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A cumulative meta-analysis of selective serotonin reuptake inhibitors in pediatric depression: did unpublished studies influence the efficacy/safety debate?

OBJECTIVE: The aim of this study was to assess whether unpublished trials of serotonin reuptake inhibitors in pediatric depression impacted efficacy or safety conclusions, and to examine the evolution of information contributing to the safety/efficacy debate. METHOD: From 939 potentially relevant studies extracted from Medline, Cinahl, Biosis, and Cochrane databases, and from the United Kingdom's Committee on Safety of Medicines website, we examined 38 studies: Ten published and five unpublished randomized, controlled trials, 22 observational studies, and one crossover trial. We performed cumulative and non-cumulative meta-analyses and generated pooled relative rates of response and serious adverse events for high-quality randomized, controlled trials. RESULTS: Unpublished studies did not substantially alter the risk-to-benefit determination. Cumulative meta-analyses of seven randomized, controlled trials for efficacy and 11 randomized, controlled trials for safety suggest an adverse safety/efficacy profile for selective serotonin reuptake inhibitors (SSRIs) overall. Fluoxetine and citalopram appear to offer favorable risk to benefit profiles, while shorter-acting agents pose greater risks and provide marginal benefit. CONCLUSIONS: While simple meta-analysis across all SSRIs for treatment of pediatric depression provided general efficacy and safety information, meta-analysis of individual drugs and use of cumulative meta-analytic techniques may have expedited our ability to formulate conclusions about safety and efficacy of SSRIs in pediatric depression.

Adolescent↗
PubMed2000

Reproducibility of peer review in clinical neuroscience. Is agreement between reviewers any greater than would be expected by chance alone?

We aimed to determine the reproducibility of assessments made by independent reviewers of papers submitted for publication to clinical neuroscience journals and abstracts submitted for presentation at clinical neuroscience conferences. We studied two journals in which manuscripts were routinely assessed by two reviewers, and two conferences in which abstracts were routinely scored by multiple reviewers. Agreement between the reviewers as to whether manuscripts should be accepted, revised or rejected was not significantly greater than that expected by chance [kappa = 0.08, 95% confidence interval (CI) -0.04 to -0.20] for 179 consecutive papers submitted to Journal A, and was poor (kappa = 0.28, 0.12 to 0. 40) for 116 papers submitted to Journal B. However, editors were very much more likely to publish papers when both reviewers recommended acceptance than when they disagreed or recommended rejection (Journal A, odds ratio = 73, 95% CI = 27 to 200; Journal B, 51, 17 to 155). There was little or no agreement between the reviewers as to the priority (low, medium, or high) for publication (Journal A, kappa = -0.12, 95% CI -0.30 to -0.11; Journal B, kappa = 0.27, 0.01 to 0.53). Abstracts submitted for presentation at the conferences were given a score of 1 (poor) to 6 (excellent) by multiple independent reviewers. For each conference, analysis of variance of the scores given to abstracts revealed that differences between individual abstracts accounted for only 10-20% of the total variance of the scores. Thus, although recommendations made by reviewers have considerable influence on the fate of both papers submitted to journals and abstracts submitted to conferences, agreement between reviewers in clinical neuroscience was little greater than would be expected by chance alone.

Abstracting and Indexing↗