PubMed · 15587366
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Lise Aagaard. 2004-11-15. [Drug interactions].. https://pubmed.ncbi.nlm.nih.gov/15587366/
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Post-marketing drug safety data sets are often massive, and entail problems with heterogeneity and selection bias. Nevertheless, quantitative methods have proven a very useful aid to help clinical experts in screening for previously unknown associations in these data sets. The WHO international drug safety database is the world's largest data set of its kind with over three million reports on suspected adverse drug reaction incidents. Since 1998, an exploratory data analysis method has been in routine use to screen for quantitative associations in this data set. This method was originally based on large sample approximations and limited to pairwise associations, but in this article we propose more accurate credibility interval estimates and extend the method to allow for the analysis of more complex quantitative associations. The accuracy of the proposed credibility intervals is evaluated through comparison to precise Monte Carlo simulations. In addition, we propose a Mantel-Haenszel-type adjustment to control for suspected confounders.
STUDY DESIGN: A systematic search of three electronic databases was done to identify randomized controlled trials on the effect of written or audiovisual information in low back pain. OBJECTIVES: To determine whether information is an effective preventive action and/or therapy for low back pain and which type of information is most effective. SUMMARY OF BACKGROUND DATA: Information is commonly used in the primary care of low back pain and mostly delivered by booklets. METHODS: A systematic computer-aided search of the Medline, PsyclInfo, and Embase database. A rating system was used to assess the strength of the evidence, based on the methodologic quality of the randomized controlled trials, the relevance of the outcome measures, and the consistency of the results. RESULTS: Eleven randomized controlled trials were selected, including seven trials of high methodologic quality, as well as one parallel group controlled survey and one longitudinal study. Only three of the seven high-quality studies showed favorable results for information. There is strong evidence that a booklet increases knowledge and moderate evidence that physician-related cues increase the confidence in a booklet and adherence to exercises. There is limited evidence that a biopsychosocial booklet is more efficient than a biomedical booklet to shift patient's beliefs about physical activity, pain, and consequences of low back trouble. There is strong evidence that booklets are not efficient on absenteeism and conflicting evidence that they are efficient on healthcare use. There is no evidence that e-mail discussion or video programs alone are effective to reduce low back pain, disability, and healthcare costs. CONCLUSIONS: Information based on a biopsychosocial model is recommended in primary care to shift patient beliefs on low back pain. Nevertheless, information delivery alone is not sufficient to prevent absenteeism and reduce healthcare costs.
OBJECTIVE: To review Public Law (PL) 109-41-the Patient Safety and Quality Improvement Act of 2005 (PSQIA)-and summarize key medication error research that contributed to congressional recognition of the need for this legislation. DATA SOURCES: Relevant publications related to medication error research, patient safety programs, and the legislative history of and commentary on PL 109-41, published in English, were identified by MEDLINE, PREMEDLINE, Thomas (Library of Congress), and Internet search engine-assisted searches using the terms healthcare quality, medication error, patient safety, PL 109-41, and quality improvement. Additional citations were identified from references cited in related publications. STUDY SELECTION AND DATA EXTRACTION: All relevant publications were reviewed. Summarization of the PSQIA was carried out by legal textual analysis. DATA SYNTHESIS: PL 109-41 provides privilege and confidentiality for patient safety work product (PSWP) developed for reporting to patient safety organizations (PSOs). It does not establish federal mandatory reporting of significant errors; rather, it relies on existing state reporting systems. The Act does not preempt stronger state protections for PSWP. The Agency for Healthcare Research and Quality is directed to certify PSOs and promote the establishment of a national network of patient safety databases. Whistleblower protection and penalties for unauthorized disclosure of PSWP are among its enforcement mechanisms. CONCLUSIONS: The Act protects clinicians who report minor errors to PSOs and protects the information from disclosure, but providers must increasingly embrace a culture of interdisciplinary concern for patient safety if this protection is to have real impact on patient care.