Rajiv gandhi university of health sciences, bangalore karnataka annexure-ii



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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE

KARNATAKA



ANNEXURE-II



PROFORMA OF REGISTRATION OF SUBJECTS FOR DISSERTATION




1.

NAME OF THE CANDIDATE AND ADDRESS


ANU.V.KURIAKOSE

VALIAYAPARAMBIL (H)

ADIMALY PO

IDUKKI 685561


2.

NAME OF THE INSTITUTION


VISVESWARAPURA INSTITUTE OF PHARMACEUTICAL SCIENCES, BANASHANKARI-II STAGE BANGALORE-70.

3.


COURSE OF THE STUDY

MASTER OF PHARMACY

IN

PHARMACY PRACTICE

4.

DATE OF ADMISSION TO THE COURSE







14-06-2010

5.

TITLE OF THE TOPIC

ASSESSMENT OF HEALTH RELATED QUALITY OF LIFE IN CHRONIC RENAL FAILURE PATIENTS AT KIMS HOSPITAL AND RESEARCH CENTRE



6.0

BRIEF RESUME OF THE INTENDED WORK


7.0

8.0

6.1 NEED FOR THE STUDY:

Renal disorders are disease of the kidney which is characterized by malfunctiong of the kidney or a deviation from normal function of kidney. CRF is a complete or near complete failure of the kidneys to function to excrete wastes, concentrates urine and regulates electrolytes. The two types of renal failure are acute (ARF) and chronic renal failure (CRF) 1.

Chronic renal failure is defined as “reduction in the glomerular filtration rate or the presence of proteinuria”. Chronic renal failure occurs when disease or disorder damages the kidneys so that they are no longer capable of adequately removing fluids and wastes from the body or of maintaining the proper level of certain kidney-regulated chemicals in the bloodstream2.

CRF is one of the serious medical disorders and is associated with increase in poor physical and mental health. Chronic kidney disease is now recognized as a significant and rapidly growing global health burden. CRF is affecting health related quality of life not only for the patient but the family also3.

The prevalence of CRF in that adult population was 0.785% or 7852/million. Monitoring a patient’s status and the subjective state of well-being, together known as quality of life (QOL) measurements, is of particular importance in patients with CRF, because the physical debility experienced by patients with uremia can be insidious and have grave consequences4.

Quality of life according to World health organization (WHO) definition is “a state of complete, physical mental and social well-being and not merely the absence of disease or infirmity”. Health related QOL focuses specifically on the influence of health, illness, and medical treatment on quality of life (QOL)5.

Health related quality of life (HRQOL) measurements are based on patient’s subjective sense of well being and are commonly used as an important clinical measure for beneficial extent of medical treatments for patients with CRF. Furthermore, patient reports of HRQOL are recognized as providing important information about the impact of CRF and its management on daily life in these patients. In recent years, more attention has been drawn toward reexamining the overall role and potential application of patient self reported states of well being and functioning by use of self administered HRQOL questionnaires in the CRF population. HRQOL assessments may be used in patient care to screen for and prioritize

Problems, to improve communication between health care workers and patient and evaluate response to treatment6.

Epidemiologic studies have suggested that CRF is associated with several fold increase in mortality and considerable morbidity. Thus HRQOL monitoring in patients with chronic kidney disease could help to guide physicians in designing interventions to reduce mortality and morbidity 7.


6.2 REVIEW OF LITERATURE:

Salim K Mujais et. al., (2009) reviewed the health related quality of life in CRF patients. They found that very few large-scale studies had been investigated the determinants of health related quality of life in CRF patients who were not on dialysis or the evolution of HRQOL over time. The study concluded that these observations highlighted the profound impact of CRF on HRQOL suggested potential areas that can be targeted for therapeutic intervention8.

Fredric O Finkelstein et. al., (2008) studied and reviewed health related quality of life and hemoglobin (Hgb) levels in CRF disease patients. The relationship between quality of life and anemia has been the subject of recent debate. It was suggested that QOL changes associated with treatment of anemia of CRF patients should not be used in making decisions to treat anemia in CRF patients and was concluded that higher Hgb levels are associated with improved QOL domains of KDQOL questionnaire 9.

Brennan M.R. Spiegel et. al., (2008) have reported biomarkers and health related quality of life in chronic kidney disease. It was observed that health related quality of life predicts mortality in CRF, yet adoption of HRQOL monitoring is not widespread, and regulatory authorities remain predominantly concerned with monitoring the traditional biologic parameters. HRQOL in CRF is most affected in the physical domains, and nutritional biomarkers are most closely associated with these domains 10.


Piter F Vos, et. al., (2005) studied the effect of short daily home haemodialysis on quality of life cognitive function and the electroencephalogram. It was observed that the end stage renal disease patients having poor quality of life suffered from impaired cognitive functioning and their electroencephalogram (EEG) showed abnormalities. It was concluded that short daily haemodialysis (SDHD) improved health related quality of life but it had no clear effect of cognitive functioning and EEG. Resumption of CRF after SDHD decreased the aspects of quality of life and EEG alpha peak frequency but had no effect on cognitive functioning11.

Health related quality of life and an estimate of utility in chronic kidney disease was reviewed by Irina Gorodetskaya –Stefanos Zenious et al., (2005). They found methods to determine the relations among kidney function, health related quality of life and estimates of utility in chronic kidney disease. The relations among estimated GFR rate and changes in health related quality of life and utility over time were estimated by using mixed effect regression models. They concluded that health related quality of life and estimates of utility were distressingly low in persons with CRF 7.

The state of health related quality of life in patients with chronic kidney disease was reviewed by Kamyar Kalantar-Zadeh and Mark Unruh (2005) and found that monitoring patient’s functional status and the subjective state of well being is related to the health condition, together known as HRQOL measurements, which is of particular importance in patients with chronic kidney disease. These recent findings underlined the critical measure of HRQOL and expanded the boundaries of multidimensional tools with technology and more patient centered concept of quality of life6.

In order to measure the prevalence of poor sleep in a population of CRF patients and to examine the association between quality of sleep and the degree of renal impairment in these populations, a study was conducted by Eduard A.Illiescu, et. al., (2004). The results showed that 53% had poor sleep defined as a global PSQI score >5. They concluded that poor sleep was common in patients with CRF and also the quality of sleep decreased in the early stage of CRF12.

Kamyar Kalantar-Zadeh (2003) studied quality of life in patients with Chronic Renal Failure and reviewed that SF36 in patients with kidney failure and SF 36 as a predictor of mortality and hospitalization in CRF patients. They concluded that monitoring a patient’s functional status and the subjective state of well being as it is related to health condition together known as HRQOL measurements was of particular importance in patients chronic renal disease 4.

Darab Mehraban and Gholamhossain Naderi (2003) have reported the development of SF36 questionnaire in measure the quality patients on renal replacement therapy. It was reviewed that in patients with chronic diseases such as renal insufficiency has come under increased attention recently. This study shows that there is a considerable change of opinion in relation to the items between test-retest. Therefore, to refine this situation, there is need to reconsider the contents of the items in the future studies13.

Amy Guo, et. al., (2002) studied in early quality of life benefits of icodextrin in peritoneal dialysis. These results found that the clinical outcomes of icodextrin patients sustained higher than dextrose patients. The study was concluded by finding that the peritoneal dialysis patients who treated icodextrin well experienced substantial improvement of their quality of life14.

Jasna B. Trbojevic, et. al., (2001) evaluated the impact of continuous ambulatory peritoneal dialysis (CAPD) on the lifestyle of elderly patients. The results showed that, in the examined group’s marital status and relationship with family members weren’t influenced by dialysis. In both groups, CAPD had a negative influence on ability to bear cold and to travel, but other life functions were not significantly affected. The study concluded that lack of large and statistical differences between the groups suggested that CAPD had an equal influence on the quality of life in younger and older patients15.

6.3 OBJECTIVE OF THE STUDY:

To assess the key factors affecting Health Related Quality of Life (HRQOL) in Chronic Renal Failure Patients.



MATERIALS AND METHODS:

7.1 SOURCE OF DATA:

Data will be collected using suitably designed patient data collection form.

  1. By one to one interview with the patient.

  2. By reviewing the patient’s case chart.

  3. By medication chart review.

  4. By administering standardized Kidney Disease Quality Of Life Short Form

(KDQOL-SFTM) Questionnaire.

    1. INCLUSION CRITERIA:

1. Both in-patients and out-patients in Nephrology Department at Kempegowda Institute of medical science (KIMS) Hospital and Research centre, Bangalore

2. CRF patients of age >18 years.

3. Patients who sign the informed consent.

7.3 EXCLUSION CRITERIA:


  1. Patients who have under gone renal transplantation.

7.4 METHODS AND COLLECTION OF DATA:

  1. A study will be conducted with both in patients and out patients having CRF at the Nephrology department, KIMS Hospital, Bangalore

  2. An informed consent will be obtained from the patient

  3. Patient’s demographic data will be collected.

  4. Comparison study will be done between two groups of patients depending on following criteria:

  1. Patients who have undergone dialysis and the patients who have not undergone dialysis.

  2. Based on the patients annual income.

  1. The patients will be enrolled for a period of first four months and follow up will be done after four months.


  2. KDQOL-SFTM questionnaire will be administered to CRF patients or their respective care takers.

  3. KDQOL-SFTM questionnaire will be administered on second and subsequent visits to check QOL.

  4. Scores will be aggregated and transformed linearly to 0-100 possible range with higher scores indicating better status.

  5. Then the data obtained will be  statistically analyzed using  analysis of variance (ANOVA)

7.5 DURATION OF THE STUDY:

The study will be conducted for a period 9 months



7.6 PLACE OF STUDY:
Department of Nephrology, KIMS Hospital & Research Centre, Bangalore.
7.7 Does the study require any investigation or intervention to be conducted on patients or other humans or animals if so, please describe briefly.

No

7.8 Has ethical clearance been obtained from your institution?

Yes, copy attached.

LIST OF REFERENCES:

1. American Institute of Nephrology. Chronic renal disease. 2005 [cited 2010 Oct 18].

Available from: http://www.kidney.org/index.html

2. Roger W, Cate W. Clinical pharmacy and Therapeutics. 4th ed. United kingdom: Churchill living stone; 2008. p.232-249

3. Sedigheh F, Marziyeh A, Althary S. Comparison of Quality of life between hemodialysis and renal transplant patients.2008 Dec 22 [cited 2008 Oct 18].

Available from: http://www.thefreelibrary.com/comparison+of+life+between+hemodialysis

4. Zadeh K. Quality of Life in Patients with Chronic Renal Failure.CIN.2003;1-16

5. Chang and Tamuran KM. Methods to assess quality of life and functional status and their applications in clinical care in elderly patients with CRF.2009 [cited 2010 Oct 17].

Available from: www.asn-online.org/education_and_meetings/.../Chapter35.pdf -

6. Zadhk KK and Unruh M. Health related quality of life in patients with chronic kidney disease. Int Urol and Nephrol. 2005; 37: 367-378.

7 Gorodetskay I, Zenios S, McCulloch CE, Bostrom A, Hsu C, Bindman AB et al. Health related quality of life and estimates of utility in chronic kidney disease. Kidney Int. 2005; 68:1-13.

8. Mujais SK, Story K, Brouillette J, Takano T, Soroka S. Health related quality of life in CRF patients. Clin J Am Soc Nephrol.2009; 45:1-6.

9. Finkelstein FO, Story K, Firanek C, Mendelssohn D, Barre P, Takano T,Soroka S, Mujais S. Health related quality of life and hemoglobin levels in chronic kidney disease patients. Clin J Am Soc Nephrol.2008; 10:1-6.

10. Spiegel BM, Melmed G, Robbins S, Esrailian E. Biomarkers and health related quality of life in end stage renal disease. Clin J Am Nephrol.2008; 3:1-17.


11. Vos PF, Zilch O, Jennekens-Schinkel A, Salden M, Nuyen J. Effect of short daily home hemodialysis on quality of life, cognitive functioning and the electroencephalogram. Kidney Int.2005; 60:456-61.
12. Iliescu EA, Yeates KE, Holland DC. Quality of sleep in patients with chronic kidney disease. Nephrology Dial Transplant. 2004; 19:95-9.
13. Mehraban D, Naderi G, Salehi M. Development of SF-36 questionnaire in the measurement of quality of life in patients on renal replacement therapy. SJKDT. 2003; 14: 15-17.
14. Guo A, Wolfson M, Holt R. Early quality of life benefits of Icodextrin in peritoneal dialysis. Kidney Int. 2002; 62(81):72-9.
15 Jasna B, Trbojevic,V B, Nesic,B B. Stojimirovic. Quality of life of elderly patient’s under-going continuous ambulatory peritoneal dialysis. Perit Dial Int, 2001 ;21:301-3.










9.0

SIGNATURE OF THE CANDIDATE




10.0

REGISTRATION NUMBER




11.0

NAME AND DESIGNATION OF THE GUIDE


Dr VANAJA K
ASSISTANT PROFESSOR
V I P S, BANGALORE


11.1

REMARKS OF THE GUIDE





11.2

SIGNATURE OF THE GUIDE





12.0

NAME OF THE HEAD OF THE DEPARTMENT


Mrs. GITHA KISHORE

ASSISTANT PROFESSOR

VIPS, BANGALORE.

12.1

SIGNATURE OF THE HEAD OF THE DEPARTMENT




13.0

NAME AND DESIGNATION OF CO-GUIDE

Dr. SANJEEV KUMAR A HIREMATH

ASSOCIATE PROFESSOR DEPARTMENT OF NEPHROLOGY KIMS, BANGALORE.

13.1


SIGNATURE OF THE CO-GUIDE




14.0

NAME OF THE PRINCIPAL

Dr. HARISH KUMAR D.H M.PHARM, Ph.D

14.1

REMARKS OF THE PRINCIPAL





14.2

SIGNATURE OF PRINCIPAL WITH SEAL










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