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

ABSTRACT:

Background

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.

Methods

Systematic review using PRISMA. We searched PubMed, EMBASE and The Cochrane Library. All studies were screened for eligibility by two authors.

Results

Our search returned 520 unique studies of which 12 were included. Only one study invest

SUBMITTER: Schroll JB 

PROVIDER: S-EPMC3401103 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature