Virginia Commonwealth University

About: Virginia Commonwealth University is a education organization based out in Richmond, Virginia, United States. It is known for research contribution in the topics: Population & Health care. The organization has 23822 authors who have published 49587 publications receiving 1787046 citations. The organization is also known as: VCU.

Informed decision making: what is its role in cancer screening?

Abstract: Interest in informed decision making (IDM) has grown in recent years. Greater patient involvement in decision making is consistent with recommendations to improve health care quality. This report provides an overview of IDM; clarifies the differences between IDM, shared decision making (SDM), and informed consent; and reviews the evidence to date about IDM for cancer screening. The authors also make recommendations for research. We define IDM as occurring when an individual understands the disease or condition being addressed and comprehends what the clinical service involves, including its benefits, risks, limitations, alternatives, and uncertainties; has considered his or her preferences and makes a decision consistent with them; and believes he or she has participated in decision making at the level desired. IDM interventions are used to facilitate informed decisions. The authors reviewed the evidence to date for IDM and cancer screening based primarily on published meta-analyses and a recent report for the Centers for Disease Control and Prevention's Guide to Community Preventive Services. IDM and SDM interventions, such as decision aids, result in improved knowledge, beliefs, risk perceptions, and combinations of these. Little or no evidence exists, however, regarding whether these interventions result in 1) participation in decision making at a level consistent with patient preferences or 2) effects on patient satisfaction with the decision-making process. These variables generally either were not assessed or were not reported in the articles reviewed. Results of interventions on uptake of screening were variable. After exposure to IDM/SDM interventions, most studies showed small decreases in prostate cancer screening, whereas four studies on breast and colorectal cancer screening showed small increases. Few data are available by which to evaluate current practices in cancer screening IDM. Patient participation in IDM should be facilitated for those who prefer it. More research is needed to assess the benefits of IDM/SDM interventions and to tailor interventions to individuals who are most likely to desire and benefit from them. There are many system barriers to IDM/SDM and few tools. More work is needed in this area as well. In addition, research is needed to learn how to incorporate IDM into ongoing clinical practice and to determine whether there are unintended negative consequences of IDM.

Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated doses of statins: the ODYSSEY COMBO II randomized controlled trial

Abstract: Aims To compare the efficacy [low-density lipoprotein cholesterol (LDL-C) lowering] and safety of alirocumab, a fully human monoclonal antibody to proprotein convertase subtilisin/kexin 9, compared with ezetimibe, as add-on therapy to maximally tolerated statin therapy in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia. Methods and results COMBO II is a double-blind, double-dummy, active-controlled, parallel-group, 104-week study of alirocumab vs. ezetimibe. Patients ( n = 720) with high cardiovascular risk and elevated LDL-C despite maximal doses of statins were enrolled (August 2012–May 2013). This pre-specified analysis was conducted after the last patient completed 52 weeks. Patients were randomized to subcutaneous alirocumab 75 mg every 2 weeks (plus oral placebo) or oral ezetimibe 10 mg daily (plus subcutaneous placebo) on a background of statin therapy. At Week 24, mean ± SE reductions in LDL-C from baseline were 50.6 ± 1.4% for alirocumab vs. 20.7 ± 1.9% for ezetimibe (difference 29.8 ± 2.3%; P < 0.0001); 77.0% of alirocumab and 45.6% of ezetimibe patients achieved LDL-C <1.8 mmol/L ( P < 0.0001). Mean achieved LDL-C at Week 24 was 1.3 ± 0.04 mmol/L with alirocumab and 2.1 ± 0.05 mmol/L with ezetimibe, and were maintained to Week 52. Alirocumab was generally well tolerated, with no evidence of an excess of treatment-emergent adverse events. Conclusion In patients at high cardiovascular risk with inadequately controlled LDL-C, alirocumab achieved significantly greater reductions in LDL-C compared with ezetimibe, with a similar safety profile. Trial registration clinicaltrials.gov Identifier: [NCT01644188][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01644188&atom=%2Fehj%2Fearly%2F2015%2F02%2F24%2Feurheartj.ehv028.atom