Elsevier

Epilepsy & Behavior

Volume 5, Issue 5, October 2004, Pages 743-745
Epilepsy & Behavior

Reporting race/ethnicity in epilepsy clinical trials

https://doi.org/10.1016/j.yebeh.2004.05.010Get rights and content

Abstract

The increasing necessity to address and answer questions regarding disparities in epilepsy among different racial/ethnic groups is not being fulfilled. The present study found that only 6.6% of clinical trials in epilepsy reported the race/ethnicity of study participants, and only 1.9% did try to analyze possible differences between them.

Introduction

There is more need in daily clinical practice to answer questions regarding health disparities among racial and ethnic groups. Investigators, clinicians, and educators are looking into the scientific literature for guidance on addressing health disparities.

The National Institutes of Health now requires that investigators carrying out clinical research demonstrate adequate representation of minorities and diverse ethnic groups in study samples to examine epidemiological characteristics, diverse diagnostic tests, and differential effects of various therapies [1], [2], [3], [4].

There is a need for representation of minorities in clinical research, especially in diseases where known disparities in health exist; in this way we can change our clinical practice so their necessities can be addressed [2], [3], [4].

Epilepsy is a public health problem affecting around 50 million people worldwide [5]. It is the most common serious neurological condition, with an incidence of 50–70 in 100,000 people in industrialized countries and between 100 and 190 per 100,000 in developing countries [6], [7].

The main aim of this study was to examine, in high-impact journals specialized in the areas of neurology and epilepsy, the reporting of race/ethnicity in clinical trials in epilepsy and to determine what factors were associated with reporting of race/ethnicity. Whether analyses by race/ethnicity were described in these reports was also examined.

Section snippets

Methods

A bibliographic search covering the period from January 2000 to January 2004 was performed to identify publications in the following major journals on neurology and epilepsy in the United States: Neurology, Annals of Neurology, Archives of Neurology, Epilepsy & Behavior, and Epilepsia. The journals were chosen because primary reports of clinical trials published in these journals have a large impact on the U.S. neurologist and epileptologist audience due to their high readership. Editorials,

Collection of data and analysis

For each clinical trial, data from tables or the results sections on race/ethnicity of participants, as well as how race/ethnicity was classified, were collected.

Year of publication, funding sources, whether the authors explicitly stated exclusion of any race or ethnicity, and whether authors reported oversampling of minorities were collected. Whether any analysis was conducted by race/ethnicity, as mentioned in the methods, results, or discussion section, was determined.

Results

A total of 318 studies were included. The trials included 160,150 study participants, with sample sizes ranging from 5 to 80,682 (mean=497, median=41). In more than half of the trials (n=176), mean age was reported and ranged from 2.8 to 73.5 years.

None of the trials were classified as race-focused. Of the 318 studies reviewed, only 6.6% (n=21) reported the race/ethnicity of study participants (Table 1). Of studies reporting race/ethnicity, 19% reported only two racial/ethnic categories. Among

Discussion

The findings of this study indicate that results according to race and ethnicity are almost never described in epilepsy clinical trials. Although federal mandates may have increased the participation of minority groups in clinical research, that inclusion has not translated into reporting of results and has not translated into the performance of clinical studies that might guide not only therapeutic, but also all general clinical decisions.

It is well known from different studies that there are

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