Out of sight but not out of mind: how to search for unpublished clinical trial evidence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: 16.38). 01/2011; 344:d8013. DOI: 10.1136/bmj.d8013
Source: PubMed
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    ABSTRACT: The primary objective of this study was to perform an updated systematic review and meta-analysis of meniscal allograft transplantation using patient reported outcome measures at final follow-up as the outcome tool. The secondary objective was to provide an up to date review of the indications, associated procedures, operative technique, rehabilitation, failures, complications, radiological outcomes, and graft healing. Medline, Embase and CENTRAL databases, trials registries, and Web-of Science were searched for studies using pre-defined eligibility criteria. Included studies were reviewed with Lysholm, International Knee Documentation Committee (IKDC) and Tegner scores, failures and complications pooled. Studies were also qualitatively assessed. There were 1,332 patients (1,374 knees) in 35 studies eligible for analysis. The mean follow-up was 5.1 years. Across all studies, Lysholm scores improved from 55.7 to 81.3, IKDC scores from 47.0 to 70.0, and Tegner activity scores from 3.1 to 4.7 between pre-operative and final follow-up assessments, respectively. The mean failure rate across all studies was 10.6 % at 4.8 years, and complication rate was 13.9 % at 4.7 years. There is a high risk of bias across the studies due to study design and missing outcomes. Based on current evidence, meniscal allograft transplantation appears to be an effective intervention for patients with a symptomatic meniscal deficient knee. This should ideally be confirmed with a randomised controlled trial. There is not currently enough evidence to determine whether it is chondroprotective.
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    ABSTRACT: To describe the sources of internal company documents used in public health and healthcare research. We searched PubMed and Embase for articles using internal company documents to address a research question about a health-related topic. Our primary interest was where authors obtained internal company documents for their research. We also extracted information on type of company, type of research question, type of internal documents, and funding source. Our searches identified 9,305 citations of which 357 were eligible. Scanning of reference lists and consultation with colleagues identified 4 additional articles, resulting in 361 included articles. Most articles examined internal tobacco company documents (325/361; 90%). Articles using documents from pharmaceutical companies (20/361; 6%) were the next most common. Tobacco articles used documents from repositories; pharmaceutical documents were from a range of sources. Most included articles relied upon internal company documents obtained through litigation (350/361; 97%). The research questions posed were primarily about company strategies to promote or position the company and its products (326/361; 90%). Most articles (346/361; 96%) used information from miscellaneous documents such as memos or letters, or from unspecified types of documents. When explicit information about study funding was provided (290/361 articles), the most common source was the US-based National Cancer Institute. We developed an alternative and more sensitive search targeted at identifying additional research articles using internal pharmaceutical company documents, but the search retrieved an impractical number of citations for review. Internal company documents provide an excellent source of information on health topics (e.g., corporate behavior, study data) exemplified by articles based on tobacco industry documents. Pharmaceutical and other industry documents appear to have been less used for research, indicating a need for funding for this type of research and well-indexed and curated repositories to provide researchers with ready access to the documents.
    PLoS ONE 05/2014; 9(5):e94709. DOI:10.1371/journal.pone.0094709 · 3.53 Impact Factor
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    BMJ (online) 01/2012; 344:d8158. DOI:10.1136/bmj.d8158 · 16.38 Impact Factor