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Biomedical subjects

Erik Cobo

Publications and source records attributed to Erik Cobo.

11 recordsLinked to original sources
PubMed2005

[Common and specific methodological features of checklists].

As medical aims, diagnosis, prognosis, intervention and prevention benefit from scientific method, although they have specific characteristics requiring distinct types of design and statistical analysis. The present article aims to provide definitions of the common and differential features of checklists for the main study designs. Distinctions are made between statistical inference and decision, systematic and random error, confirmation and exploration, prediction and intervention, observation and experimentation, and random allocation and random selection. In addition, the main tools available to researchers to control random and systematic errors are described. How all of these elements are contained in the main types of design is discussed. Importantly, checklists are not a measure of the quality of a study but rather represent minimum requirements that aim to improve the quality of scientific reports.

Authorship↗
PubMed2005

[Non-randomized evaluation studies (TREND)].

Nonrandomized intervention trials are needed when randomized clinical trials cannot be performed. To report the results from nonrandomized intervention studies transparently, the TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) checklist should be used. This implies that nonrandomized studies should follow the remaining methodological tools usually employed in randomized trials and that the uncertainty introduced by the allocation mechanism should be explicitly reported and, if possible, quantified.

Authorship↗
PubMed2004

Efficiency of the cross-over design: an empirical estimation.

The aim of the present study is to estimate the relative efficiency of cross-over clinical trials as compared to the corresponding parallel designs. A MEDLINE 'full text' search covering years 2000-2003 over the word 'cross-over' identified 40 true cross-over studies with the parametric approach published in leading medical journals. A parallel design is expected to need, in order to achieve the same power, between 4 and 10 times more subjects than the corresponding cross-over design, meaning that cost of a parallel design can be between 2 and 5 times higher. There is a high proportion (18/40 = 45.0 per cent) of cross-over studies recently published in leading medical journals that, disregarding the CONSORT recommendations, does not provide estimates for the effect size and its standard error, hence, not allowing for the posterior use of the data in a meta-analysis.

Cross-Over Studies↗
PubMed2003

[Effect of statistical review on manuscript quality in Medicina Clínica (Barcelona): a randomized study].

BACKGROUND AND OBJECTIVE: The statistical review of biomedical articles should result in an improved quality. The objective of this study was to compare the effects of clinical review and joint clinical and statistical review on manuscript quality, in articles submitted to Medicina Clínica (Barcelona), a Spanish weekly journal of internal medicine. METHOD: Original papers arriving between May 2000 and February 2001 were randomized either to a clinical review group or a clinical and statistical review group. Two evaluators, blinded to the paper's group, assessed the quality improvement in both groups, from submission to publication using a modified version ot the Goodman et al. scale. The protocol required that final versions arrived before the end of May 2001. RESULTS: Final sample size was 43 manuscripts, evaluated before and after peer review. On the intention to treat analysis, the estimated effect of statistical review was 1.35 (95% CI: -0.45 to 3.16) positive, but not statistically significant. The analysis of the reviewers' comments revealed some protocol deviations. Taking into account the spontaneous inclusion of statistical experts in the clinical group, the estimated effect was statistically significant, with a confidence interval of 0.3 to 3.7. CONCLUSION: The inclusion of a statistical expert in the peer review process improves manuscript quality, although in the intention to treat analysis the improvement was not statistically significant.

Humans↗
PubMed2002

Oral citicoline in acute ischemic stroke: an individual patient data pooling analysis of clinical trials.

BACKGROUND AND PURPOSE: No single neuroprotective agent has been shown to influence outcome after acute stroke. Citicoline has been studied worldwide in many clinical trials with positive findings, but only 1 trial has obtained significant results in the primary efficacy variables. Our objective was to evaluate the effects of oral citicoline in patients with acute ischemic stroke by a data pooling analysis of clinical trials. The primary efficacy end point chosen was the common evaluation of recovery, combining National Institutes of Health Stroke Scale </=1, modified Rankin Scale score </=1, and Barthel Index >/=95 at 3 months using the generalized estimating equations analysis. METHODS: A systematic search of all prospective, randomized, placebo-controlled, double-blind clinical trials with oral citicoline (MEDLINE, Cochrane, and Ferrer Group bibliographic databases) was undertaken. Individual patient data were extracted from each study and pooled in a single data file. The main inclusion criteria included compatible neuroimaging with ischemic stroke, National Institutes of Health Stroke Scale >/=8, and prior modified Rankin Scale score </=1. Four clinical trials using various doses of oral citicoline (500, 1000, and 2000 mg) were identified. RESULTS: Of 1652 randomized patients, 1372 fulfilled the inclusion criteria (583 received placebo, 789 received citicoline). Recovery at 3 months was 25.2% in citicoline-treated patients and 20.2% in placebo-treated patients (odds ratio [OR], 1.33; 95% CI, 1.10 to 1.62; P=0.0034). The dose showing the largest difference with placebo was 2000 mg, with 27.9% of patients achieving recovery (OR, 1.38; 95% CI, 1.10 to 1.72; P=0.0043). The overall safety of citicoline was similar to placebo. CONCLUSIONS: Treatment with oral citicoline within the first 24 hours after onset in patients with moderate to severe stroke increases the probability of complete recovery at 3 months.

Acute Disease↗