Pragmatic Trials: Solving the Dilemma of Psychiatric Nonadherence
This chapter aims to describe pragmatic clinical trials and how they differ from traditional explanatory trials in terms of validity, design, and setting. We discuss the defining principles of pragmatic clinical trials and how they are vital in moving psychiatric research forward to the development of better-informed treatment choices for patients and providers. We describe the Patient-Centered Outcomes Research Institute (PCORI), their tenets, and how they are a large funding source of pragmatic trials and clinical effectiveness research. We highlight two pragmatic clinical trials in the field of child psychiatry as a way of showcasing how pragmatic clinical trials can help in shared decision-making and solve the dilemma of psychiatric nonadherence.
KeywordsPragmatic Clinical trials Adherence
- 6.Trochim W. Translation won’t happen without dissemination and implementation: some measurement and evaluation issues. In: 3rd annual conference on the science of dissemination and implementation. Bethesda. 2010.Google Scholar
- 11.Patient-Centered Outcomes Research Institute (PCORI). (Posted: September 10, 2014; Updated: March 27, 2017) Retrieved from https://www.pcori.org/about-us/our-story. Accessed 26 Aug 2018.
- 12.Star neuroscientist Tom Insel leaves the Google-spawned Verily for…a startup? Wired. https://www.wired.com/2017/05/star-neuroscientist-tom-insel-leaves-google-spawned-verily-startup/. Accessed 26 Aug 2018.
- 13.Paulus MP. Evidence-based pragmatic psychiatry-a call to action. JAMA Psychiatry. 2017;74:1185–6.Google Scholar
- 15.Olfson M, King M, Schoenbaum M. Treatment of young people with antipsychotic medications in the United States. JAMA Psychiatry. 2015;72:867–74.Google Scholar
- 17.Goldstein BI, Birmaher B, Axelson DA, Goldstein TR, Esposito-Smythers C, Strober MA, Hunt J, Leonard H, Gill MK, Iyengar S, Grimm C, Yang M, Ryan ND, Keller MB. Preliminary findings regarding overweight and obesity in pediatric bipolar disorder. J Clin Psychiatry. 2008;69:1953–9.CrossRefGoogle Scholar
- 20.Patel NC, Hariparsad M, Matias-Akthar M, Sorter MT, Barzman DH, Morrison JA, Stanford KE, Strakowski SM, DelBello MP. Body mass indexes and lipid profiles in hospitalized children and adolescents exposed to atypical antipsychotics. J Child Adolesc Psychopharmacol. 2007;17:303–11.CrossRefGoogle Scholar
- 27.Galling B, Roldán A, Nielsen RE, Nielsen J, Gerhard T, Carbon M, Stubbs B, Vancampfort D, De Hert M, Olfson M, Kahl KG, Martin A, Guo JJ, Lane HY, Sung FC, Liao CH, Arango C, Correll CU. Type 2 diabetes mellitus in youth exposed to antipsychotics: a systematic review and meta-analysis. JAMA Psychiatry. 2016;73:247–59.CrossRefGoogle Scholar
- 28.Christian R, Saavedra L, Gaynes BN, et al. Future research needs for first- and second-generation antipsychotics for children and young adults. [Internet]. Rockville: Agency for Healthcare Research and Quality (US); 2012. (Future Research Needs Papers, No. 13).Google Scholar
- 38.Alvarez-Jimenez M, Martinez-Garcia O, Perez-Iglesias R, Ramirez ML, Vazquez-Barquero JL, Crespo- Facorro B. Prevention of antipsychotic-induced weight gain with early behavioural intervention in first-episode psychosis: 2-year results of a randomized controlled trial. Schizophr Res. 2010;116:16–9.CrossRefGoogle Scholar
- 41.Alvarez-Jimenez M, Gonzalez-Blanch C, Vazquez-Barquero JL, Perez-Iglesias R, Martinez-Garcia O, Perez-Pardal T, Ramirez-Bonilla ML, Crespo-Facorro B. Attenuation of antipsychotic-induced weight gain with early behavioral intervention in drug-naive first-episode psychosis patients: a randomized controlled trial. J Clin Psychiatry. 2006;67:1253–60.CrossRefGoogle Scholar
- 42.Gierisch JM, Nieuwsma JA, Bradford DW, Wilder CM, Mann-Wrobel MC, McBroom AJ, Hasselblad V, Williams JW Jr. Pharmacologic and behavioral interventions to improve cardiovascular risk factors in adults with serious mental illness: a systematic review and meta-analysis. J Clin Psychiatry. 2014;75:e424–40.CrossRefGoogle Scholar
- 43.American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists, North American Association for the Study of Obesity. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care. 2004;27:596–601.CrossRefGoogle Scholar