Comparative efficacy and tolerability of pharmacological interventions for attention-deficit/hyperactivity disorder in children, adolescents and adults: protocol for a systematic review and network meta-analysis

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Abstract

Introduction

Attention-deficit/hyperactivity disorder (ADHD) is a major public health issue. Pharmacological treatments play an important role in the multimodal treatment of ADHD. Currently, there is a lack of up-to-date and comprehensive evidence on how available ADHD drugs compare and rank in terms of efficacy and tolerability, in children or adolescents as well as in adults. We will conduct a network meta-analysis (NMA), integrating direct and indirect comparisons from randomised controlled trials (RCTs), to rank pharmacological treatments for ADHD according to their efficacy and tolerability profiles.

Methods and analysis

We will search a broad range of electronic databases, including PubMed, MEDLINE, EMBASE, PsycINFO, ERIC and Web of Science, with no date or language restrictions. We will also search for unpublished studies using international clinical trial registries and contacting relevant drug companies. We will identify and include available parallel-group, cross-over and cluster randomised trials that compare methylphenidate, dexmethylphenidate, amphetamine derivatives (including lisdexamfetamine), atomoxetine, clonidine, guanfacine, bupropion or modafinil (as oral therapy) either with each other or to placebo, in children, adolescents or adults with ADHD. Primary outcomes will be efficacy (indicated by reduction in severity of ADHD core symptoms measured on a standardised scale) and tolerability (the proportion of patients who left a study early due to side effects). Secondary outcomes will be global functioning, acceptability (proportion of patients who left the study early by any cause) and changes in blood pressure and body weight. NMA will be conducted in STATA within a frequentist framework. The quality of RCTs will be evaluated using the Cochrane risk of bias tool, and the quality of the evidence will be assessed using the GRADE approach. Subgroup and sensitivity analyses will be conducted to assess the robustness of the findings.

Ethics and dissemination

No ethical issues are foreseen. Results from this study will be published in a peer-reviewed journal and possibly presented at relevant national and international conferences.

Trial registration number

CRD42014008976.

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Most cited references 43

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The age-dependent decline of attention deficit hyperactivity disorder: a meta-analysis of follow-up studies.

STEPHEN V. FARAONE, JOSEPH BIEDERMAN, ERIC MICK (2006)

This study examined the persistence of attention deficit hyperactivity disorder (ADHD) into adulthood. We analyzed data from published follow-up studies of ADHD. To be included in the analysis, these additional studies had to meet the following criteria: the study included a control group and it was clear from the methods if the diagnosis of ADHD included subjects who did not meet full criteria but showed residual and impairing signs of the disorder. We used a meta-analysis regression model to separately assess the syndromatic and symptomatic persistence of ADHD. When we define only those meeting full criteria for ADHD as having 'persistent ADHD', the rate of persistence is low, approximately 15% at age 25 years. But when we include cases consistent with DSM-IV's definition of ADHD in partial remission, the rate of persistence is much higher, approximately 65%. Our results show that estimates of ADHD's persistence rely heavily on how one defines persistence. Yet, regardless of definition, our analyses show that evidence for ADHD lessens with age. More work is needed to determine if this reflects true remission of ADHD symptoms or is due to the developmental insensitivity of diagnostic criteria for the disorder.

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ADHD prevalence estimates across three decades: an updated systematic review and meta-regression analysis.

Guilherme Polanczyk, Erik Willcutt, Giovanni A Salum … (2014)

Previous studies have identified significant variability in attention-deficit / hyperactivity disorder (ADHD) prevalence estimates worldwide, largely explained by methodological procedures. However, increasing rates of ADHD diagnosis and treatment throughout the past few decades have fuelled concerns about whether the true prevalence of the disorder has increased over time. We updated the two most comprehensive systematic reviews on ADHD prevalence available in the literature. Meta-regression analyses were conducted to test the effect of year of study in the context of both methodological variables that determined variability in ADHD prevalence (diagnostic criteria, impairment criterion and source of information), and the geographical location of studies. We identified 154 original studies and included 135 in the multivariate analysis. Methodological procedures investigated were significantly associated with heterogeneity of studies. Geographical location and year of study were not associated with variability in ADHD prevalence estimates. Confirming previous findings, variability in ADHD prevalence estimates is mostly explained by methodological characteristics of the studies. In the past three decades, there has been no evidence to suggest an increase in the number of children in the community who meet criteria for ADHD when standardized diagnostic procedures are followed.

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Prevalence and correlates of adult attention-deficit hyperactivity disorder: meta-analysis.

Viktória Simon, Pál Czobor, Sára Bálint … (2009)

In spite of the growing literature about adult attention-deficit hyperactivity disorder (ADHD), relatively little is known about the prevalence and correlates of this disorder. To estimate the prevalence of adult ADHD and to identify its demographic correlates using meta-regression analysis. We used the MEDLINE, PsycLit and EMBASE databases as well as hand-searching to find relevant publications. The pooled prevalence of adult ADHD was 2.5% (95% CI 2.1-3.1). Gender and mean age, interacting with each other, were significantly related to prevalence of ADHD. Meta-regression analysis indicated that the proportion of participants with ADHD decreased with age when men and women were equally represented in the sample. Prevalence of ADHD in adults declines with age in the general population. We think, however, that the unclear validity of DSM-IV diagnostic criteria for this condition can lead to reduced prevalence rates by underestimation of the prevalence of adult ADHD.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2017

Publication date (Electronic): 10 January 2017

Volume: 7

Issue: 1

Electronic Location Identifier: e013967

Affiliations

[1 ]Department of Psychology, Developmental Brain-Behaviour Laboratory, Academic Unit of Psychology, Clinical and Experimental Sciences (CNS and Psychiatry), Faculty of Medicine, University of Southampton, and Solent NHS Trust , Southampton, UK

[2 ]New York University Child Study Center , New York City, New York, USA

[3 ]MRC Social, Genetic and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London , London, UK

[4 ]Research Unit of Child and Adolescent Psychiatry, Aalborg Psychiatric Hospital, Aalborg University Hospital , Aalborg, Denmark

[5 ]Department of Psychiatry, University of Oxford, Warneford Hospital , Oxford, UK

[6 ]Oxford Health NHS Foundation Trust, Warneford Hospital , Oxford, UK

[7 ]Child and Adolescent Neuropsychiatric Unit, ‘A. Cao’ Paediatric Hospital, ‘G. Brotzu’ Hospital Trust , Cagliari, Italy

[8 ]Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia , Modena, Italy

[9 ]Department of Child and Adolescent Psychiatry and Psychotherapy, Medical Faculty, Central Institute of Mental Health, Mannheim/Heidelberg University , Mannheim, Germany

[10 ]Institute of Psychiatry, Psychology and Neurosciences, King's College London, and the Maudsley Hospital , London, UK

[11 ]Child and Adolescent Neuropsychiatry Unit, University of Cagliari , Cagliari, Italy

[12 ]Department of Neuroscience, Biomedicine and Movement Sciences, Section of Psychiatry, WHO Collaborating Centre for Research and Training in Mental Health and Service Evaluation, University of Verona , Verona, Italy

[13 ]Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University , Baltimore, USA

[14 ]Department of Child and Adolescent Psychiatry, Psychiatric University Clinic Zurich , Switzerland

[15 ]Department of Clinical Psychology and Epidemiology, Psychology, University of Basel , Basel, Switzerland

[16 ]Department of Capital Region Psychiatry, Child and Adolescent Mental Health Centre , Copenhagen, Denmark

[17 ]Cochrane Schizophrenia Group, Institute of Mental Health, a Partnership between the University of Nottingham and Nottinghamshire Healthcare NHS Trust , UK

[18 ]Division of Neuroscience, Ninewells Hospital and Medical School, University of Dundee , Dundee, UK

[19 ]Department of Paediatrics, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne , Melbourne, Victoria, Australia

[20 ]Department of Psychiatry, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne , Melbourne, Victoria, Australia

Author notes

[Correspondence to ] Dr David Coghill; d.r.coghill@ 123456dundee.ac.uk

Author information

Andrea Cipriani http://orcid.org/0000-0001-5179-8321

Article

Publisher ID: bmjopen-2016-013967

DOI: 10.1136/bmjopen-2016-013967

PMC ID: 5253538

PubMed ID: 28073796

SO-VID: f4044f86-0276-42a3-a78e-37dbf96907ff

Copyright © Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

History

Date received : 20 August 2016

Date revision received : 7 November 2016

Date accepted : 16 November 2016

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Comparative efficacy and tolerability of pharmacological interventions for attention-deficit/hyperactivity disorder in children, adolescents and adults: protocol for a systematic review and network meta-analysis

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Abstract

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Related collections

Herbal Medicines Journal (Herb Med J)

Most cited references 43

The age-dependent decline of attention deficit hyperactivity disorder: a meta-analysis of follow-up studies.

ADHD prevalence estimates across three decades: an updated systematic review and meta-regression analysis.

Prevalence and correlates of adult attention-deficit hyperactivity disorder: meta-analysis.

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Cited by 11

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