I nvestigators who conduct randomized controlled trials (RCTs) and meta-analyses of RCTs often perform analyses of effect modification to assess whether intervention effects might vary by another variable such as age, disease severity or, in a meta-analysis, study setting or year of study. 1-14 The terminology varies; Box 1 presents the alternatives currently in use. Investigators sometimes make claims that an effect modification is present. Literature surveys suggest that 14%-26% of RCTs and meta-analyses emphasize at least 1 potential effect modification in their abstract or discussion. 4-9,11 The interest in effect modification is understandable: if patients with differing characteristics respond differently to the same intervention, the overall effect estimate is misleading for some, if not all, patients. Identifying situations in which true variation in effects exist is important, and the notion of tailoring therapy to patients has enormous appeal. Moreover, the opportunities for analyzing effect modification grow with the increasing number of newly developed diagnostic and genomic markers. However, mistaken claims of effect modification may compromise optimal patient care, and many claims of effect modification have subsequently proved spurious. 15-24 Applying a mistaken claim of effect modification may cause harms through administration of ineffective treatment or may lead to patients' being denied beneficial therapies, and will likely increase health care costs. Numerous theoretical analyses and simulation studies show that the fundamental reason for misleading claims of effect RESEARCH Development of the Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) in randomized controlled trials and meta-analyses
Shoulder complaints are common and have an unfavourable outcome in many patients. Only 50% of all new episodes of shoulder disorders end in complete recovery within 6 months. There is no consensus about prognostic indicators that can identify patients at high and low risk of chronicity. By a systematic search of the literature we identified 16 studies focusing on the prognosis of shoulder disorders. The methodological quality of these 16 studies was assessed. Six of these were considered to be of relatively 'high quality'. There was a wide variety among the studies in length of follow-up, study population, evaluated prognostic factors, type of outcome measure and method of analysis. Due to this large heterogeneity, we refrained from statistical pooling. Instead, we used a best-evidence synthesis. There is strong evidence that high pain intensity predicts a poorer outcome in primary care populations and that middle age (45-54) is associated with poor outcome in occupational populations. There is moderate evidence that a long duration of complaints, and high disability score at baseline predict a poorer outcome in primary care. These results need to be interpreted with caution because of the small number of studies on which these conclusions are based, and the large heterogeneity among studies regarding follow-up, outcome measures, and analysis.
Background: The treatment of non-specific chronic low back pain is often based on three different models regarding the development and maintenance of pain and especially functional limitations: the deconditioning model, the cognitive behavioral model and the biopsychosocial model.
As yet, there seems to be little evidence to support the use of ultrasound therapy in the treatment of musculoskeletal disorders. The large majority of 13 randomized placebo-controlled trials with adequate methods did not support the existence of clinically important or statistically significant differences in favour of ultrasound therapy. Nevertheless, our findings for lateral epicondylitis may warrant further investigation.
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