Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review
Objective To study how composite outcomes, which have combined several components into a single measure, are defined, reported, and interpreted.Design Systematic review of parallel group randomised clinical trials published in 2008 reporting a binary composite outcome. Two independent observers extr...
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| Veröffentlicht in: | BMJ 2010-08, Vol.341 (7769), p.381-381 |
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| creator | Cordoba, Gloria Schwartz, Lisa Woloshin, Steven Bae, Harold Gøtzsche, Peter C |
| description | Objective To study how composite outcomes, which have combined several components into a single measure, are defined, reported, and interpreted.Design Systematic review of parallel group randomised clinical trials published in 2008 reporting a binary composite outcome. Two independent observers extracted the data using a standardised data sheet, and two other observers, blinded to the results, selected the most important component.Results Of 40 included trials, 29 (73%) were about cardiovascular topics and 24 (60%) were entirely or partly industry funded. Composite outcomes had a median of three components (range 2–9). Death or cardiovascular death was the most important component in 33 trials (83%). Only one trial provided a good rationale for the choice of components. We judged that the components were not of similar importance in 28 trials (70%); in 20 of these, death was combined with hospital admission. Other major problems were change in the definition of the composite outcome between the abstract, methods, and results sections (13 trials); missing, ambiguous, or uninterpretable data (9 trials); and post hoc construction of composite outcomes (4 trials). Only 24 trials (60%) provided reliable estimates for both the composite and its components, and only six trials (15%) had components of similar, or possibly similar, clinical importance and provided reliable estimates. In 11 of 16 trials with a statistically significant composite, the abstract conclusion falsely implied that the effect applied also to the most important component.Conclusions The use of composite outcomes in trials is problematic. Components are often unreasonably combined, inconsistently defined, and inadequately reported. These problems will leave many readers confused, often with an exaggerated perception of how well interventions work. |
| doi_str_mv | 10.1136/bmj.c3920 |
| format | Article |
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Two independent observers extracted the data using a standardised data sheet, and two other observers, blinded to the results, selected the most important component.Results Of 40 included trials, 29 (73%) were about cardiovascular topics and 24 (60%) were entirely or partly industry funded. Composite outcomes had a median of three components (range 2–9). Death or cardiovascular death was the most important component in 33 trials (83%). Only one trial provided a good rationale for the choice of components. We judged that the components were not of similar importance in 28 trials (70%); in 20 of these, death was combined with hospital admission. Other major problems were change in the definition of the composite outcome between the abstract, methods, and results sections (13 trials); missing, ambiguous, or uninterpretable data (9 trials); and post hoc construction of composite outcomes (4 trials). Only 24 trials (60%) provided reliable estimates for both the composite and its components, and only six trials (15%) had components of similar, or possibly similar, clinical importance and provided reliable estimates. In 11 of 16 trials with a statistically significant composite, the abstract conclusion falsely implied that the effect applied also to the most important component.Conclusions The use of composite outcomes in trials is problematic. Components are often unreasonably combined, inconsistently defined, and inadequately reported. These problems will leave many readers confused, often with an exaggerated perception of how well interventions work.</description><edition>International edition</edition><identifier>ISSN: 0959-8138</identifier><identifier>ISSN: 0959-8146</identifier><identifier>ISSN: 0959-535X</identifier><identifier>EISSN: 1468-5833</identifier><identifier>EISSN: 1756-1833</identifier><identifier>DOI: 10.1136/bmj.c3920</identifier><identifier>PMID: 20719825</identifier><identifier>CODEN: BMJOAE</identifier><language>eng</language><publisher>England: British Medical Journal Publishing Group</publisher><subject>Attention deficit disorder ; Bias ; Breast cancer ; Clinical outcomes ; Clinical trials ; Confusion ; Data Interpretation, Statistical ; Death ; Evidence-based medicine ; Funding ; Health outcomes ; Heart attacks ; Pain ; Phlebitis ; Product development ; Randomized Controlled Trials as Topic - standards ; Research Design - standards ; Statistical analysis ; Systematic review ; Treatment Outcome ; Trials</subject><ispartof>BMJ, 2010-08, Vol.341 (7769), p.381-381</ispartof><rights>Cordoba et al 2010</rights><rights>2010 BMJ Publishing Group Ltd</rights><rights>Copyright: 2010 © Cordoba et al 2010</rights><rights>2010 Cordoba et al 2010 Cordoba et al This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Copyright BMJ Publishing Group Aug 21, 2010</rights><rights>Cordoba et al 2010 2010 Cordoba et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b702t-620d584f1961f8aaffcbe6199a47e9c3f87d4dc72189ae5eb3bbe30ac81f8bd93</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmj.com/content/341/bmj.c3920.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmj.com/content/341/bmj.c3920.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>114,115,230,314,776,780,799,881,3182,23551,27903,27904,30978,30979,55325,57996,58229,77347,77378,77406,77432</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20719825$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cordoba, Gloria</creatorcontrib><creatorcontrib>Schwartz, Lisa</creatorcontrib><creatorcontrib>Woloshin, Steven</creatorcontrib><creatorcontrib>Bae, Harold</creatorcontrib><creatorcontrib>Gøtzsche, Peter C</creatorcontrib><title>Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review</title><title>BMJ</title><addtitle>BMJ</addtitle><addtitle>BMJ</addtitle><description>Objective To study how composite outcomes, which have combined several components into a single measure, are defined, reported, and interpreted.Design Systematic review of parallel group randomised clinical trials published in 2008 reporting a binary composite outcome. Two independent observers extracted the data using a standardised data sheet, and two other observers, blinded to the results, selected the most important component.Results Of 40 included trials, 29 (73%) were about cardiovascular topics and 24 (60%) were entirely or partly industry funded. Composite outcomes had a median of three components (range 2–9). Death or cardiovascular death was the most important component in 33 trials (83%). Only one trial provided a good rationale for the choice of components. We judged that the components were not of similar importance in 28 trials (70%); in 20 of these, death was combined with hospital admission. Other major problems were change in the definition of the composite outcome between the abstract, methods, and results sections (13 trials); missing, ambiguous, or uninterpretable data (9 trials); and post hoc construction of composite outcomes (4 trials). Only 24 trials (60%) provided reliable estimates for both the composite and its components, and only six trials (15%) had components of similar, or possibly similar, clinical importance and provided reliable estimates. In 11 of 16 trials with a statistically significant composite, the abstract conclusion falsely implied that the effect applied also to the most important component.Conclusions The use of composite outcomes in trials is problematic. Components are often unreasonably combined, inconsistently defined, and inadequately reported. These problems will leave many readers confused, often with an exaggerated perception of how well interventions work.</description><subject>Attention deficit disorder</subject><subject>Bias</subject><subject>Breast cancer</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Confusion</subject><subject>Data Interpretation, Statistical</subject><subject>Death</subject><subject>Evidence-based medicine</subject><subject>Funding</subject><subject>Health outcomes</subject><subject>Heart attacks</subject><subject>Pain</subject><subject>Phlebitis</subject><subject>Product development</subject><subject>Randomized Controlled Trials as Topic - standards</subject><subject>Research Design - standards</subject><subject>Statistical analysis</subject><subject>Systematic review</subject><subject>Treatment Outcome</subject><subject>Trials</subject><issn>0959-8138</issn><issn>0959-8146</issn><issn>0959-535X</issn><issn>1468-5833</issn><issn>1756-1833</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><sourceid>7QJ</sourceid><recordid>eNqFks1u1DAUhS0EoqOhCx4AFEERQmqKHSf-YVEJDVBABTYFdWc5zk3xkMTB9hT69jhMmRYQg6XIis6X4-uTg9Bdgg8Ioexp3S8PDJUFvoFmpGQirwSlN9EMy0rmglCxg3ZDWGKMC8qFZNVttFNgTqQoqhmCF9DawUbrhv3Mw-h8tMPZfqaHJrNDBD96iHqSM9dmxvWjCzZC5lYxvUBIUGa65GB0l0VvdReeZeEiROjTVyZZnlv4dgfdapMCu5f7HH189fJk8To__nD0ZvH8OK85LmLOCtxUomyJZKQVWretqYERKXXJQRraCt6UjeEFEVJDBTWta6BYG5HwupF0jg7XvuOq7qExMESvOzV622t_oZy26ndlsJ_VmTtXhSwoS88cPb408O7rCkJUvQ0Guk4P4FZB8UoQLAgT_yfLlHXJCU3kgz_IpVv5IeWQ7LDkgnGcoIf_gijmTFJMKd9GEUkwL3n661spnhYmspgu8GRNGe9C8NBuYiJYTc1SqVnqZ7MSe_96rhvyV48ScG8NLEN0_rrOGKmmXPO1blMzvm907b8oximv1PtPC8WPTk_elu9O1XTg3pqfZtg216Mr7OqSf3E_ALjn-eE</recordid><startdate>20100818</startdate><enddate>20100818</enddate><creator>Cordoba, Gloria</creator><creator>Schwartz, Lisa</creator><creator>Woloshin, Steven</creator><creator>Bae, Harold</creator><creator>Gøtzsche, Peter C</creator><general>British Medical Journal Publishing Group</general><general>British Medical Association</general><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><general>BMJ Publishing Group Ltd</general><scope>9YT</scope><scope>ACMMV</scope><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88I</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ASE</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FPQ</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>HCIFZ</scope><scope>K6X</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M2O</scope><scope>M2P</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7QJ</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20100818</creationdate><title>Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review</title><author>Cordoba, Gloria ; Schwartz, Lisa ; Woloshin, Steven ; Bae, Harold ; Gøtzsche, Peter C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b702t-620d584f1961f8aaffcbe6199a47e9c3f87d4dc72189ae5eb3bbe30ac81f8bd93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Attention deficit disorder</topic><topic>Bias</topic><topic>Breast cancer</topic><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Confusion</topic><topic>Data Interpretation, Statistical</topic><topic>Death</topic><topic>Evidence-based medicine</topic><topic>Funding</topic><topic>Health outcomes</topic><topic>Heart attacks</topic><topic>Pain</topic><topic>Phlebitis</topic><topic>Product development</topic><topic>Randomized Controlled Trials as Topic - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMJ</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cordoba, Gloria</au><au>Schwartz, Lisa</au><au>Woloshin, Steven</au><au>Bae, Harold</au><au>Gøtzsche, Peter C</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review</atitle><jtitle>BMJ</jtitle><stitle>BMJ</stitle><addtitle>BMJ</addtitle><date>2010-08-18</date><risdate>2010</risdate><volume>341</volume><issue>7769</issue><spage>381</spage><epage>381</epage><pages>381-381</pages><issn>0959-8138</issn><issn>0959-8146</issn><issn>0959-535X</issn><eissn>1468-5833</eissn><eissn>1756-1833</eissn><coden>BMJOAE</coden><abstract>Objective To study how composite outcomes, which have combined several components into a single measure, are defined, reported, and interpreted.Design Systematic review of parallel group randomised clinical trials published in 2008 reporting a binary composite outcome. Two independent observers extracted the data using a standardised data sheet, and two other observers, blinded to the results, selected the most important component.Results Of 40 included trials, 29 (73%) were about cardiovascular topics and 24 (60%) were entirely or partly industry funded. Composite outcomes had a median of three components (range 2–9). Death or cardiovascular death was the most important component in 33 trials (83%). Only one trial provided a good rationale for the choice of components. We judged that the components were not of similar importance in 28 trials (70%); in 20 of these, death was combined with hospital admission. Other major problems were change in the definition of the composite outcome between the abstract, methods, and results sections (13 trials); missing, ambiguous, or uninterpretable data (9 trials); and post hoc construction of composite outcomes (4 trials). Only 24 trials (60%) provided reliable estimates for both the composite and its components, and only six trials (15%) had components of similar, or possibly similar, clinical importance and provided reliable estimates. In 11 of 16 trials with a statistically significant composite, the abstract conclusion falsely implied that the effect applied also to the most important component.Conclusions The use of composite outcomes in trials is problematic. Components are often unreasonably combined, inconsistently defined, and inadequately reported. These problems will leave many readers confused, often with an exaggerated perception of how well interventions work.</abstract><cop>England</cop><pub>British Medical Journal Publishing Group</pub><pmid>20719825</pmid><doi>10.1136/bmj.c3920</doi><tpages>1</tpages><edition>International edition</edition><oa>free_for_read</oa></addata></record> |
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| subjects | Attention deficit disorder Bias Breast cancer Clinical outcomes Clinical trials Confusion Data Interpretation, Statistical Death Evidence-based medicine Funding Health outcomes Heart attacks Pain Phlebitis Product development Randomized Controlled Trials as Topic - standards Research Design - standards Statistical analysis Systematic review Treatment Outcome Trials |
| title | Definition, reporting, and interpretation of composite outcomes in clinical trials: systematic review |
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