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
AIMS AND OBJECTIVES: This is a protocol of a scoping review that will aim to synthesise methodological evidence on formulating plain language versions of recommendations from guidelines both for clinical practice and for public health. METHOD: We will conduct a search in MEDLINE (Ovid), Embase (Ovid) databases, and webpages of guidelines developers with no language and date limitations. The title/abstract and full-text screening will be performed by two reviewers independently. The team of reviewers will extract data on methods used for developing plain language versions of recommendations in a standardised manner. The data analysis and synthesis will be presented narratively in tabular form. RESULTS AND CONCLUSION: We will conduct a scoping review based on this protocol.
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- jazyk (prostředek komunikace) MeSH
- lidé MeSH
- přehledová literatura jako téma MeSH
- směrnice pro lékařskou praxi jako téma * normy MeSH
- výzkumný projekt normy MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
Posouzení plodnosti muže je založeno na vyšetření spermatu. Neexistuje univerzální ukazatel, o plodnosti vypovídá až komplex kvantitativních a kvalitativních parametrů. Metody ke stanovení těchto parametrů se stále vyvíjejí a zpřesňují. Jsou standardizovány v Manuálu WHO, který je pravidelně aktualizován. Poslední, šesté vydání je z roku 2021. Cílem přehledového článku je stručně shrnout současné možnosti vyšetření plodnosti muže a současně poukázat na některé změny, které přineslo poslední vydání manuálu.
The assessment of fertility in a man is based on the semen examination. There isn't any single universal indicator, fertility is determined by a complex of quantitative and qualitative parameters. Methods for determining these parameters are evolving and becoming more precise. They are standardised in the WHO Manual, which is regularly updated. The latest is the sixth edition of 2021. The aim of this review article is to summarize the current options for male fertility testing and to highlight some of the changes brought by the latest edition of the manual.
Minimal/measurable residual disease (MRD) diagnostics using real-time quantitative PCR analysis of rearranged immunoglobulin and T-cell receptor gene rearrangements are nowadays implemented in most treatment protocols for patients with acute lymphoblastic leukemia (ALL). Within the EuroMRD Consortium, we aim to provide comparable, high-quality MRD diagnostics, allowing appropriate risk-group classification for patients and inter-protocol comparisons. To this end, we set up a quality assessment scheme, that was gradually optimized and updated over the last 20 years, and that now includes participants from around 70 laboratories worldwide. We here describe the design and analysis of our quality assessment scheme. In addition, we here report revised data interpretation guidelines, based on our newly generated data and extensive discussions between experts. The main novelty is the partial re-definition of the "positive below quantitative range" category by two new categories, "MRD low positive, below quantitative range" and "MRD of uncertain significance". The quality assessment program and revised guidelines will ensure reproducible and accurate MRD data for ALL patients. Within the Consortium, similar programs and guidelines have been introduced for other lymphoid diseases (e.g., B-cell lymphoma), for new technological platforms (e.g., digital droplet PCR or Next-Generation Sequencing), and for other patient-specific MRD PCR-based targets (e.g., fusion genes).
- MeSH
- akutní lymfatická leukemie genetika diagnóza MeSH
- genová přestavba MeSH
- geny pro imunoglobuliny MeSH
- kvantitativní polymerázová řetězová reakce metody normy MeSH
- lidé MeSH
- reziduální nádor * genetika diagnóza MeSH
- směrnice pro lékařskou praxi jako téma normy MeSH
- zajištění kvality zdravotní péče MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Klíčová slova
- Charta EACH,
- MeSH
- dítě hospitalizované * dějiny MeSH
- dítě MeSH
- institucionální etika dějiny MeSH
- klinická etika dějiny MeSH
- lidé MeSH
- ochrana práv dítěte * etika normy MeSH
- směrnice pro lékařskou praxi jako téma normy MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
Patients with multiple myeloma frequently present with substantial immune impairment and an increased risk for infections and infection-related mortality. The risk for infection with SARS-CoV-2 virus and resulting mortality is also increased, emphasising the importance of protecting patients by vaccination. Available data in patients with multiple myeloma suggest a suboptimal anti-SARS-CoV-2 immune response, meaning a proportion of patients are unprotected. Factors associated with poor response are uncontrolled disease, immunosuppression, concomitant therapy, more lines of therapy, and CD38 antibody-directed and B-cell maturation antigen-directed therapy. These facts suggest that monitoring the immune response to vaccination in patients with multiple myeloma might provide guidance for clinical management, such as administration of additional doses of the same or another vaccine, or even temporary treatment discontinuation, if possible. In those who do not exhibit a good response, prophylactic treatment with neutralising monoclonal antibody cocktails might be considered. In patients deficient of a SARS-CoV-2 immune response, adherence to measures for infection risk reduction is particularly recommended. This consensus was generated by members of the European Multiple Myeloma Network and some external experts. The panel members convened in virtual meetings and conducted an extensive literature research and evaluated recently published data and work presented at meetings, as well as findings from their own studies. The outcome of the discussions on establishing consensus recommendations for COVID-19 vaccination in patients with multiple myeloma was condensed into this Review.
- MeSH
- COVID-19 prevence a kontrola MeSH
- konsensus MeSH
- lidé MeSH
- mnohočetný myelom komplikace farmakoterapie imunologie MeSH
- SARS-CoV-2 MeSH
- směrnice pro lékařskou praxi jako téma normy MeSH
- vakcinace MeSH
- vakcíny proti COVID-19 aplikace a dávkování MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
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.
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- hodnocení výsledků zdravotní péče metody organizace a řízení MeSH
- informační management * metody organizace a řízení MeSH
- konsensus MeSH
- lidé MeSH
- medicína založená na důkazech normy trendy MeSH
- směrnice pro lékařskou praxi jako téma normy MeSH
- systematický přehled jako téma MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
In this consensus statement, we provide updated recommendations on multiple sclerosis (MS) management during the COVID-19 crisis and the post-pandemic period applicable to neurology services around the world. Statements/recommendations were generated based on available literature and the experience of 13 MS expert panelists using a modified Delphi approach online. The statements/recommendations give advice regarding implementation of telemedicine; use of disease-modifying therapies and management of MS relapses; management of people with MS at highest risk from COVID-19; management of radiological monitoring; use of remote pharmacovigilance; impact on MS research; implications for lowest income settings, and other key issues.
- MeSH
- COVID-19 epidemiologie terapie MeSH
- farmakovigilance MeSH
- internacionalita * MeSH
- lidé MeSH
- management nemoci MeSH
- pandemie prevence a kontrola MeSH
- roztroušená skleróza epidemiologie terapie MeSH
- směrnice pro lékařskou praxi jako téma normy MeSH
- telemedicína normy trendy MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- konsensus - konference MeSH
- přehledy MeSH
This Policy Review presents the International Myeloma Working Group's clinical practice recommendations for the treatment of relapsed and refractory multiple myeloma. Based on the results of phase 2 and phase 3 trials, these recommendations are proposed for the treatment of patients with relapsed and refractory disease who have received one previous line of therapy, and for patients with relapsed and refractory multiple myeloma who have received two or more previous lines of therapy. These recommendations integrate the issue of drug access in both low-income and middle-income countries and in high-income countries to help guide real-world practice and thus improve patient outcomes.
- MeSH
- antitumorózní látky terapeutické užití MeSH
- chemorezistence účinky léků MeSH
- lidé MeSH
- lokální recidiva nádoru farmakoterapie patologie MeSH
- mnohočetný myelom farmakoterapie patologie MeSH
- směrnice pro lékařskou praxi jako téma normy MeSH
- záchranná terapie * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
A unique collaboration of multidisciplinary experts from the European Dermatology Forum, the European Association of Dermato-Oncology and the European Organization for Research and Treatment of Cancer (EORTC) was formed to make recommendations on cutaneous melanoma diagnosis and treatment, based on systematic literature reviews and the experts' experience. Cutaneous melanomas are excised with 1- to 2-cm safety margins. Sentinel lymph node dissection shall be performed as a staging procedure in patients with tumour thickness ≥1.0 mm or ≥0.8 mm with additional histological risk factors, although there is as yet no clear survival benefit for this approach. Therapeutic decisions in stage III/IV patients should be primarily made by an interdisciplinary oncology team ("Tumor Board"). Adjuvant therapies in stage III/IV patients are primarily anti-PD-1, independent of mutational status, or dabrafenib plus trametinib for BRAF-mutant patients. In distant metastasis, either resected or not, systemic treatment is indicated. For first-line treatment, particularly in BRAF wild-type patients, immunotherapy with PD-1 antibodies alone or in combination with CTLA-4 antibodies shall be considered. In particular scenarios for patients with stage IV melanoma and a BRAF-V600 E/K mutation, first-line therapy with BRAF/MEK inhibitors can be offered as an alternative to immunotherapy. In patients with primary resistance to immunotherapy and harbouring a BRAF-V600 E/K mutation, this therapy shall be offered in second-line. Systemic therapy in stage III/IV melanoma is a rapidly changing landscape, and it is likely that these recommendations may change in the near future.
- MeSH
- diagnostické zobrazování normy MeSH
- Evropská unie MeSH
- kombinovaná terapie MeSH
- konsensus MeSH
- lidé MeSH
- melanom klasifikace diagnóza terapie MeSH
- mezioborová komunikace * MeSH
- směrnice pro lékařskou praxi jako téma normy MeSH
- staging nádorů MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
