Evaluation of quality of life in hemodialysis patients and measurement of clinical outcomes

End stage renal disease is the final stage of chronic kidney disease in which the kidneys longer function well enough to meet needs of life. The treatments for ESRD are dialysis or kidney transplant. Hemodialysis (HD) is the most common type of dialysis which can cause significant impairment in health related quality of life (HRQOL) and outcomes. The aim of the present study was to learn about the quality of life in patients receiving dialysis treatment and to evaluate the influence of various factors associated with poor HRQOL. In addition, this study compares SF-36 scores of various domains between survival and deceased patients. The study was a prospective observational, analytical study, conducted for 7 months in IPD/OPD of Dialysis Department at Sagar Hospitals, Bengaluru. The validated and authorized health related quality of life questionnaire (RAND SF-36) consists of 36 questions measuring physical and mental health status was used. Statistical significance of differences in physical component summary and mental component summary was calculated by using Kruskal-Wallis test and the Mann-Whitney U test. A total of 126 patients meeting the study criteria participated and completed the study. Overall, 85(67%) were male and the mean ± standard deviation age was 58.10± 11.38 years. Both PCS and MCS scores have significant negative association with age, total number of chronic medications and the total number of chronic co-morbid diseases. Among eight scales of SF-36, Bodily Pain (BP), Physical Function (PF), Role limitation due to Physical health (RP) and Vitality scores were significantly higher in surviving patients when compared to that of deceased patients respectively. Our study showed that important variables like PF, BP, RP and VT scores can be taken into consideration when dealing with hemodialysis patients. Healthcare providers should be aware of poor physical health as well as mental health among female gender, elderly patients, unemployed patients, patients with no formal education, multiple co-morbid diseases, and multiple chronic medications to improve their quality of life.


INTRODUCTION
End stage renal disease (ESRD) or renal disease is a growing worldwide public health concern. ESRD is the final stage of chronic kidney disease in which the kidneys longer function well enough to meet needs of life. People with diabetes or hypertension have the highest risk of developing ESRD 1, 2 . In the United States of America (USA), the number of newly reported ESRD cases in 2013 was 117,162 corresponding to an unadjusted incidence rate of 363 per million per year 3,4 .
The two main treatment modalities for ESRD are transplantation and dialysis (i.e., hemodialysis [HD] or peritoneal dialysis (PD) 5,6 . Patients on maintenance hemodialysis (MHD) experience decreased quality of life (QOL) and significantly greater rates of malnutrition, inflammation, hospitalization, and mortality compared with the normal population 7.8 .The ability to predict future morbidity and mortality is a key to reduce the burden of CKD. To this end, monitoring a patient's functional and subjective status of well-being, collectively known as healthrelated quality of life (HRQOL), is of particular importance in ESRD patients 9, 10 .
According to the World Health Organization, health is defined as "a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity" 11 . Quality of life defined as the general well being of a person or society, defined interims of health and happiness rather than wealth 12 . Health related quality of life is a multidimensional concept that includes domains related to physical, mental, emotional, and social functioning. It goes beyond direct measures of population health, life expectancy, and causes of death, and focuses on the impact health status has on quality of life. A related concept of HRQOL is well being which assesses the positive aspects of a person's life, such as positive emotions and life satisfaction 13 .
Although HRQOL cannot be measured directly, the 36-item Short-Form health survey (SF36) has been validated as a QOL assessment tool for a wide variety of patients, including CKD patients 14,15 . Here, we evaluate HRQOL using the SF36 and assess the impact of HRQOL on mortality in the elderly, who are likely to develop or already have CKD. A larger study, involving 5256 patients at 243 dialysis facilities in the United States and Europe, presented evidence that the psychological or mental components of quality of life predict death and hospitalization in hemodialysis patients 16 . Furthermore, HRQOL has been shown to be an independent predictor of survival in ESRD patients 17,18 . Clinicians and public health officials have used HRQOL and well-being to measure the effects of chronic illness, treatments, and short and long term disabilities 19 .
Although several studies were carried out and published about HRQOL in different disease populations in Palestine such as diabetic or hypertensive patients 20,21 . No such studies were carried out among HD patients in India. Therefore, the present objective for treatment of end stage renal disease are 2 folds in the first place increase patient survival and in the second place to improve the quality of life it is essential to properly control the symptoms and complications of ESRD and work towards the full rehabilitation of the renal patient. The aim of the present study was to learn about the quality of life in patients receiving dialysis treatment and to evaluate the influence of various factors associated with poor HRQOL and factors related to treatment and patient conditions the co-morbidity associated with renal insufficiency.

Study design and settings:
This was a prospective, observational, analytical study of chronic kidney disease (IV&V stage) patients registered in /OPD of Dialysis Department at Sagar Hospitals, Bengaluru, India from September 2016 to February 2017(seven months) and was followed up for one year.

Ethics approval and consent to participate:
All participants had given written informed consent to participate. The study protocol was prepared and submitted to the Dayananda Sagar College of Pharmacy ethics committee on human subject research for ethical clearance. The study was approved by Institutional ethics committee and issued ethical clearance certificate for the same.

Sources of data and study material:
The sources of data used for this study includes out patient records, personnel interviews of patients and their representatives and Patient's treatment files in case of In-patients. The study materials include Patient Information Sheet, Informed Consent Form, Patient Data Collection (PDC) Form, Questionnaires for assessing (HRQOL).

Inclusion criteria:
All patients either sex who diagnosed with ESRD, patients 18 years of age or older, all patients admitted to dialysis department for hemodialysis, patients on regular hemodialysis for minimum of 3 months prior to the interview, patients who completed the survey.

Exclusion criteria:
Patients under 18, Patients who cannot complete a RAND SF-36 questionnaire due to cognitive Impairment, Dementia, Active Psychosis, Patients on dialysis less than 3 months, Patients who refuse to complete questionnaire method

Statistical analysis:
Data were recorded on a pre-designed data collection form and managed on an MS Office Excel spread sheet. The descriptive statistics are represented by mean ± standard deviation and percentages. The differences between the groups were determined by the parametric ttest & non-parametric statistical test: fisher's exact test or chi-square tests wherever appropriate. Graph Pad prism-5 statistical software was used for the data analysis. Data that were not normally distributed were analyzed using the Mann-Whitney U test or Kruskal-Wallis test according to the number of groups to compare. Statistical significance was defined as p<0.05. All P values were two tailed.

Patient characteristics:
Among 140 patients, as per inclusion and exclusion criteria, 130 patients were enrolled in the study, 126 patients completed the study, 4 continued to take further treatment at different dialysis centers. Among all patients, 85 (67%) were males and 41 (32.53%) were females. The age of the patients ranged from 21 to 82 years with a mean (SD) of 58.10(11.38) years. Majority of the patients were from > 60 age group with 43 males and 22 females. Of 126 patients, 49(38.88%) were graduated, 96(76.19%) were married, 51(40.47%) were employed. Majority of patients (52.38%) were non smokers. 71 patients (56.34 %) were on dialysis for less than two years and 105 patients (83.33%) receiving dialysis three times weekly. Most of the patients (66.66%) were having either 1 or 2 co-morbidities. 62.69% (79) were receiving medications less than four and mean no of medications taken by each patients was 3.16. The socio-demographic and clinical characteristics of the study participants are displayed in Table 3.1   Males scored slightly, but statistically significantly, higher than women on all scales. The differences were more pronounced for the scales more closely associated with Physical health than for the scales associated with mental health. The similar results were obtained in the study conducted by Sa'ed et al. 2016 24 .
Our results demonstrated that increased age was associated with lower QOL. Younger patients in the current study reported that significantly better QOL. Among all patients elderly patients (> 60 years) had significantly reduced PCS (51) and MCS (56) compared to other age groups. These results were in agreement with the findings reported by F. Moreno and colleague's study 25,26 .
Divorced and Unmarried patients were strong both physically and mentally compared to other categories. Married females were having low scores in RP (34%), PF (43%) indicated that they had poor physical functioning. There were limited studies reported on marital status. Patients with more number of co-morbidities associated with poor PCS (48.98) and MCS (58.68) scores significantly. Most commonly observed co-morbidities are Diabetes mellitus, Hypertension associated with poor quality of life. The similar associations were found by a study 30 .
Patients with medication history more than 4 medications were affected in both PCS (56%), MCS (62%) compared to patients with less than 4 medications per day. Patients taking less number of medications associated with good quality of life. There was statistical difference between these two groups in PCS and MCS scores. These results were in agreement with previous studies 31 .
Patients who were on dialysis for short period of time had better quality of life scores than patients on long period of time. Patients who were on dialysis more than 4 years had poor quality of life. A study reported that the dialysis vintage period negatively associated with HRQOL 24 .

CONCLUSION
HRQOL monitoring and use have great potential to improve patient outcomes, yielding benefits that exceed burden for patients and clinics.
Our study showed that number of important variables that can be taken into consideration when dealing with hemodialysis patients are females, elderly patients, unemployed patients, patients with no formal education were well associated with poor HRQOL. Higher number of co-morbid diseases as well as higher number of medications was also associated with lower HRQOL. In addition, there is a significant difference between survival and deceased patients in PF, BP, RP and VT scores. Healthcare providers should be aware of these SF-36 domains to improve their quality of life.