Nicolas Hoertel1, Pierre de Maricourt, Julien Katz, Raphaël Doukhan, Pierre Lavaud, Hugo Peyre, Frédéric Limosin. 1. From the *Service de Psychiatrie, Assistance Publique-Hôpitaux de Paris, Hôpital Corentin-Celton; †Université Paris Descartes, PRES Sorbonne Paris Cité; ‡INSERM UMR 894, Centre Psychiatrie et Neurosciences; §Service Hospitalo-Universitaire, Hôpital Sainte-Anne, Paris; ∥Groupe Henri Mondor-Albert Chenevier, Pôle de Psychiatrie, Assistance Publique-Hôpitaux de Paris, Créteil; ¶Service de Pédopsychiatrie, Assistance Publique-Hôpitaux de Paris, Hôpital Robert Debré; and #Laboratoire de Sciences Cognitives et Psycholinguistique, Ecole Normale Supérieure, CNRS, EHESS, Paris, France.
Abstract
BACKGROUND: The present study sought to quantify the generalizability of clinical trial results in individuals with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of social anxiety disorder (SAD) to a large representative community sample. METHODS: Data were derived from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions, a large nationally representative sample of 34,653 adults from the US population. We applied a standard set of exclusion criteria representative of pharmacological and psychotherapy clinical trials to all adults with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of SAD (n = 965) in the past 12 months and then to a subsample of participants seeking treatment (n = 363). Our aim was to assess how many participants with SAD would fulfill typical eligibility criteria. RESULTS: We found that more than 7 of 10 respondents from the overall SAD sample in a typical pharmacological efficacy trial and more than 6 of 10 participants in a typical psychotherapy efficacy trial would have been excluded by at least 1 criterion. In addition, more than 8 of 10 respondents seeking treatment for SAD would have been excluded from participation in a typical pharmacological or psychotherapy efficacy trial. Having a current major depression explained a large proportion of ineligibility. CONCLUSIONS: Clinical trials should carefully consider the impact of exclusion criteria on the generalizability of their results and explain the rationale for their use. For SAD treatment trials to adequately inform clinical practice, the eligibility rate must be increased through a general relaxation of overly stringent eligibility criteria.
BACKGROUND: The present study sought to quantify the generalizability of clinical trial results in individuals with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of social anxiety disorder (SAD) to a large representative community sample. METHODS: Data were derived from the 2004-2005 National Epidemiologic Survey on Alcohol and Related Conditions, a large nationally representative sample of 34,653 adults from the US population. We applied a standard set of exclusion criteria representative of pharmacological and psychotherapy clinical trials to all adults with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of SAD (n = 965) in the past 12 months and then to a subsample of participants seeking treatment (n = 363). Our aim was to assess how many participants with SAD would fulfill typical eligibility criteria. RESULTS: We found that more than 7 of 10 respondents from the overall SAD sample in a typical pharmacological efficacy trial and more than 6 of 10 participants in a typical psychotherapy efficacy trial would have been excluded by at least 1 criterion. In addition, more than 8 of 10 respondents seeking treatment for SAD would have been excluded from participation in a typical pharmacological or psychotherapy efficacy trial. Having a current major depression explained a large proportion of ineligibility. CONCLUSIONS: Clinical trials should carefully consider the impact of exclusion criteria on the generalizability of their results and explain the rationale for their use. For SAD treatment trials to adequately inform clinical practice, the eligibility rate must be increased through a general relaxation of overly stringent eligibility criteria.
Authors: Carlos Blanco; Aimee N Campbell; Melanie M Wall; Mark Olfson; Shuai Wang; Edward V Nunes Journal: J Clin Psychiatry Date: 2017-01 Impact factor: 4.384
Authors: Rany Abend; Leone de Voogd; Elske Salemink; Reinout W Wiers; Koraly Pérez-Edgar; Amanda Fitzgerald; Lauren K White; Giovanni A Salum; Jie He; Wendy K Silverman; Jeremy W Pettit; Daniel S Pine; Yair Bar-Haim Journal: Depress Anxiety Date: 2017-12-06 Impact factor: 6.505
Authors: Charles Ouazana-Vedrines; Thomas Lesuffleur; Anne Cuerq; Anne Fagot-Campagna; Antoine Rachas; Chrystelle Gastaldi-Ménager; Nicolas Hoertel; Frédéric Limosin; Cédric Lemogne; Philippe Tuppin Journal: Front Psychiatry Date: 2022-09-08 Impact factor: 5.435