Communicating statin evidence to support shared decision-making

BMC Family Practice

Volumn 17, Issue 1, 2016, Pages

  Barrett, Bruce ^a   Ricco, Jason ^b   Wallace, Margaret ^c   Kiefer, David ^d   Rakel, Dave ^a  

^a UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^b UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^c UNIV OF MINNESOTA HOSP AND CLINIC   (United States)

^d Group Health Cooperative   (United States)

Author keywords

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

Indexed keywords

HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR;

CARDIOVASCULAR DISEASES; CLINICAL DECISION MAKING; DECISION MAKING; DOCTOR PATIENT RELATION; ETHICS; EVIDENCE BASED MEDICINE; HUMAN; INTERPERSONAL COMMUNICATION; PATIENT PARTICIPATION; PATIENT PREFERENCE; PERSONAL AUTONOMY; PRACTICE GUIDELINE; PROCEDURES; PSYCHOLOGY; UNCERTAINTY;

CARDIOVASCULAR DISEASES; CLINICAL DECISION-MAKING; COMMUNICATION; DECISION MAKING; EVIDENCE-BASED MEDICINE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; PATIENT PARTICIPATION; PATIENT PREFERENCE; PERSONAL AUTONOMY; PHYSICIAN-PATIENT RELATIONS; PRACTICE GUIDELINES AS TOPIC; UNCERTAINTY;

EID: 84962773846     PISSN: None     EISSN: 14712296     Source Type: Journal    
DOI: 10.1186/s12875-016-0436-9     Document Type: Article

References (82)

1. Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, et al. Heart disease and stroke statistics - 2014 update: a report from the American Heart Association. Circulation. 2014;129:e28-292.
2. National Institute for Health and Care Excellence. Lipid modification: cardiovascular risk assessment and the modification of blood lipids for the primary and secondary prevention of cardiovascular disease. NICE guidelines [CG181] 2014. https://www.nice.org.uk/guidance/cg181. Accessed 31 March 2016.
3. Law MR, Morris JK, Wald NJ. Use of blood pressure lowering drugs in the prevention of cardiovascular disease: meta-analysis of 147 randomised trials in the context of expectations from prospective epidemiological studies. BMJ. 2009;338:b1665.
4. James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311:507-20.
5. Mancia G. Effects of intensive blood pressure control in the management of patients with type 2 diabetes mellitus in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Circulation. 2010;122:847-9.
6. Diao D, Wright JM, Cundiff DK, Gueyffier F. Pharmacotherapy for mild hypertension. Cochrane Database Syst Rev. 2012;8:CD006742.
7. Turnbull FM, Abraira C, Anderson RJ, Byington RP, Chalmers JP, Duckworth WC, et al. Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia. 2009;52:2288-98.
8. Dluhy RG, McMahon GT. Intensive glycemic control in the ACCORD and ADVANCE trials. N Engl J Med. 2008;358:2630-3.
9. Taylor F, Huffman MD, Macedo AF, Moore TH, Burke M, Davey SG, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2013;1:CD004816.
10. Mihaylova B, Emberson J, Blackwell L, Keech A, Simes J, Barnes EH, et al. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet. 2012;380:581-90.
11. Ray KK, Seshasai SR, Erqou S, Sever P, Jukema JW, Ford I, et al. Statins and all-cause mortality in high-risk primary prevention: a meta-analysis of 11 randomized controlled trials involving 65,229 participants. Arch Intern Med. 2010;170:1024-31.
12. Montori VM, Brito JP, Ting HH. Patient-centered and practical application of new high cholesterol guidelines to prevent cardiovascular disease. JAMA. 2014;311:465-6.
13. Krumholz HM. The new cholesterol and blood pressure guidelines: perspective on the path forward. JAMA. 2014;311:1403-5.
14. D'Agostino Sr RB, Ansell BJ, Mora S, Krumholz HM. Clinical decisions. The guidelines battle on starting statins. N Engl J Med. 2014;370:1652-8.
15. Stone NJ, Robinson J, Lichtenstein AH, Merz CN, Blum CB, Eckel RH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;129:S1-45.
16. Mosca L, Benjamin EJ, Berra K, Bezanson JL, Dolor RJ, Lloyd-Jones DM, et al. Effectiveness-based guidelines for the prevention of cardiovascular disease in women - 2011 update: a guideline from the American Heart Association. J Am Coll Cardiol. 2011;57:1404-23.
17. National Institute for Health and Care Excellence. Statins for the prevention of cardiovascular events. Technology appraisal 94. National Institute for Health and Clinical Excellence. NICE technology appraisal guidance [TA94]. 2006. https://www.nice.org.uk/guidance/ta94. Accessed 31 March 2016.
18. National Heart Lung and Blood Institute. Risk Assessment Tool for Estimating Your 10-year Risk of Having a Heart Attack. 2014. http://cvdrisk.nhlbi.nih.gov/. Accessed 31 March 2016.
19. Emberson JR, Kearney PM, Blackwell L, Newman C, Reith C, Bhala N, et al. Lack of effect of lowering LDL cholesterol on cancer: meta-analysis of individual data from 175,000 people in 27 randomised trials of statin therapy. PLoS One. 2012;7:e29849.
20. Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376:1670-81.
21. Cholesterol Treatment Trialist Collaboration. CTT (Cholesterol Treatment Trialists' Collaboration). https://www.ctsu.ox.ac.uk/research/meta-trials/ctt. Accessed 31 March 2016.
22. Mills EJ, Rachlis B, Wu P, Devereaux PJ, Arora P, Perri D. Primary prevention of cardiovascular mortality and events with statin treatments: a network meta-analysis involving more than 65,000 patients. J Am Coll Cardiol. 2008;52:1769-81.
23. Abramson J, Wright JM. Are lipid-lowering guidelines evidence-based? Lancet. 2007;369:168-9.
24. Mills EJ, Wu P, Chong G, Ghement I, Singh S, Akl EA, et al. Efficacy and safety of statin treatment for cardiovascular disease: a network meta-analysis of 170,255 patients from 76 randomized trials. QJM. 2011;104:109-24.
25. Ioannidis JP. More than a billion people taking statins?: Potential implications of the new cardiovascular guidelines. JAMA. 2014;311:463-4.
26. Fernandez G, Spatz ES, Jablecki C, Phillips PS. Statin myopathy: a common dilemma not reflected in clinical trials. Cleve Clin J Med. 2011;78:393-403.
27. Thompson PD, Clarkson P, Karas RH. Statin-associated myopathy. JAMA. 2003;289:1681-90.
28. Davidson MH, Clark JA, Glass LM, Kanumalla A. Statin safety: an appraisal from the adverse event reporting system. Am J Cardiol. 2006;97:32C-43.
29. Macedo AF, Taylor FC, Casas JP, Adler A, Prieto-Merino D, Ebrahim S. Unintended effects of statins from observational studies in the general population: systematic review and meta-analysis. BMC Med. 2014;12:51.
30. Mansi IA, Mortensen EM, Pugh MJ, Wegner M, Frei CR. Incidence of musculoskeletal and neoplastic diseases in patients on statin therapy: results of a retrospective cohort analysis. Am J Med Sci. 2013;345:343-8.
31. Zhang H, Plutzky J, Skentzos S, Morrison F, Mar P, Shubina M, et al. Discontinuation of statins in routine care settings: a cohort study. Ann Intern Med. 2013;158:526-34.
32. Buettner C, Davis RB, Leveille SG, Mittleman MA, Mukamal KJ. Prevalence of musculoskeletal pain and statin use. J Gen Intern Med. 2008;23:1182-6.
33. Golomb BA, Evans MA, Dimsdale JE, White HL. Effects of statins on energy and fatigue with exertion: results from a randomized controlled trial. Arch Intern Med. 2012;172:1180-2.
34. Mikus CR, Boyle LJ, Borengasser SJ, Oberlin DJ, Naples SP, Fletcher J, et al. Simvastatin impairs exercise training adaptations. J Am Coll Cardiol. 2013;62:709-14.
35. Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, et al. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010;375:735-42.
36. Ma Y, Culver A, Rossouw J, Olendzki B, Merriam P, Lian B, et al. Statin therapy and the risk for diabetes among adult women: do the benefits outweigh the risk? Ther Adv Cardiovasc Dis. 2013;7:41-4.
37. Mora S, Glynn RJ, Hsia J, MacFadyen JG, Genest J, Ridker PM. Statins for the primary prevention of cardiovascular events in women with elevated high-sensitivity C-reactive protein or dyslipidemia: results from the Justification for the Use of Statins in Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) and meta-analysis of women from primary prevention trials. Circulation. 2010;121:1069-77.
38. Culver AL, Ockene IS, Balasubramanian R, Olendzki BC, Sepavich DM, Wactawski-Wende J, et al. Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative. Arch Intern Med. 2012;172:144-52.
39. Robinson JG. Statins and diabetes risk: how real is it and what are the mechanisms? Curr Opin Lipidol. 2015;26:228-35.
40. Hippisley-Cox J, Coupland C. Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database. BMJ. 2010;340:c2197.
41. Golomb BA, Evans MA. Re: Statin therapy is associated with reduced neuropathologic changes of Alzheimer disease. Neurology. 2008;70:2349-50.
42. Tatley M, Savage R. Psychiatric adverse reactions with statins, fibrates and ezetimibe: implications for the use of lipid-lowering agents. Drug Saf. 2007;30:195-201.
43. Golomb BA, Kane T, Dimsdale JE. Severe irritability associated with statin cholesterol-lowering drugs. QJM. 2004;97:229-35.
44. Golomb BA, Evans MA. Potential link between HMG-CoA reductase inhibitor (statin) use and interstitial lung disease. Med J Aust. 2007;187:253.
45. Golomb BA, Evans MA. Statin adverse effects: a review of the literature and evidence for a mitochondrial mechanism. Am J Cardiovasc Drugs. 2008;8:373-418.
46. Chaipichit N, Krska J, Pratipanawatr T, Jarernsiripornkul N. Statin adverse effects: patients' experiences and laboratory monitoring of muscle and liver injuries. Int J Clin Pharm. 2015;37:355-64.
47. Ott BR, Daiello LA, Dahabreh IJ, Springate BA, Bixby K, Murali M, et al. Do statins impair cognition? A systematic review and meta-analysis of randomized controlled trials. J Gen Intern Med. 2015;30:348-58.
48. Stroes ES, Thompson PD, Corsini A, Vladutiu GD, Raal FJ, Ray KK, et al. Statin-associated muscle symptoms: impact on statin therapy - European Atherosclerosis Society consensus panel statement on assessment, aetiology and management. Eur Heart J. 2015;36:1012-22.
49. Abramson JD, Rosenberg HG, Jewell N, Wright JM. Should people at low risk of cardiovascular disease take a statin? BMJ. 2013;347:f6123.
50. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ. 1996;312:71-2.
51. Montori VM, Brito JP, Murad MH. The optimal practice of evidence-based medicine: incorporating patient preferences in practice guidelines. JAMA. 2013;310:2503-4.
52. Braithwaite RS. A piece of my mind. EBM's six dangerous words. JAMA. 2013;310:2149-50.
53. Elwyn G, Edwards A, Hood K, Robling M, Atwell C, Russell I, et al. Achieving involvement: process outcomes from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice. Fam Pract. 2004;21:337-46.
54. Sandman L, Munthe C. Shared decision-making and patient autonomy. Theor Med Bioeth. 2009;30:289-310.
55. Sieber WJ, Kaplan RM. Informed adherence: The need for shared medical decision making. Control Clin Trials. 2000;21:233s-40.
56. Baird M, Blount A, Brungardt S, Dickinson P, Dietrich A, Epperly T, et al. Joint principles: integrating behavioral health care into the patient-centered medical home. Ann Fam Med. 2014;12:183-5.
57. Schwenk TL. The patient-centered medical home: one size does not fit all. JAMA. 2014;311:802-3.
58. Geyman JP. POEMs as a paradigm shift in teaching, learning, and clinical practice. Patient-oriented evidence that matters. J Fam Pract. 1999;48:343-4.
59. Smith R. A POEM a week for the BMJ. BMJ. 2002;325:983.
60. Shaughnessy AF, Slawson DC. POEMs: patient-oriented evidence that matters. Ann Intern Med. 1997;126:667.
61. Selby JV, Beal AC, Frank L. The Patient-Centered Outcomes Research Institute (PCORI) national priorities for research and initial research agenda. JAMA. 2012;307:1583-4.
62. Department of Health. NHS Constitution for England. 2015. https://www.gov.uk/government/publications/the-nhs-constitution-for-england. Accessed 31 March 2016.
63. Department of Health NHS. Equity and excellence: Liberating the NHS. London: The Stationary Office; 2010.
64. Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014;1:CD001431.
65. Mayo Foundation. Mayo Clinic Statin Choice Decision Aid. https://statindecisionaid.mayoclinic.org/. Accessed 31 March 2016.
66. National Institute for Health and Care Excellence. Taking a statin to reduce the risk of coronary heart disease and stroke. http://www.nice.org.uk/guidance/cg181/resources/cg181-lipid-modification-update-patient-decisionaid2. Accessed 31 March 2016.
67. Diener A, Celemin-Heinrich S, Wegscheider K, Kolpatzik K, Tomaschko K, Altiner A, et al. In-vivo-validation of a cardiovascular risk prediction tool: the arriba-pro study. BMC Fam Pract. 2013;14:13. http://www.arriba-hausarzt.de/.
68. Hirsch O, Keller H, Krones T, Donner-Banzhoff N. Acceptance of shared decision making with reference to an electronic library of decision aids (arriba-lib) and its association to decision making in patients: an evaluation study. Implement Sci. 2011;6:70.
69. Nelson W, Reyna V. Numeracy: A critical (and often overlooked) competence for health decision making. Ann Behav Med. 2007;33:S8.
70. Peters E, Vastfjall D, Slovic P, Mertz CK, Mazzocco K, Dickert S. Numeracy and decision making. Psychol Sci. 2006;17:407-13.
71. Andrews JC, Schunemann HJ, Oxman AD, Pottie K, Meerpohl JJ, Coello PA, et al. GRADE guidelines: 15. Going from evidence to recommendation-determinants of a recommendation's direction and strength. J Clin Epidemiol. 2013;66:726-35.
72. Ades PA. A controversial step forward: a commentary on the 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults. Coron Artery Dis. 2014;25:360-3.
73. Wallace ML, Ricco JA, Barrett B: Screening strategies for cardiovascular disease in aymptomatic adults. Primary Care: Clinics in Office Practice 2014, In press.
74. Koschack J, Weibezahl L, Friede T, Himmel W, Makedonski P, Grabowski J. Scientific versus experiential evidence: Discourse analysis of the chronic cerebrospinal venous insufficiency debate in a multiple sclerosis forum. J Med Internet Res. 2015;17:e159.
75. Ziebland S, Herxheimer A. How patients' experiences contribute to decision making: illustrations from DIPEx (personal experiences of health and illness). J Nurs Manag. 2008;16:433-9.
76. Jaeschke R, Singer J, Guyatt GH. Measurement of health status: Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407-15.
77. Barrett B, Brown R, Mundt M, Dye L, Alt J, Safdar N, et al. Using benefit harm tradeoffs to estimate sufficiently important difference: the case of the common cold. Med Decis Mak. 2005;25:47-55.
78. Barrett B, Brown D, Mundt M, Brown R. Sufficiently important difference: expanding the framework of clinical significance. Med Decis Mak. 2005;25:250-61.
79. Barrett B, Brown R, Mundt M. Comparison of anchor-based and distributional approaches in estimating important difference in common cold. Qual Life Res. 2008;17:75-85.
80. Barrett B. Sufficiently important difference: Concepts, caveats, and challenges. Med Decis Mak. 2013;33:869-74.
81. Ferreira ML, Herbert RD, Ferreira PH, Latimer J, Ostelo RW, Nascimento DP, et al. A critical review of methods used to determine the smallest worthwhile effect of interventions for low back pain. J Clin Epidemiol. 2012;65:253-61.
82. Franco MR, Ferreira ML, Howard K, Sherrington C, Rose J, Haines TP, Ferreira P. How big does the effect of an intervention have to be? Application of two novel methods to determine the smallest worthwhile effect of a fall prevention programme: a study protocol. BMJ Open. 2013;3(2):1-5. http://bmjopen.bmj.com/content/3/2/e002355.full. Accessed 31 March 2016.