“Salami Slicing” in Pooled Analyses of Second-Generation Antipsychotics for the Treatment of Depression

Spielmans, Glen I.; Olson, Shaundra; Keicher, Ruth M.

doi:10.1159/000464251

Cited by 2 publications

(2 citation statements)

References 14 publications

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“…Studies of fragmented publishing need to consider possible differences across disciplines or even subdisciplines. The majority of the existing studies analyze fragmented publishing using publications or projects from a specific field (Cheung, Lam, Wang, & Chadha, 2014;Durani, 2006;Hennessey et al, 2012;Le, Moran, Bezuhly, & Hong, 2015;Schein & Paladugu, 2001;Spielmans, Olson, & Keicher, 2017;Trujillo & Oren, 2018), but exceptions to this rule do exist. Ebrahim et al (2016) use a study type as starting point focusing on randomized controlled trials, and Kim, Bae, Hahm, and Cho (2014) analyze medical journals from a specific country.…”

Section: Introductionmentioning

confidence: 99%

Fragmented publishing: a large-scale study of health science

et al. 2019

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Section: Introductionmentioning

confidence: 99%

Fragmented publishing: a large-scale study of health science

et al. 2019

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“…The research question of pooled-trials publications also often differs from the original research question. For example, they may focus on differential efficacy in patient subgroups, leading to substantial redundancy and the suggestion that many of these articles represent ‘salami publications’ (Spielmans et al ., 2010, 2017). Additionally, negative trials, in contrast to positive trials, may be published exclusively in pooled-trials publications.…”

Section: Introductionmentioning

confidence: 99%

Hiding negative trials by pooling them: a secondary analysis of pooled-trials publication bias in FDA-registered antidepressant trials

et al. 2018

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BackgroundPrevious studies on reporting bias generally examined whether trials were published in stand-alone publications. In this study, we investigated whether pooled-trials publications constitute a specific form of reporting bias. We assessed whether negative trials were more likely to be exclusively published in pooled-trials publications than positive trials and examined the research questions, individual trial results, and conclusions presented in these articles.MethodsData from a cohort of 105 randomized controlled trials of 16 antidepressants were extracted from earlier publications and the corresponding Food and Drug Administration (FDA) reviews. A systematic literature search was conducted to identify pooled-trials publications.ResultsWe found 107 pooled-trials publications that reported results of 23 (72%) of 32 trials not published in stand-alone publications. Only two (3.8%) of 54 positive trials were published exclusively in pooled-trials publications, compared with 21 (41.1%) of 51 negative trials (p < 0.001). Thirteen (12%) of 107 publications had as primary aim to present data on the trial's primary research question (drug efficacy compared with placebo). Only four of these publications, reporting on five (22%) trials, presented individual efficacy data for the primary research question. Additionally, only five (5%) of 107 pooled-trials publications had a negative conclusion.ConclusionsCompared with positive trials, negative trials of antidepressants for depression were much more likely to be reported exclusively in pooled-trials publications. Pooled-trials publications flood the evidence base with often-redundant articles that, instead of addressing the original primary research question, present (positive) results on secondary questions. Therefore, pooled-trials publications distort the apparent risk–benefit profile of antidepressants.

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“Salami Slicing” in Pooled Analyses of Second-Generation Antipsychotics for the Treatment of Depression

Cited by 2 publications

References 14 publications

Fragmented publishing: a large-scale study of health science

Fragmented publishing: a large-scale study of health science

Hiding negative trials by pooling them: a secondary analysis of pooled-trials publication bias in FDA-registered antidepressant trials

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