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Abstract
Objectives To analyse to what extent clinical practice guidelines on drug treatment of depression in children and adolescents mention the risk of adverse effects, to characterise the citations in the guidelines and to assess to what extent data from a major study (Treatment for Adolescents With Depression Study, TADS) was used as basis for information about adverse effects.
Design Systematic review of clinical guidelines and clinical decision support tools.
Data sources PubMed, EMBASE, guideline collections, Health libraries.
Eligibility criteria We included national guidelines on depression in children and adolescents from European and/or English-speaking countries, published in English, German, French or any Scandinavian language since 2008. We also included well-known, international clinical decision support tools.
Data extraction and synthesis Guidelines were examined by all authors to identify and classify information on adverse effects. Citations for statements on adverse effects were extracted and classified by category. The extent of citations about suicidality risk versus other adverse effects was assessed.
Results 19 guidelines were assessed. All guidelines discussed risk of suicidal behaviour connected with use of antidepressants. Most guidelines mentioned some other psychiatric adverse effects. Several guidelines did not include information on well-known and common somatic adverse effects. Most references concerned risk of suicidality. Adverse effects identified in underlying studies were not always presented. The TADS study was referred to, directly or indirectly, by 18/19 guidelines, but some only referred to TADS with regard to suicidality without citing the study’s findings of somatic adverse effects. No guideline commented on the lack of long-term adverse effects data from TADS.
Conclusions Guidelines for treatment of depression in children and adolescents vary widely regarding information on adverse effects. Many guidelines do not provide information on common somatic adverse effects. There is no consensus as to what extent risks of adverse effects connected with use of antidepressants should be described in guidelines.
- clinical pharmacology
- psychiatry
- adverse events
- protocols & guidelines
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Footnotes
Contributors The research question was developed by all authors. All authors discussed and defined the project. TW researched the literature and made the initial assessments. All authors discussed the guidelines included in the study, including interpretation and classification of information in the guidelines. TW drafted and finalised the manuscript as lead author. SN and MK commented on the draft and revised the manuscript at all stages.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request. Tables of references used in guidelines and their corresponding text statements are available on request.