Challenges in coding adverse events in clinical trials: a systematic review

Research output: Contribution to journal › Journal article › Research › peer-review

Standard

Challenges in coding adverse events in clinical trials : a systematic review. / Schroll, Jeppe Bennekou; Maund, Emma; Gøtzsche, Peter C.

In: P L o S One, Vol. 7, No. 7, 2012, p. e41174.

Research output: Contribution to journal › Journal article › Research › peer-review

Harvard

Schroll, JB, Maund, E & Gøtzsche, PC 2012, 'Challenges in coding adverse events in clinical trials: a systematic review', P L o S One, vol. 7, no. 7, pp. e41174. https://doi.org/10.1371/journal.pone.0041174

APA

Schroll, J. B., Maund, E., & Gøtzsche, P. C. (2012). Challenges in coding adverse events in clinical trials: a systematic review. P L o S One, 7(7), e41174. https://doi.org/10.1371/journal.pone.0041174

Vancouver

Schroll JB, Maund E, Gøtzsche PC. Challenges in coding adverse events in clinical trials: a systematic review. P L o S One. 2012;7(7):e41174. https://doi.org/10.1371/journal.pone.0041174

Author

Schroll, Jeppe Bennekou ; Maund, Emma ; Gøtzsche, Peter C. / Challenges in coding adverse events in clinical trials : a systematic review. In: P L o S One. 2012 ; Vol. 7, No. 7. pp. e41174.

Bibtex

@article{63c33dfc19a9493fa8265ee5d890b030,
title = "Challenges in coding adverse events in clinical trials: a systematic review",
abstract = "Misclassification of adverse events in clinical trials can sometimes have serious consequences. Therefore, each of the many steps involved, from a patient's adverse experience to presentation in tables in publications, should be as standardised as possible, minimising the scope for interpretation. Adverse events are categorised by a predefined dictionary, e.g. MedDRA, which is updated biannually with many new categories. The objective of this paper is to study interobserver variation and other challenges of coding.",
author = "Schroll, {Jeppe Bennekou} and Emma Maund and G{\o}tzsche, {Peter C}",
year = "2012",
doi = "10.1371/journal.pone.0041174",
language = "English",
volume = "7",
pages = "e41174",
journal = "PLoS ONE",
issn = "1932-6203",
publisher = "Public Library of Science",
number = "7",

}

RIS

TY - JOUR

T1 - Challenges in coding adverse events in clinical trials

T2 - a systematic review

AU - Schroll, Jeppe Bennekou

AU - Maund, Emma

AU - Gøtzsche, Peter C

PY - 2012

Y1 - 2012

N2 - Misclassification of adverse events in clinical trials can sometimes have serious consequences. Therefore, each of the many steps involved, from a patient's adverse experience to presentation in tables in publications, should be as standardised as possible, minimising the scope for interpretation. Adverse events are categorised by a predefined dictionary, e.g. MedDRA, which is updated biannually with many new categories. The objective of this paper is to study interobserver variation and other challenges of coding.

AB - Misclassification of adverse events in clinical trials can sometimes have serious consequences. Therefore, each of the many steps involved, from a patient's adverse experience to presentation in tables in publications, should be as standardised as possible, minimising the scope for interpretation. Adverse events are categorised by a predefined dictionary, e.g. MedDRA, which is updated biannually with many new categories. The objective of this paper is to study interobserver variation and other challenges of coding.

U2 - 10.1371/journal.pone.0041174

DO - 10.1371/journal.pone.0041174

M3 - Journal article

C2 - 22911755

VL - 7

SP - e41174

JO - PLoS ONE

JF - PLoS ONE

SN - 1932-6203

IS - 7

ER -

ID: 48458781