Establishing an Ethical Assessment Index System for the Clinical Admittance of Medical Technologies: a Grounded Theory study[1]
CHENG Hua 1, MA Hong-xia 2, GU Ping 2, YANG Hao-hao1, ZHANG Li-bin 2, LI En-chang 3，WANG Ya-jing 4, HUANG Gang 1[2]
1 Lingnan Normal University, Guangdong, Zhanjiang, 524048;
2 Affiliated Hospital of Guangdong Medical School, Guangdong, Zhanjiang, 524001;
3 Xi'an Jiaotong University, Shanxi, Xi'an, 710049;
4 Huizhou No.2 Maternal and Child Care Service Centre,Guangdong,Huizhou,516000
Abstract
To explore the index System in Ethical Assessment of clinical admission of Chinese medical technology with the method of qualitative analysis, we choosing 78 literature data about ethical assessment of medical admission from 2000 to 2015 . A constructivist, grounded theory qualitative design was used for this study. Content analysis was undertaken electronically, using NVivo 10. an ethical Assessment Index System is built with 56 third-class indexes, 16 second-class indexes and 3 first-class indexes, after content are extracted through three stages: open, axial and selective coding.
Key Words
Grounded Theory; Ethical Assessment; Assessment Index;Medical Technology
1.Introduction
According to the medical practices in China, the clinical application of medical technology has been proven to be a double-edged sword. On one hand, medical technology has made great contributions to the health of human being. On the other hand, due to the uncertainty in technology, the differences in users’ aptitudes. and the abuse of technology, medical technology inevitably triggers a range of side effects, such as the hidden danger of unsafety practices as well as the possible breach of social ethics[1, 2]. For instance, organ transplant surgery might lead to illegal organ trading[3]; the prenatal diagnostic techniques (PNDTs) might cause a gender imbalance[4]; and excessive medical treatments and health care might trigger rising costs, a waste of resources, and damage to health [5]. In addition, the Ministry of Health in China halted the applications of technology such as clinical operations for drug abuse and electrical stimulation for Internet abuse[6, 7]. This indicates that before the clinical application of medical technology, there must be a systematic and overall scientific assessment (namely the evaluation of medical care technology).
When it comes to the evaluation of medical care technology, not only are the safety and effectiveness of the technology involved, but the social and ethical issues should also be considered. The ethical assessment refers to the assessment of the social and ethical issues created, which is an indispensable and significant evaluation of medical technology [8]. In May of 2005, the Ministry of Health in China issued the Regulations on the Clinical Application of Medical Technology (Ministry of Health Medical Administration［2009］, No 18). According to the fourth item of the regulation, “The clinical application of health care technology must adhere to ethical principles.” The seventh item stipulates that “There must be ethical censorship for the clinical application of the second category and third category medical technology.” Furthermore, the 41st item stipulates that "Any clinical application of medical technology with ethical defects by any medical organizations must be put to a stop.” These items indicate that ethical assessment has become a standard for the Chinese government to decide whether a medical technology should be clinically applied, halted, or forbidden. They also show that the ethical selection of the clinical application of medical technology has been legalized in China.
Making ethical assessment a legal standard for the evaluation of medical technology and the study of the ethical assessment evaluation standard system has been a focus point and challenge for the study of the clinical admittance of ethical assessment of medical technology[9, 10]. This paper aims to study the establishment of an ethical assessment index system for the Chinese clinical admittance of medical technology based on Grounded Theory.
2. Methods
2.1. Material
· Standards for the Source of the Research Recourses
Purposeful sampling was adopted[11], and considering the extensiveness, representativeness, and authoritativeness, the standards were set as follows: (1) international medical ethics regulations; (2) domestic (Chinese) medical ethics regulations; (3) academic papers about ethical assessment written by experts from the Committee of Experts on Medical Ethics of the Chinese Ministry of Health; (4) academic papers from experts (standing committee members and above) in the Society of Medical Ethics of the Chinese Medical Association; and(5) academic papers about ethical assessment written by Chinese senior ethicists.
· The Number of Research Resource samples
Theoretical sampling was adopted. And 78 literature resources were chosen, including: (1) 11 international medical ethics regulations and 20 Chinese medical ethics regulations; (2) 13 academic papers about ethical assessment written by experts in the Committee of Experts on Medical Ethics of the Chinese Ministry of Health; (3) 17 academic papers about ethical assessment written by experts (standing committee members and above) in the Society of Medical Ethics of the Chinese Medical Association; and (4) 17 academic papers about ethical assessment written by Chinese senior ethicists.
· Grounded Theory
Grounded Theory was put forward by Barney Glaser and Anselm Strauss in their book The Discovery of Grounded Theory: Strategies for qualitative research in 1967 [12]. The theory was further developed in 1990 in the book Basics of Qualitative Research: Grounded Theory Procedures and Techniques by Anselm Strauss and Juliet Corbin [13], as well as in 1993 in the book Qualitative Data Analysis: A Sourcebook of New Methods by Matthew Miles and Michael Huberman[14]. Based on the in-depth analysis of the original data, Grounded Theory aims to analyze, compare, and summarize all of the useful information extracted and collected, and then theorize the concept. The main features of the theory are as follows, (1) The theory comes from data: The framework of the theory was built upon an in-depth analysis of the original data. (2) High theoretical sensitivity: This method aims mainly to construct a theory; therefore, the study requires the researchers to have high theoretical sensitivity. (3) Constant comparison: There were constant comparisons from data to data, theory to theory, and then categories and their properties were extracted from the relationships between the data and theories. (4) Theoretical sampling: On the basis of comparison, the focus has been put on resourceful data, which are directly related to the establishment of the theory. (5)Construct theory: the detailed procedure can be seen in Fig.1.
Figure 1 Research procedure of Grounded Theory
· Qualitative Research Software NVivo10.0
In this study, the qualitative research software NVivo10.0 (Sage Corporation, US) was applied to establish an ethical assessment index system for the clinical admittance of medical technology. NVivo was based on Grounded Theory and can analyze non-numerical and unstructured data, offer statistical management to qualitative research, and provide various data, such as words, photographs, videos, open coding, associated coding and core coding. Eventually, the concept or theory was formed and the qualitative research was completed [15-17].
· Building Index Code
The 78 research data items collected according to the standards for the sources of research recourses were imported into NVivo10.0.
Figure 2.1 Import Literature Data
· Open Coding
With regard to the open data, first coded were the units which reflected the significance of the ethical assessment of the clinical admittance of medical technology and the free nodes were formed. According to Grounded Theory, the formation of the free nodes was grounded on that data. Through repetitive comparison and evaluation, new nodes were constantly brought to the previous data in order to reach the code saturation. After code to the 78 copies of the research one by one, as coding to data No.69 ，it was shown that no new categories or relationships were found, which proves that the theoretical model built in this research was saturated. According to the needs of the theoretical saturation, 283 nodes were obtained. The 56 third-class assessment indexes were obtained by merging the similar nodes.
Table 1: Open Coding Sample
Excerpts from the Original Paper / Meaning Unites / Free NodesOver-treatment, Appropriate Medical Care, and Optimization of Medical Care
DU Zhi-zheng
Abstract: Over-treatment is different from over-service. Appropriate Medical Care should offer patients suffering from different diseases effective, safe, convenient and low-cost medical care. The optimal medical care aims to achieve the medial care which is the most effective, safest, most convenient, and causes low cost and minimized pain. Generally speaking, the optimal medical care is supposed to be appropriate medical care in the first place, only more demanding. Optimal medical care should not replace appropriate medical care and appropriate medical care should not be renamed as optimal medical care. Appropriate medical care can be the basic requirement for health care services, while optimal medical care can serve as the ideal goal to be striving for. This is while ensuring that people have the basic medical care and medical insurance that appropriate medical care is supposed to advocate. / The optimal medical care aims to achieve medial care which is the most effective, safest, most convenient, and causes low cost and minimized pain. /
Most Effective
Safest
Minimized Pain
Most Convenient
Low Cost
· Associated Coding
The 56 third-class assessment index item codes obtained by open coding were subjected to associated coding, which means the second-class assessment index item codes were extracted. In NVivo10.0, the associated coding was done by building tree nodes, and the equivalent, similar, and different third-class evaluation codes were categorized into second-class evaluation codes. Eventually, 16 second-class evaluation codes were obtained, which were benefits for patients, benefits for families, benefits for the industry, benefits for the society, prevent abuse, ethics of the creation of medical technology, ethics of the fruits of medical technology, ethics of medical technology' subjects, legitimacy of technology application rights as principles, legitimacy of medical disclosure, legitimacy of the consent of the consenters, measures to prevent false consent, medical standards for the acceptor's choices, ethical standards for the acceptor's choices, legitimacy of the approval of the acceptor's choices, and the halt mechanism of technology' admittance. The establishment of second-class evaluation codes can be seen in figure 2.2、figure 2.3 and figure 2.4.
Figure 2.2 The Establishment of second-class evaluation codes (1)
Figure 2.3 The Establishment of second-class evaluation codes (2)
Figure 2.4 The Establishment of second-class evaluation codes (3)
After finishing the second-class assessment index item coding, the relationships between the nodes were dealt with, and the direction and type of relationship were settled. We set the direction of the coding as a one-way direction from free nodes to tree nodes, and relationship type as“belong to”and then establishes the relations type of associated coding by adding relations links one by one.
· Core Coding
After finishing the associated coding, via the consistent discussion, comparison, and summary of the researchers, the equivalent, similar and different second-class evaluation codes were deduceded and further categorized into first-class evaluation codes. Eventually, three first-class assessment index codes were obtained, and indexed for ethical purposes, ethical tools, and ethical behaviors. A module was built in NVivo10.0, which clearly showed the features of each class of codes and the inter-relationships between the nodes. The module can be seen in Fig. 2.5.
Figure 2.5 The module of third-class codes
· Theoretical Saturation Detection
This research made use of the last ten research data sets (from No. 69 to No. 78) to detect the theoretical saturation. The results showed that no new categories or relationships were found, which proves that the theoretical model built in this research was saturated.
· Reliability Test after Coding
According to Grounded Theory method, the results of coding are often tested using the agreement percentage and K coefficient. In this study, the agreement percentage is used as an index to check the reliability. If the two researchers' scales of agreement were both above 70%, the codes were efficient.[Agreement Percentage (Reliability) = the number of codes with mutual agreement / （the number of codes with mutual agreement+ the number of codes with mutual disagreement)]
In this study, 7 copies of the data were randomly selected, and the NVivo10.0 search function was used by clicking "search" in the navigation window, the comparative search was done.
3. Results
3.1.The Table of the Index Codes for the Clinical Admittance of Medial Technology
Through open coding, 56 third-class index codes were obtained, through associated coding, 16 second-class index codes were obtained, and through core coding, 3 first-class index codes were obtained. (Table 2)
Table 2: Index Code Table - An Index system for the Clinical Admission of the ethical assessment of medical technology
First-class Code / Second-class Code / Third-class CodeNo. / Content / No. / Content / No. / Content / ENTRY ID
1 / Index for Ethical Purposes / 1-1 / Patient' Benefits Assessment / 1-1-1 / Eliminate Patient' Pain / 1
1-1-2 / Improve Patients' Functions / 2
1-1-3 / Prolong Patients' Life / 3
1-1-4 / Help with Patients' Recovery / 4
1-2 / Family' Benefits Assessment / 1-2-1 / Economic Benefits / 5
1-2-2 / Emotional Benefits / 6
1-2-3 / Energy benefits / 7
1-3 / Medical Industry's Benefits Assessment / 1-3-1 / Improve Medical Level / 8
1-3-2 / Improve Economic Benefits / 9
1-3-3 / Improve Social Benefits / 10
1-4 / Society' Benefits Assessment / 1-4-1 / Meet the Needs of Medical Care / 11
1-4-2 / Maintain Marriage Morality / 12
1-4-3 / Maintain Social Morality / 13
1-5 / Presentation of Abuse Assessment / 1-5-1 / Prevent Subjective Deliberate Abuse / 14
1-5-2 / Prevent Objective Deliberate Abuse / 15
1-5-3 / Prevent the Abuse of Behavior / 16
2 / Index for Ethical Tools / 2-1 / Ethics of the Creation of Medical Technology / 2-1-1 / Ethical Experiments in Laboratory / 17
2-1-2 / Ethical Animal Test Process / 18
2-1-3 / Ethical Human Test Process / 19
2-2 / Ethics of the Fruits of Medical Technology / 2-2-1 / Ethical Clinical Test Process / 20
2-2-2 / Best Effect of Medical Technology / 21
2-2-3 / Safest Medical Technology / 22
2-2-4 / Cheapest Medical Technology / 23
2-2-5 / Medical Technology with Easy Operation / 24
2-3 / Legal Medical Technology Application Subject / 2-3-1 / Government-planned Diagnosis / 25
2-3-2 / Belong to Government-approved Diagnosis Subject / 26
2-3-3 / Belong to Government-forbidden Diagnosis Subject / 27
3 / Index for Ethical Behaviors / 3-1 / Legitimacy of Technology Application Rights as Principle / 3-1-1 / Legitimacy of Medical
Organizations Rights as Principle / 28
3-1-2 / Legitimacy of Medical Staff Rights as Principle / 29
3-1-3 / Legitimacy of Medical Disclosure Rights as Principle / 30
3-1-3 / Legal Qualification of Consenters / 31
3-1-4 / Immoral Records of Medical Care Organization / 32
3-2 / Legitimacy of Medical Disclosure / 3-2-1 / Legitimacy of Informing Patients of Medical Care's Effects / 33
3-2-2 / Legitimacy of Informing Patients of Medical Care's Risks / 34
3-2-3 / Legitimacy of Informing Patients of Medical Care's Interests / 35
3-2-4 / Legitimacy of Informing of the Remedies for Danger / 36
3-3 / Legitimacy of the Consent of Consenters / 3-3-1 / Ethics of the Consent of Patients / 37
3-3-2 / Ethics of the Consent of Guardians / 38
3-3-3 / Ethics of the Consent of Agents / 39
3-4 / Measures to Prevent False Medical Consent / 3-4-1 / Prevention of Seduced Consent / 40
3-4-2 / Prevention of Deceived Consent / 41
3-4-3 / Prevention of Forced Consent / 42
3-5 / Medical Index for Accepter and Donor Choices / 3-5-1 / Standards for Indication / 43
3-5-2 / Index for Contraindication / 44
3-5-3 / Index for Medical Care Acceptability / 45
3-6 / Ethical Index for Accepter and Donor Choices / 3-6-1 / Principle of Patients Independence / 46
3-6-2 / Principle of Respecting Life / 47
3-6-3 / Principle of Non-malfeasance / 48
3-6-4 / Principle of Justice and Fairness / 49
3-6-5 / Principle of Beneficence / 50
3-7 / Legitimacy of the Approval of Accepter and Donor Choices / 3-7-1 / Legitimacy of the Approval Authority and Process of Medical Care Institutions / 51
3-7-2 / Legitimacy of the Approval Authority and Process of Authority of Government Organizations / 52
3-7-3 / Legitimacy of the Approval Authority and Process of Ethics Organizations / 53
3-8 / Halt Mechanism of Medical Technology' Admittance / 3-8-1 / Halt System of Defects in Medical Technology' Effectiveness / 54
3-8-2 / Halt System of Defects in Medical Technology' Safety / 55
3-8-3 / 56Halt System of Defects in Medical Technology' Ethics / 56
3.2 Reliability Test for Coding