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The Sunderland Pharmacy School University of Sunderland

A Systematic Review Examining Whether Patients Receiving Haemodialysis at Home have a Greater Health-Related Quality of Life in Comparison to Patients Receiving InCentre Haemodialysis Treatment

Rafchana Khanam 2018 – 2019

Master of Pharmacy Degree Programme Year Three MPH328 Project Report

Plagiarism Declaration

I certify that I have read and understood the entry on plagiarism in the module guide for MPH328 and have read and understood AHQ-F7a Academic Integrity and Academic Misconduct – A Guide produced by the University of Sunderland.

I further certify that all aspects of the following project are my own work, except where I have indicated with the appropriate references. I understand the possible consequences should plagiarism be proven.

Signed: ___________________________

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Abstract This systematic review’s objective was to determine whether the health-related quality of life is greater for those who undergo haemodialysis treatment at home versus those who have treatment in-centre. This was conducted via a comparison of quality of life scores between a selection of studies chosen as well as outcome measures, such as biological indicators of renal disease. Overall, there was a positive correlation between having a higher quality of life score and being on home haemodialysis, however, not all of the data was deemed to be significant. Furthermore, due to different quality of life measurement tools being used, comparison between studies could not be accurate. For any conclusive statements to be made, more research is required in this field; this is of importance as the cohort of haemodialysis patients is increasing by number and age and therefore require insight into the best treatment plan.

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Acknowledgements I would like to give thanks to Alan Green, who provided me with advice and insight into this subject matter as well as support throughout this project. I would also like to acknowledge the help and guidance I received from my family, friends and peers; I am grateful for all the time they have given to me.

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Table of Contents Plagiarism Declaration..................................................................................................2 Abstract.........................................................................................................................3 Acknowledgements.......................................................................................................4 Table of Contents..........................................................................................................5 Introduction...................................................................................................................7 Aim and Objectives.....................................................................................................13 Research Question.....................................................................................................13 Methodology...............................................................................................................14 Results........................................................................................................................22 Discussion..................................................................................................................31 Conclusion..................................................................................................................35 References.................................................................................................................36 Appendices.................................................................................................................37

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Introduction In the United Kingdom alone, approximately 3 million people have Chronic Kidney Disease (CKD) and around 61,000 of those people are being treated for kidney failure, with an additional 19 people developing kidney failure everyday (Kidney Care UK, 2019). Kidney failure, which is known as End Stage Renal Disease (ESRD), is the fifth and last stage of CKD; this occurs when the kidney’s glomerular filtration rate is at less than 15% of its capacity (NICE, 2015). At this point of irreversible loss of kidney function, the only means for survival is via Renal Replacement Therapy (RRT) in the form of dialysis or a kidney transplant. Patients with low kidney functioning develop many issues, one being oedema due to the excess fluid not being adequately eliminated. They are, therefore, prescribed diuretics to manage this. However, diuretics will not manage this fluid build-up in patients with renal failure, who are at risk of hypertension and pulmonary oedema (Plantinga, 2017) Additionally, the accumulation of waste products in the blood, such as urea and creatinine, can cause uremia and the onset of symptoms such as confusion, nausea, vomiting, cramps and pruritis. Furthermore, kidneys affected by ESRD cannot regulate the levels of electrolytes, such as potassium, sodium and magnesium; this can lead to negative changes to normal body functions, such as fluid retention, abnormal heart rhythm and changes in mental state. Hyperkalaemia is another common symptom of ESRD which can cause serious electrocardiographic abnormalities (Putcha and Allon, 2007). Due to the above mentioned symptoms and resultant effects of ESRD, transplantation or regular dialysis treatment is vital in managing a patient’s health. 6|Page

Although transplantation would be the preferable treatment for many, there are currently over 5000 people on the UK donor list, with the average wait being three years (Kidney Care UK, 2019). Moreover, due to around 30% of patients having significant co-morbidities, transplantation would not be considered as a viable option. Therefore, there is an inevitability that many patients who have ESRD will have to have either temporary or long term dialysis. In terms of prognosis, surviving the first year of chronic renal replacement therapy has shown to be the ‘rite of passage’ – as termed by one literature – as the mortality rate is highest in the first twelve months. According to published data, the first year mortality rate is approximately 25%, which is over three times higher than the mortality rate from the second year and onward. This increased mortality after the initiation of dialysis looks to be universal, in that the risk of death peaks on the third month, regardless of age, gender, race or country (Wingard, 2009). The principle forms of dialysis are peritoneal dialysis and haemodialysis. Peritoneal dialysis involves a catheter filling the peritoneal cavity in the abdomen with a cleansing fluid, referred to as the dialysate. The waste products from the blood pass through the peritoneal membrane, into the solution via diffusion and ultrafiltration. The dialysate is then drained out and discarded and fresh fluid is instilled to resume and continue the process (Khanna and Krediet, 2009). The two main forms of peritoneal dialysis include continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD). CAPD exchanges the patient’s fluid every four to five hours during the day as well as 8 hours overnight whereas APD only occurs overnight.

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Haemodialysis, on the other hand, involves the waste products being removed via a dialysis machine. This machine controls the process by taking the blood from a patient and passing it through a dialyser which allows the waste materials from the blood to pass through a semi-permeable membrane and into the dialysate, which is then disposed of. The dialysate itself has a chemical composition that only attracts the excess salts and water across the membrane and therefore does not come in contact with the blood. The process of haemodialysis can also be delivered in various ways depending on the patient’s circumstance; the setting, duration and frequency of sessions are custom to the patient’s condition. As per NICE guidelines, all patients are offered a choice of dialysis modalities and it is ensured that the patients’ decision is informed by clinical considerations and preferences towards treatment (NICE, 2018). For the purposes of this review, the mode of dialysis that will be taken into consideration will be haemodialysis only. In the effort to make health care and health policies more patient-centred, there requires a certain knowledge that can only be obtained directly from the patient themselves, without input or interpretation from a healthcare professional (Anker et al., 2014). Haemodialysis results in the lives of those needing treatment being reorganised and adapted due to the nature of the disease. Many patients with ESRD place a greater value on their health-related quality of life (HRQOL) – in some cases, even over survival – and therefore have an active interest in how their choice of dialysis modality will affect their lives (Ramkumar et al., 2005). In reality, the health-related quality of life (HRQOL) of haemodialysis patients is hardpressed; HRQOL is a multi-dimensional concept, which can be defined as the perceived health status in physical, social and mental domains (Testa and Simonson,

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1996). It is a fundamental concept in healthcare as it recognises the effects of illness on patients, evaluates treatments, and facilitates resource decisions (Mandzuk and McMillan, 2004). For haemodialysis patients, the intrusiveness of a time-consuming treatment coincided with the chronic health problems associated with renal failure, results in the HQROL of this particular population of patients being lower than patients with congestive heart failure, chronic lung disease or cancer (Mittal et al., 2001). This becomes understandable when considering the multiple limitations that come hand in hand with dialysis treatment. In conjunction to the reduced physical activity, there are also restrictions in respect to food and drink. Simultaneous to the symptoms of CKD, patients also suffer the symptoms of dialysis, which include low blood pressure, fatigue, pain, cramps, nausea and vomiting, all off which can either occur during treatment or persist as a form of ‘hangover’. These adverse effects contribute to the perceived burden of treatment and, thus, the lower quality of life. The quality of life in the kidney failure population has been widely discussed with varying results, leading to the hypothesis from one literature claiming that is not possible to analyse all renal patients jointly; instead, comparison can only be done as a function of the type of treatment received (Martin-Diaz et al., 2006), such as the setting of which haemodialysis takes place. Conventional haemodialysis takes places in-centre, at either a hospital or satellite unit, and occurs at an average rate of three sessions per week in order to sustain life. Over 2 million people worldwide undergo this conventional type of treatment and are therefore more likely to be subject to having a lower HRQOL (Couser et al., 2011). More frequent haemodialysis sessions, such as five or six session per week,

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have been observed to increase HRQOL; this is thought to be associated with the resultant solute and fluid removal being greater per week, thus the patient having a higher serum albumin, vitamin D and haemoglobin level (Suri et al., 2006; Anand et al., 2011). However, due to the limitations of conventional dialysis settings, more frequent dialysis would be difficult to maintain in-centre due to the time needed to travel and the time required for the treatment process itself, which can last anywhere from two to five hours. Furthermore, the length of travel time in order to receive dialysis has been found to have negative associations with quality of life (Moist et al., 2008). Although haemodialysis between patients can differ in many categories (see Figure 1), in many cases, the same combination of haemodialysis that is delivered in hospital can also be delivered at a home setting. The only exception to this would be the rare occasion where a patient is receiving haemodialysis more than three times per week in hospital or if the patient requires medical assistance with the complexities of haemodialysis due to learning difficulties or disabilities. Figure 1: The variety of components which can differ between patients in regards to the delivery of haemodialysis.

Haemodialysis Setting Membrane Equipment Dialysate

Frequency

Duration

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Home haemodialysis is a viable option for many patients with ESRD. Many reports have indicated that those who have short daily or nocturnal home haemodialysis gain a variety of benefits, such as requiring less medication to treat hypotension and anaemia, improvements in neuropathy and less frequent occurrences of restless leg syndrome. There is also evidence for patients feeling better during the actual process, having less of a ‘hangover’ after treatment as well as sleeping better. Additionally, there has been some reports stating that short daily dialysis can also increase life expectancy. By allowing patients to have autonomy over their treatment, gives them a sense of purpose and responsibility that tends to be lost when diagnosed with a terminal condition. Overall, this can result in an improved HRQOL. Nevertheless, there remains negatives associated with home haemodialysis, such as the space that must be allocated for the machinery and equipment. Another factor which must be considered is that some Trusts insist on a partner being trained to a high standard in order to assist with the dialysis sessions, if the patient themselves are not considered competent to manage alone. This is in addition to the actual patient being obligated to undertake all the necessary training and responsibility for their treatment. Another barrier patients face is the requirement to self-needle, which can take time to overcome (Tong et al., 2012). These factors may be considered a burden for many patients. For many patients, the choice between home and in-centre haemodialysis is a difficult decision to make. By considering which will prove to be more beneficial is paramount to what their quality of life will be.

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Aim and Objectives The aim of this project is to determine whether the setting of haemodialysis can affect the health-related quality of life of patients with end stage renal disease. The objective will be to analyse and systematically review home haemodialysis versus in-centre haemodialysis. In-centre haemodialysis includes hospital settings and satellite units. This will be conducted via the evaluation of quality of life scores and outcome measures, such as biochemical indicators of renal disease.

Research Question A systematic review examining whether patients receiving haemodialysis at home have a greater health-related quality of life in comparison to patients receiving in centre haemodialysis treatment

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Methodology In order to research and evaluate the literature content pertinent to the topic of home haemodialysis versus in-centre dialysis, the PRISMA guidelines (PRISMA, 2015) were adopted so as to ensure a thorough yet comprehensive investigation was completed. To constrict results, an inclusion and exclusion criteria was implemented based upon the PICOSS framework (Frankis, 2005). To guarantee the research had been subjected to suitable quality checks, only peer reviews journal articles were used. Articles that had not been written in the English language were also omitted due to comprehension issues. Only articles that had been published within the last ten years were included so as to allow the most recent, and therefore, most applicable data to be considered and reflected upon. The extent of the filters applied can be seen in figures 2 a, b and c. A strategic search was conducted using two databases, Discover and PubMed. The Boolean search strings (MIT Libraries, 2019) of ‘AND’, ‘OR’ and ‘NOT’ were used to cultivate the given results and therefore choose the necessary journals. Figures 2 a, b and c below display how the search was across the two databases.

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Figure 2a: Search conducted on Discover Discover Terms searched haemodialysis or hemodialysis or

Number of Results 87

dialysis or renal replacement therapy or renal treatment AND quality of life haemodialysis or hemodialysis or

87

dialysis or renal replacement therapy or renal treatment AND quality of life NOT children or adolescents or youth or child or teenager Filters Applied Peer Reviewed Publication Date: Last 10 years

79 66

(2009–2019) English Language Full Text Final Number of Results

65 65 65

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Figure 2b: Search conducted on PubMed PubMed Terms searched Haemodialysis AND quality of life AND

Number of Results 184

"United Kingdom"

Filters Applied Full Text Publication Date: Last 10 years

74 61

(2009–2019) English Language Species: Human Final Number of Results

61 48 48

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Figure 2c: Search conducted on PubMed PubMed Terms searched Haemodialysis AND quality of life AND

Number of Results 829

United States

Filters Applied Full Text Publication Date: Last 10 years

338 257

(2009–2019) English Language Species: Human Final Number of Results

257 219 219

This preliminary search generated 331 results; the study selection process is shown in figure 5. An initial screening of the results excluded 306 journals based upon the article titles being of little relevance to the nature of this review. A secondary screening involving the abstracts eliminated a further 19 results as it became clear that the measures used were not applicable to the title of this report; for example, any reviews which did not include how the studies were synthesised, i.e. did not contain a methods section, were excluded. Although this systematic review is looking at the difference between quality of life indictors for home haemodialysis versus hospital haemodialysis, the studies looked at did not have to include a comparison of both. It was decided that, as part of the inclusion criteria, any study which analysed the quality of life in either home haemodialysis or in centre haemodialysis could be used for data extraction, therefore not limiting the search to journals that only compared the two settings.

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The participant population included adults whom were diagnosed with ESRD and were currently on haemodialysis; those on peritoneal dialysis were excluded due to being outside the remits of this review. Any data which included children was also omitted. The types of studies that could be used was initially restricted to randomised controlled trials only. However, due to limited data in this field, randomised controlled trials (RCTs), controlled clinical trials or observational cohort studies was decided to be included for analysis. Outcomes included were those which considered quality of life scoring as well as biochemical indicators. The inclusion and exclusion criteria applied can be seen in figure 4. This resulted in a total of 6 journal articles to be actively evaluated as part of the data extraction process and thereby being included in the results and discussion below. The study selection process is shown in figure 5.

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Figure 4: The criteria for the inclusion and exclusion of studies in this review. Inclusion criteria

Exclusion criteria

Review Title: A systematic review examining whether patients receiving haemodialysis at home have a greater heath related quality of life in comparison to patients receiving in centre haemodialysis treatment

Population