From the June 1 issue of Spine:
Malmivaara, Antti; Koes, Bart W.; Bouter, Lex; van Tulder, Maurits W. Applicability and Clinical Relevance of Results in Randomized Controlled Trials: The Cochrane Review on Exercise Therapy for Low Back Pain as an Example. Spine 31(13):1405-1409, June 1, 2006.
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.
From the June 15 issue of Spine:
Clarke, Judy; van Tulder, Maurits; Blomberg, Stefan; de Vet, Henrica; van der Heijden, Geert; Bronfort, Gert. Traction for Low Back Pain With or Without Sciatica: An Updated Systematic Review Within the Framework of the Cochrane Collaboration. Spine. 31(14):1591-1599, June 15, 2006.
Study Design. Systematic review.Objective. To determine if traction is more effective than reference treatments, placebo/sham traction, or no treatment for low back pain (LBP).
Summary of Background Data. Various types of traction are used in the treatment of LBP, often in conjunction with other treatments. Methods. We searched MEDLINE, EMBASE, and CINAHL to November 2004, and screened the latest issue of the Cochrane Library (2004, issue 4) and references in relevant reviews and our personal files. We selected randomized controlled trials (RCTs) involving any type of traction for the treatment of acute (less than 4 weeks duration), subacute (4-12 weeks), or chronic (more than 12 weeks) nonspecific LBP with or without sciatica. Sets of 2 reviewers independently performed study selection, methodological quality assessment, and data extraction. Because available studies did not provide sufficient data for statistical pooling, we performed a qualitative “levels of evidence” analysis, systematically estimating the strength of the cumulative evidence on the difference/lack of difference observed in trial outcomes.Results. A total of 24 RCTs (2177 patients) were included. There were 5 trials considered high quality. For mixed groups of patients with LBP with and without sciatica, we found: (1) strong evidence that there is no statistically significant difference in short or long-term outcomes between traction as a single treatment, (continuous or intermittent) and placebo, sham, or no treatment; (2) moderate evidence that traction as a single treatment is no more effective than other treatments; and (3) limited evidence that adding traction to a standard physiotherapy program does not result in significantly different outcomes. For LBP with sciatica, we found conflicting evidence in several of the comparisons: autotraction compared to placebo, sham, or no treatment; other forms of traction compared to other treatments; and different forms of traction. In the remaining comparisons, there were no statistically significant differences; level of evidence is moderate regarding continuous or intermittent traction compared to placebo, sham, or no treatment, and is limited regarding different forms of traction.Conclusion. Based on the current evidence, intermittent or continuous traction as a single treatment for LBP cannot be recommended for mixed groups of patients with LBP with and without sciatica. Neither can traction be recommended for patients with sciatica because of inconsistent results and methodological problems in most of the studies involved. However, because high-quality studies within the field are scarce, because many are underpowered, and because traction often is supplied in combination with other treatment modalities, the literature allows no firm negative conclusion that traction, in a generalized sense, is not an effective treatment for patients with LBP.
Filed under: Chiropractic/CAM