Jordi Pardo

Updated Method Guidelines for Cochrane Musculoskeletal Group Systematic Reviews and Metaanalyses

The Cochrane Musculoskeletal Group (CMSG), one of 53 groups of the not-for-profit, international Cochrane Collaboration, prepares, maintains, and disseminates systematic reviews of treatments for musculoskeletal diseases. It is important that authors conducting CMSG reviews and the readers of our reviews be aware of and use updated, state-of-the-art systematic review methodology. One hundred sixty reviews have been published. Previous method guidelines for systematic reviews of interventions in the musculoskeletal field published in 2006 have been substantially updated to incorporate methodological advances that are mandatory or highly desirable in Cochrane reviews and knowledge translation advances. The methodological advances include new guidance on searching, new risk-of-bias assessment, grading the quality of the evidence, the new Summary of Findings table, and comparative effectiveness using network metaanalysis. Method guidelines specific to musculoskeletal disorders are provided by CMSG editors for various aspects of undertaking a systematic review. These method guidelines will help improve the quality of reporting and ensure high standards of conduct as well as consistency across CMSG reviews.

A summary to communicate evidence from systematic reviews to the public improved understanding and accessibility of information: a randomized controlled trial.

OBJECTIVES To evaluate a new format of a summary, which presents research from synthesized evidence to patients and the public. STUDY DESIGN AND SETTING We conducted a randomized controlled trial in 143 members of the public from five countries (Canada, Norway, Spain, Argentina, and Italy). Participants received either a new summary format (a plain language summary [PLS]) or the current format used in Cochrane systematic reviews. The new PLS presents information about the condition and intervention, a narrative summary of results, and a table of results with absolute numbers for effects of the intervention and quality of the evidence using Grading of Recommendations Assessment, Development, and Evaluation. RESULTS With the new PLS, more participants understood the benefits and harms and quality of evidence (53% vs. 18%, P < 0.001); more answered each of the five questions correctly (P ≤ 0.001 for four questions); and they answered more questions correctly, median 3 (interquartile range [IQR]: 1-4) vs. 1 (IQR: 0-1), P < 0.001). Better understanding was independent of education level. More participants found information in the new PLS reliable, easy to find, easy to understand, and presented in a way that helped make decisions. Overall, participants preferred the new PLS. CONCLUSION This new PLS format for patients and the public is a promising tool to translate evidence from synthesized research.

Update of Strategies to Translate Evidence from Cochrane Musculoskeletal Group Systematic Reviews for Use by Various Audiences

For rheumatology research to have a real influence on health and well-being, evidence must be tailored to inform the decisions of various audiences. The Cochrane Musculoskeletal Group (CMSG), one of 53 groups of the not-for-profit international Cochrane Collaboration, prepares, maintains, and disseminates systematic reviews of treatments for musculoskeletal diseases. While systematic reviews provided by the CMSG fill a major gap in meeting the need for high-quality evidence syntheses, our work does not end at the completion of a review. The term “knowledge translation” (KT) refers to the activities involved in bringing research evidence to various audiences in a useful form so it can be used to support decision making and improve practices. Systematic reviews give careful consideration to research methods and analysis. Because the review is often long and detailed, the clinically relevant results may not be apparent or in the optimal form for use by patients and their healthcare practitioners. This paper describes 10 formats, many of them new, for ways that evidence from Cochrane Reviews can be translated with the intention of meeting the needs of various audiences, including patients and their families, practitioners, policy makers, the press, and members of the public (the “5 Ps”). Current and future knowledge tools include summary of findings tables, patient decision aids, plain language summaries, press releases, clinical scenarios in general medical journals, frequently asked questions (Cochrane Clinical Answers), podcasts, Twitter messages, Journal Club materials, and the use of storytelling and narratives to support continuing medical education. Future plans are outlined to explore ways of improving the influence and usefulness of systematic reviews by providing results in formats suitable to our varied audiences.

Assessing bias in osteoarthritis trials included in Cochrane reviews: protocol for a meta-epidemiological study.

Introduction The validity of systematic reviews and meta-analysis depends on methodological quality and unbiased dissemination of trials. Our objective is to evaluate the association of estimates of treatment effects with different bias-related study characteristics in meta-analyses of interventions used for treating pain in osteoarthritis (OA). From the findings, we hope to consolidate guidance on interpreting OA trials in systematic reviews based on empirical evidence from Cochrane reviews. Methods and analysis Only systematic reviews that compare experimental interventions with sham, placebo or no intervention control will be considered eligible. Bias will be assessed with the risk of bias tool, used according to the Cochrane Collaboration’s recommendations. Furthermore, center status, trial size and funding will be assessed. The primary outcome (pain) will be abstracted from the first appearing forest plot for overall pain in the Cochrane review. Treatment effect sizes will be expressed as standardised mean differences (SMDs), where the difference in mean values available from the forest plots is divided by the pooled SD. To empirically assess the risk of bias in treatment benefits, we will perform stratified analyses of the trials from the included meta-analyses and assess the interaction between trial characteristics and treatment effect. A relevant study-level covariate is defined as one that decreases the between-study variance (τ2, estimated as Tau-squared) as a consequence of inclusion in the mixed effects statistical model. Ethics and dissemination Meta-analyses and randomised controlled trials provide the most reliable basis for treatment of patients with OA, but the actual impact of bias is unclear. This study will systematically examine the methodological quality in OA Cochrane reviews and explore the effect estimates behind possible bias. Since our study does not collect primary data, no formal ethical assessment and informed consent are required. Trial registration number PROSPERO (CRD42013006924).

Development and Alpha-testing of a Stepped Decision Aid for Patients Considering Nonsurgical Options for Knee and Hip Osteoarthritis Management.

Objective. To develop an innovative stepped patient decision aid (StDA) comparing the benefits and harms of 13 nonsurgical treatment options for managing osteoarthritis (OA) and to evaluate its acceptability and effects on informed decision making. Methods. Guided by the Ottawa Decision Support Framework and the International Patient Decision Aid Standards, the process involved (1) developing a decision aid with evidence on 13 nonsurgical treatments from the 2012 American College of Rheumatology OA clinical practice guidelines; and (2) interviewing patients with OA and healthcare providers to test its acceptability and effects on knowledge and decisional conflict. Results. The StDA helped make the decision explicit, and presented evidence on 13 OA treatments clustered into 5 steps or levels according to their benefits and harms. Probabilities of benefits and harms were presented using pictograms of 100 faces formatted to allow comparisons across sets of options. It also included a values clarification exercise and knowledge test. Feedback was obtained from 49 patients and 7 healthcare providers. They found that the StDA presented evidence in a clear manner, and helped patients clarify their values and make an informed decision. Some participants found that there was too much information and others said that there was not enough on each treatment option. Conclusion. This innovative StDA allows patients to consider both the evidence and their values for multiple options. The findings are being used to revise and plan future evaluation. The StDA is an example of how research evidence in guidelines can be implemented in practice.

SAT0458 A Meta-Analysis of the Effects of Calcium Channel Blockers for the Treatment of Raynaud's Phenomenon Including Low and Higer Doses of Calcium Channel Blockers

Background It is known that calcium channel blockers (CCBs) can be effective in the treatment of Raynauds Phenomenon (RP). However, the differences in treatment effect between primary (idiopathic) RP and RP secondary to a connective tissue disease are not as well described and the various doses of CCBs and their efficacy are less known. Objectives To assess the benefits and harms of calcium channel blockers (CCBs) versus placebo for the treatment of Raynauds phenomenon (RP) in this review. Methods The Cochrane library (including CENTRAL), MEDLINE, EMBASE and Clinicaltrials.gov were searched up to June 2014 for randomized controlled trials (RCTs) examining RP. Outcomes of interest were: 1) Frequency of Raynauds attacks (average/week), 2) Duration of attacks (minutes), 3) Severity of attacks (10 cm Visual analogue scale) 4) Pain, 5) Patient global, 6) Withdrawals and 7) Serious adverse events. Fixed effects models were used to calculate mean differences (MD) or standardized mean differences (SMD) for continuous outcomes and pooled risk ratios (RR) for dichotomous outcomes. Heterogeneity was determined using Chi-squared and I2tests and was considered significant if I2>50%. Subgroup analysis by disease type (primary or secondary), CCB dosage (low, medium or high) and CCB type (mainly Nifedipine and Nicardipine) were performed. Results Of the 2337 articles, 939 participants from 36 RCTs investigating the effect of CCBs vs. placebo were included. The majority of these studies were crossover RCTs with low to moderate quality of evidence and used low dose CCBs (i.e. Nifedipine<60mg/day, Nicardipine<90mg/day). Most trials reported only some of the outcomes of interest. CCBs were significantly more effective in reducing the frequency of attacks in 22 RCTs with 978 participants [(MD -2.6295%CI -3.38,-1.88), p<0.00001] and the severity of attacks in 17 trials with 792 participants [(MD -0.73 95% CI -0.99, -0.47), p<0.00001].There were no statistically significant differences in duration, pain or withdrawals due to adverse events between CCBs and placebo. Patient global was only reported in one study and serious adverse events were not reported. The presence of significant heterogeneity was addressed by sensitivity and subgroup analyses. Overall, CCBs reduced the frequency and severity of attacks irrespective of dosage, particularly for primary RP. Low dose CCBs reduced the frequency of attacks by 3.3 per week vs. medium dose at 5.6. CCBs reduced frequency of attacks (per week) in primary RP by 3.9 vs. 0.5 in secondary RP. Similar trends were seen in severity of attacks for low dose vs. medium dose CCBs and primary vs. secondary RP. Limitations were identified such as cross over studies with possible carryover effects, low trial quality, missing outcomes of interest and heterogeneity of trials. Conclusions CCBs are effective in managing RP, particularly primary RP. The effect may be blunted in secondary RP. Low dose CCBs are not as effective as higher dosing. Disclosure of Interest None declared