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Published on: February 6, 2020
Developing clinical recommendations for breast, colorectal, and lung cancer adjuvant treatments using the GRADE
Rossana De Palma1, Alessandro Liberati, Giovannino Ciccone
1PRI-ER Oncology Research Group, Agenzia Sanitaria Regionale, Viale Aldo Moro 21, Bologna, Italy. rdepalma@regione.emilia-romagna.it
Purpose:
In the area of anticancer drugs, the legitimate search for effective interventions can be jeopardized by the strong pressure for accelerated approval, which may hinder the full assessment of their benefit-risk profile. We aimed to produce drug-specific recommendations using an explicit approach that separates the judgments on quality of evidence from the judgment about strength of recommendations.
Materials And Methods:
We used the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) system to develop recommendations for the use of specific anticancer drugs/regimens; 12 clinical questions relevant to adjuvant treatment of breast (three), colorectal (four) and lung (five) cancer have been assessed by multidisciplinary panels supported by a group of methodologists.
Results:
For nine of 12 questions, recommendations were produced (one strong and six weak in favor and one weak and one strong against the index treatment); for the remaining three questions no specific course of action could be recommended. The perceived benefits to risk balance of the treatment was the most important and statistically significant (P < .01) predictor of panels' recommendations and of their strength, whereas panelists' personal (age, sex) and professional (specialty) characteristics were not statistically associated.
Conclusion:
Because the GRADE system sets out an explicit process going from evaluation of the quality of evidence and benefit-risk profile to the judgment of the strength of recommendations, in this experience, it proved very useful to combine methodologic rigor with the interdisciplinary participation that is important in the definition of evidence based clinical policies.
Insights
The GRADE system effectively guides recommendations for anticancer drugs by separating evidence quality from recommendation strength. This approach ensures rigorous, interdisciplinary decision-making for cancer treatment policies.
Area of Science:
- Oncology
- Clinical Pharmacology
- Evidence-Based Medicine
Background:
- Accelerated approval of anticancer drugs can compromise benefit-risk assessment.
- Developing robust drug-specific recommendations is crucial for effective cancer treatment.
Purpose of the Study:
- To create drug-specific recommendations for anticancer therapies using an explicit framework.
- To differentiate judgments on evidence quality from the strength of recommendations.
Main Methods:
- Utilized the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system.
- Assessed 12 clinical questions on adjuvant treatment for breast, colorectal, and lung cancer via multidisciplinary panels.
- Supported by methodologists to ensure rigorous evaluation.
Main Results:
- Recommendations were generated for 9 out of 12 questions, including strong and weak recommendations for or against treatments.
- The perceived benefit-risk balance was the primary predictor of panel recommendations and their strength (P < .01).
- No specific course of action was recommended for the remaining 3 questions.
Conclusions:
- The GRADE system facilitates explicit decision-making by evaluating evidence quality and benefit-risk profiles.
- This methodology proved effective in integrating methodologic rigor with interdisciplinary input for evidence-based clinical policies.
- The approach supports the development of clear clinical policies for anticancer drug use.
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