Consent for the discontinuation of life-prolonging treatment in cancer patients: a retrospective 1 comparative analysis before and after the enforcement of the Life Extension Medical Decision 2


 Background The Life Extension Medical Decision law enacted on February 4, 2018 in South Korea was the first to consider the suspension of nonsensical life-prolonging treatment, and its enactment raised big controversy in Korean society. However, there is no study on whether the actual life-prolonging treatment for patients has decreased after enforcing the law. This study aimed to compare the provision of patient consent before and after the enforcement of the law among cancer patients who visited a tertiary university hospital's emergency room to understand the effects of the law on cancer patients' clinical care. Methods This retrospective single cohort study included advanced cancer patients over 19 years of age who visited the emergency room at a tertiary university hospital. The two study periods were as follows: from February 2017 to January 2018 (before) and from May 2018 to April 2019 (after). The primary outcome was the average length of hospital stay. The consent rate for cardiopulmonary resuscitation (CPR), intubation, continuous renal replacement therapy (CRRT), and intensive care unit (ICU) admission were the secondary outcomes. Results The average length of hospital stay decreased after the law was enforced, from 4 days to 2 days (p= 0.001). The rates of direct transfers to secondary and nursing hospitals increased from 8.2% to 21.2% (p=0.001) and from 1.0% to 9.7%, respectively (p<0.001). The rate of provision of consent for admission to the ICU decreased from 6.7% to 2.3% (p=0.032). For CPR and CRRT, the rate of provision of consent decreased from 1.0% to 0.0% and from 13.9% to 8.8%, respectively, but the differences were not significant (p=0.226 and p=0.109, respectively). Conclusion According to previous research, for patients wishing only conservative treatment, the reduction in hospital stays at tertiary hospitals ultimately reduces the physical, emotional, financial burdens and also improves the quality of end-of-life at home or in a hospice facility. In this context, this research ultimately show that the purpose of the LEMD law has been achieved. Further research in several hospitals including those patients who completed the consent after hospitalization is needed to generalize the clinical implication of the LEMD law.

ER visit. If a contract was created but lacked the specific classification and accurate information, the 147 corresponding patients were excluded from the study. 148 Outcomes 149 We investigated the length of hospital stay as the primary outcome.. In addition, CPR, intubation, 150 CRRT, and ICU admissions were considered as secondary outcomes, to confirm whether the rate of 151 aggressive treatments actually reduced with the enactment of the law. Furthermore, variables such as Decision law procedure involved in this process is shown in Fig. 1 (12). 175 Statistical analysis 176 The collected data were analyzed using the SAS software (version 9.4, SAS Inc., Cary, NC, USA).

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All continuous variables did not satisfy the normality assumption; thus, the variables were analyzed 178 using the Wilcoxon rank-sum test and results were presented as medians (Q1, Q3). Categorical 179 variables were analyzed using the chi-square test (Fisher's exact test) and presented as counts (%). 180 The Monte Carlo estimation method was used to accurately determine the location of the primary 181 cancer. A p-value < 0.05 was considered significant. respectively. Prior to the enforcement, 197 patients had written consent letters in advance or planned 188 their treatment plans in the ER, while after the enforcement of the law, 220 people had advance 189 directives beforehand or planned their treatment plans in the ER. Of these, five patients (two before 190 and three after the enforcement) were excluded from the study due to incomplete information on the 191 forms. Finally, 195 patients presenting before and 217 patients presenting after the enforcement were 192 included as subjects of this study. Among these, 20 patients had obtained DNR orders in advance 193 before the enforcement, and 78 patients had advance directives after the enforcement of the law. The number of patients who filled out their DNR consent form in the ER was 175, and 139 patients wrote 195 their life-sustaining plan in the ER (Fig. 2). 196 After the LEMD law was enforced, the average time taken to prepare a patient consent letter was 197 reduced to 232 minutes from 273 minutes (p=0.031); conversely, the time spent in the ER increased 198 from 817 minutes to 1,195 minutes (p=0.006). The length of stay in the hospital decreased from 4 199 days to 2 days (p=0.001), along with a decrease in average medical expenses (p=0.008). Furthermore, 200 the rate of direct transfers to secondary hospitals from the ER increased from 8.2% to 21.2% 201 (p=0.001), and that of transfers to nursing hospitals increased from 1.0% to 9.7% (p<0.001).

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In addition, the rate of provision of consent for admission to the ICU decreased from 6.7% before the 203 enforcement to 2.3% after the enforcement (p= 0.032). In the case of CPR and CRRT, the rates of 204 provision of consent decreased from 1.0% to 0.0% and from 13.9% to 8.8%, respectively, but the 205 difference was not significant (p=0.226 and p=0.109, respectively). After the enforcement of the law, 206 a larger number of patients were found to survive until discharge (p= 0.001) ( Table 1).

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On comparing only those patients who created the DNR order or life-sustaining treatment plan in the 208 ER, it was found that the average time taken from reception to creating the consent letter was 296 209 minutes before the enforcement, while the same task took significantly longer (466 minutes) after the 210 enforcement (p<0.001). However, consistent with the results of the overall comparison, the average 211 time spent in the ER increased from 864 minutes before the enforcement to 1,391 minutes after the 212 enforcement (p= 0.003), and the length of hospital stay decreased from 4 days to 2 days (p=0.001).

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The rates of direct transfers to secondary and tertiary hospitals, and nursing hospitals from the ER also 214 increased in the period after the enforcement from 9.1% to 20.1%, and from 1.1% to 10.1%, 215 respectively (p= 0.005, p= 0.001, respectively). The proportion of patient deaths in the ER decreased 216 from 88.6% to 80.6% after the law was implemented (p=0.049).

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The percentage of aggressive treatments or procedures specified in the DNR order or life-sustaining 218 plan decreased after the enforcement of the law. The rates of CPR, intubation, and CRRT decreased admission to the ICU decreased after enforcement. The rate of survival to discharge was particularly 245 high in the group of patients who had completed a consent form before the ER visit.

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The time from ER registration to signing the consent form was longer after the enforcement of the 247 law, and this can be attributed to the peculiarity of the legal system. As shown in Fig. 1, if a patient 248 who has not indicated an intention to discontinue life-prolonging treatment in advance is unconscious 249 and cannot confirm their intention, a decision can be made only after all of the family members come 250 to a unanimous agreement. In the period following the enforcement, not many patients had prepared 251 such documents in advance, and many severely ill patients were unconscious at presentation; thus, it  In this study, the increase in the length of ER stay can be understood in relation to the increase in the 261 rate of direct transfer from the ER to other hospitals. Before the LEMD law was implemented, the rate 262 of transfer to other hospitals was only 8.2% and that of transfer to a nursing hospital was 1.0%, but 263 the corresponding rates increased to 21.2% and 9.7%, respectively, after implementation (Table 1).

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Considering that the length of ER stay has been extended in the same way in the patient group who 265 wrote the life-sustaining treatment plan in advance, the longer stay in the ER is a separate issue from