Evaluating the risk of bias in randomized clinical trials of methylphenidate in attention deficit/hyperactivity disorder: application of confirmatory factor analysis

• Grant number: 16/08208-8
• Support type: Scholarships in Brazil - Scientific Initiation
• Effective date (Start): August 01, 2016
• Effective date (End): July 31, 2017
• Field of knowledge: Health Sciences - Medicine - Psychiatry
• Principal researcher: Hugo Cogo Moreira
• Grantee: Raissa Rodrigues Tartari
• Home Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil

Abstract

The attention deficit hyperactivity disorder (ADHD) is described by the early onset of symptomatic triad of inattention, hyperactivity and impulsivity, causing significant interference in social, academic or occupational functioning. The treatment of ADHD involves psychopharmacological and psychotherapeutic interventions. The use of stimulants for the treatment of ADHD is recommended by US and most recent European guidelines as first choice in the treatment of the disorder. Methylphenidate is one of the most widely studied and used medications for treating ADHD in Brazil.Moreover, randomized clinical trials when well designed and executed provide the best level of scientific evidence on the effectiveness of interventions in health, but clinical trials with inadequate methodology are associated with bias. Thus, assessing the risks of the underlying biases in the methodology of clinical trials included in systematic reviews is importance to analyze the results, since clinical studies with questionable methodologies can generate uncertain results. In summary, the medicine depends on the transparency of clinical trials reports. That way, in the context of systematic reviews/ meta-analyzes of clinical trials, there is a section dedicated to assess the possible biases of risks contained in each of the clinical trials included there. Systematic reviews from Cochrane Group follow seven assessment bias indicators in clinical studies.It is proposed with this project to provide evidence regarding the construct validity of the indicators used by Cochrane in the context of clinical trials of methylphenidate use in ADHD, involving methylphenidate in children with ADHD and, consequently, generate a factor score (one dimensional indicator) of the risk of bias in the studies. Confirmatory factor analysis will be used to assess the factor score, by the Mplus software. The sample consists of clinical trials in a systematic review on the use of methylphenidate in the treatment of ADHD. The systematic reviews database is Cochrane Library. The systematic review used is titled "Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD)", from November/2015 (publication date),and has a total of 185 clinical trials. For each study, 7 indicators will be tabulated using a Likert scale format (three categories of responses, low risk, unclear, and high risk).Thus, it is expected with this research project provide evidence of construct validity about the indicators used in clinical trials on the use of methylphenidate in attention deficit hyperactivity disorder (ADHD). Provide evidence about this assessment tool in the risk of bias will bring a very direct and pragmatic response: are these indicators adequately evaluating the latent trait of risk of bias in clinical trials?

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

RODRIGUES-TARTARI, RAISSA; SWARDFAGER, WALTER; SALUM, GIOVANNI A.; ROHDE, LUIS A.; COGO-MOREIRA, HUGO. Assessing risk of bias in randomized controlled trials of methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD). INTERNATIONAL JOURNAL OF METHODS IN PSYCHIATRIC RESEARCH, v. 27, n. 1 MAR 2018. Web of Science Citations: 5.