%0 Journal Article %T Assessing harmful effects in systematic Reviews %A Heather M McIntosh %A Nerys F Woolacott %A Anne-Marie Bagnall %J BMC Medical Research Methodology %D 2004 %I BioMed Central %R 10.1186/1471-2288-4-19 %X We described and compared the methods used in three systematic reviews. Our evaluation focused on the review question, study designs and quality assessment.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.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.Systematic reviews are important tools for evidence-based health care. They are certainly one of the reasons for the progress that has been made in obtaining reliable evidence on the beneficial effects of interventions. A recent study of the medical literature, using Medline and the Cochrane Library, showed that the number of systematic reviews published has increased dramatically, from a single publication in the years 1966 to 1970, to 23 in 1981 to 1985, and 2467 in 1996 to 2000 [1]. Most of the systematic reviews focused on efficacy or effectiveness. However, to make a balanced decision about any intervention it is essential to have reliable evid %U http://www.biomedcentral.com/1471-2288/4/19