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

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-04-30 DOI:10.1007/s40264-024-01428-2
Robin E. Ferner, Jeffrey K. Aronson
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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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利益竞争与危害竞争:合理治疗中个体患者的利弊平衡
对个人的任何治疗干预都需要在潜在的益处和可能的危害之间取得平衡。在特定情况下,益处的可取程度取决于干预的有效性、获得干预的机会以及病情的严重程度和强度。危害的可取程度取决于可能导致危害的危险的性质、危害发生的几率及其严重程度和强度。合理的治疗决策要求临床医生考虑相互竞争的行动方案,这些方案的潜在益处具有不同的可取性,潜在危害具有不同的不可取性。他们也有责任向病人解释所考虑的干预措施可能带来的益处以及病人可能认为重要的潜在危害。对于个别病人,有必要考虑(a)干预和不干预的获益概率和(b)干预和不干预的伤害概率。然而,这其中存在几个潜在问题。在此,我们将考虑未能区分最大获益与可能获益,或危害(潜在危害)与可能危害,以及未能考虑所有相互竞争的概率是如何导致治疗决策不完善的。我们还简要讨论了评估利弊平衡的方法。
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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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