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ORIGINAL ARTICLE
Ahead of print publication  

Economic impact, clinical features and outcomes of hospitalised patients with SLE in India


1 Department of General Medicine, Christian Medical College, Vellore, Tamil Nadu, India
2 Medical Officer In Nalam Medical Center and Hospital, Vellore, Tamil Nadu, India
3 Department of Biostatistics, Christian Medical College, Vellore, Tamil Nadu, India
4 Department of Clinical Immunology and Rheumatology, Christian Medical College, Vellore, Tamil Nadu, India

Date of Submission09-Feb-2022
Date of Acceptance01-May-2022
Date of Web Publication27-Aug-2022

Correspondence Address:
Tarun K George,
Department of General Medicine, Christian Medical College, Vellore, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/injr.injr_30_22

  Abstract 


Background: Systemic lupus erythematosus (SLE), a rare multisystem disorder with a female preponderance, has a high cost for the care; however, there is no evidence relevant to the Indian setting. The primary objective of our study was to determine the financial burden of the index admission (IA) and subsequent costs during follow-up and ascertain the proportion with a catastrophic health expenditure (CHE).
Methodology: This was an observational retrospective cohort study where inpatients of a general medicine ward were recruited from January 2019 to October 2020. Clinical details and costs were obtained from the hospital's electronic records and bills. Patients were telephonically interviewed for follow-up clinical details and costs incurred. A patient-family payer perspective was used. Linear regression analysis was used.
Results: Of the 73 patients recruited during the study period, 96% were females and the majority (71%) were admitted through casualty, with 59% of patients having high disease activity (SLE Disease Activity Index >12). The hospital mortality was 9.6%. After a median follow-up of 12 months, there was good quality of life with no difference between the two severity groups. The total cost of the IA was 135,768 INR (94,053–223,954) and it was higher for the severe disease group (P = 0.038). The direct medical costs compromised 83% of admission costs. In the multivariate regression, the duration of hospital and intensive care unit stay were predictors of high cost. The median 6 months follow-up cost was 32,978 (14,240–80,940) and the total calculated annualized cost was 202,124 (136,188–331,508), which was not statistically different between the two groups. There was a CHE among 86% of patient-families.
Conclusion: This study demonstrates that there is high morbidity and cost involved in the management of a flare of SLE. However, with appropriate care, there are reasonably good outcomes and quality of life beyond six months.

Keywords: Cost, economic, India, lupus, mortality, outcomes, quality of life, systemic lupus erythematosus



How to cite this URL:
J. Sumeir ME, George TK, Bonela VS, Mani T, Mathew J, Abraham O C, Jambugulam M. Economic impact, clinical features and outcomes of hospitalised patients with SLE in India. Indian J Rheumatol [Epub ahead of print] [cited 2022 Oct 3]. Available from: https://www.indianjrheumatol.com/preprintarticle.asp?id=354876




  Introduction Top


Systemic lupus erythematosus (SLE) is an uncommon, multisystem disease that may present with nonspecific clinical features, and is often diagnosed with a high index of suspicion. The point prevalence of SLE in India, as per a study done in North India, is 3.2/100,000 population[1] and it is a disease that disproportionately affects young women.[2] From evidence and experience, clinicians are aware that there is a high cost to the diagnosis and long-term care for patients with SLE.[3] Often, the disease is eminently treatable into remission; however, in most cases, the economic burden borne by the family is also very significant and requires ardent commitment to follow-up. There are no data from India regarding the cost of diagnosis, follow-up and obstacles to appropriate care. In countries like India, where about 55% of the population seek private sector for inpatient (IP) care and 63% of health expenditure is out-of-pocket, it is imperative to determine the economic impact of diseases on households.[4],[5]

In our institution, the department of general medicine diagnoses and manages a sizeable proportion of SLE cases presenting to the hospital and there is a streamlined liaison with the department of rheumatology in managing complex presentations. The aim of our study was to determine the clinical course, follow-up and assess the economic impact of hospitalized patients with SLE in the General Medicine department of a tertiary academic center.

Our primary objective was as follows:

  1. To determine the financial burden, from a patient perspective, of the Index admission (IA) and subsequent costs during follow-up for a period of 1 year
  2. To ascertain what proportion of these patients, have a catastrophic health expenditure (CHE).


The secondary objectives were as follows:

  1. To determine the clinical features and outcomes of hospitalized patients with SLE
  2. To determine the quality of life during follow-up and describe patients' perceptions and experiences regarding the disease.



  Methodology Top


This was an observational study where we retrospectively recruited a cohort of patients, interviewed them and determined their clinical outcomes and costs. The study was conducted in the general ward of the Department of General Medicine, Christian Medical College, Vellore, in the state of Tamil Nadu, India. This is an academic, tertiary, charitable private hospital where patients admitted in the general and private wards have different prices for services. The general ward has common shared spaces, is cheaper, and is utilized largely by patients from the lower economic strata. However, the quality of care is the same in both. For general patients, concessions on the final bill are made on a case-by-case basis, after a review of the family's socioeconomic background and paying capacity. The inclusion criteria were inpatients (IPs), above 18 years of age, from the general medical wards with a diagnosis of SLE (satisfying the SLICC criteria). The patients who were excluded were those admitted only for IV immunosuppressive therapy, patients admitted under other departments, or in private wards and those who did not give consent for the interview. The IRB was approved in April 2019 with IRB number 11,966. Due to the COVID-19 pandemic, there were difficulties in outpatient (OP) visits and hence after an IRB modification, patients were followed up by telephonic interviews after administration of informed consent. Patients were recruited from January 2019 to October 2020 from the hospital's electronic database. They were telephonically contacted, and after explaining the nature of the study and obtaining consent, the interview was administered. From the IP records, the clinical details at the time of admission, the components of direct medical costs (DMC) were obtained, and the subsequent admissions and OP visits were also captured. The patient and the primary caregiver were interviewed regarding the members of the household, income, direct nonmedical costs, and indirect costs (IC). Using this, we would have IA costs, cost of follow-up, and total annualized cost. For patients where we did not have a total 12-month follow-up, we planned to use the median monthly cost to project an annualized cost. We also administered an interview with questions on their perceptions of the disease, quality of life using EuroQol 5-dimensions and 5 levels (EQ5D-5 L), and challenges faced for follow-up. The EQ5D-5L has five components which include mobility, self-care, usual activities, pain or discomfort, and anxiety or depression, which captures different aspects of living quality. This was administered at the time of the interview.

The following terms were used in this study. Direct costs refer to the costs borne by the patient and family in accessing healthcare. This can be DMC toward professional fees, investigation and drug charges and direct nonmedical costs toward travel, boarding, and food costs. The IC is the loss in wages and productivity by the patient and family due to the illness. CHE occurs when the cost of medical care poses a threat to a family's ability to maintain its every day or subsistence needs. Due to the challenges in determining the income or expenditure of a household, a total health expenditure exceeding 10% of the total income or 40% of the household nonsubsistence income is considered a CHE.[6] For this study, we used health-care expenses above 40% of the declared household income as a cut-off as CHE. The study follows the strobe guidelines for reporting and the cost of illness checklist for economic studies.[7],[8]

Statistical methods

Sample size calculation was done based on proportion with CHE. From an audit of our IP records, we found that 40% may have a CHE. Based on this, the sample size was calculated with an estimated proportion of 0.4, desired precision 5% and a confidence interval of 0.95 for a population of about 90 patients, which is our approximate annual SLE admissions.[9] The sample collection required was 72.

The survey, financial, and clinical details were collected by the investigators via questionnaire and entered into a paper proforma. This was transferred into Microsoft Excel and all the analysis was carried out using SPSS 21.0 version (Armonk, NY: IBM Corp). The data were analyzed using mean and standard deviation for normally distributed data. Moreover, nonnormally distributed data were analyzed using the median and interquartile range. Qualitative data were described using counts and percentages. Summary statistics were used for reporting demographic and clinical characteristics. Means were compared using independent sample t-test, and medians were analyzed using the nonparametric Mann–Whitney test. The outcome variable of total Index admission (IA) costs was log transformed and simple linear regression analysis was used to look for predictors. The predictors that were statistically significant and clinically important variables were included in the multivariable linear regression analysis.


  Results Top


We present the results as three parts – the clinical course, economic costs, and qualitative components.

Clinical course

Over the study period from January 2019 to October 2020, there were 14,628 IPs in the medicine department. Of these, there were 159 patients with a discharge diagnosis of SLE. Of these, 23 met our exclusion criteria, 36 could not be contacted due to inaccessible telephone numbers (due to wrong numbers, relative's/friend's phone, or inactive service), 25 were unwilling to share economic details, and two had inadequate data. Thus, the final number included for analysis was 73 [Figure 1].
Figure 1: Flow diagram of patients included in the study

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Demographic baseline

Almost all (96%) of our patients were females with a mean age of 33.4 years (standard deviation [SD] = 10.3). Most of our patients were from Tamil Nadu (55%), followed by Andhra Pradesh (15%). There were also patients from distant states such as Bihar, West Bengal, and Tripura. We defined “local” as places within 150 km from our center. Almost all (99%) patients were educated, with 55% with secondary level and 26% with a graduate education. Majority of the patients (86%) were married and most (93%) were housewives [Table 1].
Table 1: Baseline characteristics of patients admitted in the general medicine department

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Clinical baseline

Most patients (63%) did not have any comorbidities, and 26% had a single associated illness, the most common was hypothyroidism. The patients were admitted to our hospital predominantly through the emergency department (71.2%) and remaining through OP services. At admission, 71% of them were undiagnosed (SLE was diagnosed in our center for the first time) and 29% had a known diagnosis of SLE. These patients had a median duration of symptoms lasting 2 months, which was 1.2 months in those with a known SLE diagnosis and 2.8 months in the undiagnosed groups.

Systemic lupus erythematosus features

The mean SLE Disease Activity Index score (SLEDAI) was 16 (SD-8.7), with 59% (n = 43) having a high disease activity >12 and 41% having a mild–moderate disease (SLEDAI ≤12). The proportion of patients with a single major organ involvement was 52% and 30% had two or more involved. The most common organ was renal (53%), followed by neuropsychiatric (27%), small vessel vasculitis (15%), and myocarditis (11%). Most of the patients (90%) had a minor organ involvement, the most common of which were arthritis (46%) and mucocutaneous involvement. Of all the patients, only eight (11%) were admitted into intensive care unit (ICU) and six of these had severe disease. The median duration of total hospital stay for all patients was 13.6 days (IQR 10.5–17.5) and for those requiring ICU admission was 14.5 days with (IQR 9.7–17.7), with a median duration of ICU stay of 5.5 days (IQR 4.2–5.5). The overall mortality of hospitalization was 9.6% (n = 7) and of these, 3 were from ward-only care. Their mean SLEDAI was 21 (SD = 6.8) and only one patient had mild–moderate disease. Among the original 159 patients (including the unreachable excluded patients), there was in-hospital mortality of 7% (n = 11).

After discharge, among the 66 patients, 15 (23%) were followed up for only 6 months, 15 (23%) between 6 and 12 months and the remaining (54%) for full 1 year. The mean follow-up of patients with severe disease was 9.6 months (SD = 2.7) and mild–moderate disease was 10.8 months (SD = 2). There was a higher proportion of severe disease patients who had a follow-up only until 6 months (32.4%) versus the moderate disease (10.3%). About 44% (n = 30) required subsequent IP admissions predominantly for IV cyclophosphamide, renal biopsy, infections, and disease flare. All these admissions occurred in the first 6 months, except one, which was in the 7th month of follow-up. The proportions requiring admission in the mild–moderate disease and severe disease categories were 34% and 56%, respectively. During the follow-up period, an additional five patients died between 3-6 months and 4 of them had severe disease during the admission.

Costs of systemic lupus erythematosus inpatient care and follow-up

We present the costs in three sections stratified by disease severity of mild-moderate and severe. The components of costs described are– the IA costs, the cost of follow-up and the annualized costs [Table 2]. We also present the proportion of patients facing a potential CHE. We report median and IQR due to the skewed distribution of economic data. US dollar conversions are adjusted for the average rate for 2020.[10]
Table 2: Summary of economic components of cost of systemic lupus erythematosus care

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Based on the Kuppuswamy scale, about half our patients (48%) were from an upper-lower, followed by lower middle (34%) and upper-middle (18%) socio-economic class. For the IA, the median cost of care was 1,35,768 (IQR 94,053–223,954) which was significantly higher (P = 0.038) for the severe 1,67,362 (IQR 1, 11, 409–250,045) than the mild-moderate 102,983 (78,391 to 185,023) disease category. The DMC (mean) compromised 83% of the total costs, and investigations were the highest component of this (36%). The DMC was significantly higher (P = 0.02) in the severe group due to a higher proportion requiring ICU stay and longer hospital stay. Direct nonmedical costs (mean) constituted 10% of the total IA costs, of which travel was the largest (41%) component [Figure 2] and in DMC were 7%. The median concession provided was 12,744 (IQR 0–42,289), which was 17.2% (IQR 0–60.3) of the total hospital bill (DMC). The median recovery and lost days for patients and attenders (after discharge) were 35 and 30 respectively.
Figure 2: Components of Index admission – Total, Direct Medical and Direct Non-Medical Costs. (Mean costs)

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We conducted a regression analysis to assess predictors of higher IA cost. Since these costs were right-skewed in distribution, it was converted into log data. Univariate regression showed significance with SLEDAI, number of major organs involved, duration of hospital and ICU stay, but not with duration of symptoms. When we controlled for these variables in the multivariate regression, the duration of hospital stay and duration of ICU stay was significant [Supplementary Table 1].



During follow up (n = 66), among the severe disease category, the cost for OP care was 43,428 (17,269–72,044) for a median of 7 OP visits and this was similar to the cost for mild–moderate disease group with a cost of 43,780 (24,954–83,536) for a median of 6 OP visits. For those who required subsequent IP care, the cost was 26,949 (18,276–113,236) for the severe category and 15,692 (8364–60,840) for the mild–moderate category. It was noted that due to the first wave of the COVID pandemic, during lockdown months, there was a reduction in the frequency of OP visits and repeat admissions.

The 6-month follow-up costs were 32,978 (14,240–80,940), which was not statistically different between the two groups. Since we did not have the follow-up of all patients for 12 months, we present the annualized costs. The total cost of the first 6 months was added to the calculated second 6-month costs (mean monthly costs of the remaining months followed up multiplied by six) to project the annualized cost. This was Rs 174,649 (119,093–299,029) and Rs. 245,579 (156,485–363,157) in the mild–moderate and severe disease categories, respectively.

The proportion of patients where the IA incurred was a CHE (IA cost was >40% of declared income) was 86% and the median IA cost/income ratio was 0.86 (0.5–1.4). The proportion of patients where the total annualized cost of the disease incurred was a CHE (annualized cost was >40% of declared income) was 94%. The median total annualized cost/income ratio was 1.3 (0.8–2.2).

The financing mechanisms were captured during the interviews and included savings, borrowing from relatives, loans, and selling assets [Table 3]. Most patients had to resort to at least two mechanisms (60%) to raise funds and the most common mechanism was using savings and selling assets.
Table 3: Coping strategies by patient families to arrange finances for systemic lupus erythematosus care

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Qualitative components

During our follow-up interview, we found that 11.4% of patients were still unaware of the disease diagnosis and 29.5% did not know of the need for long-term medication and follow-up. Most patients (90%) were able to travel and access health care if needed, however, during the COVID-19 pandemic in 2021, about 70% had difficulty in accessing healthcare and purchasing medicines due to lockdown and financial challenges. Most patients preferred to follow up with our center rather than with a regional specialist. Many patients (77%) developed side effects of steroids and were concerned about weight gain and acne.

The quality of life at follow-up, had an EQ5D-5 L index value (converted for a developing country, Zimbabwe) was 0.78 (SD.1). There was not a significant difference (P = 0.35) in the index value between those with severe disease 0.77 (SE 0.9) and mild-moderate disease 0.80(SD 0.12). The lower scores, being better, were seen in the domains of self-care and higher scores with more difficulty was noted in the domain of pain or discomfort and anxiousness or depressed. Although most people were able to assist in household work, they had not achieved a premorbid functional status; and only one male had re-joined employment. We were encouraged by statements given by relatives, such as “I am happy that my daughter is fine even if it means an economic burden to my family.” and “It has been very difficult, but I am glad my wife is okay.” We felt that most patients were financially and emotionally supported by their families.


  Discussion Top


This is the first Indian study to provide data on health-care resource utilization for patients with SLE. The economic burden of SLE has been studied and published in western countries such as the USA, Canada, and UK.[11],[12],[13],[14] and to the best of our knowledge, there is no literature in developing countries about the same. The patients in the study represent the course of illness following a diagnosis with a flare of disease at a tertiary center. Like other studies, most patients were young females and had a favorable clinical course.[15],[16],[17] The high cost of care reflects the complexity of the disease, where multiple investigations (31% of the DMC) are needed to establish a diagnosis, organ involvement and ascertain the presence of co-infections, if any [Supplementary Table 2], [Supplementary Table 3]. There are often multiple consultations needed to optimize care. As expected, the total and DMC in the severe group are significantly higher than in the mild–moderate group by up to 62%. This is due to the increased ward/ICU stay, investigations, antibiotics, and immunosuppression. Despite the high severity, the inhospital mortality was only 10%. Our center was able to provide a median concession of 17% of the hospital bill for 56% of patients.



After discharge, most patients had 6–7 visits with a physician over the period of follow up, we noticed that this was more regular during the first 6 months. The obstacles to follow up included a preference to follow-up in the primary center, difficulty traveling and improvement during the initial phase of recovery. About 57% of patients were beyond 150 km away and from different states and the superimposition of the lockdown due to the COVID-19 pandemic added to these challenges. The cost of OP-based follow-up for the subsequent months was not significant between the two severity groups. The severe disease group had a higher proportion requiring subsequent IP admissions, but the costs of subsequent IP care, 6-month follow-up and annualized costs were not statistically different, suggesting that the costs of care eventually even out between the groups. Most of our patients had a good quality of life and were active, with no perceivable difference in the QALYs of patients who were admitted with the severe and mild-moderate disease.

Although the cost of care is high at admission, with regular follow-up, drug compliance, and control of diseases, these patients can return to a normal life. Since this is a disease that has a predilection to women in the reproductive age group, there are several implications for marriage, child-bearing, and continuity of care. There have been situations where, the diagnosis was hidden, marriages were broken, and treatment abruptly stopped due to poor understanding of the nature of the disease, financial catastrophes, and social stigma. The lack of autonomy for women in our communities often leaves the decision of their health in the hands of other family members. This is compounded by the lack of the health system engaging with the patients and their families and educating them about the various aspects of the disease.

Even with motivated health-seeking behavior the cost of illness in the private sector is tremendous and is out of reach of the common man. Not only did the IA cost of 1,35,768 induce a catastrophic expenditure for over 86% and the total annualized cost of 2,02,124 do so for 94% of the households, but the cost of illness is often more than the household income. Tamil Nadu has a State GDP per capita of 193,750 (current price 2018–2019)[18] and in a family where the woman does not work it is plain to see how such diseases can push a family into poverty where discretionary expense on children's education and nutrition will be compromised. Thus, there would need support through government schemes or insurance programs to ensure appropriate adherence to care. Although there are reimbursements under the PMJAY national health insurance scheme (Rs 2000–5000 per day) and the Tamil Nadu Chief Minister's scheme (up to 50,000), it is grossly inadequate and it does not support OP based care.[19],[20] It is unfortunate that once diagnosed private insurance companies may not provide insurances since this would be an antecedent medical condition. Furthermore, the low amount of coverage for IP costs would prevent private hospitals from admitting patients of a lower economic class. The lack of OP support by state and private insurances compounds the challenge of lack of care where secondary prevention would prevent further flare of disease. The national Rheumatology societies may consider registries for patients with SLE disease and develop a network of Rheumatologists and physicians to enable effective referral and continuity of care. It may also consider developing Indian relevant, cost-effective diagnostic and treatment pathways for different severity groups that General Medicine and family physicians can follow in secondary centers. This is a role for wider education of the medical fraternity.

Limitations

This was an experience from the general ward of an academic, tertiary referral center where patients were admitted with a flare and high disease activity, and hence, the costs may be different from other hospitals. These values represent the price of care to the patient and not the true “cost” of services. However, these are relevant from the payer perspective. These patients were evaluated and managed by a General Medicine team in consultation with Rheumatologists, it is possible that these costs may have been different in a superspecialist or family physician practice setting. As it was a retrospective study, there were limitations in collecting clinical details and there could have been recall bias regarding costs and events. The effect of the COVID-19 pandemic significantly affected admissions and follow-up and this may have had an impact on the course of disease and follow-up costs.


  Conclusion Top


This study provides a valuable projection to the approximate cost of care for patients admitted with a flare of SLE– the IA cost, cost of follow-up and an annual cost, enabling treating teams and families to prepare for the course. It demonstrates that although there is a high morbidity and cost of managing a flare, with appropriate care, there are good outcomes and quality of life. There is a need for better referral and follow-up systems and there needs to be financial and social support for patients and their families to surmount the massive economic costs.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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[PUBMED]  [Full text]  
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