Evaluation of quality of life in hemodialysis and renal transplant patients

Mini A.M.*, Emmanuel J, V.N.Unni, Deepa A.R., Shameena Aboobacker Department of Pharmacy Practice, Amrita School of Pharmacy, Amrita Vishwa Vidyapeetham University, Kochi-

682041, Kerala, India.

Abstract

The study was conducted in a tertiary care hospital in Kerala to compare the quality of life between hemodialysis and transplant patients using WHOQOL-BREF scale. The study also focused on the clinical laboratory parameters of both the groups. The various immunosuppressive drug combinations prescribed for the renal transplant patients were also examined.About 50 patients each were included in both the hemodialysis and transplant groups. In the hemodialysis group, 74% were males and 26% females while in the transplant patients, 78% were males and 22% females. The patients in the hemodialysis group had a mean age of 57.32 ± 10.41 years while the transplant patients had a mean age of 36 ± 11.0 years. The mean of the serum creatinine and hemoglobin values of the hemodialysis patients were 9.68 ± 2.31 mg/dL and 9.91 ± 1.42 g/dL respectively while that of the transplant patients were 1.5 ± 0.42 mg/dL and 13.43 ± 2.11 g/dL respectively. The QOL scores in renal transplant patients in all the four domains were significantly higher (P<0.05) than that of the hemodialysis patients. The renal transplant patients were prescribed immunosuppressive drugs which have to be taken lifelong. About 36% of the transplant patients were on azathioprine + prednisolone combination. Quality of life improved after successful kidney transplant compared to dialysis. Although initially expensive, renal transplantation is a cheaper renal replacement therapy on the long run and is associated with reduced mortality. Keywords: Hemodialysis, Transplantation, Quality of life

INTRODUCTION

Chronic kidney disease (CKD) is a worldwide public health problem with an increasing incidence and prevalence, poor outcomes, and high cost. Outcomes of chronic kidney disease include not only kidney failure but also complications of decreased kidney function and cardiovascular disease. Current evidence suggests that some of these adverse outcomes can be prevented or delayed by early detection and treatment1

There are five stages of CKD based on the severity and stage 5 is the end stage renal disease (ESRD) where there is poor life expectancy. Stage 5 chronic kidney disease is also referred to as kidney failure, end-stage kidney disease, or end-stage renal disease, wherein there is total or near-total loss of kidney function2. There is dangerous accumulation of water, waste, and toxic substances, and most individuals in this stage of kidney disease need dialysis or transplantation to stay alive.

The option of treatment for an ESRD patient may be dialysis or transplantation. Dialysis is a procedure that is performed routinely. It involves removing waste substances and fluid from the blood that are normally eliminated by the kidneys. Renal dialysis attempts to mimic the excretory and to a lesser extent the homeostatic roles of the kidney. For the majority of ESRD patients, a renal transplant is the best possible treatment, as a relatively normal lifestyle is re-established. Advances in renal transplant procedures and immunosuppressive therapies have increased dramatically over the last decades, one year allograft survival rates are currently over 90%. The major goal of transplantation is to achieve maximal quality and quantity of life while minimising the effects of disease and also the costs of care. In renal transplantation the costs of care are not only limited to the transplant procedure but also to the evolving costs to treat adverse events, some of them caused by the immunosuppressive therapy.

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Patients with end stage renal disease need renal replacement therapy as a substitute for their original kidneys. Different renal replacement therapies have different levels of impact on physical, psychological and social health. Quality of life (QOL) as perceived by patients with end-stage renal disease is an important measure of patient outcome. Kidney transplantation remains the best option in the management of patients with end stage renal disease (ESRD). It confers the best possible quality of life, less morbidity and mortality, and considerable cost savings in the long-term in patients with ESRD3. The national kidney dialysis and kidney transplant study found that while 79.1% of transplant recipients had almost normal physical function, only approximately half of dialysis patients reported being able to function at the same level. End-stage renal disease and its treatment profoundly affect health related quality of life not only for the patient but the family also. Although renal replacement therapy ameliorates some of the symptoms of end-stage renal disease they may not be completely alleviated. Moreover, with treatment often comes significant life style changes, all of which impact on quality of life.

Quality of life is used to evaluate the general wellbeing of individuals and societies. Now a days it is a significant topic since for a number of chronic diseases there is a depletion of Quality of Life4. It is used in a wide range of contexts, including field of international development, health care and political sciences. WHO has defined QOL as “an individual’s perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns”. HRQOL is also increasingly recognised as an important measure of outcome following solid organ transplantation. HRQOL is

becoming more of an issue in terms of outcome measurements after renal transplantation. Advances in immunosuppressive therapy improved graft and patient survival, but it remains unknown whether this objective success projected also in subjective patients appreciation and well-feeling. Kidney transplant recipients’ life are with varying degrees of disease specific physical and psychical impairments, some of them attributed to adverse effects of immunosuppressants.

Transplantation is a highly successful treatment modality. Transplantation can alter quality of life in many ways, both positively and negatively5. However, this is often at a personal cost; for example, transplant patients may have to face the side effects of immunosuppressive drugs, rejection of the transplanted organ, psychosocial stress and excessive financial burden6. Graft rejection may mean a return to dialysis and/or re-graft, with attendant health and cost implications7. This also has an emotional toll on families. Quality of life has become an increasingly important parameter to provide information about the well being of the population. QOL studies on transplantation have been done mainly in the Western countries. India is a developing country and thus these studies can help in evaluating the role of transplantation. Also quality of life studies are a part of pharmacoeconomics and focuses on the assessment of end results or outcome associated with the health care. METHODOLOGY:

A non-experimental (observational), prospective and cross sectional study was conducted for a period of 5 months in the Nephrology department of Amrita Institute of Medical Sciences. Patients who were willing to participate and in the age group of 18-70 years, were included in the study.

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Patients with cognitive, psychiatric, hearing or speech problems were excluded.

Out of the 75 hemodialysis patients visiting the dialysis unit per week, 50 patients were selected on the basis of inclusion and exclusion criteria. 25 patients did not meet the criteria. Also, 50 transplant patients were selected from those visiting the O.P. clinic. About 150 transplant patients had visited the O.P. during the study period (5 months). The transplant O.P. clinic was on every Friday of the week with about 15 patients visiting each time. The patients were randomly selected, that is every fifth patient was included in the study.

Information concerning each patient’s MRD number, name, age, sex, marital status, history of allergy, socioeconomic status, co morbid conditions, date of transplantation, symptoms of renal disease, duration of dialysis, donor details, laboratory values and prescribed drugs were recorded in the data collection form. For assessing the QOL, the WHOQOL-BREF assessment questionnaire was used

for both the groups of patients. This questionnaire contains about 26 questions dealing with patient’s quality of life, health or other areas of their life. This scale assesses four domains i.e. physical health, psychological, social and environmental relationship of the patient.

For the comparison of the QOL of the hemodialysis and transplant patients, independent t-test was used with the help of the software SPSS version 13.0. RESULTS

About 50 patients each were included in both the hemodialysis and transplant groups. In the hemodialysis group, 74% were males and 26% females while in the transplant patients, 78% were males and 22% females. The patients of the hemodialysis group had a mean age of 57.32 ± 10.41 years while the transplant patients had a mean age of 36.0 ± 11.0 years. The age wise distribution of hemodialysis and transplant patients is shown in Table 1.

Table 1: Agewise distribution of hemodialysis and transplant patients

Age

group

Hemodialysis patients (n=50)

Transplant patients (n=50)

No. of patients

Percentages No. of

patients Percentages

≤ 20 0 0 2 4

21-30 2 4 16 32

31-40 3 6 11 22

41-50 3 6 14 28

51-60 14 28 7 14

61-70 28 56 0 0

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Table 2: Different immunosuppressant drug regimens used in transplant patients

Drug regimen No. of

patients Percentage

Azathioprine + steroid

18 36

MMF + steroid 1 2

Cyclosporin + MMF + steroid

7 14

MMF + steroid+ sirolimus

3 6

MMF + steroid + tacrolimus

5 10

Sirolimus + steroid + azathioprine

9 18

Tacrolimus + steroid

2 4

Cyclosporin + azathioprine + steroid

3 6

Tacrolimus + azathioprine + steroid

2 4

Total 50 100

Table 3: WHOQOL-BREF scores of hemodialysis and transplant patients in various domains

Domains Hemodialysis

Patients (n=50)

Transplant patients (n=50)

P Value

Domain-1 (Physical health)

20.54 ± 3.21 24.92 ± 2.51 < .001

Domain-2 (Psychological)

17.78 ± 3.32 23.22 ± 2.45 < .001

Domain-3 (Social

relationship) 9.44 ± 1.95 12.24 ± 1.87 < .001

Domain-4 (Environment)

24.58 ± 4.36 32.08 ± 3.32 < .001

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The clinical laboratory parameters that were checked for both the hemodialysis and transplant patients included serum creatinine and haemoglobin levels. The mean of the serum creatinine and hemoglobin values of the hemodialysis patients were 9.68 ± 2.31 mg/dL and 9.91 ± 1.42 g/dL respectively while that of the transplant patients were 1.5 ± 0.42 mg/dL and 13.43 ± 2.11 g/dL respectively.

The renal transplant patients were prescribed immunosuppressive drugs which they have to take lifelong. About 36% of the transplant patients were on azathioprine + prednisolone combination, followed by sirolimus + prednisolone + azathioprine (18%) and cyclosporin + MMF + prednisolone (14%) [Table 2].

The mean scores of Domain-1, Domain-2, Domain-3 and Domain-4 were 20.54 ± 3.21, 17.78 ± 3.32, 9.44 ± 1.95 and 24.58 ± 4.36 respectively in the case of hemodialysis Patients and the mean scores of Domain-1, Domain-2, Domain-3 and Domain-4 were 24.92 ± 2.15, 23.22 ± 2.45, 12.24 ± 1.87 and 32.08 ± 3.32 respectively in the case of transplant patients [Table 3]. The quality of life scores of hemodialysis and transplant patients were compared using the independent t test. The quality of life scores in all the four domains, that is Physical health, Psychological, Social relationship and Environmental, of the transplant patients was found to be significantly (P < 0.05) higher than that of the hemodialysis patients. DISCUSSION

End-stage renal disease (ESRD) has a considerable impact on the functional status and quality of life (QOL) perceived by the patient. Even in relatively early stages, it may be accompanied by symptoms that affect daily life; renal replacement therapies such as hemodialysis or peritoneal dialysis partially correct the uremia and also render necessary substantial lifestyle changes. This

study illustrates how physical, psychological, social functioning and environment, and general health were affected in ESRD patients undergoing different modes of renal replacement therapy.

In this study, the gender distribution in the hemodialysis patients were 74% (37) males and 26% (13) females while in transplant patients 78% (39) were males and 22% (11) were females. In both the groups, the number of males exceeded the females, as in other studies8,9,10.

In this study, the patients in the hemodialysis group had a mean age of 57.32 ± 10.41 years while the transplant patients had a mean age of 36 ± 11.0 years. This indicated that ESRD patients of younger age were undergoing transplantation, the reasons being the presence of co morbidities in older patients and the risk for surgery. In another study by Tomasz and Piotr 8, the hemodialysis patients had a mean age of 57.84 ± 11.85, while the transplant patients had a mean age of 43.30 ± 11.73. Also a study by Arogundade et al10 showed similar lower mean age for transplant patients (38.23 ± 10.37 years) while hemodialysis patients had a mean age of 42.96 ± 12.45 years.

The renal transplant patients were prescribed immunosuppressive drugs which have to be taken lifelong. About 36 % of the transplant patients were on azathioprine + prednisolone combination followed by sirolimus + steroid + azathioprine (18%) and cyclosporin + MMF + steroid (14%).

The clinical laboratory parameters that were checked for both the hemodialysis and transplant patients included serum creatinine and haemoglobin levels. The mean of the serum creatinine and hemoglobin values of the hemodialysis patients were 9.68 ± 2.31 mg/dL and 9.91 ± 1.42 g/dL respectively while that of the transplant patients were 1.5 ± 0.415 mg/dL and 13.43 ± 2.106 g/dL

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respectively. This shows the improvement in these lab parameters after renal transplantation. These were in agreement with the other studies9,11.

The QOL scores in renal transplant patients in all the four domains were significantly higher (P<0.05) than that of the hemodialysis patients. This showed that the renal transplant patients were able to lead a better life after transplantation. A successful kidney transplant has a positive impact on perceived health status and brings forth promises of an extended, enhanced QOL and a sense of personal liberation by raising the self-esteem due to the empowerment bestowed. A live-related kidney transplant would reinforce and intensify the emotional bondage between the recipient and a supportive family, leading to better psychological well being of the recipient12. Similar observations have been reported in other studies where the QOL of hemodialysis and renal transplant patients were compared9,13,14. But, a study conducted by Fayazi15 et al showed no significant difference in the social functioning of hemodialysis and transplant patients. CONCLUSION

Quality of Life (QOL) is very important in the evaluation of any type of therapeutic intervention; therefore, more and more studies of QOL related to health and of the ideal instruments for measuring it are being performed. The renal replacement therapies (RRT) including dialysis and kidney transplantation carry some side effects influencing patient's life. Thus, a therapeutic management that improves quality of life of the CRF patients treated with RRT is very essential. To know the patients' needs better, it is necessary to carry out further research on their QOL. Moreover, QOL studies on renal transplantation are limited in India.

The QOL scores were significantly higher for the transplant patients than the

hemodialysis patients. To conclude, quality of life improved after successful kidney transplant compared to dialysis. Although initially expensive, renal transplantation is a cheaper renal replacement therapy on the long run and is associated with reduced mortality. Quality of life has gained increasing attention in the evaluation of the outcomes associated with health care and pharmacotherapy. Health related quality of life is an appropriate final measure in pharmacoeconomic analysis as it examines health status and allows comparison of treatments of different conditions. REFERENCES 1.Levey AS, Coresh J, Balk E, Kausz AT,

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