Deng-Feng Kong, Xiao-Chi Shi, Bao-He Wang, Yu-Hong Huang, Qiang Xu, Peng Tian, Ying-Qiang Zhao,Wei Mu*, Hong-Cai Shang*

1Tianjin University of Traditional Chinese Medicine, Tianjin, China. 2Department of Clinical Ph3armacology,Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China. The second Affiliate4d Hospital of Tianjin University of Traditional Chinese Medicine, Cardiovascular Department, Tianjin,China. Key Laboratory of Chinese Medicine Department of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.

Background

The traditional disease-centered mode usually focuses on the biological level of disease without regarded to the human attributes such as s society, behavior, spirit,and psychology, in which the medical service process is passive. As the “biomedical” model gradually develops into a “bio-psycho-social” model, the medical concept of “patient-centered” PtDA between doctors and patients has gradually entered the field of vision[1].

Traditionally, the production and dissemination of clinical practice guidelines and evidence have been designed primarily to meet the needs of clinicians [2].Patients often delegate treatment decisions to doctors and they rarely participate in the decision-making process. When clinicians and patients are faced with the choice of multiple treatment options, due to poor communication between doctors and patients, or unclear preferences for patients, it often leads to uncertainty [3]. Co-determination is the process by which patients participate in clinical decision-making and reach a treatment agreement with a doctor [4-5]. It emphasizes the patient’s dominant position. Based on specific values, preferences, and personal circumstances, decision is made for them [6].

PtDA was designed to help people participate in the decision-making. It was very important to judge the feasibility of the PtDA [7]. Evidence-based medicine and narrative medicine could provide the main evidence to make the judgement, as evidence-based medicine could provide quantitative decision-making evidence and narrative medicine provides qualitative decision-making basis for narrative research (such as individual patient stories). PtDA can provide information about the options and help the patient build and communicate with the individual values associated with the different features of the options [8].With PtDA, patients participate more in medical decision-making [9-12], reduce decision-making conflicts [13] and enhance compliance to interventions[14].

There were many risk factors for cardiovascular disease, which was world’s leading death disease,accounting for 31% of global deaths. China Cardiovascular Disease Report 2016 have showed that many cardiovascular disease patients in China were 290 million and the mortality of cardiovascular disease was the highest, accounting for more than 40% of the deaths of residents [15-16]. In the prevention and treatment of cardiovascular diseases, the cases of co-determination were particularly prominent. For example, the treatment of stable coronary artery disease, patients are required to decision on the anticoagulation, and interventional treatment [17].Symptoms, risk factors, and lifestyle behaviors should be managed during the whole cardiovascular disease in order to obtained the best treatment and prognosis.Therefore, patients have to change their behaviors,such as giving up smoking, starting to exercise or taking long-term including aspirin for lowering blood pressure or cholesterol levels. In particular, there were a large number of high-quality prospective studies for the latter, and the related endpoints can be used for patients and doctors' clinical decision-making [18-23].

Methods and data

Study design

The development of PtDA has been developed rapidly in European and American countries with strict quality evaluation standards. Among them, the Ottawa Patient Decision Aids database (www.ohri.ca/decisionaid) of Ottawa Hospital Research Institute has registered and collected 684 PtDA for patients. In the recent Cochrane Decision Assisted Assessment (2017), 105 decision aids were eventually incorporated. There are 13 PtDA in the National Institute for Heath and Care Excellence(NICE) [24]. These three databases were included in most of the existing PtDA and were in line with the international patient PtDA evaluation criteria (IPDAS).We have selected the three databases to study the status of PtDA for cardiovascular disease. Finally, a total of 70 PtDA for cardiovascular diseases were screened from three databases, as shown in Table 1.

Data and results

For the different contents of the 70 PtDA, preliminary statistics were made from the aspects of decision-making types, health themes (Figure 1), PtDA(Figure 2), and source countries. In terms of health topics, there were 20 cases of arrhythmia, 11 cases of coronary heart disease, and 11 cases of risk factors for heart disease. In terms of tools, there are 43 paper versions and 41 online versions, 39 of which use two forms at the same time. Source countries are mainly the United States, Britain and Canada.

Figure 1 Distribution table of health topics

Table 1 A list of basic information

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Analysis and conclusion

Decision-making background

When we emphasize the applicability and effectiveness of assistive decision-making, we must understand the importance of broader treatment decision-making contexts. Of the 70 tools included, 5 were used for the screening phase and only 2 for the prevention phase[25]. This shows that the current decision-making aids are unevenly distributed during the diagnosis and treatment of diseases. However, the disease treatment process is dynamic and complex. We can develop and implement different intervention programs for different stages of the same disease and one or more treatment goals in a certain stage of the disease to achieve the entire process of disease development. For example,according to the severity of coronary heart disease and different stages, the decision assistance for different stages such as screening, treatment or prevention was made.

Development process and effect evaluation

In the era of evidence-based practice, one of the main challenges of co-determination is to ensure that the PtDA are optimal and comprehensive. So that can ensure the quality, accuracy and reliability of the information contained in PtDA [27]. Most of PtDA in the paper cited a series of evidence-based medical methods to obtain research evidence including systematic reviews, meta-analysis, or randomized controlled trials. However, 67% of PtDA did not report the registration or conduct relevant clinical trials to evaluate the impact of decision-making intervention on the process and results. Many RCTs in recent years have shown that the use of decision support tools is effective in improving the patient’s outcomes, and these positive results can facilitate research on decision making. Therefore, it is necessary to carry out relevant clinical trials on PtDA to verify its utility.

The form of PtDA

The forms of PtDA vary, including nurse core group interviews, personalized informed consent, video or decision making guidance [28]. The form of PtDA for different subjects of cardiovascular disease was mainly focused on network (37%), paper (35%), video (8%)and so on (Figure 2).

Figure 2 Decision aid forms

Network PtDA

With the development of internet, it has become an important resource for disseminating medical information. A large number of patients with cardiovascular diseases have accessed to the internet for health information. However, the population distribution was not uniform, and patients living suburb cannot receive the same level of health care as urban patients [29-30]. Web-based PtDA, as a convenient and convenient way, can provide effective health information for patients suburb [31].

Network PtDA is defined as using the internet to provide some or all of the components to assist participating individuals (eg., patients, caregivers,agent decision makers, etc.) make appropriate healthcare options. This broad definition covers a range of methods, from a PtDA based paper to online video-based PtDA, etc. [32]

Hess EP et al. conducted a multi-center parallel randomized controlled trial to collect patient information, calculated the probability of acute coronary syndrome using an online risk, then educate the patients with decision-making aid tools, and finally let the patient choose the treatment option on their preference. The study showed that decision-making aid tools facilitated co-determination, increased patient knowledge and participation, reduced decision-making conflicts, and reduced the number of re-hospitalization visits within 30 days [33]. SCDA is an interactive tool that helps clinicians and patients discuss the use of statins. Information used to assess cardiovascular risk in patients over the next 10 years, the extent of risk reduction using statins, and the likelihood of adverse events (https://statindecisionaid.mayoclinic.org) [34].A large number of randomized trials have shown that using SCDA can increase the patient’s knowledge and participation, reduce decision-making conflicts, and can help patients accurately perceive the potential risk of heart attack [35-39].

PtDA in paper version

Due to the complexity of network decision aid tools,limited time and financial resources, and privacy issues,some of PtDA’s advantageous attributes such as portability and interactivity have not been realized.Some patients, especially the old stated that they were conservative about the PC version of PtDA because they feared lack of sufficient computer skills or access to computers/internet [40]. Therefore, the paper version of PtDA can more easily meet their needs. The paper version of PtDA includes single pages, PDFs,brochures, etc. Presented in texts, numbers and charts,summarizing the best evidence in the simplest language, is a convenient and intuitive way for elderly patients who are disconnected from the network.Fatima et al. conducted a decision aids tool to develop and validate antithrombotic drugs for atrial fibrillation,covering a variety of antithrombotic options. The results showed that this decision-making aids tool help the patients understand the disease and treatment,which is useful in decision-making [41].

PtDA in video version

With the development of science and technology,multimedia has been applied to all aspects of society,especially in the medical field. It delivers information to patients through graphic and images, by which helps patients understand the advantages and disadvantages of different treatments, and helps patients actively participate in decision-making. Video decision aids tools have been developed and applied to the clinic to improve patient understanding of treatment decisions,disease expectations, and treatment preferences [42].Areej El-Jawahri et al. conducted a multi-center randomized controlled trial. The intervention group received 6-minute videos on CPR / intubation and the oral description of tertiary care (including extended life care, limited care, comfort, etc.), while the control group received only oral description of tertiary care.The results showed that patients with heart failure who watched videos were more aware of the situation than patients who only oral description, were more likely to choose comfort concerns, and were less likely to need CPR / intubation [43-44]. In a study on self-care for elderly patients with heart failure, researchers provided a 29-minute DVD-PtDA to the trial group, which describe a detailed life-style of heart failure. The results showed that DVD-PtDA promoted self-care behavior in heart failure patients. The intervention group was more concerned with daily weight monitoring, fluid intake and elimination, and with low sodium diet than the experimental group [45-46].

At present, there is no consensus on the merits and demerits of various forms of PtDA. Several studies have shown that different forms of decision aids tools have no significant differences in improving decision-making results. In terms of acceptability, it is more influenced by personal preferences [47-49].

Limitations

One of the obstacles for patients is the difficulty of obtaining and using these tools. The tools included in this study are all from Europe and the United States,and are presented in English. What is more, 59% of the tools are in the internet format. There hinder the patients in non-English-speaking countries access to PtDA, especially the patients with low education levels,poor medical conditions. The difficulty of using tools has reduced the use of PtDA and affected the popularity. Therefore, it is necessary to further develop and evaluate PtDA.

Discussion

Comprehensive, transparent and unbiased communication with clinicians was irreplaceable.Developing high-quality PtDA were also crucial [30].co-determination which support the patient-centered medical model, can discuss the risks and benefits of different options, help patients express their preferences and make decisions together with doctors.Therefore, it has broad development and application prospects in the field of TCM prevention and treatment of cardiovascular diseases.

In China, the concept of co-determination was lately started, and the development of PtDA in the field of cardiovascular disease was relatively slow. A large number of patients cannot participate in medical decision-making. In reality, doctor’s consulting time was short, with information asymmetry, professional medical terms. These were obstacles of co-determination. Under the medical system of integrated traditional Chinese and Western medicine and the existence and development of national medicine, it is more difficult for patients to make decision. In the clinical, PtDA could help patients to make the best choice, and tell patients how to weigh the effects and side effects of Western medicine and TCM. In the field of TCM, Mou Wei et al. first tried to develop paper and network decision manual for angina pectoris in 2014. He took two kind of representative drugs Tongxinluo and isosorbide mononitrate as alternative drugs, and used handbooks to help patients identify the value of medicines. This promoted co-determination. The results have showed that with PtDA, patients could understand related information,identify personal medication expectations and preferences. It showed that the PtDA can effectively reduced the contradiction in decision-making and significantly improved ability and quality of decision-making.

Prospect

It is a global trend to make co-determination. Through various of PtDA, patients could understand the co-determination. But we cannot blindly copy the PtDA abroad. It is necessary to establish reasonable evidence-based evaluation methods and procedures with Chinese characteristics and to develop PtDA suitable for the Chinese environment and the population. What is more, medical staff should also change attitude and encourage patients to actively participate in co-determination. In recent years, the emergence of narrative evidence-based medicine has provided a new opportunity for the further development of co-determination. The combination of“the best scientific evidence” and “the most appropriate individual evidence” will provide patients with medical evidence as well as humanistic care. This was not only an important way to help doctors and patients choose the treatments in the era of precision medicine, but also the key link of “patient-centered” in TCM clinical practice.

1. Barratt A. Evidence based medicine and shared decision making: the challenge of getting both evidence and preferences into health care. Patient Education Couseling 2008, 73: 407-412.

2. Agoritsas T, Heen AF, Brandt L, et al. Decision aids that really promote shared decision making:the pace quickens. BMJ 2015, 350 : g7624.

3. Rodriguez-Gutierrez, Rene G, Michael SO, et al.Shared decision making in endocrinology: present and future directions. Lancet Diabetes Endocri 2016, 28: 33-35.

4. Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango)Social sci med 1997, 44: 681-692.

5. Charles C, Gafni A, Whelan T. Decision-making in the physician-patient encounter: revisiting the shared treatment decision-making model. Soc Sci Med 1999, 49: 651-661.

6. Joseph WN, Elwyn G, EdwardsA. Knowledge is not power for patients: a systematic review and thematic synthesis of patient-reported barriers and facilitators to shared decision making. Patient Educ Couns 2014, 94: 291-309.

7. Wyatt KD, Branda ME, Anderson RT, et al.Peering into the black box: a meta-analysis of how clinicians use decision aids during clinical encounters. Implement Sci 2014, 9: 26.

8. Mann DM, Ponieman D, Montori VM, et al. The statin choice decision aid in primary care: a randomized trial. Patient Educ Couns 2010, 80:138-140.

9. Hess EP, Knoedler MA, Shah ND, et al. The chest pain choice decision aid: a randomized trial. Circ cardiovasc qual outcomes 2012, 5: 251-259.

10. Nannenga MR, Montori VM, Weymiller AJ, et al.A treatment decision aid may increase patient trust in the diabetes specialist. Statin Choice 2009,12:38-44.

11. Decision aids for patients facing health treatment or screening decisions: systematic review BMJ.1999, 18: 731-734.

12. Victor MM, Maggie B, Matthew M, et al.Creating a conversation: insights from the development of a decision. AidPLoS Med 2007, 4:e233.

13. Chen WW, Gao RL, Liu LS, et al. Summary of Chinese cardiovascular disease report 2016.Chinese Circul J 2017, 32: 521-530.

14. Tanja K, Heidemarie K, Andreas S, et al.Absolute cardiovascular disease risk and shared fecision making in primary care: a randomized controlled trial. Ann Fam Med 2008, 6: 218 227.

15. Cholesterol Treatment Trialists’ (CTT)Collaborators. 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: 581-590.

16. Collaborators GT. Smoking prevalence and attributable disease burden in 195 countries and territories, 1990-2015: a systematic analysis from the Global Burden of Disease Study 2015. Lancet 2017, 3, 8-9.

17. Taylor RS, Brown A, Ebrahim S, et al.Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials.American J Med 2004, 116: 682-692.

18. Antithrombotic Trialists’ Collaboration.Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death,myocardial infarction and stroke in high risk patients. BMJ 2002, 324: 71-86.

19. Psaty BM, Lumley T, Furberg CD, et al. Health outcomes associated with various antihypertensive therapies used as first-line agents:a network meta-analysis. JAMA 2003, 289:2534-2544.

20. Waljee JF, Rogers MA, Alderman AK. Decision aids and breastcancer: do they influence choice for surgery and knowledge of treatment options. J Clin Onco 2007, 25: 1067-1073.

21. Stacey D, Légaré F, Lewis K, et al. Decision aids for people facing health treatment or screening decisions. Cochrane database of systematic reviews 2017, 44- 23-35.

22. Charles C, Gafni A, Whelan T, et al. Treatment decision aids: conceptual issues and future directions. Health Expectations 2016, 8: 114–125.

23. Montori VM, LeBlanc A, Buchholz A, et al.Basing information on comprehensive, critically appraised, and up-to-date syntheses of the scientific evidence: a quality dimension of the international patient decision aid standards. BMC Med Inform Decis Mak 2013, 13: 1.

24. Clifford AM, Ryan J, Walsh C, et al. What information is used in treatment decision aids? A systematic review of the types of evidence populating health decision aids. BMC Med 2017,17: 22.

25. Coylewright M, Shepel K, Leblanc A, et al.Shared decision making in patients with stable coronary artery disease: PCI choice. PLoS ONE 2012, 7: e49827.

26. Neubeck, L. Can the Internet help people with cardiovascular disease? Int J Clin Pract 2011,929-931.

27. Ohlow，MA, Brunelli A. Internet use in patients with cardiovascular diseases: BABSY. Int J Clin Pract 2015, 67, 990-995.

28. Lear SA, Araki Y, Maric B, et al. Prevalence and characteristics of home internet access in patients with cardiovascular disease from diverse geographical locations. Canadian J Cardio 2009,25: 589-593.

29. Aubri SH，Robert JV，Robert JV, et al. Delivering patient decision aids Internet: definitions, theories,current evidence, emerging research areas. BMC 2013, 1: 3.

30. Hess EP, Hollander JE, Schaffer JT, et al. Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial.BMJ 2016, 05: i6165.

31. Aimee YB, Maya K, Marianne S, et al. Montori and Rajeev Chaudhry. BMC Med 2017, 17: 118.

32. Nannenga MR, Montori VM, Weymiller AJ, et al.A treatment decision aid may increase patient trust in the diabetes specialist. Health Expect 2009, 12: 38-44.

33. Jones LA, Weymiller AJ, Shah, N. Should clinicians deliver decision aids? Further exploration of the Statin Choice randomized trial results. Med Decis Making 2009, 29: 468-474.

34. Weymiller AJ, Montori VM, Jones LA, et al.Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial. Arch Intern Med 2007, 167:1076-1082.

35. Montori VM, Breslin M, Maleska M, et al.Creating a conversation: insights from the development of a decision aid. PLoS Med 2007, 4:233.

36. Mann DM, Ponieman D, Montori VM, et al. The Statin Choice decision aid in primary care: a randomized trial. Patient Educ Couns 2010, 80:138-140.

37. Ingrid N, Constance HC, Heleen C, et al.Development of a web-based patient decision aid for initiating disease modifying anti-rheumatic drugs using user-centred design methods. BMC Med 2017, 17: 1.

38. Fatima, S. Development and validation of a decision aid for choosing among antithrombotic agents for atrial fibrillation. Thrombosis Res 2016,145: 143-148.

39. Liao ZF, Fang HP, Liu HJ. Current status and progress of patient decision support research.Nursing res 2014, 28: 4360-4363.

40. Volandes AE, Levin TT, Slovin S, et al.Augmenting advance care planning in poor prognosis cancer with a video decision aid: a preintervention study. Cancer 2012, 118:4331-4338.

41. Volandes AE, Paasche MK, Mitchell SL, et al.Randomized controlled trial of a video decision support tool for cardiopulmonary resuscitation decision making in advanced cancer. J Clin Oncol 2013, 31: 380-386.

42. Areej E. Randomized, controlled trial of an advance care planning video decision support tool for patients with advanced heart failure circulation. BMC Med 2016, 134: 52-60.

43. David R. Veroff BB, Lisa A, et al. Population Health Management. February 2012, 15: 37-45.

44. Allen, K. Internet versus DVD decision aids for hip and knee osteoarthritis. Musculoskelet 2016 14: 87-97.

45. Icholas Z, Phyllis B, Stephanie T, et al. A systematic review of decision aids for patients making a decision about treatment for early breast cancer. Breast 2016, 1: 31-45.

46. Hinsberg L, Marques F, Leavitt L, et al.Comparing the effectiveness of two different decision aids for stable chest discomfort. Coron Artery Dis 2017, 1: 27.

47. Engelen A, Vanderhaegen J, Van PH, et al.Patients’ views on using decision support tools: a systematic review. European J Person Centered Healthcare 2016, 4: 161-186.

48. Erica S. Spatz MD. The new era of informed consent getting to a reasonable-patient standard through shared decision aking. JAMA 2016, 315:2063-2064.

49. Mou W, Zhai JB, Li J, et al. The transformation strategy of TCM clinical evidence: the development of decision aid tool. World Chin Med 2017, 12: 1261-1267.