Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation.

Large pragmatic trials provide the most reliable data about the effects of treatments, but should be designed, analysed, and reported to enable the most effective use of treatments in routine practice. Subgroup analyses are important if there are potentially large differences between groups in the r...

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Main Author: Rothwell, P
Format: Journal article
Language:English
Published: 2005
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author Rothwell, P
author_facet Rothwell, P
author_sort Rothwell, P
collection OXFORD
description Large pragmatic trials provide the most reliable data about the effects of treatments, but should be designed, analysed, and reported to enable the most effective use of treatments in routine practice. Subgroup analyses are important if there are potentially large differences between groups in the risk of a poor outcome with or without treatment, if there is potential heterogeneity of treatment effect in relation to pathophysiology, if there are practical questions about when to treat, or if there are doubts about benefit in specific groups, such as elderly people, which are leading to potentially inappropriate undertreatment. Analyses must be predefined, carefully justified, and limited to a few clinically important questions, and post-hoc observations should be treated with scepticism irrespective of their statistical significance. If important subgroup effects are anticipated, trials should either be powered to detect them reliably or pooled analyses of several trials should be undertaken. Formal rules for the planning, analysis, and reporting of subgroup analyses are proposed.
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spelling oxford-uuid:35a1bbd0-ddc9-4f4f-806b-6bd01a66a6032022-03-26T13:33:06ZTreating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:35a1bbd0-ddc9-4f4f-806b-6bd01a66a603EnglishSymplectic Elements at Oxford2005Rothwell, PLarge pragmatic trials provide the most reliable data about the effects of treatments, but should be designed, analysed, and reported to enable the most effective use of treatments in routine practice. Subgroup analyses are important if there are potentially large differences between groups in the risk of a poor outcome with or without treatment, if there is potential heterogeneity of treatment effect in relation to pathophysiology, if there are practical questions about when to treat, or if there are doubts about benefit in specific groups, such as elderly people, which are leading to potentially inappropriate undertreatment. Analyses must be predefined, carefully justified, and limited to a few clinically important questions, and post-hoc observations should be treated with scepticism irrespective of their statistical significance. If important subgroup effects are anticipated, trials should either be powered to detect them reliably or pooled analyses of several trials should be undertaken. Formal rules for the planning, analysis, and reporting of subgroup analyses are proposed.
spellingShingle Rothwell, P
Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation.
title Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation.
title_full Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation.
title_fullStr Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation.
title_full_unstemmed Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation.
title_short Treating individuals 2. Subgroup analysis in randomised controlled trials: importance, indications, and interpretation.
title_sort treating individuals 2 subgroup analysis in randomised controlled trials importance indications and interpretation
work_keys_str_mv AT rothwellp treatingindividuals2subgroupanalysisinrandomisedcontrolledtrialsimportanceindicationsandinterpretation