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Je něco špatně v tomto záznamu ?
GRADE concept 4: rating the certainty of evidence when study interventions or comparators differ from PICO targets
M. Goldkuhle, GH. Guyatt, N. Kreuzberger, EA. Akl, P. Dahm, EC. van Dalen, LG. Hemkens, M. Klugar, RA. Mustafa, F. Nonino, HJ. Schünemann, M. Trivella, N. Skoetz
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, práce podpořená grantem
NLK
ProQuest Central
od 2003-01-01 do Před 2 měsíci
Nursing & Allied Health Database (ProQuest)
od 2003-01-01 do Před 2 měsíci
Health & Medicine (ProQuest)
od 2003-01-01 do Před 2 měsíci
Health Management Database (ProQuest)
od 2003-01-01 do Před 2 měsíci
Public Health Database (ProQuest)
od 2003-01-01 do Před 2 měsíci
- MeSH
- lidé MeSH
- medicína založená na důkazech * MeSH
- randomizované kontrolované studie jako téma * MeSH
- zkreslení výsledků (epidemiologie) * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem 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.
Cochrane Canada Hamilton Ontario Canada
Department of Biomedical Sciences Humanitas University Milan Italy
Department of Cardiovascular Medicine John Radcliffe Hospital University of Oxford UK
Department of Clinical Research University Hospital Basel University of Basel Basel Switzerland
Department of Medicine McMaster University Hamilton Ontario Canada
Department of Population Health London School of Hygiene and Tropical Medicine London
Institute of Health Information and Statistics of the Czech Republic 100 00 Prague Czech Republic
Meta Research Innovation Center at Stanford Stanford University Stanford CA USA
Meta Research Innovation Center Berlin Berlin Institute of Health Berlin Germany
Princess Máxima Center for Pediatric Oncology Heidelberglaan 25 3584CS Utrecht the Netherlands
Citace poskytuje Crossref.org
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- $a 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.
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