Assessing harmful effects in systematic Reviews

<p>Abstract</p> <p>Background</p> <p>Balanced decisions about health care interventions require reliable evidence on harms as well as benefits. Most systematic reviews focus on efficacy and randomised trials, for which the methodology is well established. Methods to sys...

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Main Authors: Woolacott Nerys F, McIntosh Heather M, Bagnall Anne-Marie
Format: Article
Language:English
Published: BMC 2004-07-01
Series:BMC Medical Research Methodology
Online Access:http://www.biomedcentral.com/1471-2288/4/19
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author Woolacott Nerys F
McIntosh Heather M
Bagnall Anne-Marie
author_facet Woolacott Nerys F
McIntosh Heather M
Bagnall Anne-Marie
author_sort Woolacott Nerys F
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>Balanced decisions about health care interventions require reliable evidence on harms as well as benefits. Most systematic reviews focus on efficacy and randomised trials, for which the methodology is well established. Methods to systematically review harmful effects are less well developed and there are few sources of guidance for researchers. We present our own recent experience of conducting systematic reviews of harmful effects and make suggestions for future practice and further research.</p> <p>Methods</p> <p>We described and compared the methods used in three systematic reviews. Our evaluation focused on the review question, study designs and quality assessment.</p> <p>Results</p> <p>One review question focused on providing information on specific harmful effects to furnish an economic model, the other two addressed much broader questions. All three reviews included randomised and observational data, although each defined the inclusion criteria differently. Standard methods were used to assess study quality. Various practical problems were encountered in applying the study design inclusion criteria and assessing quality, mainly because of poor study design, inadequate reporting and the limitations of existing tools. All three reviews generated a large volume of work that did not yield much useful information for health care decision makers. The key areas for improvement we identified were focusing the review question and developing methods for quality assessment of studies of harmful effects.</p> <p>Conclusions</p> <p>Systematic reviews of harmful effects are more likely to yield information pertinent to clinical decision-making if they address a focused question. This will enable clear decisions to be made about the type of research to include in the review. The methodology for assessing the quality of harmful effects data in systematic reviews requires further development.</p>
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spelling doaj.art-fc37a0e8a35a4fcb8df2e8c476fe40032022-12-21T23:21:52ZengBMCBMC Medical Research Methodology1471-22882004-07-01411910.1186/1471-2288-4-19Assessing harmful effects in systematic ReviewsWoolacott Nerys FMcIntosh Heather MBagnall Anne-Marie<p>Abstract</p> <p>Background</p> <p>Balanced decisions about health care interventions require reliable evidence on harms as well as benefits. Most systematic reviews focus on efficacy and randomised trials, for which the methodology is well established. Methods to systematically review harmful effects are less well developed and there are few sources of guidance for researchers. We present our own recent experience of conducting systematic reviews of harmful effects and make suggestions for future practice and further research.</p> <p>Methods</p> <p>We described and compared the methods used in three systematic reviews. Our evaluation focused on the review question, study designs and quality assessment.</p> <p>Results</p> <p>One review question focused on providing information on specific harmful effects to furnish an economic model, the other two addressed much broader questions. All three reviews included randomised and observational data, although each defined the inclusion criteria differently. Standard methods were used to assess study quality. Various practical problems were encountered in applying the study design inclusion criteria and assessing quality, mainly because of poor study design, inadequate reporting and the limitations of existing tools. All three reviews generated a large volume of work that did not yield much useful information for health care decision makers. The key areas for improvement we identified were focusing the review question and developing methods for quality assessment of studies of harmful effects.</p> <p>Conclusions</p> <p>Systematic reviews of harmful effects are more likely to yield information pertinent to clinical decision-making if they address a focused question. This will enable clear decisions to be made about the type of research to include in the review. The methodology for assessing the quality of harmful effects data in systematic reviews requires further development.</p>http://www.biomedcentral.com/1471-2288/4/19
spellingShingle Woolacott Nerys F
McIntosh Heather M
Bagnall Anne-Marie
Assessing harmful effects in systematic Reviews
BMC Medical Research Methodology
title Assessing harmful effects in systematic Reviews
title_full Assessing harmful effects in systematic Reviews
title_fullStr Assessing harmful effects in systematic Reviews
title_full_unstemmed Assessing harmful effects in systematic Reviews
title_short Assessing harmful effects in systematic Reviews
title_sort assessing harmful effects in systematic reviews
url http://www.biomedcentral.com/1471-2288/4/19
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AT bagnallannemarie assessingharmfuleffectsinsystematicreviews