Socioeconomic rehabilitation of successful renal transplant patients and impact of funding source: Indian scenario.

INTRODUCTION: Socio-economic rehabilitation is an important outcome parameter in successful renal transplant recipients, particularly in developing countries with low income patients who often depend on extraneous sources to fund their surgery costs. We studied the socioeconomic rehabilitation and changes in socioeconomic status (SES) of successful renal allograft recipients among Indian patients and its correlation with their source of funding for the surgery. MATERIALS AND
METHOD: A cross-sectional, questionnaire-based study was conducted on 183 patients between January 2010 to January 2013. Patients with follow up of at least 1 year after successful renal transplant were included. During interview, two questionnaires were administered, one related to the SES including source of funding before transplantation and another one relating to the same at time of interview. Changes in SES were categorized as improvement, stable and deterioration if post-transplant SES score increased >5%, increased or decreased by <5% and decreased >5% of pre-transplant value, respectively.
RESULTS: In this cohort, 97 (52.7%), 67 (36.4%) and 19 (10.3%) patients were non-funded (self-funded), one-time funded and continuous funded, respectively. Fifty-six (30.4%) recipients had improvement in SES, whereas 89 (48.4%) and 38 (20.7%) recipients had deterioration and stable SES. Improvement in SES was seen in 68% patients with continuous funding support whereas, in only 36% and 12% patients with non-funded and onetime funding support (P = 0.001) respectively. Significant correlation was found (R = 0.715) between baseline socioeconomic strata and changes in SES after transplant. 70% of the patients with upper and upper middle class status had improving SES. Patients with middle class, lower middle and lower class had deterioration of SES after transplant in 47.4%, 79.6% and 66.7% patients, respectively.
CONCLUSIONS: Most of the recipients from middle and lower social strata, which included more than 65% of our patient's population, had deteriorating SES even after a successful transplant. One-time funding source for transplant had significant negative impact on SES and rehabilitation.

INTRODUCTION

In India, the incidence of end-stage renal disease (ESRD) is around 226 per million population.[1] Due to the lack of widespread availability and access to hemodialysis, renal transplantation remains the preferred and most suitable treatment option for ESRD patients in India. Transplant patients face many hurdles, like the adverse effects of immunosuppressive drugs, graft failure with possibility of return to dialysis and/or re-graft, recurrent infection, psychosocial stress and extreme monetary burdens.[23456] This also takes an emotional, social and economical toll on the family, which is more evident in the scenario of a developing country like India where the cost of health facilities are borne by the patient out of his own pocket. Health insurance and reimbursement for healthcare is available only to a miniscule of the population in India. Transplant centers are inadequate, unevenly distributed throughout the country and inequality exits between various states as far as the transplantation facilities are concerned. Therefore, patients need to travel long distances, frequently with multiple family members to seek out transplant facilities, adding extra expenses on travel, food and lodging.[5] Loss of job, business and break of education of patients and family members make the situation worse. Multiple studies and meta-analysis have evaluated the direct and indirect cost incurred by living kidney donors, renal transplant recipients and their family in setting of various countries of world.[7] The cost of treatment in Indian ESRD subjects has been associated with severe financial burden to the recipients and their families.[8]

The socioeconomic status (SES) is an important determinant of health, nutritional status, mortality and morbidity of an individual as well as family. SES also influences the accessibility, affordability, acceptability and actual utilization of available health facilities.[9] There are many scales to assess the SES that have been validated in Indian urban and rural circumstances. They can also be applied as a surrogate tool to assess the global impact of health care-related costs, treatment-related outcomes and subsequent social rehabilitation of the patients and their family. Thus, assessing SES, which includes various domains including education, occupation, monthly income, land possession, and social participation, etc can evaluate the socioeconomic impact of renal transplantation and subsequent socioeconomic rehabilitation of transplant patients in a broader aspect. However, the socioeconomic rehabilitation in successful renal transplant recipient in Indian scenario has not been addressed previously. With this view, we have conducted this study to determine socioeconomic rehabilitation of successful renal transplant patients and the impact of funding sources using a well validated SES scoring questionnaire.

MATERIALS AND METHODS

The study was approved by the institutional ethical committee and written consent was obtained from all the patients. A cross-sectional, questionnaire-based study was conducted on 183 patients from January 2010 to January 2013. Patients with a follow up of at least 1 year after successful renal transplant (defined as nadir creatinine value of <1.5 mg/dl) were included.

A systematic sampling method was used to select a subset of 183 subjects (Every 5th patient, i.e. 20% of total patient pool) from the 915 patients who visited renal transplant outpatient clinic during the study period following successful transplantation. This sample size was used with an expectation of a 50 percent response rate. Patients who failed to or declined responding to the questionnaire were excluded from the study. Overall response rate was 73%.

At the time of interview, two questionnaires (based on SES assessment scale developed by Tiwari et al.[10]) were filled, one related to the SES before transplantation and another related to SES at the time of interview. The questionnaires were administered by resident doctors of the transplant department (Urology) in local language readily comprehensible by the patients. The assessment tool includes seven domains including occupation, education and social participation which also reflect the rehabilitation of transplant patients. Changes in SES were categorized as improvement, stable and deterioration if post-transplant score increased >5%, increased or decreased by <5% and decreased <5% of pre-transplant value respectively. Subjects were also asked regarding the overall satisfaction related to transplant in terms of either satisfied or unsatisfied. Extent of current financial debt status (if any) and loss in property (land, house or gold) to meet the cost of transplant were also recorded. The employment status, including loss of job, and social participation were assessed as a part of SES scale.

Socioeconomic status and rehabilitation assessment tool

We have used questionnaire based scale developed by Tiwari et al.[10] to measure SES in urban and rural communities in India. It is a reliable and valid tool for the estimation of SES of individuals and their families in urban and rural areas of India.[10] This scale consists of seven domains, namely house, material possession, education, occupation, monthly income, land, social participation and understanding. All seven domains were equally weighted, each having a maximum score of 10. The score range (0-70) was categorized into five groups based on Central Government city compensatory allowance rules for each category of cities. The scale classifies the subjects into five classes, i.e. upper, upper-middle, middle, lower-middle and lower class. This scale was found to be highly reliable with a co-relation coefficient of 0.998 and the applicability of the scale was tested for its concurrent validity through field trials.[10]

Funding source

Funding sources were grouped as non-funded (Self funded), one-time funded support (single time financial support to meet the cost of transplant surgery and related expenses, paid by Govt under the scheme known as “Mukhya Mantri Sahayta Kosh {Chief minister relief fund}”, social agencies, private organisation or rarely by insurance companies) and continuous funding support (continuous funding support to meet all the cost related to transplant and post-transplant medication including immunosuppression, this was usually provided by Govt or agencies to their permanent employees)

Institutional setting

A government tertiary care referral centre in a north Indian state, Uttar Pradesh with established renal transplant program for more than last 20 years., According to hospital policy, the treatment is provided at a subsidized rate. The rough cost of a living donor renal transplant is around Rs. 2,50,000 which includes the investigations charges, surgical expenses of both donor and recipient, bed charges of donor and recipients and cost of the medications including perioperative renal replacement support during the same stay. Patients with a household income below poverty line, defined by the government are entitled to waiver of a part of hospital charges. Several patients receive assistance from government or private charities to meet with a part or whole of the treatment cost. This information was recorded during interview and confirmed from official database system.

Statistical analysis

Statistical analysis was done using the statistical software package SPSS version 20.0 (SPSS, Inc., Chicago). Data were presented as mean ± standard deviation or median (range) or number (percentage), as appropriate. Student t-test was used to compare the mean SES score before and after transplant. One-way ANOVA was used to evaluate the impact of funding source and social class on post-transplant SES. Regression analysis was used to assess the co-relation of variables on post-transplant SES. A P value of less than 0.05 was considered statistically significant

RESULTS

Demographic details, pre-transplant and post-transplant employment status, educational qualifications are tabulated in Table 1. In this cohort, 97 (52.7%) patients were non-funded (Self-funded), 67 (36.4%) had one-time funding support, whereas only 19 (10.3%) had continuous funding support. The predominant population (53%) was from the middle class.

Table 1

Patients demographic profile and overall results summary

Fifty-six (30.4%) recipients had improvement in SES, whereas 89 (48.4%) recipients had deterioration in SES. With continuous funding support, 68% had improvement in SES, whereas only 36% and 12% of non-funded and one-time funded patients (P = 0.000, R = 0.812) showed improvement in SES [Figure 1]. On subgroup analysis, there was significant correlation (R = 0.769) between baseline social strata and SES after transplant [Figure 2]. 70% of the patients of upper and upper middle class had improving SES. Patients with middle class, lower middle and lower class had deterioration of SES after transplant in 47.4%, 79.6% and 66.7% of the patients, respectively. There was significant association (P = 0.012) and positive correlation (R = 0.581) between the educational qualification and changes in SES [Table 2, Figure 3].

Figure 1

Changes in SES after transplant in related to funding source

Figure 2

Changes in SES in correlation with pre-transplant socioeconomic class

Table 2

Impacts of different variables on post-transplant changes in SES

Figure 3

Correlation between educations profile and Changes in SES after transplantation

Loss of job and financial crisis

Employment status at pre and post-transplant period is tabulated in Table 1. Focusing on their current debt status, 43% patient families were in debt after transplantation with mean debt of Rs. 4,78,800 ± 62,272. This financial crisis was pronounced in patients from lower middle class or middle class (P = 0.004) and negatively correlated with pre-transplant social strata (R = 0.761). Ninety-nine (54%) of the patients or their families had to sell a part or whole of their land and/or gold ornaments to meet the cost of transplantation or post-transplant healthcare expenses. Forty-two patients (22.8%) had history of poor compliance to immunosuppressive drugs at one or more occasion in the post-transplant period due to the lack of finances, lack of availability at their local place, or inability to attend the transplant OPD on time.

Social participation and outlook toward transplant

Overall, social participation was reduced by 34% in post-transplant period (P = 0.001). It was 51.5% (29/56) in patients with improved SES as compared to 26.31% (10/38) and 13.95% (12/89) in patients with stable or deteriorated SES (P = 0.009). Even after successful renal transplant, only 53% patients had satisfactory outlook toward transplant.

DISCUSSION

In a developed country, successful kidney transplantation is associated with considerable improvements in survival and quality of life, positive psychosocial outcome as well as significant cost-savings when compared with dialysis.[1112] Serious global inequities in access to transplantation exist internationally. For most low and middle-income countries, transplantation programs face many challenges due to the lack of infrastructure, financial constraints and lack of adequate cadaveric donor programs. Similarly, survival can also be compromised by the affordability of immunosuppressive drugs, malnutrition and recurrent infections. In 2011-2012, India had a meager per capita income of Rs 38,037 per annum.[13] Evidently, only few patients can afford any form of organ replacement therapy that on average costs of Rs 3,00,000.[14] A significant number of ESRD patients in India either fail to initiate the treatment, die or discontinue renal replacement therapy (RRT) due to financial disability.[151617] The present study evaluated the global impact of renal transplant related costs and associate shortcomings, the consequence incurred by the renal transplant recipient and their family along with subsequent social rehabilitation in setting of successful transplantation. This is the first study related to socioeconomic rehabilitation after successful renal transplantation in Indian prospect where renal transplant program faces several adversities.

In this study group, the predominant population (53%) was from the middle class followed by the lower middle class (26.8%). Hence, the population profile and more so the funding source of our study group may not be the true reflection of Indian population because of the setting and treatment policy of this hospital. As this center provides health care at a subsidized rate, yet not free of cost, where the cost of a renal transplantation is approximately Rs 2,50,000 which is at least half as compared to cost of renal transplantation at corporate sectors. Even in this favorable scenario, only 30.4% recipients had improvement in SES where as 48.4% and 20.7% recipients had deterioration and stable SES. We also noticed that the pre-transplant social strata have a significant impact on post-transplant socioeconomic rehabilitation. There was significant correlation (R = 0.715) between baseline socio-economic strata and SES after transplant. This finding makes it very clear that long-term positive impact of renal transplantation is only seen in the higher social class of patients in our country.

We found that one-time funding support for transplant surgery had adverse impact on socioeconomic rehabilitation. This may partly be because of very high indirect costs related to transplant, like cost of hemodialysis during long waiting period, cost of travel, food and accommodation for patients and donor family members. More so, high cost of immunosuppression adds to significant out-of-pocket financial expenditure by the patients and their family members. Secondly, 72% of the one-time funded support group belongs to the lower middle or lower socioeconomic strata; they were already overburdened by financial crisis and debt before reaching this hospital. A study by Ramachandran[8] et al., on cost analysis for transplantation in India, found that indirect expenses ranged from US $226 to 15,283 and most of the indirect expenses were related to the loss of income of the patient and caregivers.

In this study, 41 (22%) patients have lost their job after transplantation as compared to 56% patients as found by Ramachandran et al.[8] This discrepancy may be explained by different population profiles of these two studies. 43% of our patient families were in debt after transplantation with mean debt of Rs. 4,78,800 ± 62,272. Ramachandran[8] et al. reported that 54% of patients had severe financial crisis in their study group in a public sector hospital of India (government funded). These are very alarming reality that should be kept in mind before offering transplant to underprivileged population, where decision of transplantation is often taken on an emotional basis and many patients are uninformed regarding of the amount of expenses and the need for continuous funding sources.

One in every four patients had a history of poor compliance to immunosuppression at one or more occasions in the post-transplant period mainly due to the lack of finances, which is a unique finding of present study. This may complicate the long-term graft survival and becomes a challenge for a successful transplant program.

There was a significant drop in social participation by 34% after transplant. This is probably related to social dogma and fear of getting infection which is largely related to lack of health education. In our study group only 53% patients had satisfactory outlook toward transplant. Such a finding is an objective measurement of achievement or attainment of transplant program in our perspective. The scenario could have been even worse, if study population would be from public sector hospitals catering the rural population and if the patients with failed transplantation were also included in the study.

Is the financial crisis and unsatisfied socioeconomic rehabilitation in our context surprising? Probably it is a veiled fact that we all aware are of. Though the spending on healthcare is 4.2% of gross domestic product (GDP), the state expenditure is only 0.9% of the total spending, being among the lowest in the world.[1819] People using their own resources spend rest of it. Thus, only around 15% of all health expenditure in the country is borne by the state, and rest 85% comes as “out-of-pocket payment” by the people. This makes the Indian public health system grossly inadequate and under-funded[181920] Moreover, only about 5.5% of the Indian population has some form of medical insurance.[18] Virtually all of the families from poor rural areas lack any form of healthcare insurance. Xu et al.[21] identified three key preconditions for household catastrophic health expenditure in a multi-country analysis: The availability of health services requiring payment, low capacity to pay, and the lack of prepayment or health insurance, all of which exist in India.

Though at its budding stage, some states like Tamil Nadu, Karnataka, Andhra Pradesh and Kerala have already taken some initiative to provide free transplant as well as immunosuppression to underprivileged people even in private care centers through government–private health insurance partnership.[2223] Various models have been developed in countries like Thailand, Malaysia, Pakistan and some Latin American states to provide universal coverage to meet the whole expenditure of RRT.[2425262728] However, this requires provision of a large budget to develop many transplant centers with qualified doctors, amendment of law for successful cadaveric donor program and to provide socioeconomic including occupational rehabilitation model for ESRD patients. Last but not the least, gender inequality, the social and economic inequality in the access to transplantation should not be ignored.[17293031] Efforts are needed to overcome these biases.

A few limitations of our study must be addressed. We evaluated the SES and thus rehabilitations in a tertiary care center which cater mostly the middle class of populations. Hence our population cohort may not be the true representation of rural India where access to health care is of much inferior quality. We have only considered recipients who had successful transplantation. Therefore patients who had adverse treatment outcome would have faced much worse scenario which merits further study. This was a cross-sectional study and two questionnaires were filled at the time of interview regarding the pre-transplant and post-transplant current SES. A possibility of recall bias regarding past SES remained an important concern.

CONCLUSION

More than 65% of our patient population, who belong to middle, lower middle and lower class, had poor socioeconomic rehabilitation even after a successful renal transplant. One-time funding source for transplant had significant negative impact on SES and rehabilitation. Restricted social participation, job loss and financial crisis measured by debt are other concerns.