Out of sight but not out of mind: How to search for unpublished clinical trial evidence

Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada.
BMJ (online) (Impact Factor: 17.45). 01/2011; 344(7838):d8013. DOI: 10.1136/bmj.d8013
Source: PubMed
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    • "To identify unpublished or ongoing trials, we will use methods that include reviewing trial registries and results databases (for example,, pharmaceutical industry trial registries and results databases, regulatory agency online databases, regulatory agency submissions, litigation documents, and conferences abstracts, as well as contacting trialists and sponsors for unpublished or ongoing trials [37]. "
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    ABSTRACT: Background Depression is an important cause of disability among children and adolescents. Depression screening is one possible method for managing depression, and screening programs have been initiated in some school and medical settings. However, in 2005, the Canadian Task Force on Preventive Health Care and the United Kingdom National Institute of Clinical Excellence did not recommend depression screening among children and adolescents. By contrast, in 2009, the United States Preventive Services Task Force recommended that all adolescents, but not younger children, be screened for depression in medical settings with integrated depression management services, although no trials of screening were identified. The objectives of this systematic review are to evaluate in children and adolescents the accuracy of depression screening tools; depression treatment efficacy; whether depression screening improves depression outcomes; and potential harms related to depression interventions and screening. Methods/design Data sources will include the bibliographic databases MEDLINE, Cochrane CENTRAL, PsycINFO, EMBASE, LILACS and Web of Science, supplemented by reference harvesting of eligible articles, relevant systematic reviews, relevant guidelines and recommendations, and selected journals, and by searches for unpublished studies. Eligible studies will report data for children and adolescents aged 6 to 18 years. Eligible diagnostic accuracy studies must compare a depression screening tool to a validated diagnostic interview for major depressive disorder and report diagnostic accuracy data. Eligible treatment studies must be randomized controlled trials of pharmacological, psychotherapeutic, or other depression treatments commonly available for children and adolescents in pediatric, primary-care, and family medicine settings. Eligible screening studies must be randomized controlled trials that compare depression outcomes between children or adolescents who underwent depression screening versus those who did not. Studies of harms will include randomized controlled trials and observational studies that evaluate harms from depression screening or treatment. Two investigators will independently review titles and abstracts, followed by full article review. Disagreements will be resolved by consensus. Two investigators will independently extract the data, with discrepancies resolved via consensus. Discussion The proposed systematic review will determine whether there is sufficient evidence of benefits in excess of harms and costs to support screening for depression in childhood and adolescence.
    Systematic Reviews 11/2012; 1(1):58. DOI:10.1186/2046-4053-1-58
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    BMJ (online) 01/2012; 344(jan03 1):d8158. DOI:10.1136/bmj.d8158 · 17.45 Impact Factor
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    ABSTRACT: Updated guidelines for the preventive treatment of episodic migraine have been issued by the American Headache Society (AHS) and the American Academy of Neurology (AAN). We summarize key 2012 guideline recommendations and changes from previous guidelines. We review the characteristics, methods, consistency, and quality of the AHS/AAN guidelines in comparison with recently issued guidelines from other specialty societies. To accomplish this, we reviewed the AHS/AAN guidelines and identified comparable recent guidelines through a systematic MEDLINE search. We extracted key data, and summarized and compared the key recommendations and assessed quality using the Appraisal of Guidelines Research and Evaluation-II (AGREE-II) tool. We identified 2 additional recent guidelines for migraine prevention from the Canadian Headache Society and the European Federation of Neurological Societies. All of the guidelines used structured methods to locate evidence and linked recommendations with assessment of the evidence, but they varied in the methods used to derive recommendations from that evidence. Overall, the 3 guidelines were consistent in their recommendations of treatments for first-line use. All rated topiramate, divalproex/sodium valproate, propranolol, and metoprolol as having the highest level of evidence. In contrast, recommendations diverged substantially for gabapentin and feverfew. The overall quality of the guidelines ranged from 2 to 6 out of 7 on the AGREE-II tool. The AHS/AAN and Canadian guidelines are recommended for use on the basis of the AGREE-II quality assessment. Recommendations for the future development of clinical practice guidelines in migraine are provided. In particular, efforts should be made to ensure that guidelines are regularly updated and that guideline developers strive to locate and incorporate unpublished clinical trial evidence.
    Headache The Journal of Head and Face Pain 06/2012; 52(6):930-45. DOI:10.1111/j.1526-4610.2012.02185.x · 2.71 Impact Factor
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