Abstract: Study design Descriptive method guidelines. Objectives To help reviewers design, conduct, and report reviews of trials in the field of back and neck pain. Summary of background data In 1997, the Cochrane Collaboration Back Review Group published method guidelines for systematic reviews. Since its publication, new methodologic evidence emerged and more experience was acquired in conducting reviews. Methods All reviews and protocols of the Back Review Group were assessed for compliance with the 1997 method guidelines. Also, the most recent version of the Cochrane Handbook (4.1) was checked for new recommendations. In addition, some important topics that were not addressed in the 1997 method guidelines were included (e.g., methods for qualitative analysis, reporting of conclusions, and discussion of clinical relevance of the results). In May 2002, preliminary results were presented and discussed in a workshop. In two rounds, a list of all possible recommendations and the final draft were circulated for comments among the editors of the Back Review Group. Results The recommendations are divided in five categories: literature search, inclusion criteria, methodologic quality assessment, data extraction, and data analysis. Each recommendation is classified in minimum criteria and further guidance. Additional recommendations are included regarding assessment of clinical relevance, and reporting of results and conclusions. Conclusions Systematic reviews need to be conducted as carefully as the trials they report and, to achieve full impact, systematic reviews need to meet high methodologic standards.
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