1. Background

Due to developments in modern medicine, the average life expectancy is increasing worldwide, and ethical and legal problems have accordingly arisen with regard to the process of deciding upon and administering proper life-sustaining treatment. Laws have been established and implemented in several countries to help patients facing imminent death to discontinue life-sustaining treatments that are considered medically meaningless and to maintain their dignity. In Taiwan and the United States, legislation has been passed to ensure that patients make choices regarding life-sustaining treatment, such as physician orders for life-sustaining treatment (POLST), natural death laws, and hospice laws; notable legal measures include the Austrian Patient Pre-Decision Act, Singapore’s Medical Advance Decision Act, and the French Patient Rights and End-of-Life Act [1]. In Korea, discussions about how to decide on life-sustaining treatment have continued since the Boramae incident in 1997, and official discussions about the suspension of meaningless life-sustaining treatment started as a result of Madam Kim’s case in 2008. In February 2016, the Act on Hospice and Palliative Care and Decisions on Life-Sustaining Treatment for Patients at the End of Life (hereinafter referred to as the Act on Decisions on Life-Sustaining Treatment was enacted, resulting in the systematization of life-sustaining treatment decisions, and the act fully came into force on February 4, 2018 after a 2-year preparation period [2].

The Act on Decisions on Life-Sustaining Treatment allows “patients at the end of life” to decide on their own whether to receive life-sustaining treatment, protects patients’ self- determination, and guarantees patients’ best interests by legally protecting their decisions. Life-sustaining treatment includes cardiopulmonary resuscitation (CPR), ventilator care, hemodialysis, and chemotherapy. Informed consent for withdrawal of life-sustaining treatment is provided in one of three ways: first, the patient clearly expresses in an advance directive or life-sustaining treatment plan that he or she does not want life-sustaining treatment; second, if the patient is unconscious, two of the patient’s family members provide consistent statements regarding the patient’s intentions; and third, through consensus of the patient’s entire family [3].

In February 2018, a system for making life-sustaining treatment decisions was implemented, but no detailed reports have yet investigated the real-world use of life-sustaining treatment. It is necessary to understand the actual conditions in the medical field for the life-sustaining treatment decisions system to be appropriately used, and it is thought that doing so will help achieve the type of life-sustaining treatment that medical staff, patients, and guardians want.

2. Purpose

This study was conducted to investigate the actual conditions and to address relevant limitations after the implementation of the Act on Decisions on Life-Sustaining Treatment for patients at a single medical institution. In this study evaluating the limitations of the Act on Decisions on Life-Sustaining Treatment and ways to address those limitations, we investigated the informed consent forms completed within a year after the Act on Decision on Life-Sustaining Treatment was implemented, and compared and analyzed the diseases encompassed by the law, the types of informed consent, differences between cancer and non-cancer patients, and whether the patient’s intentions were reflected when the consent form was completed. Based on this analysis, this study discusses the supplemental steps necessary to promote patient-centered self-determination in life-sustaining treatment decisions.

1. Subjects

This study conducted a retrospective analysis of the medical records of patients who had provided written informed consent for life-sustaining treatment decisions from February 1, 2018 to August 1, 2018 at a tertiary university hospital in Busan.

All patients who provided informed consent for life-sustaining treatment decisions were included, with the exception of patients who made this decision on an outpatient basis and were not hospitalized.

2. Data collection

From patients’ medical records, information was extracted on sex, age, where the life-sustaining treatment plan was written, whether or not the patient died, the length of the hospital stay, when the life-sustaining treatment document was written, the period from the completion of the document to death, the type of the document that was written, the content of the document, underlying diseases that led to death, and special life-sustaining treatments such as inotropics, CPR, mechanical ventilation, high-flow nasal cannula therapy, and dialysis. Patients were divided into terminal patients and patients at the end stage of life based on the main diagnosis on the death certificate. Terminal patients included those with cancer, AIDS, chronic obstructive pulmonary disease, and cirrhosis. Other patients at the end stage of life were those with diseases of the central nervous system, diseases of the respiratory system, cardiovascular disease, infectious disease, kidney disease, or liver disease. This study was conducted with the approval of the institution’s Institutional Review Board (KUGH-IRB-2019-02-014).

3. Content of the informed consent for withdrawal of life-sustaining treatment

When the informed consent for withdrawal of life-sustaining treatment was written, the patient (terminal or at the end stage of life) declared his or her intention to withhold or withdraw life-saving medical treatment through the life-sustaining treatment plan. Furthermore, all citizens over the age of 19 have been encouraged to write an advance directive regarding life-sustaining treatment and hospice care in case they reach the end stage of life. If there is no advance directive or life-sustaining treatment plan when the decision to withhold or withdraw life-sustaining treatment must be made, a patient confirmation form (a statement from the patient’s family) is prepared by the guardian to describe the patient’s intentions regarding life-sustaining treatment. Alternatively, the statement can be completed with the agreement of all of the patient’s family members. The issues addressed in the informed consent form included whether to continue or discontinue CPR, hemodialysis, chemotherapy, or ventilator care.

4. Data analysis

Patients’ characteristics were analyzed according to the cause of death, whether the patient’s intentions were reflected in the informed consent for withdrawal of life-sustaining treatment, and the degree of implementation of special life-sustaining treatment before consent was provided to withdraw the life-sustaining treatment.

SPSS version 24 (IBM Corp, Armonk, NY, USA) was used for statistical analysis. The Mann-Whitney U test was used to evaluate statistical significance in comparative analyses of continuous variables, and the chi-square test and the Fisher exact test were used for nominal variables.

1. General characteristics of subjects

In total, 409 patients provided consent for life-sustaining treatment decisions at K University Hospital in the 7-month period from February 2018 to August 2018, while 65 patients were excluded because they filled out the forms on an outpatient basis and were not hospitalized. Thus, 334 patients were included in the final analysis, of whom 26.0% were at the end stage of life, and 74.0% were terminal patients. Malignant tumors were present in 69.2% of the patients. The patient wrote the life-sustaining treatment plan in 26.0% of cases and an advance directive in 8.4% of cases, while a patient’s intention statement was prepared by family members in 12.3% of cases and a joint statement from the patient’s guardian and family members was provided in 53.3% of cases. In most cases, written confirmation from the patient’s guardian and family members was prepared (Table 1).

Table 1 . Patients Characteristics (N=334)..

Variables	n (%) or Mean±SD
Sex
Male	213 (63.8)
Female	121 (36.2)
Age (yr)	67.8±12.3
Place where consent for withholding life-sustaining treatment was provided
General ward	183 (54.8)
Intensive care unit	104 (31.1)
Emergency room	47 (14.1)
Survival or location of death
Survival	27 (8.1)
Death at our hospital	261 (78.1)
Death at other place	46 (13.8)
Duration of hospitalization (days)
Admission to consent for withholding of life-sustaining treatment	13.4±19.5
Consent for withholding life-sustaining treatment to death	17.0±32.0
Form of agreement to withhold life-sustaining treatment
POLST	87 (26.0)
Advance directives	28 (8.4)
Patient’s decision confirmation (statement made by the patient’s family)	41 (12.3)
Confirmation of the decision by the patient’s family	178 (53.3)
Types of patients
End stage of life patients	87 (26.0)
Cardiovascular disease	28 (8.4)
Disease of the respiratory system	19 (5.7)
Disease of the central nervous system	15 (4.5)
Kidney disease	11 (3.3)
Infectious disease	6 (1.8)
Liver disease	3 (0.9)
Gastrointestinal disease	3 (0.9)
Endocrine disease	2 (0.6)
Terminal patients	247 (74.0)
Cancer	231 (69.2)
Liver cirrhosis	9 (2.7)
COPD	7 (2.1)
Special life-sustaining treatments mentioned in the consent form (multiple responses)
Cardiac resuscitation	333 (99.7)
Intubation and ventilator care	267 (79.9)
Hemodialysis	275 (82.3)
Chemotherapy	292 (87.4)
Intensive end of life care before the provision of consent for withholding life-sustaining treatment
Inotropics	136 (40.7)
Intubation and ventilator care	79 (23.7)
HFNC	50 (15.0)
Hemodialysis	44 (13.2)
Cardiac resuscitation	21 (6.3)

Values are presented as mean±standard deviation or number (%)..

POLST: physician orders for life-sustaining treatment, CNS: central nerve system, AIDS: acquired immunodeficiency syndrome, COPD: chronic obstructive pulmonary disease, HFNC: high-flow nasal cannula..

2. Specialties of the physicians treating patients who provided informed consent for withdrawal of life-sustaining treatment

In an analysis of the treating physicians according to the patients’ underlying disease, it was found that 79.3% of patients were treated by physicians in the Department of Internal Medicine, including 29.9% who were treated by hematologists, 16.8% who were treated by pulmonologists, and 13.5% who were treated by hepatologists. Furthermore, 15.2% of patients were treated by surgeons (Figure 1).

Figure 1. Departments responsible for the care of patients who provided consent for withholding life-sustaining treatment permit. Others: endocrinology, 3; infectious diseases 2; urology, 1; pediatrics, 1; rehabilitation medicine, 1; orthopedics, 1.

3. Differences between cancer and non-cancer patients

Patients with malignant tumors (cancer patients) and other diseases (non-cancer patients) were compared and analyzed. There were 231 cancer patients and 103 non-cancer patients. The mean age of the cancer patients was 65.2 years (±11.3), while that of the non-cancer patients was 73.6 years (±12.6). Of the cancer patients who provided written consent to discontinue life-sustaining treatment, 70.1% did so in the general ward and 29.9% did so in the intensive care unit. In contrast, of the non-cancer patients, 58.4% completed the consent form in the intensive care unit, whereas only 41.7% did so in the general ward (P<0.01). Among the cancer patients, the average period from hospitalization to completion of the informed consent for withdrawal of life-sustaining treatment was 14.6 days (±18.5), and the average period from completion of the informed consent for withdrawal of life-sustaining treatment to death was 18.2 days (±31.5). Among the non-cancer patients, the corresponding intervals were 10.6 days (±21.2) and 14.0 days (±33.2), respectively. Although this difference was not statistically significant, it is noteworthy that both of these intervals were shorter among non-cancer patients (Table 2).

Table 2 . Comparative Analysis according to Cause of Death (N=334)..

Variables	Cancer (N=231)	Non-cancer (N=103)	P-value
	n (%) or Mean±SD	n (%) or Mean±SD
Sex			0.77
Male	149 (64.5)	64 (62.1)
Female	82 (35.5)	39 (37.9)
Age (yr)	65.2±11.3	73.6±12.6
Place where consent for withholding life-sustaining treatment was provided			<0.001
General ward	162 (70.1)	21 (20.4)
Intensive care unit	44 (19.0)	60 (58.3)
Emergency room	25 (10.8)	22 (21.4)
Survival or location of death			0.047
Survival	13 (5.6)	14 (13.6)
Death at our hospital	185 (80.1)	76 (73.8)
Death at other place	33 (14.3)	13 (12.6)
Duration of hospitalization (days)
Admission to consent for withholding of life-sustaining treatment	14.6±18.5	10.6±21.2	0.081
Consent for withholding life-sustaining treatment to death	18.2±31.5	14.0±33.2	0.306
Form of agreement to withhold life-sustaining treatment			<0.001
POLST	79 (34.2)	8 (7.8)
Advance Directives	23 (10.0)	5 (4.9)
Patient’s decision confirmation (statement made by the patient’s family)	28 (12.1)	13 (12.6)
Confirmation of the decision by the patient’s family	101 (43.7)	77 (74.8)
Special life-sustaining treatments mentioned in the consent form (multiple responses)
Cardiac resuscitation	231 (100.0)	102 (99.0)	0.678
Intubation and ventilator care	207 (89.6)	60 (58.3)	<0.001
Hemodialysis	208 (90.0)	67 (65.0)	<0.001
Chemotherapy	196 (84.8)	103 (100.0)	<0.001
Intensive end of life care before the provision of consent for withholding life-sustaining treatment
Inotropics	159 (68.8)	39 (37.9)	<0.001
Intubation and ventilator care	205 (88.7)	50 (48.5)	<0.001
HFNC	201 (87.0)	83 (80.6)	0.175
Hemodialysis	215 (93.1)	75 (72.8)	<0.001
Cardiac resuscitation	228 (98.7)	85 (82.5)	<0.001
Intensive end of life care before provision of consent for withholding life-sustaining treatment
Done	86 (37.2)	81 (78.6)	<0.001

Values are presented as mean standard deviation or number (%)..

POLST: physician orders for life-sustaining treatment, HFNC: high flow nasal cannula..

For cancer patients, 44.2% of the completed documents were written by the patient, while 54.8% were written by a guardian. In contrast, for non-cancer patients, only 12.7% were written by the patient, while the remaining 87.4% were written by the guardian. This was a significant difference (P<0.01).

All cancer patients refused CPR, and ventilator care was rejected by 89.6% of patients, hemodialysis by 90.0%, and chemotherapy by 84.8%. Of the non-cancer patients, 99.0% refused CPR, 58.3% refused ventilator care, 65.0% refused hemodialysis, and 93.2% refused chemotherapy, showing that non-cancer patients refused special life-sustaining treatments at a lower overall rate, except for chemotherapy.

The life-sustaining treatment administered prior to the patients providing informed consent for withdrawal of life-sustaining treatment was inotropics in 31.2% of cases, ventilator care in 11.3%, high-flow nasal cannula therapy in 13%, hemodialysis in 6.9%, and CPR in 1.3% for cancer patients. For non-cancer patients, the corresponding rates were 62.1% for inotropics, 51.5% for ventilator care, 19.4% for a high-flow nasal cannula therapy, 27.2% for hemodialysis, and 17.5% for CPR. Non-cancer patients showed a higher overall rate of life-sustaining treatment than cancer patients. One or more special life-sustaining treatments were received by 37.2% of cancer patients, but by 78.6% non-cancer patients, showing a significant difference (P<0.01).

4. Comparison of patient’s decision-making when preparing informed consent for withdrawal of life-sustaining treatment

Cases in which the patient provided informed consent for withdrawal of life-sustaining treatment were compared to those in which a guardian or family members provided consent. The average age of patients who provided written consent themselves (patient group) was 63.9 years (±10.4), while that of patients for whom a guardian or family members provided written consent (guardian group) was 69.9 years (±12.8). The patients in the guardian group were significantly older (P<0.01) (Table 3). The consent form was filled out in the general ward in 86.1% of cases in the patient group, in the intensive care unit in 7.8% of cases, and in the emergency room in 6.1% of cases. In the guardian group, the corresponding percentages were 38.4% for the general ward, 43.4% for the intensive care unit, and 18.3% for the emergency room, reflecting a significant difference from the patient group (P<0.01). The average period from hospitalization to the provision of written consent to withdraw life-sustaining treatment was 11.7 days (±14.2) in the patient group and 14.2 days (±21.7) in the guardian group, which was not statistically significant (P=0.204). However, the average period to death after completion of the consent form for the withdrawal of life-sustaining treatment was 28.7 days (±41.3) in the patient group and 10.5 days (±23.2) in the guardian group, demonstrating that there was a significant difference according to who made the decision (P<0.01). In the patient group, 7.8% of patients were in the end stage of life and 92.2% were terminal patients, whereas the corresponding proportions were 35.6% and 64.4%, respectively, in the guardian group (P<0.01). Patients were more likely to refuse all types of life-sustaining treatment than guardians. In particular, in the patient group, ventilator care and hemodialysis were refused in 96.5% of cases, but only in 71.2% and 74.9% of cases in the guardian group, respectively. This was a significant difference (P<0.01). Life-sustaining treatment was administered prior to the written consent to discontinue the life-sustaining medical treatment in 18.3% of cases in the patient group, but in 66.7% of cases in the guardian group (P<0.01).

Table 3 . Comparison of Various Factors according to Whether the Patient or the Patient’s Family Made the Decision to Provide Consent to Withdraw Life-Sustaining Treatment (N=334)..

Variables	Patient decision (N=115)	Family decision (N=219)	P-value
	n(%) or Mean±SD	n(%) or Mean±SD
Sex			0.246
Male	68 (59.1)	145 (66.2)
Female	47 (40.9)	74 (33.8)
Age (yr)	63.9±10.4	69.9±12.8	<0.001
Place where consent for withholding life-sustaining treatment was provided			<0.001
General ward	99 (86.1)	84 (38.4)
Intensive care unit	9 (7.8)	95 (43.4)
Emergency room	7 (6.1)	40 (18.3)
Survival or location of death			0.061
Survival	6 (5.2)	21 (9.6)
Death at our hospital	87 (75.7)	174 (79.5)
Death at other place	22 (19.1)	24 (11.1)
Duration of hospitalization (days)
Admission to consent for withholding of life-sustaining treatment	11.7±14.2	14.2±21.7	0.204
Consent for withholding life-sustaining treatment to death	28.7±41.3	10.5±23.2	<0.001
Types of patients			<0.001
End stage of life patients	9 (7.8)	78 (35.6)
Terminal patients	106 (92.2)	141 (64.4)
Special life-sustaining treatments mentioned in the consent form (multiple responses)
Cardiac resuscitation	115 (100)	218 (99.5)	1
Intubation and ventilator care	111 (96.5)	156 (71.2)	<0.001
Hemodialysis	111 (96.5)	164 (74.9)	<0.001
Chemotherapy	102 (88.7)	190 (86.8)	0.739
Intensive end of life care before provision of consent for withholding life-sustaining treatment
Done	21 (18.3)	146 (66.7)	<0.001

Values are presented as mean±standard deviation or number (%)..