Objective To investigate the effect of an additional review based on reporting guidelines such as STROBE and CONSORT on quality of manuscripts.Design Masked randomised trial.Population Original research manuscripts submitted to the Medicina Clínica journal from May 2008 to April 2009 and considered suitable for publication.Intervention Control group: conventional peer reviews alone. Intervention group: conventional review plus an additional review looking for missing items from reporting guidelines.Outcomes Manuscript quality, assessed with a 5 point Likert scale (primary: overall quality; secondary: average quality of specific items in paper). Main analysis compared groups as allocated, after adjustment for baseline factors (analysis of covariance); sensitivity analysis compared groups as reviewed. Adherence to reviewer suggestions assessed with Likert scale.Results Of 126 consecutive papers receiving conventional review, 34 were not suitable for publication. The remaining 92 papers were allocated to receive conventional reviews alone (n=41) or additional reviews (n=51). Four papers assigned to the conventional review group deviated from protocol; they received an additional review based on reporting guidelines. We saw an improvement in manuscript quality in favour of the additional review group (comparison as allocated, 0.25, 95% confidence interval –0.05 to 0.54; as reviewed, 0.33, 0.03 to 0.63). More papers with additional reviews than with conventional reviews alone improved from baseline (22 (43%) v eight (20%), difference 23.6% (3.2% to 44.0%), number needed to treat 4.2 (from 2.3 to 31.2), relative risk 2.21 (1.10 to 4.44)). Authors in the additional review group adhered more to suggestions from conventional reviews than to those from additional reviews (average increase 0.43 Likert points (0.19 to 0.67)).Conclusions Additional reviews based on reporting guidelines improve manuscript quality, although the observed effect was smaller than hypothesised and not definitively demonstrated. Authors adhere more to suggestions from conventional reviews than to those from additional reviews, showing difficulties in adhering to high methodological standards at the latest research phases. To boost paper quality and impact, authors should be aware of future requirements of reporting guidelines at the very beginning of their study. Trial registration and protocol Although registries do not include trials of peer review, the protocol design was submitted to sponsored research projects (Instituto de Salud Carlos III, PI081903).
Background and Purpose-There is a lack of agreement regarding measuring the effects of stroke treatment in clinical trials, which often relies on the dichotomized value of 1 outcome scale. Alternative analyses consist mainly of 2 strategies: use all the information from an ordinal scale and combine information from several outcome scales in a single estimate. Methods-We reanalyzed 3 outcome scales that assessed patient recovery (modified Rankin Scale, National Institutes of Health Stroke Scale, and Barthel Index). With data collected from the 1652 patients in the Citicoline pooling data analysis, we used 2 standard techniques of exploratory multivariate analysis to analyze the distances among ranks and to isolate the common and the unique information provided by each of the 3 scales. Results-The different scale values correspond to gradually different patient status, confirming that information is lost when a scale is collapsed to just 2 values, whether recovered or not. The scales shared 90.7% (95% CI, 84.5-96.9) of their information, with no individual scale contributing unique information. Conclusions-Salient stroke outcome information is lost when an ordinal scale is collapsed into fewer categories. In contrast, the full scales provide a comprehensive patient outcome estimate. Furthermore, in the context of stroke clinical trials, those scales are highly correlated, providing the rationale to pool them into a single estimate. These insights may be used to optimize the analysis of stroke trials to increase study power to detect efficacious interventions. (Stroke. 2010;41:e143-e150.)
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