Usefulness of beta blockers in high-risk patients after myocardial infarction in conjunction with captopril and/or valsartan (from the VALsartan In Acute Myocardial Infarction [VALIANT] trial).

Concern has been raised about combining beta blockers with angiotensin-receptor blockers in patients with heart failure. The VALsartan In Acute myocardial infarction (VALIANT) trial enrolled 14,703 patients with myocardial infarction complicated by heart failure or documented left ventricular systolic dysfunction. These patients were randomly allocated to treatment with valsartan, captopril, or both.

Considerations of net present value in policy making regarding diagnostic and therapeutic technologies.

Background: The pharmaceutical and medical device industries function in a business environment in which shareholders expect companies to optimize profit within legal and ethical standards. A fundamental tool used to optimize decision making is the net present value calculation, which estimates the current value of cash flows relating to an investment.

Methods: We examined 3 prototypical research investment decisions that have been the source of public scrutiny to illustrate how policy decisions can be better understood when their impact on societally desirable investments by industry are viewed from the standpoint of their impact on net present value.

Operationalization of the UFuRT methodology for usability analysis in the clinical research data management domain.

Data management software applications specifically designed for the clinical research environment are increasingly available from commercial vendors and open-source communities, however, general-purpose spreadsheets remain widely employed in clinical research data management (CRDM). The suitability of spreadsheets for this use is controversial, and no formal comparative usability evaluations have been performed. We report on an application of the UFuRT (user, function, representation, and task (analyses) methodology to create a domain-specific process for usability evaluation.

Research ethics. Certificates of confidentiality and compelled disclosure of data.

Certificates of Confidentiality have gained prominence in the context of efforts to build large-scale research platforms and new requirements for an unprecedented degree of data sharing. There is, however, a remarkable paucity of evidence upon which to base conclusions about the strength, applicability, and durability of the legal protections a Certificate affords. Here we describe a recent legal challenge in which a research participant’s data, collected under a Certificate, were subpoenaed as part of a criminal case that reached the North Carolina Court of Appeals.

Quantifying data quality for clinical trials using electronic data capture.

Background: Historically, only partial assessments of data quality have been performed in clinical trials, for which the most common method of measuring database error rates has been to compare the case report form (CRF) to database entries and count discrepancies. Importantly, errors arising from medical record abstraction and transcription are rarely evaluated as part of such quality assessments. Electronic Data Capture (EDC) technology has had a further impact, as paper CRFs typically leveraged for quality measurement are not used in EDC processes.

Consistency of financial interest disclosures in the biomedical literature: the case of coronary stents.

Background: Disclosure of authors' financial interests has been proposed as a strategy for protecting the integrity of the biomedical literature. We examined whether authors' financial interests were disclosed consistently in articles on coronary stents published in 2006.

Methodology/principal Findings: We searched PubMed for English-language articles published in 2006 that provided evidence or guidance regarding the use of coronary artery stents.