An evidence based approach to individualising treatment
To which groups of patients can the results of clinical trials be applied? This question is often inappropriately answered by reference to the trial entry criteria. Instead, the benefit and harm (adverse events, discomfort of treatment, etc) of treatment could be assessed separately for individual p...
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Published in | BMJ Vol. 311; no. 7016; pp. 1356 - 1359 |
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Main Authors | , |
Format | Journal Article |
Language | English |
Published |
England
British Medical Journal Publishing Group
18.11.1995
British Medical Association BMJ Publishing Group LTD BMJ Group |
Subjects | |
Online Access | Get full text |
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Abstract | To which groups of patients can the results of clinical trials be applied? This question is often inappropriately answered by reference to the trial entry criteria. Instead, the benefit and harm (adverse events, discomfort of treatment, etc) of treatment could be assessed separately for individual patients. Patients at greatest risk of a disease will have the greatest net benefit as benefit to patients usually increases with risk while harm remains comparatively fixed. To assess net benefit, the relative risks should come from (a meta-analysis of) randomised trials; the risk in individual patients should come from multivariate risk equations derived from cohort studies. However, before making firm conclusions, the assumptions of fixed adverse effects and constant reduction in relative risk need to be checked. |
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AbstractList | To which groups of patients can the results of clinical trials be applied? This question is often inappropriately answered by reference to the trial entry criteria. Instead, the benefit and harm (adverse events, discomfort of treatment, etc) of treatment could be assessed separately for individual patients. Patients at greatest risk of a disease will have the greatest net benefit as benefit to patients usually increases with risk while harm remains comparatively fixed. To assess net benefit, the relative risks should come from (a meta-analysis of) randomised trials; the risk in individual patients should come from multivariate risk equations derived from cohort studies. However, before making firm conclusions, the assumptions of fixed adverse effects and constant reduction in relative risk need to be checked. The basic model: separating benefit and harm Lubsen and Tijssen proposed a separate assessment of the benefit and harm of treatment. 4 As shown in figure 1 , their model suggests patient benefit increases with risk from the disease--those most at risk have most to gain--but that harm or rates of adverse event will remain comparatively fixed. [...]at some low level of risk the benefits will only just balance the harm and we should refrain from treatment. 5 6 This model works by converting the reduction in relative risk, which is useful for assessing the strength of the intervention, to a reduction in absolute risk, which is useful for assessing the clinical worth of the intervention. [...]a necessary check is a meta-analytic review of all trial data, with an examination of whether the reduction in relative risk varies with risk. |
Author | Glasziou, Paul P Irwig, Les M |
AuthorAffiliation | Department of Social and Preventive Medicine, Medical School, Herston, Queensland, Australia |
AuthorAffiliation_xml | – name: Department of Social and Preventive Medicine, Medical School, Herston, Queensland, Australia |
Author_xml | – sequence: 1 givenname: Paul P surname: Glasziou fullname: Glasziou, Paul P organization: aDepartment of Social and Preventive Medicine, Medical School, Herston, Queensland, Australia – sequence: 2 givenname: Les M surname: Irwig fullname: Irwig, Les M organization: bDepartment of Public Health and Community Medicine, Building A, University of Sydney, Sydney, New South Wales, Australia |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/7496291$$D View this record in MEDLINE/PubMed |
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References | Singer 1993; 3 Dickersin, Berlin 1992; 14 Davey-Smith, Egger 1994; 308 Lubsen, Tijssen 1989; 10 Greenland 1987; 9 1981; 124 Maclure 1993; 15 Kassirer, Pauker 1981; 305 Fihn, McDonell, Martin, Henikoff, Vermes, Kent 1993; 118 Landefeld, Beyth 1993; 95 Laupacis, Sackett, Roberts 1988; 318 Pauker, Kassirer 1980; 302 1992; 116 1988; ii Laupacis, Wells, Richardson, Tugwell 1994; 272 McIntosh 1995; No 4 Boissel, Collet, Lievre, Girard 1993; 22 Glasziou, Bromwich, Simes 1994; 161 1993; 342 |
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Snippet | To which groups of patients can the results of clinical trials be applied? This question is often inappropriately answered by reference to the trial entry... The basic model: separating benefit and harm Lubsen and Tijssen proposed a separate assessment of the benefit and harm of treatment. 4 As shown in figure 1 ,... |
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SubjectTerms | Anticoagulants Assumption of risk Atrial fibrillation Clinical trials Control groups Decision Support Techniques Disease Education & Debate Experimentation Health risk assessment Humans Intracranial hemorrhages Military benefits Mortality Outcome Assessment (Health Care) Predisposing factors Randomized Controlled Trials as Topic Risk Assessment Risk factors Stroke Strokes |
Title | An evidence based approach to individualising treatment |
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