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Competing Benefits and Competing Hazards: The Benefit to Harm Balance in Individual Patients in Rational Therapeutics

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Abstract

For any therapeutic intervention in an individual, there is a balance between the potential benefits and the possible harms. The extent to which the benefits are desirable in a given condition depends on the efficacy of the intervention, the chance of obtaining it and the seriousness and intensity of the condition. The extent to which the harms are undesirable depends on the nature of the hazard that can lead to harm, the chance that the harm will occur and its seriousness and intensity. Rational therapeutic decisions require clinicians to consider competing courses of action, with potential benefits of different desirability and potential harms of different undesirability. They also have a duty to explain to the patient, for the contemplated interventions, both the possible benefits and the potential harms that the patient may consider significant. In an individual patient, it is necessary to consider (a) the probabilities of benefit from both intervention and non-intervention and (b) the probabilities of harm from both intervention and non-intervention. However, there are several potential problems. Here, we consider how failure to distinguish maximum benefits from probable benefits, or hazards (potential harms) from probable harms, and failure to consider all the competing probabilities may lead to imperfect therapeutic decisions. We also briefly discuss methods to assess the benefit to harm balance.

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Acknowledgements

We thank Prof. Aroon Hingorani and anonymous reviewers for helpful comments on a draft of this paper.

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Correspondence to Robin E. Ferner.

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Robin E. Ferner has undertaken research and published on adverse drug reactions and medication errors and has acted as an expert witness in legal cases related to these. Jeffrey K. Aronson has published papers in bioscience journals and edited textbooks on adverse drug reactions; he has often acted as an expert witness in civil actions relating to suspected adverse drug reactions and in coroners’ courts.

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REF and JKA contributed equally to the intellectual content; REF wrote the first draft. Both authors have read and agreed upon the final version.

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Ferner, R.E., Aronson, J.K. Competing Benefits and Competing Hazards: The Benefit to Harm Balance in Individual Patients in Rational Therapeutics. Drug Saf (2024). https://doi.org/10.1007/s40264-024-01428-2

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