Article type
Year
Abstract
Background: In systematic reviews of randomized controlled trials (RCTs) critical appraisal of methodological quality is considered important. So far little attention has been paid to the assessment of the applicability, and the clinical relevance of the results. Objectives: To formulate criteria for applicability and clinical relevance of results of RCTs. And to apply these criteria to a Cochrane review to enable a further operationalization.
Methods: An update of the Cochrane review on exercise therapy for low back pain including 49 RCTs was used. Most of the trials did not score positively on the five Cochrane Back Review Group basic items describing patients, intervention and setting, outcome, effect size and benefits related to harms. Item one was met by 88% of the trials, but item two only by 51%, item three by 67%, item four by 35% and item five by 0% (only 10% of the papers reported on potential harms). Subsequently we developed a more comprehensive list of items for the assessment of applicability and clinical relevance of RCTs. These criteria were pilot tested on the 49 RCTs. After pilot testing and a subsequent consensus meeting, the recommendations were drafted and circulated among the members of the Editorial Board of the Cochrane Back Review Group. Changes were made in response to comments.
Results: The final criteria list consists of 40 items. The items are ordered under two headings: does the report enable the assessment of applicability, and are the study results clinically relevant. We present examples of good and bad reporting of RCTs in order to illustrate how information on applicability and clinical relevance of results can be assessed.
Conclusion: Authors of RCTs should adequately report on items that are essential to assess the applicability and clinical relevance of results. Our list of items may help to improve the quality of reporting and will also enable authors of systematic reviews to draw more balanced conclusions on applicability and clinical relevance.
Methods: An update of the Cochrane review on exercise therapy for low back pain including 49 RCTs was used. Most of the trials did not score positively on the five Cochrane Back Review Group basic items describing patients, intervention and setting, outcome, effect size and benefits related to harms. Item one was met by 88% of the trials, but item two only by 51%, item three by 67%, item four by 35% and item five by 0% (only 10% of the papers reported on potential harms). Subsequently we developed a more comprehensive list of items for the assessment of applicability and clinical relevance of RCTs. These criteria were pilot tested on the 49 RCTs. After pilot testing and a subsequent consensus meeting, the recommendations were drafted and circulated among the members of the Editorial Board of the Cochrane Back Review Group. Changes were made in response to comments.
Results: The final criteria list consists of 40 items. The items are ordered under two headings: does the report enable the assessment of applicability, and are the study results clinically relevant. We present examples of good and bad reporting of RCTs in order to illustrate how information on applicability and clinical relevance of results can be assessed.
Conclusion: Authors of RCTs should adequately report on items that are essential to assess the applicability and clinical relevance of results. Our list of items may help to improve the quality of reporting and will also enable authors of systematic reviews to draw more balanced conclusions on applicability and clinical relevance.