Risk of cardiac valvulopathy with use of bisphosphonates: a population-based, multi-country case-control study.

UNLABELLED: Analyses of healthcare data from 30 million individuals in three countries showed that current use of bisphosphonates may be associated with a small increased risk of cardiac valvulopathy (vs. those not exposed within the previous year), although confounding cannot be entirely ruled out. The observed tendency for decreased valvulopathy risk with cumulative duration of bisphosphonate use >6 months may even indicate a protective effect with prolonged use. Further studies are still needed to evaluate whether bisphosphonates increase or decrease the risk of valvulopathy. INTRODUCTION: A signal of cardiac valve disorders with use of bisphosphonates was identified in the literature and EudraVigilance database, which contains reports of suspected adverse drug reactions from worldwide sources. The aim of this study was to evaluate the association using population-based healthcare data. METHODS: This was a case-control study among users of bisphosphonates and other drugs for osteoporosis in six healthcare databases covering over 30 million individuals in Italy, Netherlands and the UK from 1996 to 2012. Prescriptions/dispensations were used to assess drug exposure. Newly diagnosed cases of cardiac valvulopathy were identified via disease codes/free-text search. Controls were matched to each case by age, sex, database and index date. Adjusted odds ratios (ORs) were estimated using conditional logistic regression for the pooled data and meta-analysis of individual database risk estimates. RESULTS: A small but statistically significant association was found between exposure to bisphosphonates as a class and risk of valvulopathy. Overall risk was 18 % higher (95 % CI 12-23 %) in those currently exposed to any bisphosphonate (mainly alendronate and risedronate) vs. those not exposed within the previous year. Risk of valve regurgitation was 14 % higher (95 % CI 7-22 %). Decreased valvulopathy risk was observed with longer cumulative duration of bisphosphonate use, compared to use of less than 6 months. Meta-analyses of database-specific estimates confirmed results from pooled analyses. CONCLUSIONS: The observed increased risks of cardiac valvulopathy with bisphosphonate use, although statistically significant, were quite small and unlikely to be clinically significant. Further studies are still needed to evaluate whether bisphosphonates increase or decrease the risk of valvulopathy and to investigate possible mechanisms for the association.

Computed critiquing integrated into daily clinical practice affects physicians' behavior--a randomized clinical trial with AsthmaCritic.

OBJECTIVE: We developed AsthmaCritic, a non-inquisitive critiquing system integrated with the general practitioners' electronic medical records. The system is based on the guidelines for asthma and chronic obstructive pulmonary disease (COPD) as issued by the Dutch College of General Practitioners. This paper assesses the effect of AsthmaCritic on monitoring and treatment of asthma and COPD by Dutch general practitioners in daily practice. METHODS: A randomized clinical trial in 32 practices (40 Dutch general practitioners) using electronic patient records. An intervention group was given the use of AsthmaCritic, a control group continued working in the usual manner. Both groups had the disposal of the asthma and COPD guidelines routinely distributed by the Dutch College of General Practitioners. We measured the average number of contacts, FEV 1 (forced expiratory volume), and peak-flow measurements per asthma/COPD patient per practice; and, the average number of antihistamine, cromoglycate, deptropine, and oral bronchodilator prescriptions per asthma/COPD patient per practice. RESULTS: The number of contacts increased in the age group of 12-39 years. The number of FEV1 , peak-flow measurements, and the ratio of coded measurements increased, whereas the number of cromoglycate prescriptions decreased in the age group of 12-39 years. CONCLUSIONS: Our study shows that the guideline-based critiquing system AsthmaCritic changed the manner in which the physicians monitored their patients and, to a lesser extent, their treatment behavior. In addition, the physicians changed their data-recording habits.

Assessment of decision support for blood test ordering in primary care. a randomized trial.

BACKGROUND: Different methods for changing blood test-ordering behavior in primary care have been proven effective. However, randomized trials comparing these methods are lacking. OBJECTIVE: To compare the effect of two versions of BloodLink, a computer-based clinical decision support system, on blood test ordering among general practitioners. DESIGN: Randomized trial. SETTING: 44 practices of general practitioners in the region of Delft, the Netherlands. PARTICIPANTS: 60 general practitioners in 44 practices who used computer-based patient records in their practices. INTERVENTION: After stratification by solo practices and group practices, practices were randomly assigned to use BloodLink-Restricted, which initially displays a reduced list of tests, or BloodLink-Guideline, which is based on the guidelines of the Dutch College of General Practitioners. MEASUREMENTS: Average number of blood tests ordered per order form per practice. RESULTS: General practitioners who used BloodLink-Guideline requested 20% fewer tests on average than did practitioners who used BloodLink-Restricted (mean [+/-SD], 5.5 +/- 0.9 tests vs. 6.9 +/- 1.6 tests, respectively; P = 0.003, Mann-Whitney test). CONCLUSIONS: Decision support based on guidelines is more effective in changing blood test-ordering behavior than is decision support based on initially displaying a limited number of tests. Guideline-driven decision support systems can be effective in reducing the number of laboratory tests ordered by primary care practitioners.

A study of PROforma, a development methodology for clinical procedures.

Knowledge engineering has shown that besides the general methodologies from software engineering it is useful to develop special purpose methodologies for knowledge based systems (KBS). PROforma is a newly developed methodology for a specific type of knowledge based systems. PROforma is intended for decision support systems and in particular for clinical procedures in the medical domain. This paper reports on an evaluation study of PROforma, and on the trade-off that is involved between general purpose and special purpose development methods in Knowledge Engineering and Medical AI. Our method for evaluating PROforma is based on re-engineering a realistic system in two methodologies: the new and special purpose KBS methodology PROforma and the widely accepted, and more general KBS methodology CommonKADS. The four most important results from our study are as follows. Firstly, PROforma has some strong points which are also strong related to requirements of medical reasoning. Secondly, PROforma has some weak points, but none of them are in any way related to the special purpose nature of PROforma. Thirdly, a more general method like CommonKADS works better in the analysis phase than the more special purpose method PROforma. Finally, to support a complementary use of the methodologies, we propose a mapping between their respective languages.

Design of a decision support system for test ordering in general practice: choices and decisions to make.

The increased availability of tests in the past years has been accompanied by an increased number of blood tests ordered by general practitioners. Dutch investigators report a lack of general practitioners' knowledge concerning the indications for blood tests leading to inappropriate and inadequate use of diagnostic tests. Taking advantage of the use of electronic patient records by Dutch general practitioners, the authors replaced the traditional paper forms for test ordering by a decision-support system. The objective of the decision-support system is to change test-ordering behavior. Designing a system to change test-ordering behavior, however, required the selection of a method to provide support. To study different methods for changing test-ordering behavior, the authors developed two versions of the decision-support system BloodLink. The first version, BloodLink-Restricted, is based on the notion of restricting the number of choices presented to the general practitioners. The second version, BloodLink-Guideline, is based on the guidelines provided by the Dutch college of general practitioners.