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Influence of Written Informed Consent for Methylphenidate on Medicine Persistence Rates in Children with Attention-Deficit Hyperactivity Disorder

Naenen-Hernani, Kristian MD*; Palazón-Bru, Antonio PhD; Colomina-Climent, Francisco MD, PhD; Gil-Guillén, Vicente F. MD, PhD; GAIPNA (Alicante Research Group in Child and Adolescent Psychiatry)

Journal of Developmental & Behavioral Pediatrics: October 2017 - Volume 38 - Issue 8 - p 603–610
doi: 10.1097/DBP.0000000000000495
Original Articles

Objective: To assess the influence of written informed consent on nonpersistence with methylphenidate treatment in children with attention-deficit hyperactivity disorder (ADHD).

Methods: We undertook a cohort study including 141 children with ADHD who started treatment with methylphenidate, with a follow-up of 6 months. The main outcome variable was nonpersistence, defined as discontinuation of treatment by the patient. Two groups were analyzed with and without written informed consent. Use of this consent was the decision of the prescribing physician because the law allows its use on a voluntary basis. The homogeneity of both groups was verified by evaluating sex, type of ADHD, methylphenidate dosage, age, severity, and other psychiatric disorders. To assess the influence of consent on nonpersistence, bootstrapping was used to determine relative risk reduction (RRR) and number needed to treat (NNT).

Results: Among the participants who completed follow-up, 67 provided written informed consent and 63 did not. We found the following nonpersistence frequencies in each group: (1) with written informed consent: 5 (7.5%) and (2) without written informed consent: 15 (23.8%). The clinically significant results were RRR, 0.67 ± 0.17; NNT, 7 (5–9).

Conclusion: The use of written informed consent yielded higher persistence rates. Further studies are needed to determine whether we can use this procedure routinely in clinical practice.

*Department of Psychiatry, General University Hospital of Alicante, Alicante, Spain;

Department of Clinical Medicine, Miguel Hernández University, San Juan de Alicante, Alicante, Spain.

Address for reprints: Antonio Palazón-Bru, PhD, Department of Clinical Medicine, Miguel Hernández University, Carretera de Valencia, Alicante S/N, 03550 San Juan de Alicante, Alicante, Spain; e-mail: antonio.pb23@gmail.com.

Disclosure: The authors declare no conflict of interest.

GAIPNA is formed by: Kristian Naenen-Hernani, Raquel García-Bouzá, María Encarnación Terrés-Ruiz, Ana Belén Martí-Martínez, Helena Romero-Escobar, Elena Catalá-Ortuño, and Tomás J Cantó-Diez.

Received January , 2017

Accepted June , 2017

Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved.