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Learn how to create strong recommendations in medical research, including determining strength, rating evidence, and considering patient values. Understand the implications of recommendations for patients, clinicians, and policymakers.
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EAST GRADE course 2019Creating Recommendations John R. Lunde, DNP, AGACNP-BC, TCRN, FCCM George Kasotakis, MD MPH FACS FCCM
Defined • The strength of a recommendation reflects the extent to which we can be confident that the desirable effects of an intervention outweigh the undesirable effects.” • The implications of recommendations have clinical and medico-legal effects.
Making a Recommendation • Determining the strength of a recommendation is separate and different from rating the quality of the evidence.
The Primary Rating Determinants: • The overall quality of the evidence across outcomes (critical outcomes first) • The balance between benefits and harms and burden • Patient values and preferences • Resource considerations • Acceptability / feasibility
Grade Level of Action Strength • Strong Recommendation • Used when the desirable effects of adherence to a recommendation clearly outweighs the undesirable effects, or clearly do not • We recommend using the phrase “we recommend” or “we recommend against”
Weak (conditional) recommendation • Used when the tradeoffs are less certain either because of low-quality evidence or when the available evidence suggests that the desirable and undesirable effects are closely balanced; or patients values and preferences vary widely or are uncertain; or the resource used involved may bot be worth in relation to the benefit achieved.
Weak cont. • We recommend using the phrase “we conditionally recommend” or “we conditionally recommend against” when a weak recommendation is warrented
Tips on Making Recommendations • Covert the PICO Question into an affirmative statement • For strong- use “recommend” or ”recommend against” • For weak- use “conditionally recommend” or “conditionally recommend against”
What contributes to the strength of a recommendation • Quality of the evidence • Uncertainty or variability in the values and preferences • Uncertainty about whether the intervention represents a wise use of resources • Balance between desirable and undesirable effects
Implications of Recommendation • The implication of a strong recommendation are: • Patients • Clinicians • Policy Makers • It essentially dictates the new standard of care
The implications of a weak recommendation are: • Patients • Clinicians • Policy Makers • It implies the intervention should be considered in the majority of clinically applicable situations
EAST GRADE course 2019Drafting the Manuscript John R. Lunde, DNP, AGACNP-BC, TCRN, FCCM George Kasotakis, MD MPH FACS FCCM
Overall Approach • JOT limits manuscripts to 5000 words • Structured abstract is limited to 300 words • Limited to 8 figures and tables which include “Summary of Recommendations” figure
Format • Title • Abstract • Introduction: Discuss the magnitude of the problem; known data; knowledge gap; aim of the project • Objectives: What you set out to accomplish
Methods • Identification of Resources – Literature Search: • How the lit search was conducted, what engines, what terms • Include Prisma flow chart! • Outcome Measure Types • What Outcomes were considered, how they were rated • Data Extraction and Methodology • How abstracts/full manuscripts were reviewed, how conflicts were adjudicated, how data points were extracted
Results for PICO #1 • Qualitative Synthesis • Discuss differences across analyzed manuscripts, how these may affect your recommendation. Comment on notable observations, specific subpopulations that may benefit more or less from the proposed intervention. • Quantitative Synthesis: • Review / Discuss the Meta-Analysis results, present the GRADE Pro table findings.
Results for PICO #1 • Grading the Evidence • Present Grade Pro table, discuss results, evaluate overall quality of evidence. • Recommendation: • State the final recommendation as an answer to your PICO. ”Based on ____ quality of evidence”. • Discuss positive outcomes that improve, and adverse outcomes that may decrease • Discuss specific circumstances, pt populations where it may be more or less applicable.
Repeat Results for PICO #2 • Repeat: • Qualitative Synthesis • Quantitative Synthesis • Grading the Evidence • Recommendation
Summary of Recommendations • Using These Guidelines in Clinical Practice: • Discuss in more detail what benefits are to be expected from application of the recommendations. • Reiterate any exclusions/populations that may benefit more or less from the proposed intervention • Conclusion • Reiterate your recommendations & the clinical setting where they may most be applicable • Summary of Recommendations • Table with recommendations per PICO