Discrepancies Between Randomized Controlled Trial Registry Entries and Content of Corresponding Manuscripts Reported in Anesthesiology Journals

Oliveira, Gildàsio S. De; Jung, Michael J.; McCarthy, Robert J.

doi:10.1213/ane.0000000000000824

Cited by 32 publications

(32 citation statements)

References 19 publications

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“…Despite ICMJE requirements, completeness and quality of trial registry information remain obstacles [13]. Nonetheless, information contained in trial registries allows for examining both publication and selective reporting bias [2]. …”

Section: Introductionmentioning

confidence: 99%

Evidence of selective reporting bias in hematology journals: A systematic review

et al. 2017

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IntroductionSelective reporting bias occurs when chance or selective outcome reporting rather than the intervention contributes to group differences. The prevailing concern about selective reporting bias is the possibility of results being modified towards specific conclusions. In this study, we evaluate randomized controlled trials (RCTs) published in hematology journals, a group in which selective outcome reporting has not yet been explored.MethodsOur primary goal was to examine discrepancies between the reported primary and secondary outcomes in registered and published RCTs concerning hematological malignancies reported in hematology journals with a high impact factor. The secondary goals were to address whether outcome reporting discrepancies favored statistically significant outcomes, whether a pattern existed between the funding source and likelihood of outcome reporting bias, and whether temporal trends were present in outcome reporting bias. For trials with major outcome discrepancies, we contacted trialists to determine reasons for these discrepancies. Trials published between January 1, 2010 and December 31, 2015 in Blood; British Journal of Haematology; American Journal of Hematology; Leukemia; and Haematologica were included.ResultsOf 499 RCTs screened, 109 RCTs were included. Our analysis revealed 118 major discrepancies and 629 total discrepancies. Among the 118 discrepancies, 30 (25.4%) primary outcomes were demoted, 47 (39.8%) primary outcomes were omitted, and 30 (25.4%) primary outcomes were added. Three (2.5%) secondary outcomes were upgraded to a primary outcome. The timing of assessment for a primary outcome changed eight (6.8%) times. Thirty-one major discrepancies were published with a P-value and twenty-five (80.6%) favored statistical significance. A majority of authors whom we contacted cited a pre-planned subgroup analysis as a reason for outcome changes.ConclusionOur results suggest that outcome changes occur frequently in hematology trials. Because RCTs ultimately underpin clinical judgment and guide policy implementation, selective reporting could pose a threat to medical decision making.

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Section: Introductionmentioning

confidence: 99%

Evidence of selective reporting bias in hematology journals: A systematic review

et al. 2017

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“…One particular form of bias, known as outcome reporting bias, occurs when trialists fail to report prespecified outcomes, report primary outcomes that were not prespecified, report statistically significant secondary outcomes as primary outcomes, or report nonsignificant primary outcomes as secondary outcomes [1,2]. This form of bias is well documented in the medical literature [3,4,5,6,7,8,9]. Dwan et al found that 40 to 62% of reviewed trials had at least one primary outcome that was changed, omitted, or newly introduced [10].…”

Section: Introductionmentioning

confidence: 99%

“…Selective outcome reporting skews this knowledge base when only “positive” findings (i.e., statistically significant or showing a benefit) are reported in clinical trials [3]. Reports with positive findings are three times more likely to be published than trials with “negative” results.…”

Section: Introductionmentioning

confidence: 99%

Systematic review: Outcome reporting bias is a problem in high impact factor neurology journals

et al. 2017

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BackgroundSelective outcome reporting is a significant methodological concern. Comparisons between the outcomes reported in clinical trial registrations and those later published allow investigators to understand the extent of selection bias among trialists. We examined the possibility of selective outcome reporting in randomized controlled trials (RCTs) published in neurology journals.MethodsWe searched PubMed for randomized controlled trials from Jan 1, 2010 –Dec 31, 2015 published in the top 3 impact factor neurology journals. These articles were screened according to specific inclusion criteria. Each author individually extracted data from trials following a standardized protocol. A second author verified each extracted element and discrepancies were resolved. Consistency between registered and published outcomes was evaluated and correlations between discrepancies and funding, journal, and temporal trends were examined.Results180 trials were included for analysis. 10 (6%) primary outcomes were demoted, 38 (21%) primary outcomes were omitted from the publication, and 61 (34%) unregistered primary outcomes were added to the published report. There were 18 (10%) cases of secondary outcomes being upgraded to primary outcomes in the publication, and there were 53 (29%) changes in timing of assessment. Of 82 (46%) major discrepancies with reported p-values, 54 (66.0%) favored publication of statistically significant results.ConclusionAcross trials, we found 180 major discrepancies. 66% of major discrepancies with a reported p-value (n = 82) favored statistically significant results. These results suggest a need within neurology to provide more consistent and timely registration of outcomes.

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“…11 As a specialty, anesthesiology is not spared this problemin 2013, 48% of registered RCTs published in five anesthesiology journals had major discrepancies between the outcomes, sample sizes, or interventions that were registered and those that were actually reported. 12 Switching the outcomes registered and those reported can ''spin'' the research results to favour positive findings 4 and may constitute one of the reasons why some observers think that a great deal of published research is suspect. 13,14 With this background in mind, we consider a study in this issue of the Journal that further investigates the issue of publication bias in the anesthesiology literature.…”

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confidence: 99%

“…11 En tant que spécialité, l'anesthésiologie n'est pas épargnée par ce problème : en 2013, 48 % des ECR enregistrés publiés dans cinq journaux d'anesthésiologie présentaient des divergences majeures entre les résultats, les tailles d'échantillons ou les interventions qui avaient été enregistrés et ceux qui avaient été effectivement publiés. 12 Le remplacement des résultats enregistrés par les résultats publiés peut « dorer » les résultats de la recherche en faveur de constatations positives 4 et pourrait être l'une des raisons pour lesquelles certains observateurs pensent qu'un grand nombre d'études publiées est suspect. 13,14 Dans ce contexte, nous examinons une étude dans ce numéro du Journal qui s'intéresse plus particulièrement aux biais de publication en anesthésiologie.…”

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Publication bias in the anesthesiology literature: shifting the focus from the “positive” to the “truth”

Jones

2016

Can J Anesth/J Can Anesth

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Discrepancies Between Randomized Controlled Trial Registry Entries and Content of Corresponding Manuscripts Reported in Anesthesiology Journals

Abstract: We detected a high rate of major discrepancies between the published results and the original registered protocols for clinical trial manuscripts in high-impact anesthesiology journals. Future action to reduce the negative impact of reporting bias in the anesthesiology field is warranted.

Cited by 32 publications

References 19 publications

Evidence of selective reporting bias in hematology journals: A systematic review

Evidence of selective reporting bias in hematology journals: A systematic review

Systematic review: Outcome reporting bias is a problem in high impact factor neurology journals

Publication bias in the anesthesiology literature: shifting the focus from the “positive” to the “truth”

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