Factors influencing research drug trials in adolescents with anorexia nervosa.
This study examined factors that contributed to patient's eligibility and participation in a randomized controlled trial involving olanzapine for the adjunctive treatment of anorexia nervosa (AN). Factors involving patient eligibility and willingness to participate were systematically recorded for all patients approached to participate. Of the 92 patients that were assessed and treated over the study timeframe, only 27 patients (29%) met full criteria for inclusion, of which just 7 enrolled (26%). The most common reasons for study refusal related to fears associated with medication effects and refusal to consider medication as a treatment option (70%). Factors affecting recruitment in psychopharmacological studies involving AN in youth are discussed.
Norris
Mark L
ML
Department of Paediatrics, Children's Hospital of Eastern Ontario/University of Ottawa, Ottawa, Ontario, Canada.
Spettigue
Wendy
W
Buchholz
Annick
A
Henderson
Katherine A
KA
Obeid
Nicole
N
D000293:Adolescent; D000856:Anorexia Nervosa / Q000188:drug therapy*; D001569:Benzodiazepines / Q000627:therapeutic use*; D017028:Caregivers; D004608:Eligibility Determination; D006801:Humans; D000077152:Olanzapine; D009864:Ontario; D010342:Patient Acceptance of Health Care; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*
D001569:Benzodiazepines; D000077152:Olanzapine; D017367:Selective Serotonin Reuptake Inhibitors