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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: We constructed Benefit-Harm Charts that show the benefit-harm balance for different combinations of outcome risks.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.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 on [http://www.benefit-harm-balance.com]. The Benefit-Harm Charts inform about the benefit-harm balance of low dose aspirin based on a patient’s risk profile. Benefit outcomes are (prevented) MI, severe ischemic stroke, and cancers, and harm outcomes are (excess) severe GI bleed and severe hemorrhagic stroke. In the first step the risk profile of an individual is determined using risk factors for the benefit and harm outcomes. Ideally, and to facilitate risk prediction, a computer processes the information on risk factors saved in the electronic patient chart and provides the 10-year risk estimates. In this example, the 60-year old woman has a 10-year risk of 6 % for MI, 6 % for severe ischemic stroke, 0.03 % for hemorrhagic stroke, 5 % for severe GI bleed (non-smoker, high blood pressure treated with atenolol tablet 50 mg per day, no diabetes, no history of gastric ulcer, no atrial fibrillation, no left-ventricular hypertrophy but chronic lower back pain; systolic blood pressure 145 mm Hg, total cholesterol 170 mg/dL, HDL cholesterol 55 mg/dL, takes ibuprofen tablet 200 mg twice a day. She eats vegetables regularly and is physically active. There is no prior history of colorectal cancer in her family). Using the online calculator [http://www.benefit-harm-balance.com] the Benefit-Harm Chart shows for specific outcome preferences (rulers on top) and for each combination of outcome risks (four 5x5 tables) the probability that aspirin provides more benefits than harms (red colored cells <40 % of the 100,000 repetitions with index >0, yellow colored cells 40–60 %, and green colored cells >60 % probability). For the 60-year old woman, the Benefit-Harm Chart shows that she is likely to experience more harms than benefits from aspirin
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Fig1: Benefit-Harm Chart for low dose aspirin on [http://www.benefit-harm-balance.com]. The Benefit-Harm Charts inform about the benefit-harm balance of low dose aspirin based on a patient’s risk profile. Benefit outcomes are (prevented) MI, severe ischemic stroke, and cancers, and harm outcomes are (excess) severe GI bleed and severe hemorrhagic stroke. In the first step the risk profile of an individual is determined using risk factors for the benefit and harm outcomes. Ideally, and to facilitate risk prediction, a computer processes the information on risk factors saved in the electronic patient chart and provides the 10-year risk estimates. In this example, the 60-year old woman has a 10-year risk of 6 % for MI, 6 % for severe ischemic stroke, 0.03 % for hemorrhagic stroke, 5 % for severe GI bleed (non-smoker, high blood pressure treated with atenolol tablet 50 mg per day, no diabetes, no history of gastric ulcer, no atrial fibrillation, no left-ventricular hypertrophy but chronic lower back pain; systolic blood pressure 145 mm Hg, total cholesterol 170 mg/dL, HDL cholesterol 55 mg/dL, takes ibuprofen tablet 200 mg twice a day. She eats vegetables regularly and is physically active. There is no prior history of colorectal cancer in her family). Using the online calculator [http://www.benefit-harm-balance.com] the Benefit-Harm Chart shows for specific outcome preferences (rulers on top) and for each combination of outcome risks (four 5x5 tables) the probability that aspirin provides more benefits than harms (red colored cells <40 % of the 100,000 repetitions with index >0, yellow colored cells 40–60 %, and green colored cells >60 % probability). For the 60-year old woman, the Benefit-Harm Chart shows that she is likely to experience more harms than benefits from aspirin

Mentions: Figure 1 and [http://www.benefit-harm-balance.com] illustrate the Benefit-Harm Charts and explain how to use them using the example of a 60-year old woman with specific characteristics and preferences for the outcomes (see caption of Fig. 1). Based on risk prediction models that are calibrated for the region and population of the patient (for example, Caucasian, Boston area, USA), the 10-year risks for MI and severe ischemic stroke are elevated (6 % and 6 %, respectively). Her 10-year risk for severe GI bleed is slightly elevated (5 %) because she takes ibuprofen. The benefit-harm balance for this woman can be located (Fig. 1) by the respective sex, age, and risk categories for MI and severe GI bleeds. The red color indicates that the benefit-harm balance does not favor aspirin because the probability of overall benefit is low.Fig. 1


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 on [http://www.benefit-harm-balance.com]. The Benefit-Harm Charts inform about the benefit-harm balance of low dose aspirin based on a patient’s risk profile. Benefit outcomes are (prevented) MI, severe ischemic stroke, and cancers, and harm outcomes are (excess) severe GI bleed and severe hemorrhagic stroke. In the first step the risk profile of an individual is determined using risk factors for the benefit and harm outcomes. Ideally, and to facilitate risk prediction, a computer processes the information on risk factors saved in the electronic patient chart and provides the 10-year risk estimates. In this example, the 60-year old woman has a 10-year risk of 6 % for MI, 6 % for severe ischemic stroke, 0.03 % for hemorrhagic stroke, 5 % for severe GI bleed (non-smoker, high blood pressure treated with atenolol tablet 50 mg per day, no diabetes, no history of gastric ulcer, no atrial fibrillation, no left-ventricular hypertrophy but chronic lower back pain; systolic blood pressure 145 mm Hg, total cholesterol 170 mg/dL, HDL cholesterol 55 mg/dL, takes ibuprofen tablet 200 mg twice a day. She eats vegetables regularly and is physically active. There is no prior history of colorectal cancer in her family). Using the online calculator [http://www.benefit-harm-balance.com] the Benefit-Harm Chart shows for specific outcome preferences (rulers on top) and for each combination of outcome risks (four 5x5 tables) the probability that aspirin provides more benefits than harms (red colored cells <40 % of the 100,000 repetitions with index >0, yellow colored cells 40–60 %, and green colored cells >60 % probability). For the 60-year old woman, the Benefit-Harm Chart shows that she is likely to experience more harms than benefits from aspirin
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig1: Benefit-Harm Chart for low dose aspirin on [http://www.benefit-harm-balance.com]. The Benefit-Harm Charts inform about the benefit-harm balance of low dose aspirin based on a patient’s risk profile. Benefit outcomes are (prevented) MI, severe ischemic stroke, and cancers, and harm outcomes are (excess) severe GI bleed and severe hemorrhagic stroke. In the first step the risk profile of an individual is determined using risk factors for the benefit and harm outcomes. Ideally, and to facilitate risk prediction, a computer processes the information on risk factors saved in the electronic patient chart and provides the 10-year risk estimates. In this example, the 60-year old woman has a 10-year risk of 6 % for MI, 6 % for severe ischemic stroke, 0.03 % for hemorrhagic stroke, 5 % for severe GI bleed (non-smoker, high blood pressure treated with atenolol tablet 50 mg per day, no diabetes, no history of gastric ulcer, no atrial fibrillation, no left-ventricular hypertrophy but chronic lower back pain; systolic blood pressure 145 mm Hg, total cholesterol 170 mg/dL, HDL cholesterol 55 mg/dL, takes ibuprofen tablet 200 mg twice a day. She eats vegetables regularly and is physically active. There is no prior history of colorectal cancer in her family). Using the online calculator [http://www.benefit-harm-balance.com] the Benefit-Harm Chart shows for specific outcome preferences (rulers on top) and for each combination of outcome risks (four 5x5 tables) the probability that aspirin provides more benefits than harms (red colored cells <40 % of the 100,000 repetitions with index >0, yellow colored cells 40–60 %, and green colored cells >60 % probability). For the 60-year old woman, the Benefit-Harm Chart shows that she is likely to experience more harms than benefits from aspirin
Mentions: Figure 1 and [http://www.benefit-harm-balance.com] illustrate the Benefit-Harm Charts and explain how to use them using the example of a 60-year old woman with specific characteristics and preferences for the outcomes (see caption of Fig. 1). Based on risk prediction models that are calibrated for the region and population of the patient (for example, Caucasian, Boston area, USA), the 10-year risks for MI and severe ischemic stroke are elevated (6 % and 6 %, respectively). Her 10-year risk for severe GI bleed is slightly elevated (5 %) because she takes ibuprofen. The benefit-harm balance for this woman can be located (Fig. 1) by the respective sex, age, and risk categories for MI and severe GI bleeds. The red color indicates that the benefit-harm balance does not favor aspirin because the probability of overall benefit is low.Fig. 1

Bottom Line: We constructed Benefit-Harm Charts that show the benefit-harm balance for different combinations of outcome risks.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.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