Children, older adults are underrepresented in eating disorder trials
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Children, adolescents and older adults were underrepresented in U.S. clinical trials investigating eating disorders, despite federal guidance urging increased participation of individuals of all ages, according to researchers.
Men and individuals of certain racial and ethnic groups were also underrepresented in eating disorder trials. The findings were published in JAMA Network Open.
“Our study further supports the need to increase diverse participation in clinical trials overall and specifically in eating disorder studies,” Helen Burton Murray, PhD, the director of the GI behavioral health program and a staff psychologist in the department of psychiatry at Massachusetts General hospital, and colleagues wrote.
In a cross-sectional study, Burton Murray and colleagues analyzed data from completed interventional studies on eating disorders that were conducted from Jan. 1, 2011, to Jan. 1, 2021. Studies conducted outside of the U.S. were excluded.
The researchers assessed the age, sex and racial and ethnic background of participants in 21 trials that met the inclusion criteria. Among the trials, 57% were for binge eating disorder, 33% were for anorexia nervosa, 5% were for bulimia nervosa and 5% were for another eating disorder. The trials investigated 16 drugs, four behavioral interventions and one other intervention.
Most trials included adults only (76%), while only five trials (24%) included both adults and children. None of the trials included children only, according to Burton Murray and colleagues. Three out of the four trials that allowed for the inclusion of older adults did not enroll any. Meanwhile, five studies (24%) included women only, and the remaining trials overrepresented them; 83% of all study participants analyzed were women.
“Although [eating disorders] occur more frequently in women, it is important to investigate the causes, treatments and outcomes across the gender spectrum, including in men.
Men were underrepresented despite national prevalence rates indicating that men make up 19% of adults with anorexia nervosa, 19% of adults with bulimia nervosa and 40% of adults with binge eating disorder,, according to the researchers.
They also reported that of the 21 trials, 13 (62%) reported race and nine (43%) reported ethnicity, with representation varying by intervention category. Of the 1,828 participants with an identified race, 3% were Asian, which is lower than the U.S. population of Asian residents (6%). Similarly, of the 1,629 participants with identified ethnicity, 13% were Hispanic, which is lower than the U.S. population of Hispanic residents (19%).
The findings suggest that there is “inadequate inclusion of males and individuals across the lifespan in clinical trial research for eating disorders,” Burton Murray told Healio. The findings also provide “evidence that reporting of race and ethnicity is subpar.”
Moreover, only 19% of the trials studied behavioral treatments, which are the “mainstay” for treating eating disorders, she added.
“Clinical trial research has been historically conducted without the input of patient stakeholders and include recruitment methods that create barriers to reaching patients who are underrepresented in clinical trial research,” Burton Murray said. “Researchers are starting to change these methods, but efforts with community engagement for recruitment can improve equitable inclusion in clinical trial research.”
References:
Flores LE, et al. JAMA Netw Open. 2022;doi:10.1001/jamanetworkopen.2022.0051.
Hudson JI, et al. Biol Psychol. 2006;doi:10.1016/j.biopsych.2006.03.040.