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Medication Adherence: does Patient Participation in Randomized Clinical Trials Affect on it?

https://doi.org/10.20996/1819-6446-2019-15-3-386-392

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Abstract

The article focuses on the problem of low adherence to treatment among patients, in general, and provides data on the high adherence among patients in randomized controlled trials. Low adherence remains one of the most debated and difficult problems to solve nowadays. Poor medication adherence of the patient can significantly worsen the effectiveness of treatment and leads to increased health care costs. And although the factors that improve adherence are varied, and include the skills of the doctor, the patient’s personal characteristics, the external environment, an individual approach to each patient and etc., the absence of a “gold standard” for assessing adherence in clinical practice makes it difficult to predict and significantly improve it among patients. Nevertheless, the article discusses the existing doctor-patient interaction model, which strictly regulates the algorithms and technical means to achieve the best medication adherence. Randomized clinical trials (RCT) are the basis of evidence-based medicine, the results obtained in RCT form the basis of existing clinical guidelines. While participating in RCT patients can receive comprehensive information about the disease, the effectiveness of drug therapy, possible side effects of the therapy being conducted, the research objectives and prognosis from their attending physician; patients are trained to be disciplined and adhere to the recommendations of the doctor. The RCT, for a number of objective reasons, uses a variety of methods for assessing adherence and ways to improve it, which leads to higher patient adherence then among patients in general.

About the Authors

N. O. Vasyukova
National Medical Research Center for Preventive Medicine
Russian Federation

MD, Postgraduate Student, Department of Preventive Pharmacotherapy

Petroverigsky per. 10, Moscow, 101990 Russia



Yu. V. Lukina
National Medical Research Center for Preventive Medicine
Russian Federation

MD, PhD, Leading Researcher, Department of Preventive Pharmacotherapy

Petroverigsky per. 10, Moscow, 101990 Russia



N. P. Kutishenko
National Medical Research Center for Preventive Medicine
Russian Federation

MD, PhD, Head of Laboratory of Pharmacoepidemiological Research, Department of Preventive Pharmacotherapy

Petroverigsky per. 10, Moscow, 101990 Russia



S. Yu. Martsevich
National Medical Research Center for Preventive Medicine
Russian Federation

MD, PhD, Professor, Head of Department of Preventive Pharmacotherapy

Petroverigsky per. 10, Moscow, 101990 Russia



O. I. Zvonareva
Siberian State Medical University
Russian Federation

PhD, Researcher, Central Research Laboratory

Moskovsky trakt 2, Tomsk, 634050 Russia



References

1. Harris M., Taylor G., Jackson D. Clinical evidence made easy. Hockley, Essex: Scion Publishing Ltd.; 2014.

2. Ulmer C., Bruno M., Burke S., eds. Future Directions for the National Healthcare Quality and Disparities Reports. Washington, DC: The National Academies Press. 2010.

3. Martsevich S.Y., Kutishenko N.P. Randomised Clinical Trials and Observational Studies: the Ratio in the Hierarchy of Evidence of the Efficacy of Drugs. Rational Pharmacotherapy in Cardiology. 2016;12(5):567-573 (In Russ.) DOI:10.20996/1819-6446-2016-12-5-567-573.

4. Viswanathan M., Golin C.E., Jones C.D., et al. Interventions to Improve Adherence to Self-administered Medications for Chronic Diseases in the United States A Systematic Review. Annals of Internal Medicine. 2012;157(11):785-795. DOI:10.7326/0003-4819-157-11-201212040-00538.

5. MRC guidelines for good clinical practice in clinical trials. London: MRC. 1998.

6. Vrijens B., De Geest S., Hughes D.A., Przemyslaw K. et al. A new taxonomy for describing and defining adherence to medications. British Journal of Clinical Pharmacology. 2012;73(5):69-705. DOI:10.1111/j.1365-2125.2012.04167.x.

7. Idänpään-Heikkilä J.E. WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products: responsibilities of the investigator. Ann Med. 1994;26(2):89-94.

8. Sabaté E. WHO Adherence Meeting Report. Geneva: World Health Organization. 2001.

9. Blaschke T.F., Osterberg L., Vrijens B., Urquhart J. Adherence to medications. Insights arising from studies on the unreliable link between prescribed and actual drug dosing histories. Annu Rev Pharmacol Toxicol. 2012;52:275-301. DOI:10.1146/annurev-pharmtox-011711-113247.

10. Haynes R.B., Ackloo E., Sahota N., et al. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2008;CD000011. DOI:10.1002/14651858.CD000011.pub3.

11. Gul R.B, Ali P.A. Clinical trials: the challenge of recruitment and retention of participants. J Clin Nurs. 2010;19(1-2):227-33. DOI:10.1111/j.1365-2702.2009.03041.x.

12. Marcum Z.A., Gellad W.F. Medication adherence to multidrug regimens. Clin Geriatr Med. 2012;28(2):287-300. DOI:10.1016/j.cger.2012.01.008.

13. European Patients' Academy. Assessing participant adherence during clinical trials. [cited by Jun 13, 2019]. Available from: https://www.eupati.eu/clinical-development-and-trials/assessing-participant-adherence-during-clinical-trials/.

14. Gellad W.F., Grenard J.L., Marcum Z.A. A systematic review of barriers to medication adherence in the elderly: looking beyond cost and regimencomplexity. Am J Geriatr Pharmacother. 2011;9(1):11-23. DOI:10.1016/j.amjopharm.2011.02.004.

15. Pladevall M., Brotons C., Gabriel R., et al. Multicenter cluster-randomized trial of a multifactorial intervention to improve antihypertensive medication adherence and blood pressure control among patients at high cardiovascular risk (the COM99 study). Circulation. 2010;122(12):1183-91. DOI:10.1161/CIRCULATIONAHA.109.892778.

16. Hughes C.M. Medication non-adherence in the elderly: how big is the problem? Drug Aging. 2004;21(12):793-811.

17. Lukina Y.V., Kutishenko N.P., Martsevich S.Y. Treatment adherence: modern view on a well known issue. Cardiovascular Therapy and Prevention. 2017;16(1):91-5 (In Russ.) DOI:10.15829/1728-8800-2017-1-91-95.

18. Miller T.A. Health literacy and adherence to medical treatment in chronic and acute illness: A metaanalysis. Patient Educ Couns. 2016 J;99(7):1079-1086. DOI:10.1016/j.pec.2016.01.020.

19. Eussen S.R., van der Elst M.E., Klungel O.H., et al. A pharmaceutical care program to improve adherence to statin therapy: a randomized controlled trial. Ann Pharmacother. 2010;44(12):1905-13. DOI:10.1345/aph.1p281.

20. Harris S.M., Kelly C.G. Patient education in clinical trials and throughout the product lifecycle. Medical Writing. 2016;25(4):23-30.

21. Zhang N.J., Terry A., McHorney C.A. Impact of health literacy on medication adherence: a systematic review and meta-analysis. Ann Phamacother. 2014;48:741-751. DOI:10.1177/1060028014526562.

22. World Health Organization. Preventing chronic diseases: a vital investment. Geneva: World Health Organization. 2005.

23. Berkman N.D., Davis T.C., McCormack L. Health literacy: what is it? J Health Commun. 2010;15:9-19. DOI:10.1080/10810730.2010.499985.

24. Self-care for better individual health and more sustainable healthcare. [cited by Jun 13, 2019]. Available from: https://www.eurobiz.com.cn/self-care-for-improved-individual-health-and-sustainablehealthcare/.

25. Conn V.S., Ruppar T.M. Medication adherence outcomes of 771 intervention trials: Systematic review and meta-analysis. Prev Med. 2017;99:269-76. DOI:10.1016/j.ypmed.2017.03.008.

26. Self-care: a winning Solution. Association of the European Self-Medication Industry [cited by Jun 13, 2019]. Available from: http://www.aesgp.eu/media/cms_page_media/68/Self-Care%20A%20Winning%20Solution.pdf.

27. Brandberg Y., Johansson H., Bergenmar M. Patients’ knowledge and perceived understanding - associations with consenting to participated in cancer clinical trials. Contemp Clin Trials Comm. 2016;2:6-11. DOI:10.1016/j.conctc.2015.12.001.

28. Nanda S., Mohabbat A.B., Nagaraju D., et al. Improving Awareness of Patients with Obesity and its Healthcare Implications. Quality in Primary Care. 2015;23(4):201-4.

29. Harris S.M, Kelly C.G. Patient education in clinical trials and throughout the product lifescycle. Medical Writing. 2016;25(4):23-30.

30. Martsevich S.Y., Semenova Y.V., Kutishenko N.P., Ginzburg М.L. Assessment of patients’ attendance at outpatient clinics and prehospital therapy: Russian acute coronary syndrome registry LISS-3 data. Indian Heart Journal. 2017; 69(1):105-6. DOI:10.1016/j.ihj.2016.11.005.

31. Di Paolo M., Gori F., Papi L., Turillazzi E. A review and analysis of new Italian law 219/2017: “provisions for informed consent and advance directives treatment”. BMC Med Ethics. 2019;20(1):17. DOI:10.1186/s12910-019-0353-2.

32. Martsevich S.Y., Semenova Y.V., Kutishenko N.P., Zagebelniy A.V. Assessment of patients compliance for ambulatory institutions visits and its influence on the quality of treatment before development of acute coronary syndrome, by the LIS-3 registry. Russian Journal of Cardiology. 2016; 134:55-60. DOI:10.15829/1560-4071-2016-6-55-60.

33. Doerr M., Grayson S., Moore S., et al. Implementing a universal informed consent process for the All of Us Research Program. Pac Symp Biocomput. 2019;24:427-38. DOI:10.1142/9789813279827_0039.

34. Breckenridge A., Aronson J.K., Blaschke T.F., et al. Poor medication adherence in clinical trials: consequences and solutions. Nature Reviews Drug Discovery. 2017;16(3):149-50. DOI: 10.1038/nrd.2017.1.

35. Fletcher B., Gheorghe A., Moore D., et al. Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open. 2012;2:e000496. DOI:10.1136/bmjopen-2011-000496.

36. Sackett D.L, Haynes R.B. Compliance with Therapeutic Regimens. Baltimore, MD: The Johns Hopkins University Press. 1976.

37. Sacristán J.A., Aguarón A., Avendaño-Solá C., et al. Patient involvement in clinical research: why, when, and how. Patient Preference and Adherence. 2016;10:631-40.

38. Lehane E., McCarthy G. Medication non-adherence - exploring the conceptual mire. Int J Nurs Pract. 2009;15:25-31. DOI:10.1111/j.1440-172x.2008.01722.x.

39. Gul R.B., Ali P.A., Clinical trials: the challenge of recruitment and retention of participants, J Clin Nurs. 2010; 227-33. DOI:10.1111/j.1365-2702.2009.03041.x.

40. Osterberg L.G., Rudd P. Medication adherence for antihypertensive therapy. In: Oparil S, Weber M.A., eds. Hypertension: a companion to Brenner and Rector’s The Kidney. 2nd ed. Philadelphia: Elsevier; 2005; 848. DOI:10.1016/b978-0-7216-0258-5.50131-9.

41. Osterberg L., Blaschke T. Adherence to medication. N Engl J Med. 2005;353:487-97. DOI:10.1056/nejmra050100.

42. Roth G.A, Morden N.E., Zhou W., et al. Clopidogrel use and early outcomes among older patients receiving a drug-eluting coronary artery stent. Circ Cardiovasc Qual Outcomes. 2012;5(1):103-12. DOI:10.1161/CIRCOUTCOMES.111.962704.

43. Efremova E.V., Menzorov M.V., Sabitov I.A. Treatment compliance in patients with chronic heart failure and comorbidities Klin Med. 2015;93(9):20-4 (In Russ.)

44. Zykov M.V., Burns S. A. , Kashtalap V.V., Barbarash O.L. Adherence to lipid lowering therapy in post-ACS patients during 3 years follow up. Atherosclerosis and Dyslipidemias. 2017;(2):58-67 (In Russ.)

45. Zhuravskaya N.Y., Kutishenko N.P., Martsevich S.Y., et al. Study of the physician recommendation adherence in patients after stroke. The role of anxiety and depression (registry LIS-2). Cardiovascular Therapy and Prevention. 2015;14(2):46-51 (In Russ.) DOI.10.15829/1728-8800-2015-2-46-51.

46. Lukina Y.V., Kutishenko N.P., Martsevich S.Y. The Problem of Adherence to the Treatment in Modern Medicine: Possibilities of Solution, Impact on the Effectiveness of Therapy and Disease Outcomes. Rational Pharmacotherapy in Cardiology. 2017;13(4):519-5. (In Russ.) DOI:10.20996/1819-6446-2017-13-4-519-524.

47. Harris M., Taylor G., Jackson D. Clinical evidence made easy. Hockley, Essex: Scion Publishing Ltd.; 2014.

48. Martsevich S.Y., Kutishenko N.P. Randomised Clinical Trials and Observational Studies: the Ratio in the Hierarchy of Evidence of the Efficacy of Drugs. Rational Pharmacotherapy in Cardiology. 2016;12(5):567-573 (In Russ.) DOI:10.20996/1819-6446-2016-12-5-567-573.

49. MRC guidelines for good clinical practice in clinical trials. London: MRC. 1998.

50. Idänpään-Heikkilä J.E. WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products: responsibilities of the investigator. Ann Med. 1994;26(2):89-94.

51. Blaschke T.F., Osterberg L., Vrijens B., Urquhart J. Adherence to medications. Insights arising from studies on the unreliable link between prescribed and actual drug dosing histories. Annu Rev Pharmacol Toxicol. 2012;52:275-301. DOI:10.1146/annurev-pharmtox-011711-113247.

52. Gul R.B, Ali P.A. Clinical trials: the challenge of recruitment and retention of participants. J Clin Nurs. 2010;19(1-2):227-33. DOI:10.1111/j.1365-2702.2009.03041.x.

53. European Patients' Academy. Assessing participant adherence during clinical trials. [cited by Jun 13, 2019]. Available from: https://www.eupati.eu/clinical-development-and-trials/assessing-participant-adherence-during-clinical-trials/.

54. Pladevall M., Brotons C., Gabriel R., et al. Multicenter cluster-randomized trial of a multifactorial intervention to improve antihypertensive medication adherence and blood pressure control among patients at high cardiovascular risk (the COM99 study). Circulation. 2010;122(12):1183-91. DOI:10.1161/CIRCULATIONAHA.109.892778.

55. Lukina Y.V., Kutishenko N.P., Martsevich S.Y. Treatment adherence: modern view on a well known issue. Cardiovascular Therapy and Prevention. 2017;16(1):91-5 (In Russ.) DOI:10.15829/1728-8800-2017-1-91-95.

56. Eussen S.R., van der Elst M.E., Klungel O.H., et al. A pharmaceutical care program to improve adherence to statin therapy: a randomized controlled trial. Ann Pharmacother. 2010;44(12):1905-13. DOI:10.1345/aph.1p281.

57. Zhang N.J., Terry A., McHorney C.A. Impact of health literacy on medication adherence: a systematic review and meta-analysis. Ann Phamacother. 2014;48:741-751. DOI:10.1177/1060028014526562.

58. Berkman N.D., Davis T.C., McCormack L. Health literacy: what is it? J Health Commun. 2010;15:9-19. DOI:10.1080/10810730.2010.499985.

59. Conn V.S., Ruppar T.M. Medication adherence outcomes of 771 intervention trials: Systematic review and meta-analysis. Prev Med. 2017;99:269-76. DOI:10.1016/j.ypmed.2017.03.008.

60. Brandberg Y., Johansson H., Bergenmar M. Patients’ knowledge and perceived understanding - associations with consenting to participated in cancer clinical trials. Contemp Clin Trials Comm. 2016;2:6-11. DOI:10.1016/j.conctc.2015.12.001.

61. Harris S.M, Kelly C.G. Patient education in clinical trials and throughout the product lifescycle. Medical Writing. 2016;25(4):23-30.

62. Di Paolo M., Gori F., Papi L., Turillazzi E. A review and analysis of new Italian law 219/2017: “provisions for informed consent and advance directives treatment”. BMC Med Ethics. 2019;20(1):17. DOI:10.1186/s12910-019-0353-2.

63. Doerr M., Grayson S., Moore S., et al. Implementing a universal informed consent process for the All of Us Research Program. Pac Symp Biocomput. 2019;24:427-38. DOI:10.1142/9789813279827_0039.

64. Fletcher B., Gheorghe A., Moore D., et al. Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open. 2012;2:e000496. DOI:10.1136/bmjopen-2011-000496.

65. Sacristán J.A., Aguarón A., Avendaño-Solá C., et al. Patient involvement in clinical research: why, when, and how. Patient Preference and Adherence. 2016;10:631-40.

66. Gul R.B., Ali P.A., Clinical trials: the challenge of recruitment and retention of participants, J Clin Nurs. 2010; 227-33. DOI:10.1111/j.1365-2702.2009.03041.x.


For citation:


Vasyukova N.O., Lukina Y.V., Kutishenko N.P., Martsevich S.Y., Zvonareva O.I. Medication Adherence: does Patient Participation in Randomized Clinical Trials Affect on it? Rational Pharmacotherapy in Cardiology. 2019;15(3):386-392. (In Russ.) https://doi.org/10.20996/1819-6446-2019-15-3-386-392

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