Out of sight but not out of mind: How to search for unpublished clinical trial evidence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
6 Reads
  • Source
    • "To identify unpublished or ongoing trials, we will use methods that include reviewing trial registries and results databases (for example,, pharmaceutical industry trial registries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agency submissions, litigation documents, and conferences abstracts, as well as contacting trialists and sponsors for unpublished or ongoing trials [37]. "
    [Show abstract] [Hide abstract]
    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relevant systematic reviews, relevant guidelines and recommendations, and selected journals, and by searches for unpublished studies.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
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Microvascular decompression (MVD) offers an effective and durable treatment for patients suffering from trigeminal neuralgia (TN). Because the disorder has a tendency to occur in older persons, the risks of surgical treatment in the elderly have been a topic of recent interest. To date, evidence derived from several small retrospective and a single prospective case series has suggested that age does not increase the complication rate associated with surgery. Using a large national database, the authors aimed to study the impact of age on in-hospital complications following MVD for TN. Using the Nationwide Inpatient Sample (NIS) for the 10-year period from 1999 to 2008, the authors selected all patients who underwent MVD for TN. The primary outcome of interest was the in-hospital mortality rate. Secondary outcomes of interest were cardiac, pulmonary, thromboembolic, cerebrovascular, and wound complications as well as the duration of hospital stay, total hospital charges, and discharge location. An elderly cohort of patients was first defined as those 65 years of age and older and then redefined as those 75 years and older. A total of 3273 patients who underwent MVD for TN were identified, having a median age of 57 years. Within this sample, 31.5% were 65 years and older and 10.7% were 75 years and older. The in-hospital mortality rate was 0.68% for patients 65 years or older (p = 0.0087) and 1.16% for those 75 years or older (p = 0.0026). In patients younger than 65 years, the in-hospital mortality rate was 0.13% (3 deaths among 2241 patients). As analyzed using the chi-square test (for both 65 and 75 years as the age cutoff) and the Pearson rank correlation coefficient, the risk of cardiac, pulmonary, thromboembolic, and cerebrovascular complications was higher in older patients (that is, those 65 and older and those 75 and older), but the risks of wound complications and CNS infection were not. The risk of any in-hospital complication occurring in a patient 65 years and older was 7.36% (p < 0.0001) and 10.0% in those 75 years and older (p < 0.0001). There was no difference in the total hospital charges associated with age. The duration of the hospital stay was longer in older patients, and the likelihood of discharge home was lower in older patients. Microvascular decompression for TN in the elderly population remains a reasonable surgical option. However, based on data from a large national database, authors of the present study suggest that complications do tend to gradually increase in tandem with an advanced age. While age does not act as a risk factor in isolation, it may serve as a convenient surrogate for complication rates. The authors hope that this information can be of use in guiding older patients through decisions for the surgical treatment of TN.
    Journal of Neurosurgery 05/2011; 115(2):202-9. DOI:10.3171/2011.4.JNS101924 · 3.74 Impact Factor
  • Source

    BMJ (online) 01/2012; 344(jan03 1):d8158. DOI:10.1136/bmj.d8158 · 17.45 Impact Factor
Show more