Applicability and Clinical Relevance of Results in Randomized Controlled Trials

Abstract

In Brief Study Design. A critical appraisal of the literature. Objectives. To increase awareness of the importance of applicability and clinical relevance of the results of randomized controlled trials (RCTs) in the field of spinal disorders by formulating a list of items for assessment of applicability and clinical relevance of results of RCTs. Summary of Background Data. In systematic reviews of randomized controlled trials (RCTs), critical appraisal of methodologic quality is considered important. Less attention has been paid to the assessment of the applicability and the clinical relevance of the results. Methods. RCTs in an update of the Cochrane review on exercise therapy for low back pain were 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 adverse effects. Item 1 was met by 88% of the trials, but item 2 only by 51%, item 3 by 67%, item 4 by 35%, and item 5 by 0%. Subsequently, a more comprehensive list of items for the assessment of applicability and clinical relevance of results of RCTs was developed. These criteria were pilot tested on the RCTs. After pilot testing and a subsequent consensus meeting, the list of items was 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 list consists of 40 items. The items are ordered on two headings: Does the report enable the assessment of applicability? Are the study results clinically relevant? We present examples of informative and noninformative reporting of RCTs in order to illustrate how information on applicability and clinical relevance of results can be assessed. Conclusions. Authors of RCTs should adequately report on items that are essential to assess the applicability and clinical relevance of results. The presented list of items may help clinicians reading RCTs and authors of systematic reviews to draw more balanced conclusions on applicability and clinical relevance of results. It is essential for readers to be able to assess the most important items related to the applicability (generalizability) and clinical relevance of results of randomized controlled trials (RCTs). This paper presents a method on how to improve the assessment of these features of RCTs. Authors writing a manuscript of an RCT or clinicians reading these papers may use the list of items, and they may also be helpful for researchers and editors reviewing manuscripts.

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