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      Communicating statin evidence to support shared decision-making

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          Abstract

          Background

          The practice of clinical medicine rests on a foundation of ethical principles as well as scientific knowledge. Clinicians must artfully balance the principle of beneficence, doing what is best for patients, with autonomy, allowing patients to make their own well-informed health care decisions. The clinical communication process is complicated by varying degrees of confidence in scientific evidence regarding patient-oriented benefits, and by the fact that most medical options are associated with possible harms as well as potential benefits.

          Discussion

          Evidence-based clinical guidelines often neglect patient-oriented issues involved with the thoughtful practice of shared decision-making, where individual values, goals, and preferences should be prioritized. Guidelines on the use of statin medications for preventing cardiovascular events are a case in point. Current guidelines endorse the use of statins for people whose 10-year risk of cardiovascular events is as low as 7.5 %. Previous guidelines set the 10-year risk benchmark at 20 %. Meta-analysis of randomized trials suggests that statins can reduce cardiovascular event rates by about 25 %, bringing 10-year risk from 7.5 to 5.6 %, for example, or from 20 to 15 %. Whether or not these benefits should justify the use of statins for individual patients depends on how those advantages are valued in comparison with disadvantages, such as side effect risks, and with inconveniences associated with taking a pill each day and visiting clinicians and laboratories regularly.

          Conclusions

          Whether or not the overall benefit-harm balance justifies the use of a medication for an individual patient cannot be determined by a guidelines committee, a health care system, or even the attending physician. Instead, it is the individual patient who has a fundamental right to decide whether or not taking a drug is worthwhile. Researchers and professional organizations should endeavor to develop shared decision-making tools that provide up-to-date best evidence in easily understandable formats, so as to assist clinicians in helping their patients to make the decisions that are right for them.

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          Most cited references52

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          2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults

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            Measurement of health status. Ascertaining the minimal clinically important difference.

            In recent years quality of life instruments have been featured as primary outcomes in many randomized trials. One of the challenges facing the investigator using such measures is determining the significance of any differences observed, and communicating that significance to clinicians who will be applying the trial results. We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change. Using this approach we have established a plausible range within which the minimal clinically important difference (MCID) falls. In three studies in which instruments measuring dyspnea, fatigue, and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item, when responses were presented on a seven point Likert scale. Furthermore, we have established ranges for changes in questionnaire scores that correspond to moderate and large changes in the domains of interest. This information will be useful in interpreting questionnaire scores, both in individuals and in groups of patients participating in controlled trials, and in the planning of new trials.
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              Statin-associated myopathy.

              Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) are associated with skeletal muscle complaints, including clinically important myositis and rhabdomyolysis, mild serum creatine kinase (CK) elevations, myalgia with and without elevated CK levels, muscle weakness, muscle cramps, and persistent myalgia and CK elevations after statin withdrawal. We performed a literature review to provide a clinical summary of statin-associated myopathy and discuss possible mediating mechanisms. We also update the US Food and Drug Administration (FDA) reports on statin-associated rhabdomyolysis. Articles on statin myopathy were identified via a PubMed search through November 2002 and articles on statin clinical trials, case series, and review articles were identified via a PubMed search through January 2003. Adverse event reports of statin-associated rhabdomyolysis were also collected from the FDA MEDWATCH database. The literature review found that reports of muscle problems during statin clinical trials are extremely rare. The FDA MEDWATCH Reporting System lists 3339 cases of statin-associated rhabdomyolysis reported between January 1, 1990, and March 31, 2002. Cerivastatin was the most commonly implicated statin. Few data are available regarding the frequency of less-serious events such as muscle pain and weakness, which may affect 1% to 5% of patients. The risk of rhabdomyolysis and other adverse effects with statin use can be exacerbated by several factors, including compromised hepatic and renal function, hypothyroidism, diabetes, and concomitant medications. Medications such as the fibrate gemfibrozil alter statin metabolism and increase statin plasma concentration. How statins injure skeletal muscle is not clear, although recent evidence suggests that statins reduce the production of small regulatory proteins that are important for myocyte maintenance.
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                Author and article information

                Contributors
                608/263-2220 , bruce.barrett@fammed.wisc.edu
                ricco004@umn.edu
                Maggie.Wallace@gmail.com
                dockiefer@gmail.com
                drakel@uwhealth.org
                Journal
                BMC Fam Pract
                BMC Fam Pract
                BMC Family Practice
                BioMed Central (London )
                1471-2296
                6 April 2016
                6 April 2016
                2016
                : 17
                : 41
                Affiliations
                [ ]Department of Family Medicine and Community Health, University of Wisconsin-Madison, 1100 Delaplaine Court, Madison, WI 53715 USA
                [ ]Department of Family Medicine and Community Health, University of Minnesota, Minneapolis, MN 55455 USA
                [ ]HealthEast Care System, St Paul, MN 55102 USA
                [ ]Group Health Cooperative, Madison, Wisconsin 53703 USA
                [ ]Department of Family Medicine & Community Health, University of Wisconsin, Madison, WI 53715 USA
                Article
                436
                10.1186/s12875-016-0436-9
                4822230
                27048421
                c13d3a83-06bd-481b-831a-af29a8721bdb
                © Barrett et al. 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 3 November 2015
                : 22 March 2016
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000064, National Center for Complementary and Alternative Medicine;
                Award ID: K24AT006543
                Award ID: T32AT006956
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100000102, Health Resources and Services Administration;
                Award ID: T32HP10010
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100000102, Health Resources and Services Administration (US);
                Award ID: T32HP10010
                Award Recipient :
                Categories
                Debate
                Custom metadata
                © The Author(s) 2016

                Medicine
                attitude to health,cholesterol,clinical significance,cost-benefit analysis,decision making,evidence-based medicine,guidelines,lipids,minimal important difference,outcomes,patient preference,preventive cardiology,primary care,quality of life,shared decision-making,statins

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