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Benefit-harm analysis and charts for individualized and preference-sensitive prevention: example of low dose aspirin for primary prevention of cardiovascular disease and cancer.

Puhan MA, Yu T, Stegeman I, Varadhan R, Singh S, Boyd CM - BMC Med (2015)

Bottom Line: Instead, if severe gastrointestinal bleeds are judged to be similarly important compared to the benefit outcomes, low dose aspirin is unlikely to provide more benefits than harms.Benefit-Harm Charts support individualized benefit-harm assessments and decision making.Similarly, individualized benefit-harm assessments may allow guideline developers to issue more finely granulated recommendations that reduce the risk of over- and underuse of interventions.

View Article: PubMed Central - PubMed

Affiliation: Department of Epidemiology; Epidemiology, Biostatistics & Prevention Institute, University of Zurich, Hirschengraben 84, Room HRS G29, CH-8001, Zurich, Switzerland. miloalan.puhan@uzh.ch.

ABSTRACT

Background: Clinical practice guidelines provide separate recommendations for different diseases that may be prevented or treated by the same intervention. Also, they commonly provide recommendations for entire populations but not for individuals. To address these two limitations, our aim was to conduct benefit-harm analyses for a wide range of individuals using the example of low dose aspirin for primary prevention of cardiovascular disease and cancer and to develop Benefit-Harm Charts that show the overall benefit-harm balance for individuals.

Methods: We used quantitative benefit-harm modeling that included 16 outcomes to estimate the probability that low dose aspirin provides more benefits than harms for a wide range of men and women between 45 and 84 years of age and without a previous myocardial infarction, severe ischemic stroke, or cancer. We repeated the quantitative benefit-harm modeling for different combinations of age, sex, and outcome risks for severe ischemic and hemorrhagic stroke, myocardial infarction, cancers, and severe gastrointestinal bleeds. The analyses considered weights for the outcomes, statistical uncertainty of the effects of aspirin, and death as a competing risk. We constructed Benefit-Harm Charts that show the benefit-harm balance for different combinations of outcome risks.

Results: The Benefit-Harm Charts ( http://www.benefit-harm-balance.com ) we have created show that the benefit-harm balance differs largely across a primary prevention population. Low dose aspirin is likely to provide more benefits than harms in men, elderly people, and in those at low risk for severe gastrointestinal bleeds. Individual preferences have a major impact on the benefit-harm balance. If, for example, it is a high priority for individuals to prevent stroke and severe cancers while severe gastrointestinal bleeds are deemed to be of little importance, the benefit-harm balance is likely to favor low dose aspirin for most individuals. Instead, if severe gastrointestinal bleeds are judged to be similarly important compared to the benefit outcomes, low dose aspirin is unlikely to provide more benefits than harms.

Conclusions: Benefit-Harm Charts support individualized benefit-harm assessments and decision making. Similarly, individualized benefit-harm assessments may allow guideline developers to issue more finely granulated recommendations that reduce the risk of over- and underuse of interventions. The example of low dose aspirin for primary prevention of cardiovascular disease and cancer shows that it may be time for guideline developers to provide combined recommendations for different diseases that may be prevented or treated by the same intervention.

No MeSH data available.


Related in: MedlinePlus

Benefit-Harm Chart for low dose aspirin for women and men. The Benefit-Harm Charts show the benefit-harm balance for four age categories and, within age categories, for 25 different combinations of 10-year risks for MI and severe GI bleeds. A comparison between women and men (for example, using age category 55–64 years) suggests that more men are likely to benefit from low dose aspirin than women. It is important to note that the Benefit-Harm Charts presented here focus on very low up to moderately high risks for MI (0–25 % 10-year risk) and severe GI bleeds (0–15 % 10-year risk). If the 10-year risks of severe GI bleeds are above 20 or 30 % (in elderly men and women who experienced gastric ulcers in the past [41]), the benefit-harm balance becomes unfavorable again since the number of excess severe GI bleeds under aspirin is high
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Fig2: Benefit-Harm Chart for low dose aspirin for women and men. The Benefit-Harm Charts show the benefit-harm balance for four age categories and, within age categories, for 25 different combinations of 10-year risks for MI and severe GI bleeds. A comparison between women and men (for example, using age category 55–64 years) suggests that more men are likely to benefit from low dose aspirin than women. It is important to note that the Benefit-Harm Charts presented here focus on very low up to moderately high risks for MI (0–25 % 10-year risk) and severe GI bleeds (0–15 % 10-year risk). If the 10-year risks of severe GI bleeds are above 20 or 30 % (in elderly men and women who experienced gastric ulcers in the past [41]), the benefit-harm balance becomes unfavorable again since the number of excess severe GI bleeds under aspirin is high

Mentions: The Benefit-Harm Chart in Fig. 2 illustrates how different outcome risks and their combinations influence the benefit-harm balance of low dose aspirin. The benefit-harm balance differs greatly across the primary prevention population. For example, there are many more men with different combinations of outcome risks who are likely to benefit from low dose aspirin than women, which is explained by their different risks for MI, stroke, and cancers. It is important to note that the Benefit-Harm Charts presented here focus on very low up to moderately high risks for MI (0–25 %) and severe GI bleeds (0–15 %), which covers a large proportion of a general population [40]. It does not include 10-year risks of severe GI bleeds above 15 %. If the 10-year risks of severe GI bleeds are above 20 or 30 % (in elderly men and women who experienced gastric ulcers in the past [41]), the benefit-harm balance becomes unfavorable again since the number of excess severe GI bleeds under aspirin is high. Within women and men, age is a strong determinant of the benefit-harm balance with more overall benefit as age increases). Also, the higher the risk of MI and the lower the risk for severe GI bleeds, the more likely is an overall benefit of aspirin.Fig. 2


Benefit-harm analysis and charts for individualized and preference-sensitive prevention: example of low dose aspirin for primary prevention of cardiovascular disease and cancer.

Puhan MA, Yu T, Stegeman I, Varadhan R, Singh S, Boyd CM - BMC Med (2015)

Benefit-Harm Chart for low dose aspirin for women and men. The Benefit-Harm Charts show the benefit-harm balance for four age categories and, within age categories, for 25 different combinations of 10-year risks for MI and severe GI bleeds. A comparison between women and men (for example, using age category 55–64 years) suggests that more men are likely to benefit from low dose aspirin than women. It is important to note that the Benefit-Harm Charts presented here focus on very low up to moderately high risks for MI (0–25 % 10-year risk) and severe GI bleeds (0–15 % 10-year risk). If the 10-year risks of severe GI bleeds are above 20 or 30 % (in elderly men and women who experienced gastric ulcers in the past [41]), the benefit-harm balance becomes unfavorable again since the number of excess severe GI bleeds under aspirin is high
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4589917&req=5

Fig2: Benefit-Harm Chart for low dose aspirin for women and men. The Benefit-Harm Charts show the benefit-harm balance for four age categories and, within age categories, for 25 different combinations of 10-year risks for MI and severe GI bleeds. A comparison between women and men (for example, using age category 55–64 years) suggests that more men are likely to benefit from low dose aspirin than women. It is important to note that the Benefit-Harm Charts presented here focus on very low up to moderately high risks for MI (0–25 % 10-year risk) and severe GI bleeds (0–15 % 10-year risk). If the 10-year risks of severe GI bleeds are above 20 or 30 % (in elderly men and women who experienced gastric ulcers in the past [41]), the benefit-harm balance becomes unfavorable again since the number of excess severe GI bleeds under aspirin is high
Mentions: The Benefit-Harm Chart in Fig. 2 illustrates how different outcome risks and their combinations influence the benefit-harm balance of low dose aspirin. The benefit-harm balance differs greatly across the primary prevention population. For example, there are many more men with different combinations of outcome risks who are likely to benefit from low dose aspirin than women, which is explained by their different risks for MI, stroke, and cancers. It is important to note that the Benefit-Harm Charts presented here focus on very low up to moderately high risks for MI (0–25 %) and severe GI bleeds (0–15 %), which covers a large proportion of a general population [40]. It does not include 10-year risks of severe GI bleeds above 15 %. If the 10-year risks of severe GI bleeds are above 20 or 30 % (in elderly men and women who experienced gastric ulcers in the past [41]), the benefit-harm balance becomes unfavorable again since the number of excess severe GI bleeds under aspirin is high. Within women and men, age is a strong determinant of the benefit-harm balance with more overall benefit as age increases). Also, the higher the risk of MI and the lower the risk for severe GI bleeds, the more likely is an overall benefit of aspirin.Fig. 2

Bottom Line: Instead, if severe gastrointestinal bleeds are judged to be similarly important compared to the benefit outcomes, low dose aspirin is unlikely to provide more benefits than harms.Benefit-Harm Charts support individualized benefit-harm assessments and decision making.Similarly, individualized benefit-harm assessments may allow guideline developers to issue more finely granulated recommendations that reduce the risk of over- and underuse of interventions.

View Article: PubMed Central - PubMed

Affiliation: Department of Epidemiology; Epidemiology, Biostatistics & Prevention Institute, University of Zurich, Hirschengraben 84, Room HRS G29, CH-8001, Zurich, Switzerland. miloalan.puhan@uzh.ch.

ABSTRACT

Background: Clinical practice guidelines provide separate recommendations for different diseases that may be prevented or treated by the same intervention. Also, they commonly provide recommendations for entire populations but not for individuals. To address these two limitations, our aim was to conduct benefit-harm analyses for a wide range of individuals using the example of low dose aspirin for primary prevention of cardiovascular disease and cancer and to develop Benefit-Harm Charts that show the overall benefit-harm balance for individuals.

Methods: We used quantitative benefit-harm modeling that included 16 outcomes to estimate the probability that low dose aspirin provides more benefits than harms for a wide range of men and women between 45 and 84 years of age and without a previous myocardial infarction, severe ischemic stroke, or cancer. We repeated the quantitative benefit-harm modeling for different combinations of age, sex, and outcome risks for severe ischemic and hemorrhagic stroke, myocardial infarction, cancers, and severe gastrointestinal bleeds. The analyses considered weights for the outcomes, statistical uncertainty of the effects of aspirin, and death as a competing risk. We constructed Benefit-Harm Charts that show the benefit-harm balance for different combinations of outcome risks.

Results: The Benefit-Harm Charts ( http://www.benefit-harm-balance.com ) we have created show that the benefit-harm balance differs largely across a primary prevention population. Low dose aspirin is likely to provide more benefits than harms in men, elderly people, and in those at low risk for severe gastrointestinal bleeds. Individual preferences have a major impact on the benefit-harm balance. If, for example, it is a high priority for individuals to prevent stroke and severe cancers while severe gastrointestinal bleeds are deemed to be of little importance, the benefit-harm balance is likely to favor low dose aspirin for most individuals. Instead, if severe gastrointestinal bleeds are judged to be similarly important compared to the benefit outcomes, low dose aspirin is unlikely to provide more benefits than harms.

Conclusions: Benefit-Harm Charts support individualized benefit-harm assessments and decision making. Similarly, individualized benefit-harm assessments may allow guideline developers to issue more finely granulated recommendations that reduce the risk of over- and underuse of interventions. The example of low dose aspirin for primary prevention of cardiovascular disease and cancer shows that it may be time for guideline developers to provide combined recommendations for different diseases that may be prevented or treated by the same intervention.

No MeSH data available.


Related in: MedlinePlus