Room for improvement? A survey of the methods used in systematic reviews of adverse effects

被引：42

作者：

Golder S. ^{[1
]}

Loke Y. ^{[2
]}

McIntosh H.M. ^{[1
,3
]}

机构：

[1] Centre for Reviews and Dissemination (CRD), University of York, York

[2] University of East Anglia

[3] NHS Quality Improvement Scotland, Delta House, Glasgow, G1 2NP

来源：

BMC Medical Research Methodology | / 6卷 / 1期

关键词：

Systematic Review; Adverse Effect Evaluation; Quality Assessment Tool; Adverse Effect Data; Evidence Hierarchy;

D O I：

10.1186/1471-2288-6-3

中图分类号：

学科分类号：

摘要：

Background: Although the methods for conducting systematic reviews of efficacy are well established, there is much less guidance on how systematic reviews of adverse effects should be performed. Methods: In order to determine where methodological research is most needed to improve systematic reviews of adverse effects of health care interventions, we conducted a descriptive analysis of systematic reviews published between 1994 and 2005. We searched the Database of Abstracts of Reviews of Effects (DARE) and The Cochrane Database of Systematic Reviews (CDSR) to identify systematic reviews in which the primary outcome was an adverse effect or effects. We then extracted data on many of the elements of the systematic review process including: types of interventions studied, adverse effects of interest, resources searched, search strategies, data sources included in reviews, quality assessment of primary data, nature of the data analysis, and source of funding. Results: 256 reviews were included in our analysis, of which the majority evaluated drug interventions and pre-specified the adverse effect or effects of interest. A median of 3 resources were searched for each review and very few reviews (13/256) provided sufficient information to reproduce their search strategies. Although more than three quarters (185/243) of the reviews sought to include data from sources other than randomised controlled trials, fewer than half (106/256) assessed the quality of the studies that were included. Data were pooled quantitatively in most of the reviews (165/256) but heterogeneity was not always considered. Less than half (123/256) of the reviews reported on the source of funding. Conclusion: There is an obvious need to improve the methodology and reporting of systematic reviews of adverse effects. The methodology around identification and quality assessment of primary data is the main concern. © 2006 Golder et al; licensee BioMed Central Ltd.

引用

共 14 条

[1]

Cuervo L.G., Clarke M., Balancing benefits and harms in health care, BMJ, 327, pp. 65-66, (2003)

[2]

Chou R., Helfand M., Challenges in systematic reviews that assess treatment harms, Ann Int Med, 142, pp. 1090-1099, (2005)

[3]

Including adverse effects, Cochrane Handbook for Systematic Reviews of Interventions 4.2.5 [Updated May 2005]

[4]

Appendix 6b

[5]

Derry S., Loke Y.K., Aronson J.K., Incomplete evidence: The inadequacy of databases in tracing published adverse drug reactions in clinical trials, BMC Med Res Methodol, 1, (2001)

[6]

Golder S., Duffy S., Glanville J., McIntosh H., Miles J., Developing efficient search strategies to identify papers on adverse events. A: Testing precision and sensitivity, 12th Cochrane Colloquium 2004 Oct 2-6

[7]

Ottawa, Ontario, Canada, pp. 75-76

[8]

Wieland S., Dickersin K., Selective exposure reporting and Medline indexing limited the search sensitivity for observational studies of the adverse effects of oral contraceptives, J Clin Epidemiol, 58, pp. 560-567, (2005)

[9]

Ernst E., Pittler M.H., Assessment of therapeutic safety in systematic reviews: Literature review, BMJ, 323, (2001)

[10]

McIntosh H.M., Woolacott N.F., Bagnall A.M., Assessing harmful effects in systematic reviews, BMC Med Res Methodol, 4, (2004)

← 1 2 →