Empirical Evidence of Study Design Biases in Randomized Trials: Systematic Review of Meta-Epidemiological Studies
To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials. Systematic review of meta-epidemiological studies. We retrieved eligible studies included in a recent AHRQ-EPC review on this topic (latest search September 2012), and...
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| Veröffentlicht in: | PloS one Jg. 11; H. 7; S. e0159267 |
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| Hauptverfasser: | , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
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United States
Public Library of Science
11.07.2016
Public Library of Science (PLoS) |
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| ISSN: | 1932-6203, 1932-6203 |
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| Abstract | To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials.
Systematic review of meta-epidemiological studies.
We retrieved eligible studies included in a recent AHRQ-EPC review on this topic (latest search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta-analyses using the random-effects model. Analyses were stratified by type of outcome ("mortality" versus "other objective" versus "subjective"). Direction of effect was standardised so that ROR < 1 and dSMD < 0 denotes a larger intervention effect estimate in trials with an inadequate or unclear (versus adequate) characteristic.
We included 24 studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate) sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies) and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7 studies). For these characteristics, the average bias appeared to be larger in trials of subjective outcomes compared with other objective outcomes. Also, intervention effects for subjective outcomes appear to be exaggerated in trials with lack of/unclear blinding of participants (versus blinding) (dSMD -0.37, 95% CI -0.77 to 0.04; 2 studies), lack of/unclear blinding of outcome assessors (ROR 0.64, 95% CI 0.43 to 0.96; 1 study) and lack of/unclear double blinding (ROR 0.77, 95% CI 0.61 to 0.93; 1 study). The influence of other characteristics (e.g. unblinded trial personnel, attrition) is unclear.
Certain characteristics of randomized trials may exaggerate intervention effect estimates. The average bias appears to be greatest in trials of subjective outcomes. More research on several characteristics, particularly attrition and selective reporting, is needed. |
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| AbstractList | OBJECTIVETo synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials.DESIGNSystematic review of meta-epidemiological studies.METHODSWe retrieved eligible studies included in a recent AHRQ-EPC review on this topic (latest search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta-analyses using the random-effects model. Analyses were stratified by type of outcome ("mortality" versus "other objective" versus "subjective"). Direction of effect was standardised so that ROR < 1 and dSMD < 0 denotes a larger intervention effect estimate in trials with an inadequate or unclear (versus adequate) characteristic.RESULTSWe included 24 studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate) sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies) and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7 studies). For these characteristics, the average bias appeared to be larger in trials of subjective outcomes compared with other objective outcomes. Also, intervention effects for subjective outcomes appear to be exaggerated in trials with lack of/unclear blinding of participants (versus blinding) (dSMD -0.37, 95% CI -0.77 to 0.04; 2 studies), lack of/unclear blinding of outcome assessors (ROR 0.64, 95% CI 0.43 to 0.96; 1 study) and lack of/unclear double blinding (ROR 0.77, 95% CI 0.61 to 0.93; 1 study). The influence of other characteristics (e.g. unblinded trial personnel, attrition) is unclear.CONCLUSIONSCertain characteristics of randomized trials may exaggerate intervention effect estimates. The average bias appears to be greatest in trials of subjective outcomes. More research on several characteristics, particularly attrition and selective reporting, is needed. To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials. We retrieved eligible studies included in a recent AHRQ-EPC review on this topic (latest search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta-analyses using the random-effects model. Analyses were stratified by type of outcome ("mortality" versus "other objective" versus "subjective"). Direction of effect was standardised so that ROR < 1 and dSMD < 0 denotes a larger intervention effect estimate in trials with an inadequate or unclear (versus adequate) characteristic. We included 24 studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate) sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies) and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7 studies). For these characteristics, the average bias appeared to be larger in trials of subjective outcomes compared with other objective outcomes. Also, intervention effects for subjective outcomes appear to be exaggerated in trials with lack of/unclear blinding of participants (versus blinding) (dSMD -0.37, 95% CI -0.77 to 0.04; 2 studies), lack of/unclear blinding of outcome assessors (ROR 0.64, 95% CI 0.43 to 0.96; 1 study) and lack of/unclear double blinding (ROR 0.77, 95% CI 0.61 to 0.93; 1 study). The influence of other characteristics (e.g. unblinded trial personnel, attrition) is unclear. Certain characteristics of randomized trials may exaggerate intervention effect estimates. The average bias appears to be greatest in trials of subjective outcomes. More research on several characteristics, particularly attrition and selective reporting, is needed. Objective To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials. Design Systematic review of meta-epidemiological studies. Methods We retrieved eligible studies included in a recent AHRQ-EPC review on this topic (latest search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta-analyses using the random-effects model. Analyses were stratified by type of outcome (“mortality” versus “other objective” versus “subjective”). Direction of effect was standardised so that ROR < 1 and dSMD < 0 denotes a larger intervention effect estimate in trials with an inadequate or unclear (versus adequate) characteristic. Results We included 24 studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate) sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies) and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7 studies). For these characteristics, the average bias appeared to be larger in trials of subjective outcomes compared with other objective outcomes. Also, intervention effects for subjective outcomes appear to be exaggerated in trials with lack of/unclear blinding of participants (versus blinding) (dSMD -0.37, 95% CI -0.77 to 0.04; 2 studies), lack of/unclear blinding of outcome assessors (ROR 0.64, 95% CI 0.43 to 0.96; 1 study) and lack of/unclear double blinding (ROR 0.77, 95% CI 0.61 to 0.93; 1 study). The influence of other characteristics (e.g. unblinded trial personnel, attrition) is unclear. Conclusions Certain characteristics of randomized trials may exaggerate intervention effect estimates. The average bias appears to be greatest in trials of subjective outcomes. More research on several characteristics, particularly attrition and selective reporting, is needed. Objective To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials. Design Systematic review of meta-epidemiological studies. Methods We retrieved eligible studies included in a recent AHRQ-EPC review on this topic (latest search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta-analyses using the random-effects model. Analyses were stratified by type of outcome ("mortality" versus "other objective" versus "subjective"). Direction of effect was standardised so that ROR < 1 and dSMD < 0 denotes a larger intervention effect estimate in trials with an inadequate or unclear (versus adequate) characteristic. Results We included 24 studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate) sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies) and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7 studies). For these characteristics, the average bias appeared to be larger in trials of subjective outcomes compared with other objective outcomes. Also, intervention effects for subjective outcomes appear to be exaggerated in trials with lack of/unclear blinding of participants (versus blinding) (dSMD -0.37, 95% CI -0.77 to 0.04; 2 studies), lack of/unclear blinding of outcome assessors (ROR 0.64, 95% CI 0.43 to 0.96; 1 study) and lack of/unclear double blinding (ROR 0.77, 95% CI 0.61 to 0.93; 1 study). The influence of other characteristics (e.g. unblinded trial personnel, attrition) is unclear. Conclusions Certain characteristics of randomized trials may exaggerate intervention effect estimates. The average bias appears to be greatest in trials of subjective outcomes. More research on several characteristics, particularly attrition and selective reporting, is needed. To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials. Systematic review of meta-epidemiological studies. We retrieved eligible studies included in a recent AHRQ-EPC review on this topic (latest search September 2012), and searched Ovid MEDLINE and Ovid EMBASE for studies indexed from Jan 2012-May 2015. Data were extracted by one author and verified by another. We combined estimates of average bias (e.g. ratio of odds ratios (ROR) or difference in standardised mean differences (dSMD)) in meta-analyses using the random-effects model. Analyses were stratified by type of outcome ("mortality" versus "other objective" versus "subjective"). Direction of effect was standardised so that ROR < 1 and dSMD < 0 denotes a larger intervention effect estimate in trials with an inadequate or unclear (versus adequate) characteristic. We included 24 studies. The available evidence suggests that intervention effect estimates may be exaggerated in trials with inadequate/unclear (versus adequate) sequence generation (ROR 0.93, 95% CI 0.86 to 0.99; 7 studies) and allocation concealment (ROR 0.90, 95% CI 0.84 to 0.97; 7 studies). For these characteristics, the average bias appeared to be larger in trials of subjective outcomes compared with other objective outcomes. Also, intervention effects for subjective outcomes appear to be exaggerated in trials with lack of/unclear blinding of participants (versus blinding) (dSMD -0.37, 95% CI -0.77 to 0.04; 2 studies), lack of/unclear blinding of outcome assessors (ROR 0.64, 95% CI 0.43 to 0.96; 1 study) and lack of/unclear double blinding (ROR 0.77, 95% CI 0.61 to 0.93; 1 study). The influence of other characteristics (e.g. unblinded trial personnel, attrition) is unclear. Certain characteristics of randomized trials may exaggerate intervention effect estimates. The average bias appears to be greatest in trials of subjective outcomes. More research on several characteristics, particularly attrition and selective reporting, is needed. |
| Audience | Academic |
| Author | Higgins, Julian P. T. Sterne, Jonathan A. C. Clayton, Gemma Page, Matthew J. Hróbjartsson, Asbjørn Savović, Jelena |
| AuthorAffiliation | 3 Center for Evidence-Based Medicine, University of Southern Denmark & Odense University Hospital, Odense, Denmark Johns Hopkins Bloomberg School of Public Health, UNITED STATES 1 School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom 4 The National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West (NIHR CLAHRC West) at University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom 2 School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia |
| AuthorAffiliation_xml | – name: 3 Center for Evidence-Based Medicine, University of Southern Denmark & Odense University Hospital, Odense, Denmark – name: 4 The National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West (NIHR CLAHRC West) at University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom – name: 1 School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom – name: Johns Hopkins Bloomberg School of Public Health, UNITED STATES – name: 2 School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia |
| Author_xml | – sequence: 1 givenname: Matthew J. surname: Page fullname: Page, Matthew J. – sequence: 2 givenname: Julian P. T. surname: Higgins fullname: Higgins, Julian P. T. – sequence: 3 givenname: Gemma surname: Clayton fullname: Clayton, Gemma – sequence: 4 givenname: Jonathan A. C. surname: Sterne fullname: Sterne, Jonathan A. C. – sequence: 5 givenname: Asbjørn surname: Hróbjartsson fullname: Hróbjartsson, Asbjørn – sequence: 6 givenname: Jelena surname: Savović fullname: Savović, Jelena |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27398997$$D View this record in MEDLINE/PubMed |
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| Copyright | COPYRIGHT 2016 Public Library of Science 2016 Page et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2016 Page et al 2016 Page et al |
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| Notes | ObjectType-Article-2 SourceType-Scholarly Journals-1 content type line 14 ObjectType-Feature-3 ObjectType-Evidence Based Healthcare-1 content type line 23 ObjectType-Review-1 ObjectType-Undefined-4 ObjectType-Article-1 ObjectType-Feature-2 Conceived and designed the experiments: MJP JPTH JS. Performed the experiments: MJP GC. Analyzed the data: MJP JPTH. Wrote the paper: MJP JPTH GC JACS AH JS. Competing Interests: JACS, AB and JS are authors of a study included in this review, but were not involved in the eligibility assessment or data extraction of these studies. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials. All other authors declare no competing interests. |
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| Snippet | To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials.
Systematic review of... Objective To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials. Design Systematic... To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials. We retrieved eligible... OBJECTIVETo synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials.DESIGNSystematic... ObjectiveTo synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials.DesignSystematic... Objective To synthesise evidence on the average bias and heterogeneity associated with reported methodological features of randomized trials. Design Systematic... |
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| SubjectTerms | Analysis Arthritis Bias Biology and Life Sciences Clinical trials Design engineering Empirical analysis Engineering and Technology Epidemiologic Studies Epidemiology Estimates Heterogeneity Humans Intervention Medicine and Health Sciences Meta-analysis Methods Physical Sciences Randomization Randomized Controlled Trials as Topic - methods Research and Analysis Methods Reviews Studies Systematic review |
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| Title | Empirical Evidence of Study Design Biases in Randomized Trials: Systematic Review of Meta-Epidemiological Studies |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/27398997 https://www.proquest.com/docview/1803069890 https://www.proquest.com/docview/1803791010 https://www.proquest.com/docview/1808631137 https://pubmed.ncbi.nlm.nih.gov/PMC4939945 https://doaj.org/article/ab0d32091c20448fb0aff68621739b42 http://dx.doi.org/10.1371/journal.pone.0159267 |
| Volume | 11 |
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