Changes in End-of-Life Discussion for Patients with Advanced Cancer after the Life- Sustaining Treatment Decisions-Making Act in Korea

26 Background: Cancer is a leading cause of death in Korea. To protect the autonomy and dignity of 27 terminally ill patients, the Life-Sustaining Treatment Decision-Making Act (LST-Act) came into full 28 effect in Korea in February 2018. However , it is unclear whether the LST-Act influences end-of-life 29 (EOL) discussion and decision-making processes for terminally ill cancer patients. 30 Methods: This was a retrospective study conducted with a medical record review of cancer patients 31 who died at Ulsan University Hospital between July 2015 and May 2020. Patients were divided into 32 two groups: those who died in the period before the implementation of the LST-Act (from July 2015 to 33 October 2017, Group 1) and after the implementation of the LST-Act (from February 2018 to May 2020, 34 Group 2). W e measured the self-determination rate and the timing of documentation of Do-Not- 35 Resuscitate (DNR) or Physician Orders for Life-Sustaining Treatment ( POLST) in both groups. 36 Results: A total of 1,834 patients were included in the analysis (Group 1, n=943; Group 2, n=891). 37 Documentation of DNR or POLST was completed by patients themselves in 1.5% and 63.5% of patients 38 in Groups 1 and 2, respectively ( p <0.001). The mean number of days between documentation of POLST 39 or DNR and death was higher in Group 2 than in Group 1 (21.2 days vs. 14.4 days, p =0.001). The rate 40 of late discussion, defined as documentation of DNR or POLST within seven days prior to death, 41 decreased significantly in Group 2 (46.6% vs. 41.4%, p =0.027). In the multivariable analysis, hospice 42 palliative care referral (OR [odds ratio] 0.25, p <0.001) and patients’ years of education (OR 0.68, 43 p =0.027) were positively related to self-determination. However, physicians with clinical experience of 44 less than three years had a higher rate of surrogate decision-making (OR 5.1, p =0.029) and late 45 discussion (OR 2.53, p =0.019). Conclusions: After the implementation of the LST-Act, the rate of self-determination increased and EOL discussion occurred earlier than in the era before the implementation of the LST-Act.

Methods: This was a retrospective study conducted with a medical record review of cancer patients 31 who died at Ulsan University Hospital between July 2015 and May 2020. Patients were divided into 32 two groups: those who died in the period before the implementation of the LST-Act (from July 2015 to 33 October 2017, Group 1) and after the implementation of the LST-Act (from February 2018 to May 2020, 34 Group 2). We measured the self-determination rate and the timing of documentation of Do-Not-  Results: A total of 1,834 patients were included in the analysis (Group 1, n=943; Group 2, n=891). 37 Documentation of DNR or POLST was completed by patients themselves in 1.5% and 63.5% of patients 38 in Groups 1 and 2, respectively (p<0.001). The mean number of days between documentation of POLST 39 or DNR and death was higher in Group 2 than in Group 1 (21.2 days vs. 14.4 days, p=0.001).   Before the implementation of the LST-Act, decisions for LST care were documented in the do-not-77 resuscitate (DNR) order, which was not legally effective and may not have entirely reflected the patients' 78 decisions. Since the implementation of the LST-Act, it has become necessary to document POLST for 79 all patients who died in hospital. However, it is unclear whether the LST-Act influences EOL discussion 80 in terms of the rate of self-determination and timing of documentation of DNR or POLST. 81 Therefore, we conducted this study to investigate the changes in EOL discussion in advanced cancer 82 patients during the EOL process after the implementation of the LST-Act.

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Patients, study design, and data collection 86 This was a single-center, retrospective study of cancer patients who died at the Ulsan University 87 Hospital between July 2015 and May 2020. 88 We assessed patients who had died during two separate periods: the period before the implementation 89 of the LST-Act (from July 2015 to October 2017, "Group 1") and after the implementation of the LST-90 Act (from February 2018 to May 2020, "Group 2"). The same inclusion and exclusion criteria were 91 applied to both groups. Cases were limited to patients with cancer at the primary site of head and neck, 92 esophagus, lung, breast, stomach, colorectal, hepatobiliary, and pancreas. We excluded patients with 93 hematologic malignancy, who were younger than 19 years old, or who passed away within two weeks 94 of their first visit to Ulsan University Hospital. 95 We obtained the two groups' data from the following sources: the clinical data warehouse platform in     127 We examined between-group associations of demographic and clinical variables using Fisher's exact 128 test for categorical variables and an independent t-test for continuous variables.

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The factors affecting surrogate decision-making and late EOL discussion (documentation of DNR or 130 POLST within seven days prior to death) were analyzed using logistic regression analysis. Statistical   Table 1.  Referral to hospice palliative care 153 The rate of referral to hospice palliative care (HPC) was 42.2% and 68.1% in Groups 1 and 2, 154 respectively (p<0.001). Among the referred patients, 35.4% and 54.7% provided consent for referral to 155 HPC in Groups 1 and 2, respectively (p<0.001).

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The mean duration between HPC referral and death was 36.5 days and 46 days in Groups 1 and 2, 7 The factors that were associated with inappropriate decision-making, late EOL discussion 161 (documentation of DNR or POLST within seven days prior to death), and surrogate decision-making 162 are presented in Table 4. improved to reach 63.5% of our study population, which is a significant increase compared to 1.5% 189 before the implementation of the LST-Act. The self-determination rate in our study is comparable 190 with the rates of previous studies carried out in Western countries, ranging from 23% to 60% [16-18].

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Our findings suggest that the LST-Act might promote patients' participation in EOL discussion.

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The timing of decision-making regarding LST occurred earlier than before the LST-Act. The mean 193 time between documentation of DNR or POLST and death increased from 14.4 days to 21.2 days after 194 the implementation of the LST-Act. In a recent retrospective study from Korea, decision-making 195 occurred earlier than before the LST-Act's implementation, ranging from 17 to 33 days prior to the 196 patient's death [19]. In Korea, DNR directives were usually documented within a week prior to death, 197 which was too late to reflect patients' wishes for EOL care [8,9]. Our results imply that the LST-Act 198 has had a positive effect on earlier EOL discussion.

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In our study, the rate of HPC referral increased from 42.2% to 68.1% over the study period, and  Multivariable analysis between inappropriate EOL decision-making (late EOL discussion or 215 surrogate decision-making) and patient characteristics showed that female patients and patients with 216 more than 12 years of education were less likely to experience late EOL discussion, and HPC referral 217 was related to less surrogate decision-making. However, physicians with less than three years of 218 professional career experience were related to a higher rate of late EOL discussion and surrogate LST-Act has increased the documentation of POLST, but physicians are still struggling with EOL 225 discussion. Therefore, physicians need to be trained and supported to discuss EOL care, and programs 226 to integrate EOL conversations and ACP documentation are needed for implementation in routine 227 medical care.

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Our study has several limitations. First, it is a study from a single institution, and the pattern of 229 EOL discussion and documentation of DNR or POLST might be different from those at other medical 230 institutions. Therefore, caution is needed to not generalize the study findings. Second, it was a 231 retrospective study, with information sources limited to medical records. Interpretation of data needs 232 to be cautious in causal relationships. Despite these limitations, to our knowledge, this is the first 233 study to compare the decision-making patterns before and after the LST-Act. Our study showed that since the implementation of the LST-Act, the self-determination rate rose in 237 clinical practice and EOL discussion occurred earlier than in the era before the LST-Act. To encourage 238 EOL discussion between physicians and patients, more active interventions, including medical 239 education and training for EOL discussion and HPC referral, are needed to ensure that patients' goals 240 and values are better reflected in the EOL process.   263 The datasets used and/or analyzed during the current study are available from the corresponding author 264 upon reasonable request.

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Competing interests 267 The authors declare that they have no competing interests.