Maria Da Silva-Gane

Survival of elderly patients with stage 5 CKD: comparison of conservative management and renal replacement therapy

Background. Elderly patients with end-stage renal disease and severe extra-renal comorbidity have a poor prognosis on renal replacement therapy (RRT) and may opt to be managed conservatively (CM). Information on the survival of patients on this mode of therapy is limited. Methods. We studied survival in a large cohort of CM patients in comparison to patients who received RRT. Results. Over an 18-year period, we studied 844 patients, 689 (82%) of whom had been treated by RRT and 155 (18%) were CM. CM patients were older and a greater proportion had high comorbidity. Median survival from entry into stage 5 chronic kidney disease was less in CM than in RRT (21.2 vs 67.1 months: P < 0.001). However, in patients aged > 75 years when corrected for age, high comorbidity and diabetes, the survival advantage from RRT was ~ 4 months, which was not statistically significant. Increasing age, the presence of high comorbidity and the presence of diabetes were independent determinants of poorer survival in RRT patients. In CM patients, however, age > 75 years and female gender independently predicted better survival. Conclusions. In patients aged > 75 years with high extra-renal comorbidity, the survival advantage conferred by RRT over CM is likely to be small. Age > 75 years and female gender predicted better survival in CM patients. The reasons for this are unclear.

Choosing not to dialyse: evaluation of planned non-dialytic management in a cohort of patients with end-stage renal failure.

Objectives: To study factors influencing the recommendation for palliative (non-dialytic) treatment in patients approaching end-stage renal failure and to study the subsequent outcome in patients choosing not to dialyse. Design: Cohort study of patients approaching end-stage renal failure who underwent multidisciplinary assessment and counselling about treatment options. Recruitment was over 54 months, and follow-up ranged from 3 to 57 months. Groups were defined on the basis of the therapy option recommended (palliative or renal replacement therapy). Setting: Renal unit in a district general hospital serving a population of about 1.15 million people. Subjects: 321 patients, mean age ± SD 61.5 ± 15.4 years (range: 16–92), 57% male, 30% diabetic. Main Outcome Measures: Survival, place of death (hospital or community). Results: Renal replacement therapy was recommended in 258 patients and palliative therapy in 63 (19.6%). By logistic regression analysis, patients recommended for palliative therapy were more functionally impaired (modified Karnofsky scale), older and more likely to have diabetes. The comorbidity severity score was not an independent predictor. Thirty-four patients eventually died during palliative treatment, 26 of whom died of renal failure. Ten patients recommended for palliative treatment opted for and were treated by dialysis. Median survival after dialysis initiation in these patients (8.3 months) was not significantly longer than survival beyond the putative date of dialysis initiation in palliatively treated patients (6.3 months). 65% of deaths occurring in dialysed patients took place in hospital compared with 27% in palliatively treated patients (p = 0.001). Conclusions: In high-risk, highly dependent patients with renal failure, the decision to dialyse or not has little impact on survival. Dialysis in such patients risks unnecessary medicalisation of death.

Broadening Options for Long-term Dialysis in the Elderly (BOLDE): differences in quality of life on peritoneal dialysis compared to haemodialysis for older patients

Background. Health-related quality of life (QOL) is an important outcome for older people who are often on dialysis for life. Little is, however, known about differences in QOL on haemodialysis (HD) and peritoneal dialysis (PD) in older age groups. Randomising patients to either modality to assess outcomes is not feasible. Methods. In this cross-sectional, multi-centred study we conducted QOL assessments (Short Form-12 Mental and Physical Component Summary scales, Hospital Anxiety and Depression Scale and Illness Intrusiveness Ratings Scale) in 140 people (aged 65 years or older) on PD and HD. Results. The groups were similar in age, gender, time on dialysis, ethnicity, Index of Deprivation (based on postcode), dialysis adequacy, cognitive function (Mini-Mental State Exam and Trail-Making Test B), nutritional status (Subjective Global Assessment) and social networks. There was a higher comorbidity score in the HD group. Regression analyses were undertaken to ascertain which variables significantly influence each QOL assessment. All were influenced by symptom count highlighting that the patient’s perception of their symptoms is a critical determinant of their mental and physical well being. Modality was found to be an independent predictor of illness intrusion with greater intrusion felt in those on HD. Conclusions. Overall, in two closely matched demographic groups of older dialysis patients, QOL was similar, if not better, in those on PD. This study strongly supports offering PD to all suitable older people.

Depression on Dialysis

Depression is the most common psychopathological condition among patients with end-stage renal disease (ESRD), yet it is still under-recognized and misdiagnosed. Depression reduces quality of life and has a negative clinical impact upon sufferers with chronic illness, including ESRD. This article discusses the negative effects of depression among the ESRD population treated with dialysis, the prevalence of the condition, the methodological issues involved with screening and treatment, and the possible psychological and somatic causes. There is a need to identify the prevalence of the disorder by effective methods, overcome the current issues surrounding depression assessment and to undertake trials of suitable treatments.

Quality of Life and Survival in Patients with Advanced Kidney Failure Managed Conservatively or by Dialysis

BACKGROUND AND OBJECTIVES Benefits of dialysis in elderly dependent patients are not clearcut. Some patients forego dialysis, opting for conservative kidney management (CKM). This study prospectively compared quality of life and survival in CKM patients and those opting for dialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS Quality-of-life assessments (Short-Form 36, Hospital Anxiety and Depression Scale, and Satisfaction with Life Scale) were performed every 3 months for up to 3 years in patients with advanced, progressive CKD (late stage 4 and stage 5). RESULTS After 3 years, 80 and 44 of 170 patients had started or were planned for hemodialysis (HD) or peritoneal dialysis, respectively; 30 were undergoing CKM; and 16 remained undecided. Mean baseline estimated GFR ± SD was similar (14.0 ± 4.0 ml/min per 1.73 m(2)) in all groups but was slightly higher in undecided patients. CKM patients were older, more dependent, and more highly comorbid; had poorer physical health; and had higher anxiety levels than the dialysis patients. Mental health, depression, and life satisfaction scores were similar. Multilevel growth models demonstrated no serial change in quality-of-life measures except life satisfaction, which decreased significantly after dialysis initiation and remained stable in CKM. In Cox models controlling for comorbidity, Karnofsky performance scale score, age, physical health score, and propensity score, median survival from recruitment was 1317 days in HD patients (mean of 326 dialysis sessions) and 913 days in CKM patients. CONCLUSIONS Patients choosing CKM maintained quality of life. Adjusted median survival from recruitment was 13 months shorter for CKM patients than HD patients.

Sertraline Versus Placebo in Patients with Major Depressive Disorder Undergoing Hemodialysis: A Randomized, Controlled Feasibility Trial

BACKGROUND AND OBJECTIVES Depression is common in patients on hemodialysis, but data on the benefits and risks of antidepressants in this setting are limited. We conducted a multicenter, randomized, double-blind, placebo-controlled trial of sertraline over 6 months in patients on hemodialysis with depression to determine study feasibility, safety, and effectiveness. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS Patients on hemodialysis at five United Kingdom renal centers completed the Beck Depression Inventory II. Those scoring ≥16 and not already on treatment for depression were invited to undergo diagnostic interview to confirm major depressive disorder. Eligible patients with major depressive disorder were randomized to receive the study medication-either sertraline or placebo. Outcomes included recruitment and dropout rates, change in the Montgomery-Asberg Depression Rating Scale and Beck Depression Inventory II, and qualitative information to guide design of a large-scale trial. RESULTS In total, 709 patients were screened and enrolled between April of 2013 and October of 2014; 231 (32.6%) had Beck Depression Inventory II scores ≥16, and 68 (29%) of these were already receiving treatment for depression. Sixty-three underwent diagnostic interview, 37 were diagnosed with major depressive disorder, and 30 were randomized; 21 completed the trial: eight of 15 on sertraline and 13 of 15 on placebo (P=0.05). Dropouts due to adverse and serious adverse events were greater in the sertraline group. All occurred in the first 3 months. Over 6 months, depression scores improved in both groups. Beck Depression Inventory II score fell from 29.1±8.4 to 17.3±12.4 (P<0.001), and Montgomery-Asberg Depression Rating Scale score fell from 24.5±4.1 to 10.3±5.8 (P<0.001). There were no differences between sertraline and placebo groups. CONCLUSIONS Although small, this is the largest randomized trial to date of antidepressant medication in patients on hemodialysis. Our results highlight recruitment issues. No benefit was observed, but trial size and the substantial dropout render consideration of benefit inconclusive. A definitive trial could use shorter follow-up and include depressed patients already taking antidepressants.

EXPLORING THE VIEWS OF PATIENTS NOT ON THE TRANSPLANT WAITING LIST: A QUALITATIVE STUDY

BACKGROUND Not all patients are suitable for kidney transplantation; however, little is known about the views and attitudes of patients who are not on the waiting list for transplantation. OBJECTIVE This study aimed to determine the views and attitudes of patients who are not on the waiting list regarding the process of transplant allocation. METHODS A grounded theory approach was used to develop theories from patient views, opinions and attitudes. Patients receiving dialysis, and not on the waiting list at a United Kingdom renal unit were identified by the renal counsellor and invited to take part. Five patients formed a focus group to enable construction of an interview schedule. Patients (n=10, different from those in the focus group) were interviewed until themes became saturated. Interview transcripts generated conceptual categories. RESULTS Seven conceptual categories emerged regarding access to transplantation. Patients experience emotions of loss relating to transplantation exacerbated by restrictions imposed by dialysis. Patients find coping mechanisms, accept their situation and trust that clinical decisions were equitable. CONCLUSIONS Patients trust their carers and support an efficacy argument when considering scarce resources. Communication should be improved to ensure clarity and understanding of clinical decisions.

Rate of Decline of Kidney Function, Modality Choice, and Survival in Elderly Patients with Advanced Kidney Disease

Aim: In elderly, dependent patients with advanced chronic kidney disease, dialysis may confer only a small survival advantage over conservative kidney management (CKM). We investigated the role of rate of decline of kidney function on treatment choices and survival. Methods: We identified a retrospective (1995-2010) cohort of patients aged over 75 years, with progressive kidney impairment and an estimated glomerular filtration rate (eGFR) between 10 and 15 ml/min/1.73 m2. All subsequently chose to be treated by either dialysis or CKM. Patients were followed for a minimum of 3 years. Results: Of 250 patients identified, 92 (37%) opted for dialysis and 158 (63%) for CKM. Mean age was 80.9 ± 4.0 years. eGFR was 13.3 ± 1.4 initially and 8.7 ± 3.0 ml/min/1.73 m2 at follow-up. Both were similar in those on dialysis and CKM pathways. Rate of decline of eGFR was more rapid in those choosing dialysis (0.45 (interquartile range, IQR 0.64) vs. 0.21 (IQR 0.28) ml/min/1.73 m2/month, p < 0.001), and independently predicted choice of CKM. In patients with high comorbidity, choice of dialysis was associated with a non-significant adjusted survival advantage of 5 months. Inclusion in models of time dependent eGFR during follow-up (eGFRtd) - a reflection of the rate of decline of kidney function - showed it to be independently associated with mortality risk in those on the CKM (p < 0.001) but not on the dialysis pathway. CKM pathway patients at the 25th centile of eGFRtd had an adjusted survival of 7 months compared to 63 months for those at the 75th centile. Conclusions: Rate of decline of kidney function is a determinant of CKM choice in elderly patients and is associated with mortality risk in patients of the CKM pathway. These findings should inform counselling.

Cognitive-behavioural therapy (CBT) for renal fatigue (BReF) : a feasibility randomised-controlled trial of CBT for the management of fatigue in haemodialysis (HD) patients

Introduction Fatigue is one of the most common and disabling symptoms in end-stage kidney disease, particularly among in-centre haemodialysis patients. This two-arm parallel group feasibility randomised controlled trial will determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of a cognitive-behavioural therapy (CBT)-based intervention for fatigue among in-centre haemodialysis patients. Methods We aim to recruit 40 adult patients undergoing in-centre haemodialysis at secondary care outpatient dialysis units, who meet clinical levels of fatigue. Patients will be randomised individually (using a 1:1 ratio) to either a 4–6 weeks’ CBT-based intervention (intervention arm) or to a waiting-list control (control arm). The primary feasibility outcomes include descriptive data on numbers within each recruiting centre meeting eligibility criteria, rates of recruitment, numbers retained postrandomisation and treatment adherence. To assess the potential benefits of the cognitive-behavioural therapy for renal fatigue intervention, secondary self-report outcomes include measures of fatigue severity (Chalder Fatigue Questionnaire), fatigue-related functional impairment (Work and Social Adjustment Scale), sleep quality (Pittsburgh Sleep Quality Index), depression (Patient Health Questionnaire-9) and anxiety (Generalised Anxiety Disorder-7). Changes in fatigue perceptions (Brief Illness Perception Questionnaire), cognitive and behavioural responses to fatigue (Cognitive and Behavioural Responses to Symptoms Questionnaire), sleep hygiene behaviours (Sleep Hygiene Index) and physical activity (International Physical Activity Questionnaire–short form) will also be explored. These self-report measures will be collected at baseline and 3 months postrandomisation. Nested qualitative interviews will be conducted postintervention to explore the acceptability of the intervention and identify any areas in need of improvement. The statistician and assessor will be blinded to treatment allocation. Ethics and dissemination A National Health Service (NHS) Research Ethics Committee approved the study. Any amendments to the protocol will be submitted to the NHS Committee and study sponsor. Trial registration number ISRCTN91238019;Pre-results.