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Novel methods to deal with publication biases: secondary analysis of antidepressant trials in the FDA trial registry database and related journal publications

Research output: Contribution to Journal/Magazine › Journal article › peer-review

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Novel methods to deal with publication biases: secondary analysis of antidepressant trials in the FDA trial registry database and related journal publications. / Moreno, Santiago G.; Sutton, Alex J.; Turner, Erick H. et al.
In: BMJ, Vol. 339, b2981, 2009.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

Harvard

Moreno, SG, Sutton, AJ, Turner, EH, Abrams, KR, Cooper, NJ, Palmer, TM & Ades, AE 2009, 'Novel methods to deal with publication biases: secondary analysis of antidepressant trials in the FDA trial registry database and related journal publications', BMJ, vol. 339, b2981.

APA

Moreno, S. G., Sutton, A. J., Turner, E. H., Abrams, K. R., Cooper, N. J., Palmer, T. M., & Ades, A. E. (2009). Novel methods to deal with publication biases: secondary analysis of antidepressant trials in the FDA trial registry database and related journal publications. BMJ, 339, Article b2981.

Vancouver

Moreno SG, Sutton AJ, Turner EH, Abrams KR, Cooper NJ, Palmer TM et al. Novel methods to deal with publication biases: secondary analysis of antidepressant trials in the FDA trial registry database and related journal publications. BMJ. 2009;339:b2981. Epub 2009 Aug 7.

Author

Moreno, Santiago G. ; Sutton, Alex J. ; Turner, Erick H. et al. / Novel methods to deal with publication biases : secondary analysis of antidepressant trials in the FDA trial registry database and related journal publications. In: BMJ. 2009 ; Vol. 339.

Bibtex

@article{a718542286bb4363b8eb2aec1630f8e6,
title = "Novel methods to deal with publication biases: secondary analysis of antidepressant trials in the FDA trial registry database and related journal publications",
abstract = "OBJECTIVE: To assess the performance of novel contour enhanced funnel plots and a regression based adjustment method to detect and adjust for publication biases.DESIGN: Secondary analysis of a published systematic literature review.DATA SOURCES: Placebo controlled trials of antidepressants previously submitted to the US Food and Drug Administration (FDA) and matching journal publications.METHODS: Publication biases were identified using novel contour enhanced funnel plots, a regression based adjustment method, Egger's test, and the trim and fill method. Results were compared with a meta-analysis of the gold standard data submitted to the FDA.RESULTS: Severe asymmetry was observed in the contour enhanced funnel plot that appeared to be heavily influenced by the statistical significance of results, suggesting publication biases as the cause of the asymmetry. Applying the regression based adjustment method to the journal data produced a similar pooled effect to that observed by a meta-analysis of the FDA data. Contrasting journal and FDA results suggested that, in addition to other deviations from study protocol, switching from an intention to treat analysis to a per protocol one would contribute to the observed discrepancies between the journal and FDA results.CONCLUSION: Novel contour enhanced funnel plots and a regression based adjustment method worked convincingly and might have an important part to play in combating publication biases.",
keywords = "Antidepressive Agents, Publication Bias, Randomized Controlled Trials as Topic, Registries, Regression Analysis, Statistics as Topic, United States, United States Food and Drug Administration",
author = "Moreno, {Santiago G.} and Sutton, {Alex J.} and Turner, {Erick H.} and Abrams, {Keith R.} and Cooper, {Nicola J.} and Palmer, {Tom M.} and Ades, {A. E.}",
year = "2009",
language = "English",
volume = "339",
journal = "BMJ",
issn = "0959-8138",
publisher = "British Medical Association",

}

RIS

TY - JOUR

T1 - Novel methods to deal with publication biases

T2 - secondary analysis of antidepressant trials in the FDA trial registry database and related journal publications

AU - Moreno, Santiago G.

AU - Sutton, Alex J.

AU - Turner, Erick H.

AU - Abrams, Keith R.

AU - Cooper, Nicola J.

AU - Palmer, Tom M.

AU - Ades, A. E.

PY - 2009

Y1 - 2009

N2 - OBJECTIVE: To assess the performance of novel contour enhanced funnel plots and a regression based adjustment method to detect and adjust for publication biases.DESIGN: Secondary analysis of a published systematic literature review.DATA SOURCES: Placebo controlled trials of antidepressants previously submitted to the US Food and Drug Administration (FDA) and matching journal publications.METHODS: Publication biases were identified using novel contour enhanced funnel plots, a regression based adjustment method, Egger's test, and the trim and fill method. Results were compared with a meta-analysis of the gold standard data submitted to the FDA.RESULTS: Severe asymmetry was observed in the contour enhanced funnel plot that appeared to be heavily influenced by the statistical significance of results, suggesting publication biases as the cause of the asymmetry. Applying the regression based adjustment method to the journal data produced a similar pooled effect to that observed by a meta-analysis of the FDA data. Contrasting journal and FDA results suggested that, in addition to other deviations from study protocol, switching from an intention to treat analysis to a per protocol one would contribute to the observed discrepancies between the journal and FDA results.CONCLUSION: Novel contour enhanced funnel plots and a regression based adjustment method worked convincingly and might have an important part to play in combating publication biases.

AB - OBJECTIVE: To assess the performance of novel contour enhanced funnel plots and a regression based adjustment method to detect and adjust for publication biases.DESIGN: Secondary analysis of a published systematic literature review.DATA SOURCES: Placebo controlled trials of antidepressants previously submitted to the US Food and Drug Administration (FDA) and matching journal publications.METHODS: Publication biases were identified using novel contour enhanced funnel plots, a regression based adjustment method, Egger's test, and the trim and fill method. Results were compared with a meta-analysis of the gold standard data submitted to the FDA.RESULTS: Severe asymmetry was observed in the contour enhanced funnel plot that appeared to be heavily influenced by the statistical significance of results, suggesting publication biases as the cause of the asymmetry. Applying the regression based adjustment method to the journal data produced a similar pooled effect to that observed by a meta-analysis of the FDA data. Contrasting journal and FDA results suggested that, in addition to other deviations from study protocol, switching from an intention to treat analysis to a per protocol one would contribute to the observed discrepancies between the journal and FDA results.CONCLUSION: Novel contour enhanced funnel plots and a regression based adjustment method worked convincingly and might have an important part to play in combating publication biases.

KW - Antidepressive Agents

KW - Publication Bias

KW - Randomized Controlled Trials as Topic

KW - Registries

KW - Regression Analysis

KW - Statistics as Topic

KW - United States

KW - United States Food and Drug Administration

M3 - Journal article

C2 - 19666685

VL - 339

JO - BMJ

JF - BMJ

SN - 0959-8138

M1 - b2981

ER -