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      2009 Updated Method Guidelines for Systematic Reviews in the Cochrane Back Review Group

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          Abstract

          Method guidelines for systematic reviews of trials of treatments for neck and back pain. To help review authors design, conduct and report systematic reviews of trials in this field. In 1997, the Cochrane Back Review Group published Method Guidelines for Systematic Reviews, which was updated in 2003. Since then, new methodologic evidence has emerged and standards have changed. Coupled with the upcoming revisions to the software and methods required by The Cochrane Collaboration, it was clear that revisions were needed to the existing guidelines. The Cochrane Back Review Group editorial and advisory boards met in June 2006 to review the relevant new methodologic evidence and determine how it should be incorporated. Based on the discussion, the guidelines were revised and circulated for comment. As sections of the new Cochrane Handbook for Systematic Reviews of Interventions were made available, the guidelines were checked for consistency. A working draft was made available to review authors in The Cochrane Library 2008, issue 3. The final recommendations are divided into 7 categories: objectives, literature search, inclusion criteria, risk of bias assessment, data extraction, data analysis, and updating your review. Each recommendation is classified into minimum criteria (mandatory) and further guidance (optional). Instead of recommending Levels of Evidence, this update adopts the GRADE approach to determine the overall quality of the evidence for important patient-centered outcomes across studies and includes a new section on updating reviews. Citations of previous versions of the method guidelines in published scientific articles (1997: 254 citations; 2003: 209 citations, searched February 10, 2009) suggest that others may find these guidelines useful to plan, conduct, or evaluate systematic reviews in the field of spinal disorders.

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          Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care.

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            Language bias in randomised controlled trials published in English and German.

            Some randomised controlled trials (RCTs) done in German-speaking Europe are published in international English-language journals and others in national German-language journals. We assessed whether authors are more likely to report trials with statistically significant results in English than in German. We studied pairs of RCT reports, matched for first author and time of publication, with one report published in German and the other in English. Pairs were identified from reports round in a manual search of five leading German-language journals and from reports published by the same authors in English found on Medline. Quality of methods and reporting were assessed with two different scales by two investigators who were unaware of authors' identities, affiliations, and other characteristics of trial reports. Main study endpoints were selected by two investigators who were unaware of trial results. Our main outcome was the number of pairs of studies in which the levels of significance (shown by p values) were discordant. 62 eligible pairs of reports were identified but 19 (31%) were excluded because they were duplicate publications. A further three pairs (5%) were excluded because no p values were given. The remaining 40 pairs were analysed. Design characteristics and quality features were similar for reports in both languages. Only 35% of German-language articles, compared with 62% of English-language articles, reported significant (p < 0.05) differences in the main endpoint between study and control groups (p = 0.002 by McNemar's test). Logistic regression showed that the only characteristic that predicted publication in an English-language journal was a significant result. The odds ratio for publication of trials with significant results in English was 3.75 (95% CI 1.25-11.3). Authors were more likely to publish RCTs in an English-language journal if the results were statistically significant. English language bias may, therefore, be introduced in reviews and meta-analyses if they include only trials reported in English. The effort of the Cochrane Collaboration to identify as many controlled trials as possible, through the manual search of many medical journals published in different languages will help to reduce such bias.
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              Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline.

              Many nonpharmacologic therapies are available for treatment of low back pain. To assess benefits and harms of acupuncture, back schools, psychological therapies, exercise therapy, functional restoration, interdisciplinary therapy, massage, physical therapies (interferential therapy, low-level laser therapy, lumbar supports, shortwave diathermy, superficial heat, traction, transcutaneous electrical nerve stimulation, and ultrasonography), spinal manipulation, and yoga for acute or chronic low back pain (with or without leg pain). English-language studies were identified through searches of MEDLINE (through November 2006) and the Cochrane Database of Systematic Reviews (2006, Issue 4). These electronic searches were supplemented by hand searching of reference lists and additional citations suggested by experts. Systematic reviews and randomized trials of 1 or more of the preceding therapies for acute or chronic low back pain (with or without leg pain) that reported pain outcomes, back-specific function, general health status, work disability, or patient satisfaction. We abstracted information about study design, population characteristics, interventions, outcomes, and adverse events. To grade methodological quality, we used the Oxman criteria for systematic reviews and the Cochrane Back Review Group criteria for individual trials. We found good evidence that cognitive-behavioral therapy, exercise, spinal manipulation, and interdisciplinary rehabilitation are all moderately effective for chronic or subacute (>4 weeks' duration) low back pain. Benefits over placebo, sham therapy, or no treatment averaged 10 to 20 points on a 100-point visual analogue pain scale, 2 to 4 points on the Roland-Morris Disability Questionnaire, or a standardized mean difference of 0.5 to 0.8. We found fair evidence that acupuncture, massage, yoga (Viniyoga), and functional restoration are also effective for chronic low back pain. For acute low back pain (<4 weeks' duration), the only nonpharmacologic therapies with evidence of efficacy are superficial heat (good evidence for moderate benefits) and spinal manipulation (fair evidence for small to moderate benefits). Although serious harms seemed to be rare, data on harms were poorly reported. No trials addressed optimal sequencing of therapies, and methods for tailoring therapy to individual patients are still in early stages of development. Evidence is insufficient to evaluate the efficacy of therapies for sciatica. Our primary source of data was systematic reviews. We included non-English-language trials only if they were included in English-language systematic reviews. Therapies with good evidence of moderate efficacy for chronic or subacute low back pain are cognitive-behavioral therapy, exercise, spinal manipulation, and interdisciplinary rehabilitation. For acute low back pain, the only therapy with good evidence of efficacy is superficial heat.
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                Author and article information

                Journal
                Spine
                Spine
                Ovid Technologies (Wolters Kluwer Health)
                0362-2436
                2009
                August 2009
                : 34
                : 18
                : 1929-1941
                Article
                10.1097/BRS.0b013e3181b1c99f
                19680101
                be378dd4-e94c-490c-995f-177f1f4d7471
                © 2009
                History

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