Article: Misrepresentation of randomized controlled trials in press releases and news coverage: a cohort study.Amélie Yavchitz, Isabelle Boutron, Aida Bafeta, Ibrahim Marroun, Pierre Charles, Jean Mantz, Philippe Ravaud[show abstract] [hide abstract]
ABSTRACT: Previous studies indicate that in published reports, trial results can be distorted by the use of "spin" (specific reporting strategies, intentional or unintentional, emphasizing the beneficial effect of the experimental treatment). We aimed to (1) evaluate the presence of "spin" in press releases and associated media coverage; and (2) evaluate whether findings of randomized controlled trials (RCTs) based on press releases and media coverage are misinterpreted. We systematically searched for all press releases indexed in the EurekAlert! database between December 2009 and March 2010. Of the 498 press releases retrieved and screened, we included press releases for all two-arm, parallel-group RCTs (n = 70). We obtained a copy of the scientific article to which the press release related and we systematically searched for related news items using Lexis Nexis. "Spin," defined as specific reporting strategies (intentional or unintentional) emphasizing the beneficial effect of the experimental treatment, was identified in 28 (40%) scientific article abstract conclusions and in 33 (47%) press releases. From bivariate and multivariable analysis assessing the journal type, funding source, sample size, type of treatment (drug or other), results of the primary outcomes (all nonstatistically significant versus other), author of the press release, and the presence of "spin" in the abstract conclusion, the only factor associated, with "spin" in the press release was "spin" in the article abstract conclusions (relative risk [RR] 5.6, [95% CI 2.8-11.1], p<0.001). Findings of RCTs based on press releases were overestimated for 19 (27%) reports. News items were identified for 41 RCTs; 21 (51%) were reported with "spin," mainly the same type of "spin" as those identified in the press release and article abstract conclusion. Findings of RCTs based on the news item was overestimated for ten (24%) reports. "Spin" was identified in about half of press releases and media coverage. In multivariable analysis, the main factor associated with "spin" in press releases was the presence of "spin" in the article abstract conclusion.PLoS Medicine 09/2012; 9(9):e1001308. · 16.27 Impact Factor
Article: Impact of single centre status on estimates of intervention effects in trials with continuous outcomes: meta-epidemiological study.Aïda Bafeta, Agnes Dechartres, Ludovic Trinquart, Amélie Yavchitz, Isabelle Boutron, Philippe Ravaud[show abstract] [hide abstract]
ABSTRACT: To compare estimates of intervention effects between single centre and multicentre randomised controlled trials with continuous outcomes. Meta-epidemiological study. 26 meta-analyses totalling 292 randomised controlled trials (177 single centre, 115 multicentre) with continuous outcomes published between January 2007 and January 2010 in the Cochrane database of systematic reviews. Data were extracted on characteristics of trials, single or multicentre status, risk of bias using the risk of bias tool of the Cochrane Collaboration, and results. The intervention effects were estimated with standardised mean differences. For each meta-analysis, random effects meta-regression was used to estimate the difference in standardised mean differences between single centre and multicentre trials. Differences in standardised mean differences were then pooled across meta-analyses by a random-effects meta-analysis model. A combined difference in standardised mean differences of less than 0 indicated that single centre trials showed larger treatment effects, on average, than did multicentre trials. Because single centre trials may be more prone to publication bias and may have lower methodological quality than multicentre trials, sensitivity analyses were done with adjustment for sample size and domains of the risk of bias tool. Single centre trials showed larger intervention effects than did multicentre trials (combined difference in standardised mean differences -0.09, 95% confidence interval -0.17 to -0.01, P=0.04), with low heterogeneity across individual meta-analyses (I(2)=0%, between meta-analyses variance τ(2)=0.00). Adjustment for sample size slightly attenuated the difference (-0.08, -0.17 to 0.01). Adjustment for risk of bias yielded similar estimates with wider confidence intervals, some of them crossing 0 (-0.09, -0.17 to 0.00 for overall risk of bias). On average, single centre clinical trials with continuous outcomes showed slightly larger intervention effects than did multicentre trials. Further research is needed to investigate potential causes of these differences.BMJ (Clinical research ed.). 01/2012; 344:e813.