherwise relevant trials are best considered issues of indirectness.
