Metylofenidat u dzieci i młodzieży z nadpobudliwością psychoruchową z deficytem uwagi (ADHD)
Información
- DOI:
- https://doi.org/10.1002/14651858.CD009885.pub2Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 25 noviembre 2015see what's new
- Tipo:
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- Intervention
- Etapa:
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- Review
- Grupo Editorial Cochrane:
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Grupo Cochrane de Problemas de desarrollo, psicosociales y de aprendizaje
- Copyright:
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- Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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Autores
Contributions of authors
OJS has overall responsibility for the review.
OJS, MS, SR, CGr, KBR, ES and CGl contributed to writing the protocol.
KBR developed the search strategy.
OJS, ER, HBK, TDN, MS, MH, SR, FLM, BF and KBR selected the studies.
OJS, ER, HBK, TDN, MS, MH, SR, CGr, FLM, CMM, DG, KBR, DG, MZ, RK and ES extracted data and evaluated bias.
OJS and CGl developed the analytical strategy.
OJS, ER, HBK, MH, FLM and CRMM entered data into RevMan.
OJS, ER, HBK, MH, FLM and CRMM conducted the statistical analysis.
All review authors participated in discussion and writing of the final review.
Sources of support
Internal sources
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Psychiatric Research Unit, Region Zealand Psychiatry, Roskilde, Denmark.
Ole Jakob Storebø, Erica Ramstad, Helle B. Krogh, Trine Danvad Nilausen, Mathilde Holmskov, Frederik Løgstrup Magnusson, and Erik Simonsen worked on this review during office hours
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Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Denmark.
Maria Skoog and Christian Gluud worked on this review during office hours
External sources
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Region Zealand Research Foundation, Denmark.
This review is supported by a grant (DKR 532,901) from the Region Zealand Research Foundation
Declarations of interest
Ole Jakob Storebø ‐ none known.
Erica Ramstad ‐ none known.
Helle B. Krogh ‐ none known.
Trine Danvad Nilausen ‐ none known.
Maria Skoog ‐ none known.
Mathilde Holmskov ‐ none known.
Susanne Rosendal ‐ none known.
Camilla Groth ‐ received funds from the Lundbeck Foundation to finance part of her Ph.D in the paediatric field on Tourette Syndrome. CG confirms that none of these funds were used to work on this review.
Frederik Løgstrup Magnusson ‐ none known.
Carlos R Moreira‐Maia ‐ receives financial research support from the Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq). CRMM has served as speaker for Novartis, has developed educational materials for Novartis, has received travel awards from the Health Technology Assessment Institute (IATS) and the Universidade Federal do Rio Grande do Sul (UFRGS), and has received travel and registration support to attend the 5th World Congress on ADHD from the World Federation of ADHD.
Donna Gillies ‐ is an Editor with the Cochrane Developmental, Psychosocial and Learning Problems Group.
Kirsten Buch Rasmussen ‐ none known.
Dorothy Gauci ‐ none known.
Morris Zwi ‐ sits on the Paediatric Medicines Expert Advisory Group at the Medicines and Healthcare Products Regulatory Agency, which considers applications regarding licensing of paediatric medicines. Payment for MZ's attendance at this meeting goes to his National Health Service (NHS) organisation.
Richard Kirubakaran ‐ is currently employed by Cochrane South Asia. His salary is funded by the Effective Healthcare Research Consortium (EHCRC) for the Department for International Development (DFID), UK.
Bente Forsbøl ‐ none known.
Erik Simonsen ‐ none known.
Christian Gluud ‐ none known.
Acknowledgements
We thank Janus Christian Jacobsen, Ph.D., at the Copenhagen Trial Unit, for elaborating the idea for this review.
We thank Trine Lacoppidan Kæstel, Research Librarian, at the Psychiatric Research Unit, Region Zealand, Denmark, for helping with searches and descriptions of measurement scales.
We thank Lise Aagaard, Ph.D. (pharm), at the University of Southern Denmark, for giving advice during production of this review.
We thank Jesper Pedersen, Ph.D., M.D., at the Department of Children and Youth Psychiatry, Region Zealand, Denmark, for supporting this project.
We thank Torben Bille, M.D., at the Pediatric Department, Holbaek Hospital, Copenhagen, Denmark, for helping to write the protocol and for selecting studies.
We thank Maria Gaardahl, Kim Boesen, Farhad Shokraneh and Rene Spijker for helping with translation of articles written in Japanese, Italian, Turkish, Farsi and Dutch.
We thank Nadia Pedersen, stud.scient.san.publ., at the Psychiatric Research Unit, Region Zealand, Denmark, for helping to finalise the review.
We thank Per Hove Thomsen, Ph.D., M.D., Department of Clinical Medicine ‐ Psychatric Hospital for Children and Adolescents, Aarhus University
We thank Dr. Martina Riegl, Senior Medical Assessor, at Medicines and Healthcare Products Regulatory Agency (MHRA), Special Populations Unit (Paediatrics), London, for helping with data extraction and assessment of risk of bias.
We thank Jacob Riis, User Experience Lead, at the Nordic Cochrane Centre, Copenhagen, Denmark, for helping with Review Manager issues.
We thank Rasmus Moustgaard, Senior Systems Architect, at the Nordic Cochrane Centre, Copenhagen, Denmark, for helping with Review Manager issues.
We are grateful to the many authors who kindly responded to our requests for further information on the trials in which they were involved.
Thanks also to the Psychiatric Research Unit, Region Zealand Psychiatry, Roskilde, Denmark; Region Zealand Research Foundation, Denmark; and the Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark, for funding and enabling the review.
We also wish to warmly thank Geraldine McDonald (Co‐ordinating Editor), Joanne Wilson (Managing Editor), Gemma O'Loughlin (Assistant Managing Editor) and Margaret Anderson (Trials Search Co‐ordinator) of the Cochrane Developmental, Psychosocial and Learning Problems Group for providing help and support.
Finally, we are grateful for the advice and support received from Toby Lasserson (Senior Editor), and David Tovey (Editor‐in‐chief) of the Cochrane Collaboration.
Version history
| Published | Title | Stage | Authors | Version |
| 2023 Mar 27 | Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD) | Review | Ole Jakob Storebø, Maja Rosenberg Overby Storm, Johanne Pereira Ribeiro, Maria Skoog, Camilla Groth, Henriette E Callesen, Julie Perrine Schaug, Pernille Darling Rasmussen, Christel-Mie L Huus, Morris Zwi, Richard Kirubakaran, Erik Simonsen, Christian Gluud | |
| 2015 Nov 25 | Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD) | Review | Ole Jakob Storebø, Erica Ramstad, Helle B. Krogh, Trine Danvad Nilausen, Maria Skoog, Mathilde Holmskov, Susanne Rosendal, Camilla Groth, Frederik L Magnusson, Carlos R Moreira‐Maia, Donna Gillies, Kirsten Buch Rasmussen, Dorothy Gauci, Morris Zwi, Richard Kirubakaran, Bente Forsbøl, Erik Simonsen, Christian Gluud | |
| 2012 May 16 | Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents | Protocol | Ole Jakob Storebø, Susanne Rosendal, Maria Skoog, Camilla Groth, Torben Bille, Kirsten Buch Rasmussen, Erik Simonsen, Christian Gluud | |
Differences between protocol and review
1. Methods section. Criteria for considering studies for this review. Types of studies.
We decided to split the review into two systematic reviews. The present review deals with benefits and harms of methylphenidate as reported by RCTs. Another systematic review is being prepared that will assess the risk of harms based on the findings of non‐randomised studies.
2. Methods section. Criteria for considering studies for this review. Types of participants.
We decided to include trials in which at least 75% of participants were 18 years of age or younger, and the mean age of the trial population was 18 years of age or younger. We included two trials with such participants. The effects of methylphenidate intervention on any outcome did not change when these two trials were removed from the analysis.
We decided to include trials in which at least 75% of participants had a normal intellectual quotient (IQ > 70). We included three trials with such participants. The effects of methylphenidate intervention on any outcome did not change when these three trials were removed from the analysis.
3. Methods section. Criteria for considering studies for this review. Types of outcome measures.
Duration of studies. We changed the subdivision of duration from short term (≤ 6 months), medium term (6 to 12 months) and long term (> 12 months) to short term (≤ 6 months) and long term (> 6 months) because no trials had a duration of between 6 and 12 months. Only one trial (Jensen 1999 (MTA)) provided data on a duration longer than six months (14 months). This change regarding duration classification was included in analyses of ADHD symptoms and general behaviour.
4. Methods section. Search methods for identification of studies.
We did not search for dissertations in WorldCat, Networked Digital Library of Theses and Dissertations, OpenGrey, DART‐Europe E‐theses Portal and Theses Canada. We did not contact the medical authorities in the European Union for information about beneficial and adverse events. We did not ask for access to security updates and risk management plans of pharmaceutical companies.
5. Methods section. Data collection and analysis. Selection of studies and data extraction and management.
More review authors than stated in the protocol screened titles and abstracts, extracted data, entered data into RevMan and conducted statistical analyses in RevMan.
6. Methods section. Data collection and analysis. Assessment of risk of bias in included studies.
Vested interests. We did not evaluate what effects might have been seen if the study author had conducted previous trials addressing the same interventions.
7. Methods section. Data collection and analysis. Measures of treatment effect. Continuous data.
For the primary outcome of teacher‐rated ADHD symptoms, we recalculated the SMD as MD on the ADHD‐RS (DuPaul 1991a), to check whether our result exceeded the minimum clinically important difference (MCID; Zhang 2005) for this specific rating scale. This was not stated in the protocol.
For the secondary outcome of quality of life, we recalculated the SMD as MD on the CHQ (Landgraf 1998), to check whether our results exceeded the MCID (Rentz 2005) for this specific rating scale. This was not stated in the protocol.
8. Methods section. Dealing with missing data.
We tried to obtain missing data by contacting the authors of the trials that were included in this review. When we were not able to obtain missing data, we conducted analyses using available (incomplete) data. We had intended to assess the impact of missing data by applying intention‐to‐treat as well as 'best‐case scenario' and 'worst‐case scenario' analyses. We could not use 'best‐case scenario' and 'worst‐case scenario' analyses in our assessment of benefits as there were no dichotomous outcomes. We decided not to use 'best‐case scenario' and 'worst‐case scenario' analyses in our assessment of adverse events, because we evaluated these analyses to be imprecise due to the high number of trials not reporting adverse events, and due to the high number of dropouts in the trials reporting adverse events. Moreover, we were unable to conduct intention‐to‐treat analyses for continuous outcomes due to lack of data for imputing means.
9. Methods section. Data collection and analysis. Assessment of reporting bias.
We did not compare results extracted from published journal reports versus results obtained from other sources (including correspondences) as a direct test for publication bias.
10. Methods section. Subgroup analysis and investigation of heterogeneity. Post hoc subgroup analyses.
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Types of scales (e.g. Conners' Teacher Rating Scale (CTRS; Conners 1998a) versus Strengths and Weaknesses of ADHD Symptoms and Normal Behavior (SWAN) Scale (Swanson 2006).
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Dose of methylphenidate (low dose (≤ 20 mg/d or ≤ 0.6 mg/kg/d) versus moderate/high dose (> 20 mg/d or > 0.6 mg/kg/d)).
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Duration of treatment (short‐term trials (≤ six months) versus long‐term trials (> six months)).
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Trial design (parallel‐group trials versus cross‐over trials (first period data and endpoint data)).
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Medication status before randomisation (medication naive (> 80% of included participants were medication naive) versus not medication naive (< 20% of included participants were medication naive)).
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Risk of bias (trials with low risk of bias versus trials with high risk of bias).
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Cohort selection bias (trials with cohort selection bias of all participants versus trials without cohort selection bias)
11. Methods section. Data collection and analysis. Heterogeneity‐adjusted required information size and Trial Sequential Analysis.
We performed a Trial Sequential Analysis on the total number of serious adverse events and on the total number of non‐serious adverse events only, as they were the only outcomes with dichotomous data with a substantial number of outcomes. Trial Sequential Analysis can be conducted on individual types of adverse events, but for this, the accrued information would represent a minute fraction of the required information size (RIS). We were not able to conduct a Trial Sequential Analysis for teacher‐, independent assessor‐ or parent‐rated outcomes, as the programme can be used only for MDs, not for SMDs.
