Study settings
Guangzhou city (GZ), as the capital of Guangdong Province (GD), has a concentration of high-quality medical resources not only in Guangdong province but also in South China. Data used in this research were real-world data drawn from the two largest affiliated hospitals of Southern Medical Universities: Nanfang Hospital and Zhujiang Hospital. Both hospitals were nationally reputable teaching hospitals and medical research centers. The Department of Hematology and Pediatric Centers in the two hospitals take care of patients from both Guangdong province and across China. In our study, 79.7% of patients were from Guangdong and 20.3% were from provinces in South China, which made the study samples of good representativeness. Patients in two hospitals followed the same clinical guideline. The two hospitals followed the same clinical guidelines: the treatment of ALL followed “GD-2008-ALL protocol” [4] and AML treatment “C-HUANAN-AML15 protocol” [5].
Data source
Data were drawn from the two hospitals’ administrative records from the year 2015 to 2019. Patients’ demographic information and treatment records were sourced from the hospital information system (HIS), while the costs and insurance reimbursement information were drawn from the health insurance discharge settlement system (DSS). Data analysis received the formal contracted approvals with strict limitation items from the Department of Administration of Southern Medical University, Zhujiang Hospital, and Nanfang Hospital. Data were de-identified and for academic use only. The study included patients who were diagnosed with ALL and AML (ICD C91.000, C92.000, and the subtypes) who received complete treatment course in the two hospitals from Jan.1, 2015, to Dec. 30, 2019. We only included patients aged ≤ 15 years due to the age restriction items in RBMI [18].
A total of 490 patients from Nanfang Hospital and 310 patients from Zhujiang Hospital were included at the first stage. One physician and two nurses who were familiar with their patients’ treatments from each study department worked together and completed the first screening. We excluded the patients who did not receive the complete treatment course in the two study hospitals. The complete treatment course of leukemia is characterized as follows—once the induction process of intensive treatment started, the patients would follow the treatment from the same physician team, and only in very rare cases did they transfer hospitals. Finally, a total of 765 consecutive patients and their 14,477 inpatient treatment medical records were included in this study.
Disease types
Two types of diseases, ALL and AML (ICD C91.000, C92.000, and the subtypes), were included in the analysis. AML and ALL involve different hematopoietic dysfunction. AML impairs the production of myeloblasts, red blood cells, and platelets, whereas ALL mainly affects the production of lymphocytes. Because only the AML patients who meet the treatment criteria could receive transplantation, and the total cost of transplantation was generally 1–2 times more than AML without transplantation, we divided all patients into three disease types: ALL—patients with ALL only, AML—patients with AML but without transplantation, and Transplantation—patients with AML and received transplantation.
Variables and coding
Two determinants were considered in categorizing the insurance types— the location of insurance, and the eligibility for the instant reimbursement at the time of discharge settlement. The location of insurance, due to the enrollment policies of RBMI in China, is generally decided by the Hukou status, namely the city the patient registered their household. The eligibility for instant reimbursement was decided by the contract between the medical insurance payers and medical service providers. The insured patients who received care in their location of insurance are generally entitled to instant reimbursement when discharged. However, for those who seek medical care out of the location of insurance, they may lose the eligibility for instant reimbursement and must prepay medical bills OOP and return to the location of insurance for the reimbursement. For patients with catastrophic diseases like leukemia, the postponed refund may increase patient’s economic burden and increase the risk of giving up treatment items.
A total of six insurance subtypes were categorized accordingly: GZ-RBMI, GD-contracted, GD-uncontracted, Other-contracted, Other-uncontracted, and OOP.
GZ-RBMI refers to the patients who had Guangzhou hukou and were covered by Guangzhou RBMI. They generally enjoyed instant reimbursement and the highest RR.
GD-contracted referred to patients who were enrolled in RBMI in the other cities in Guangdong Province, covered by RBMI, and eligible for instant reimbursement according to the payer-provider contract.
GD-uncontracted referred to patients who were enrolled in RBMI in the other cities in GD and covered by GD RBMI, but they were not eligible for instant reimbursement at the time of discharge. These patients had to pay for bills OOP and get reimbursed after returning to their location of insurance.
Other-contracted referred to the patients who were enrolled in RBMI outside GD by RBMI but eligible for instant reimbursement.
Other-uncontracted referred to the patients who were enrolled in RBMI outside GD province by RBMI but ineligible for instant reimbursement. They also had to pay for bills OOP and get reimbursed after returning to their location of insurance.
The OOP group referred to those who had no insurance records in HIS files and paid all bills OOP in ISS when discharged.
The economic burden of patients was described as OOP, reimbursement, and total cost, which referred to the out-of-pocket costs, reimbursed costs, and total costs paid by patients for the complete treatment course. The reimbursement rate (RR) was defined as the percentage of reimbursement divided by total cost. The types of cost here referred to the added cost during the complete treatment course.
The cost structure was described by four types: operation/procedure cost, simple treatment cost, blood products cost, and drug cost following the ISS record structure.
The treatment duration refers to the average number of days required to complete the treatment process. The average inpatient days equaled total inpatient days divided by times of hospitalization. Three age groups were divided, 0–5, 6–10, and 11–15. The regions were categorized according to where the patients came from: the developed Pear-River Delta cities in Guangdong Province (GD-PRD), the less developed east, west, and north wings of Guangdong Province (GD-Other), and the other provinces outside GD (Outside GD).
Statistics
The statistical description was made to report the distribution of all variables. The cost was described as non-normal distributed and reported as the median and interquartile range (IQR). Wilcoxon test was used to make the univariate analysis of cost data. Generalized linear model with log link was also used to analyze the influencing factors of economic burden and cost structure. The cost was logarithmically transformed to the normal distribution and then the coefficients are exponentially transformed accordingly. All analyses were conducted using SAS version 9.3 (SAS Institute, Inc). Two-tailed p < 0.05 was considered statistically significant.