A comparison of treatment options for management of End Stage Kidney Disease in elderly patients: A systematic review protocol

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1 A comparison of treatment options for management of End Stage Kidney Disease in elderly patients: A systematic review protocol Leanne Brown Master of Nursing Science (Nurse Practitioner) 1 Glenn Gardner PhD 2 Ann Bonner PhD 2 1. Doctorate Student at Queensland University of Technology.Affiliated with The Joanna Briggs Institute, School of Translational Health Science, Faculty of Health Sciences, The University of Adelaide 2. Professor, Queensland University of Technology. Corresponding Author Leanne Brown ; leanne_brown@health.gov.au Review question/objective The primary objective is to assess the effect of dialysis compared with non-dialysis management for the population of 65 years and over with end stage kidney disease (ESKD). ESKD is defined as an estimated glomerular filtration rate (egfr) of less than 15mL/min. Dialysis is defined as either hemodialysis or peritoneal dialysis. Non-dialysis management is also known as conservative management, palliative care and supportive care. More specifically, the sub objectives are to identify: The effects of dialysis on quality of life in elderly patients (65 years and over) with ESKD (<15mL/min) compared with non-dialysis management The effects of dialysis on survival in elderly patients (65 years and over) with ESKD (<15mL/min) compared with non-dialysis management Compare the functional capacity in elderly patients (65 years and over) with ESKD (<15mL/min) on dialysis compared with those on non-dialysis management Compare the symptoms and severity of ESKD (<15mL/min) in patients (65 years and over) on dialysis with that of those receiving non-dialysis management Page 197

2 Compare the rate of hospital admissions for those elderly patients (65 years and over) with ESKD (15mL/min) on dialysis with those receiving non-dialysis management. Background Description of the condition Chronic Kidney Disease (CKD) is defined as kidney damage or glomerular filtration rate (GFR) < 60mL/min/1.7m 2 for three months or more irrespective of cause 1. There are five stages of kidney disease defined by The National Kidney Foundation Disease Outcomes Quality Initiative 1 (Table 1). Table 1 Stages of Chronic Kidney Disease 1 Stage Description GFR (ml/min/1.73m 2 ) 1 Kidney damage with normal or raised GFR >=90 2 Kidney damage with mild decrease in GFR Moderate decrease in GFR Severe decrease in GFR Kidney Failure < 15 (or dialysis) Damage to the kidney can sometimes be reversible but more often the damage is progressive, long term and may result in end stage organ damage (i.e. End Stage Kidney Disease - ESKD). CKD is a global public health problem of increasing prevalence. For instance, the prevalence of CKD (stages 3 5 see table 1) in the United States is estimated to be greater than 10% of the adult population (more than 20 million people) 2 and in the United Kingdom 9% of the adult population is estimated to have CKD stage The prevalence of CKD is also of concern in Australia and it is estimated that 1 in 7 (approximately 11%) of the adult population have some degree of CKD 4. Of this there is a higher proportion (30%) of the Australian population with CKD in the age category of over 65 years 5. Description of the intervention Dialysis is a clinical treatment for kidney failure where the solute composition of a solution is altered through exposure to a second solution via a semi permeable membrane 6. Dialysis can be undertaken through two different methods. One technique involves exposure of the individuals blood to an artificial semi permeable membrane external to the body known as hemodialysis, the second method is via infusion of a solute into the individuals peritoneal cavity with solute exchange occurring via the body s own semi permeable membrane. This technique is known as peritoneal dialysis. Both forms of dialysis are treatment options that are available when the kidney function reaches end stage (egfr < 15mL/min). Generally these treatments are offered to patients when their kidney function is < 10ml/min. Treatments such as dialysis are required as a life sustaining measure for people once ESKD Page 198

3 occurs and are frequently a burden for the person and their family and expensive in terms of health care costs. ESKD and the issue of treatment options is a worldwide concern as there has been a rapid increase in the number of people commencing Kidney Replacement Therapy (KRT) over the last 20 years. In Australia the incidence of people commenced KRT has risen by 167% over the period 1989 to 2009, with a majority of this increase occurring in people over 65 years of age 7. While not as dramatic, the incident rate of ESKD receiving KRT is predicted to continue to increase from 100 cases per million to 190 cases per million from In the USA the increase has been approximately 20% with the current new case rate at 355 cases per million 2. The UK data is similar to Australian data with the incident rate at 107 case per million 9. With older (i.e. greater than 65) ESKD patients that have other health related problems, it is sometimes difficult to determine whether dialysis would prolong their life or improve their quality of life. Non-dialysis (conservative) management is a treatment option and for some people who have ESKD this treatment may provide the best outcome. Non-dialysis management is a treatment choice for all people approaching ESKD, although it is mostly those people over 65 years of age with significant co-morbid conditions and a poorer life expectancy who consider opting for non-dialysis management. The poor outcomes for people over 65 who commence KRT are demonstrated by statistics found in the registries throughout the world. For example the Australian and New Zealand registry (ANZDATA) report that 22% of Australians who commence KRT in the age category 65 years and over die within the first year, 34% are dead after being on KRT for two years and 68% have died after five years 10. The outcomes in the United Kingdom are similar. For the population of 65yrs and over there is a 25% death rate at one year, 39% death rate at two years and 73.1% death rate at 5 years 11. Why it is important to do this review The poor prognosis for those patients who are 65 years and over commencing on dialysis raises issues around management of ESKD in this population. It is important to review the studies that have been undertaken comparing the outcomes of the elderly ESKD patients who have commenced dialysis with those who received non-dialysis management. Preliminary searches of the JBI Library of Systematic Reviews, Cochrane Library, PubMed, PROSPERO, DARE and CINAHL have shown there is not other systematic review published or underway on this topic. Keywords Dialysis; renal replacement therapy; kidney replacement therapy; RRT; KRT; Non Dialysis management; conservative care; supportive care; palliative care; Elderly; 65 years and over; aged; old Inclusion criteria Types of participants This review will consider studies that include participants who are 65 years and older. These participants need to have been diagnosed with ESKD for greater than three months and also be either receiving dialysis (hemodialysis or peritoneal dialysis) or non-dialysis management. The settings for the studies would be home, self-care centre, satellite centers, hospital, hospice or nursing homes. Types of intervention(s) Page 199

4 This review will consider studies where the intervention is dialysis (peritoneal or hemodialysis) for the participants with ESKD. There is no restriction on frequency of dialysis or length of time the participant receives dialysis. The comparator will be patients who are not undergoing dialysis. Types of outcomes Primary outcomes This review will consider studies that include any of the following outcome measures: Quality of life (e.g. KDQOL 12, SF36 13, HRQOL 14 ), Co-morbidities (eg. Charlson Comorbidity index 15 ) Survival, Functional capacity (eg. Karnofsky Performance score 16 ), Symptoms and severity of ESKD and Hospital admissions. Types of studies This review will consider both experimental and epidemiological study designs including randomized controlled trials, non-randomized controlled trials, quasi-experimental, before and after studies, prospective and retrospective cohort studies, case control studies and analytical cross sectional studies. This review will also consider descriptive epidemiological study designs including case series, individual case reports and descriptive cross sectional studies for inclusion. Search strategy The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in this review. Electronic searches An initial limited search of MEDLINE and CINAHL will be undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference list of all identified reports and articles will be searched for additional studies. There will be no restriction by date range and only studies published in English will be considered. The databases to be searched will include: MEDLINE CINAHL PsycARTICLES Page 200

5 EMBASE EBM Reviews Scopus ProQuest Web of Science Science Direct Searching other resources The grey literature search will consist of searching reference lists or bibliographies of included articles, contacting authors who may be knowledgeable about the phenomena of interest so that further published, un-published or ongoing studies may be identified, and conducting an online search of databases and websites including: MedNar Australian Centre for Evidence Based Clinical Practice ( National Institutes of Health (NIH) Clinical Trials Database host, ( Initial keywords or terms Dialysis/ renal replacement therapy/kidney replacement therapy/rrt/krt Non Dialysis management/conservative care/supportive care/ palliative care Elderly/65 years and over/aged/old All studies identified during the database search will be assessed for relevance to the review based on the information provided in the title and the abstract. A full copy of the article will be retrieved for all studies that meet the inclusion criteria. Studies identified by study title from reference list searches will be assessed for relevance based on their abstract and if suitable the full article will be retrieved. Assessment of methodological quality Two reviewers and an associate reviewer will assess the papers selected for retrieval independently. The reviewers will assess for methodological quality prior to inclusion in the review. In the assessment process a standardized appraisal instrument, the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I) will be used. Page 201

6 Data collection Quantitative data will be extracted from the included papers by using the standardized data extraction tool from JBI-MAStARI (Appendix II). Details regarding the type of participants, the comparison between dialysis and non-dialysis management, the number of participants and the outcomes (e.g. Quality of life, comorbidities, survival, hospital admissions, functional capacity and symptoms) will be extracted. Data synthesis With quantitative data results the overall effect of similar single studies can be combined to calculate a summary of effect of the intervention, which may have statistical significance. Where possible, data will be pooled in statistical meta-analysis using JBI-MAStARI. This will provide a statistical summary of the effectiveness of dialysis compared with non-dialysis. Effect sizes may be expressed as odds ratio (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard Chi-square and also explored using subgroup analyses based on the different study designs included in this review. Where statistical pooling is not possible the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate. Conflicts of interest There are no Conflicts of Interest Acknowledgements This systematic review is being undertaken as part of a Doctorate program undertaken at Queensland University of Technology. Page 202

7 References 1. National Kidney Foundation. K/DOQI Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification and Stratification. KDOQI CKD Guidelines National Institute of Diabetes and Digestive and Kidney Disease. Kidney and Urologic Diseases Statistics for the United States. National Kidney and Urologic Diseases Information Clearinghouse National Health Service. Kidney Disease: Key facts and figures Australian Institute of Health and Welfare. An overview of chronic kidney disease in Australia. 2009; (ISBN ). 5. Grace B, Excell L, Dent H, McDonald S. New patients commencing treatment in ANZZDATA Registry 2010 Report. 2010; Chapter 2 (2-1 to 2-12). 6. Daugiradas J, Blake P, Ing T. Handbook of Dialysis Australian Institute of Health and Welfare. End stage kidney disease in Australia total incidence, AIHW media release. Projections of the incidence of treated end-stage kidney disease in Australia, Gilg J, Castledine C, D Fogarty. UK Renal Registry 14th Annual Report: Chapter 1 UK RRT Incidence in 2010: national and centre-specific analyses. UK Renal Registry McDonald S, Excell L, Livingston B. Chapter 3 Death. ANZZDATA Registry 2010 Report (3-1 to 3-10). 11. Steenkamp R, Castledine C, T Feest. UK Renal Registry 14th Annual Report: Chapter 6 Survival and Causes of Death of UK Adult Patients on Renal Replacement Therapy in 2010: national and centre-specific analyses. UK Renal Registry Hays RD, Kallich JD, Mapes DL, Coons SJ, Carter WB. Development of the Kidney Disease Quality of Life (KDQOLTM) Instrument. Quality of Life Research.1994; 3(5): Hawthorne G, Osborne RH, Taylor A, Sansoni J. The SF36 Version 2: critical analyses of population weights, scoring algorithms and population norms. Quality of Life Research. 2007; 16( 4): Guyatt GH, Feeny DH, Patrick DL. Measuring Health-related Quality of Life. Annals of Internal Medicine.1993; 118(8): Charlson M, Pompei P, Ales K, MacKenzie C. Prognostic Comorbidity in Longitudinal Studies. Journal of Chronic Disease.1987; 40(5): Karnofsky DA, Abelmann WH, Craver LF, Burchenal JH. The use of the nitrogen mustards in the palliative treatment of carcinoma, with particular reference to bronchogenic carcinoma. Cancer. 1948; 1(4): Page 203

8 Appendix I: Appraisal instruments MAStARI Appraisal instrument Page 204

9 Page 205

10 Page 206

11 Appendix II: Data extraction instruments MAStARI data extraction instrument Page 207

12 Page 208

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