Patient and caregiver values, beliefs and experiences when considering home dialysis as a treatment option: a semi-structured interview study

Background Home dialysis can offer improved quality of life and economic benefits compared with facility dialysis. Yet the uptake of home dialysis remains low around the world, which may be partly due to patients' lack of knowledge and barriers to shared and informed decision-making. We aimed to describe patient and caregiver values, beliefs and experiences when considering home dialysis, to inform strategies to align policy and practice with patients' needs. Methods Semi-structured interviews with adult patients with chronic kidney disease Stage 4–5D (on dialysis <1 year) and their caregivers, recruited from three nephrology centres in New Zealand. Transcripts were analysed thematically. Results In total, 43 patients [pre-dialysis (n = 18), peritoneal dialysis (n = 13), home haemodialysis (n = 4) and facility haemodialysis (n = 9)] and 9 caregivers participated. We identified five themes related to home dialysis: lacking decisional power (complexity of information, limited exposure to home dialysis, feeling disempowered, deprived of choice, pressure to choose), sustaining relationships (maintaining cultural involvement, family influence, trusting clinicians, minimizing social isolation), reducing lifestyle disruption (sustaining employment, avoiding relocation, considering additional expenses, seeking flexible schedules, creating free time), gaining confidence in choice (guarantee of safety, depending on professional certainty, reassurance from peers, overcoming fears) and maximizing survival. Conclusions To engage and empower patients and caregivers to consider home dialysis, a stronger emphasis on the development of patient-focused educational programmes and resources is suggested. Pre-dialysis and home dialysis programmes that address health literacy and focus on cultural and social values may reduce fears and build confidence around decisions to undertake home dialysis. Financial burdens may be minimized through provision of reimbursement programmes, employment support and additional assistance for patients, particularly those residing in remote areas

Dietary patterns for adults with chronic kidney disease

This is the protocol for a review and there is no abstract. The objectives are as follows: This review will evaluate the benefits and harms of dietary patterns among adults with CKD (any stage including people with end-stage kidney disease (ESKD) treated with dialysis, transplantation or supportive care)

Polyclonal and monoclonal antibodies for induction therapy in kidney transplant recipients

Background Prolonging kidney transplant survival is an important clinical priority. Induction immunosuppression with antibody therapy is recommended at transplantation and non‐depleting interleukin‐2 receptor monoclonal antibodies (IL2Ra) are considered first line. It is suggested that recipients at high risk of rejection should receive lymphocyte‐depleting antibodies but the relative benefits and harms of the available agents are uncertain. Objectives We aimed to: evaluate the relative and absolute effects of different antibody preparations (except IL2Ra) when used as induction therapy in kidney transplant recipients; determine how the benefits and adverse events vary for each antibody preparation; determine how the benefits and harms vary for different formulations of antibody preparation; and determine whether the benefits and harms vary in specific subgroups of recipients (e.g. children and sensitised recipients). Search methods We searched the Cochrane Kidney and Transplant's Specialised Register to 29 August 2016 through contact with the Information Specialist using search terms relevant to this review. Selection criteria Randomised controlled trials (RCTs) comparing monoclonal or polyclonal antibodies with placebo, no treatment, or other antibody therapy in adults and children who had received a kidney transplant. Data collection and analysis Two authors independently extracted data and assessed risk of bias. Dichotomous outcomes are reported as relative risk (RR) and continuous outcomes as mean difference (MD) together with their 95% confidence intervals (CI). Main results We included 99 studies (269 records; 8956 participants; 33 with contemporary agents). Methodology was incompletely reported in most studies leading to lower confidence in the treatment estimates. Antithymocyte globulin (ATG) prevented acute graft rejection (17 studies: RR 0.63, 95% CI 0.51 to 0.78). The benefits of ATG on graft rejection were similar when used with (12 studies: RR 0.61, 0.49 to 0.76) or without (5 studies: RR 0.65, 0.43 to 0.98) calcineurin inhibitor (CNI) treatment. ATG (with CNI therapy) had uncertain effects on death (3 to 6 months, 3 studies: RR 0.41, 0.13 to 1.22; 1 to 2 years, 5 studies: RR 0.75, 0.27 to 2.06; 5 years, 2 studies: RR 0.94, 0.11 to 7.81) and graft loss (3 to 6 months, 4 studies: RR 0.60, 0.34 to 1.05; 1 to 2 years, 3 studies: RR 0.65, 0.36 to 1.19). The effect of ATG on death‐censored graft loss was uncertain at 1 to 2 years and 5 years. In non‐CNI studies, ATG had uncertain effects on death but reduced death‐censored graft loss (6 studies: RR 0.55, 0.38 to 0.78). When CNI and older non‐CNI studies were combined, a benefit was seen with ATG at 1 to 2 years for both all‐cause graft loss (7 studies: RR 0.71, 0.53 to 0.95) and death‐censored graft loss (8 studies: RR 0.55, 0.39 to 0.77) but not sustained longer term. ATG increased cytomegalovirus (CMV) infection (6 studies: RR 1.55, 1.24 to 1.95), leucopenia (4 studies: RR 3.86, 2.79 to 5.34) and thrombocytopenia (4 studies: RR 2.41, 1.61 to 3.61) but had uncertain effects on delayed graft function, malignancy, post‐transplant lymphoproliferative disorder (PTLD), and new onset diabetes after transplantation (NODAT). Alemtuzumab was compared to ATG in six studies (446 patients) with early steroid withdrawal (ESW) or steroid minimisation. Alemtuzumab plus steroid minimisation reduced acute rejection compared to ATG at one year (4 studies: RR 0.57, 0.35 to 0.93). In the two studies with ESW only in the alemtuzumab arm, the effect of alemtuzumab on acute rejection at 1 year was uncertain compared to ATG (RR 1.27, 0.50 to 3.19). Alemtuzumab had uncertain effects on death (1 year, 2 studies: RR 0.39, 0.06 to 2.42; 2 to 3 years, 3 studies: RR 0.67, 95% CI 0.15 to 2.95), graft loss (1 year, 2 studies: RR 0.39, 0.13 to 1.30; 2 to 3 years, 3 studies: RR 0.98, 95% CI 0.47 to 2.06), and death‐censored graft loss (1 year, 2 studies: RR 0.38, 0.08 to 1.81; 2 to 3 years, 3 studies: RR 2.45, 95% CI 0.67 to 8.97) compared to ATG. Creatinine clearance was lower with alemtuzumab plus ESW at 6 months (2 studies: MD ‐13.35 mL/min, ‐23.91 to ‐2.80) and 2 years (2 studies: MD ‐12.86 mL/min, ‐23.73 to ‐2.00) compared to ATG plus triple maintenance. Across all 6 studies, the effect of alemtuzumab versus ATG was uncertain on all‐cause infection, CMV infection, BK virus infection, malignancy, and PTLD. The effect of alemtuzumab with steroid minimisation on NODAT was uncertain, compared to ATG with steroid maintenance. Alemtuzumab plus ESW compared with triple maintenance without induction therapy had uncertain effects on death and all‐cause graft loss at 1 year, acute rejection at 6 months and 1 year. CMV infection was increased (2 studies: RR 2.28, 1.18 to 4.40). Treatment effects were uncertain for NODAT, thrombocytopenia, and malignancy or PTLD. Rituximab had uncertain effects on death, graft loss, acute rejection and all other adverse outcomes compared to placebo. Authors' conclusions ATG reduces acute rejection but has uncertain effects on death, graft survival, malignancy and NODAT, and increases CMV infection, thrombocytopenia and leucopenia. Given a 45% acute rejection risk without ATG induction, seven patients would need treatment to prevent one having rejection, while incurring an additional patient experiencing CMV disease for every 12 treated. Excluding non‐CNI studies, the risk of rejection was 37% without induction with six patients needing treatment to prevent one having rejection. In the context of steroid minimisation, alemtuzumab prevents acute rejection at 1 year compared to ATG. Eleven patients would require treatment with alemtuzumab to prevent 1 having rejection, assuming a 21% rejection risk with ATG. Triple maintenance without induction therapy compared to alemtuzumab combined with ESW had similar rates of acute rejection but adverse effects including NODAT were poorly documented. Alemtuzumab plus steroid withdrawal would cause one additional patient experiencing CMV disease for every six patients treated compared to no induction and triple maintenance, in the absence of any clinical benefit. Overall, ATG and alemtuzumab decrease acute rejection at a cost of increased CMV disease while patient‐centred outcomes (reduced death or lower toxicity) do not appear to be improved

Dietary interventions for adults with chronic kidney disease

Background: Dietary changes are routinely recommended in people with chronic kidney disease (CKD) on the basis of randomised evidence in the general population and non-randomised studies in CKD that suggest certain healthy eating patterns may prevent cardiovascular events and lower mortality. People who have kidney disease have prioritised dietary modifications as an important treatment uncertainty. Objectives: This review evaluated the benefits and harms of dietary interventions among adults with CKD including people with end-stage kidney disease (ESKD) treated with dialysis or kidney transplantation. Search methods: We searched the Cochrane Kidney and Transplant Specialised Register (up to 31 January 2017) through contact with the Information Specialist using search terms relevant to this review. Studies contained in the Specialised Register are identified through search strategies specifically designed for CENTRAL, MEDLINE, and EMBASE; handsearching conference proceedings; and searching the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. Selection criteria: Randomised controlled trials (RCTs) or quasi-randomised RCTs of dietary interventions versus other dietary interventions, lifestyle advice, or standard care assessing mortality, cardiovascular events, health-related quality of life, and biochemical, anthropomorphic, and nutritional outcomes among people with CKD. Data collection and analysis: Two authors independently screened studies for inclusion and extracted data. Results were summarised as risk ratios (RR) for dichotomous outcomes or mean differences (MD) or standardised MD (SMD) for continuous outcomes, with 95% confidence intervals (CI) or in descriptive format when meta-analysis was not possible. Confidence in the evidence was assessed using GRADE. Main results: We included 17 studies involving 1639 people with CKD. Three studies enrolled 341 people treated with dialysis, four studies enrolled 168 kidney transplant recipients, and 10 studies enrolled 1130 people with CKD stages 1 to 5. Eleven studies (900 people) evaluated dietary counselling with or without lifestyle advice and six evaluated dietary patterns (739 people), including one study (191 people) of a carbohydrate-restricted low-iron, polyphenol enriched diet, two studies (181 people) of increased fruit and vegetable intake, two studies (355 people) of a Mediterranean diet and one study (12 people) of a high protein/low carbohydrate diet. Risks of bias in the included studies were generally high or unclear, lowering confidence in the results. Participants were followed up for a median of 12 months (range 1 to 46.8 months). Studies were not designed to examine all-cause mortality or cardiovascular events. In very-low quality evidence, dietary interventions had uncertain effects on all-cause mortality or ESKD. In absolute terms, dietary interventions may prevent one person in every 3000 treated for one year avoiding ESKD, although the certainty in this effect was very low. Across all 17 studies, outcome data for cardiovascular events were sparse. Dietary interventions in low quality evidence were associated with a higher health-related quality of life (2 studies, 119 people: MD in SF-36 score 11.46, 95% CI 7.73 to 15.18; I = 0%). Adverse events were generally not reported. Dietary interventions lowered systolic blood pressure (3 studies, 167 people: MD -9.26 mm Hg, 95% CI -13.48 to -5.04; I = 80%) and diastolic blood pressure (2 studies, 95 people: MD -8.95, 95% CI -10.69 to -7.21; I = 0%) compared to a control diet. Dietary interventions were associated with a higher estimated glomerular filtration rate (eGFR) (5 studies, 219 people: SMD 1.08; 95% CI 0.26 to 1.97; I = 88%) and serum albumin levels (6 studies, 541 people: MD 0.16 g/dL, 95% CI 0.07 to 0.24; I = 26%). A Mediterranean diet lowered serum LDL cholesterol levels (1 study, 40 people: MD -1.00 mmol/L, 95% CI -1.56 to -0.44). Authors' conclusions: Dietary interventions have uncertain effects on mortality, cardiovascular events and ESKD among people with CKD as these outcomes were rarely measured or reported. Dietary interventions may increase health-related quality of life, eGFR, and serum albumin, and lower blood pressure and serum cholesterol levels. Based on stakeholder prioritisation of dietary research in the setting of CKD and preliminary evidence of beneficial effects on risks factors for clinical outcomes, large-scale pragmatic RCTs to test the effects of dietary interventions on patient outcomes are required

the validity of drug effects on proteinuria albuminuria serum creatinine and estimated gfr as surrogate end points for eskd a systematic review

Rationale & Objective Proteinuria, albuminuria, and serum creatinine level are widely used as surrogate end point measures of end-stage kidney disease (ESKD). We evaluated the correlation between antihypertensive drug effects on surrogate renal end points and ESKD. Study Design Systematic review. Setting & Participants Randomized controlled trials of blood pressure–lowering therapy. Selection Criteria for Studies Trials of pharmacological blood pressure–lowering strategies reporting drug effects on albuminuria, proteinuria, or serum creatinine level and ESKD through March 26, 2018. Analytical Approach Bayesian bivariate meta-analysis to calculate correlations between drug effects on surrogate end points and drug effects on ESKD. Risks of bias were adjudicated using the Cochrane tool. Results 22 randomized controlled trials involving 69,642 participants were eligible. Risks of bias in the included trials were frequently unclear due to incomplete reporting. Relative risk for ESKD was statistically significant in 1 of 29 (3.4%) treatment comparisons. There appeared to be little or no correlation between antihypertensive drug effects on serum creatinine level, albuminuria, proteinuria, and the corresponding effects on ESKD. All correlations had wide 95% credible intervals that included the null effect. Limitations Low power due to infrequent outcomes of ESKD and incomplete data reporting in primary trials. Conclusions The association between antihypertensive drug effects on doubling of serum creatinine level and albuminuria or proteinuria with ESKD in treatment trials is not sufficiently certain to enable the confident use of these markers to guide clinical or regulatory decision making

Economic considerations of patients and caregivers in choosing a dialysis modality

Introduction Broader adoption of home dialysis could lead to considerable cost savings for health services. Globally, however, uptake remains low. The aim of this study was to describe patient and caregiver perspectives of the economic considerations that influence dialysis modality choice, and elicit policy-relevant recommendations. Methods Semistructured interviews with predialysis or dialysis patients and their caregivers, at three hospitals in New Zealand. Interview transcripts were analyzed thematically. Findings 43 patients and 9 caregivers (total n = 52) participated. The three themes related to economic considerations were: (i) productivity losses associated with changes in employment; (ii) the need for personal subsidization of home dialysis expenses; and (iii) the role of socio-economic disadvantage as a barrier to home dialysis. Patients weighed the flexibility of home dialysis which allowed them to remain employed, against time required for training and out-of-pocket costs. Patients saw the lack of reimbursement of home dialysis costs as unjust and suggested that reimbursement would incentivize home dialysis uptake. Social disadvantage was a barrier to home dialysis as patients’ housing was often unsuitable; they could not afford the additional treatment costs. Home hemodialysis was considered to have the highest out-of-pocket costs and was sometimes avoided for this reason. Discussion Our data suggests that economic considerations underpin the choices patients make about dialysis treatments, however these are rarely reported. To promote home dialysis, strategies to improve employment retention and housing, and to minimize out-of-pocket costs, need to be addressed directly by healthcare providers and payers

Economic considerations of patients and caregivers in choosing a dialysis modality

Introduction Broader adoption of home dialysis could lead to considerable cost savings for health services. Globally, however, uptake remains low. The aim of this study was to describe patient and caregiver perspectives of the economic considerations that influence dialysis modality choice, and elicit policy-relevant recommendations. Methods Semistructured interviews with predialysis or dialysis patients and their caregivers, at three hospitals in New Zealand. Interview transcripts were analyzed thematically. Findings 43 patients and 9 caregivers (total n = 52) participated. The three themes related to economic considerations were: (i) productivity losses associated with changes in employment; (ii) the need for personal subsidization of home dialysis expenses; and (iii) the role of socio-economic disadvantage as a barrier to home dialysis. Patients weighed the flexibility of home dialysis which allowed them to remain employed, against time required for training and out-of-pocket costs. Patients saw the lack of reimbursement of home dialysis costs as unjust and suggested that reimbursement would incentivize home dialysis uptake. Social disadvantage was a barrier to home dialysis as patients’ housing was often unsuitable; they could not afford the additional treatment costs. Home hemodialysis was considered to have the highest out-of-pocket costs and was sometimes avoided for this reason. Discussion Our data suggests that economic considerations underpin the choices patients make about dialysis treatments, however these are rarely reported. To promote home dialysis, strategies to improve employment retention and housing, and to minimize out-of-pocket costs, need to be addressed directly by healthcare providers and payers

Stakeholders’ Perspectives on the Quality of End-of-Life Health Care Services for Chronic Obstructive Airways Disease: A Focus Group Study

Introduction: Delivery of end-of-life care for severe chronic obstructive pulmonary disease (COPD) has been hampered by an unpredictable disease trajectory and poor integration of health care and social services. Objective: To critically explore the perspectives, values, and experiences of stakeholders in COPD end-of-life healthcare services in a large district in Aotearoa New Zealand. Design: Focus groups analysed utilising critical theory and Actor-Network Theory. Methods: Stakeholders in end-of-life COPD healthcare services were purposively sampled from a large healthcare network in Canterbury, Aotearoa New Zealand to participate in seven focus groups (bereaved carers, community-based health professionals, non-Māori, non-Pacific patients, and support people (two groups), Māori patients, supporters and health professionals, Pacific patients, support people and health professionals, and hospital-based health professionals). Participants discussed end-of-life care services for people with COPD. Transcripts were coded utilising descriptive and structural coding to develop themes related to provision of quality care. Participants were positioned as experts. We considered how the themes arising supported and disrupted the healthcare network for end-of-life COPD. Results: Five themes related to quality of care for end-of-life COPD were identified: compassion, competence, community, commitment, and collaboration. The absence of any of these five themes required for quality care led to power imbalances within healthcare systems. Power inequities created disconnection among stakeholders which then disrupted commitment, community, and collaboration. A dysfunctional healthcare network impeded compassion between stakeholders and did not support their competence, leading to lower quality care. All five themes were identified as essential to delivery of high-quality end-of-life care in COPD. Conclusion: Stakeholders’ perspectives of end-of-life care for COPD identified of core features of a health system network that enabled or impeded the actions of stakeholders and allocation of resources to provide quality care

Association of Drug Effects on Serum Parathyroid Hormone, Phosphorus, and Calcium Levels With Mortality in CKD: A Meta-analysis

Background Serum parathyroid hormone (PTH), phosphorus, and calcium levels are surrogate outcomes that are central to the evaluation of drug treatments in chronic kidney disease (CKD). This systematic review evaluates the evidence for the correlation between drug effects on biochemical (PTH, phosphorus, and calcium) and all-cause and cardiovascular mortality end points in adults with CKD. Study Design Systematic review and meta-analysis. Setting & Population Adults with CKD. Selection Criteria for Studies Randomized trials reporting drug effects on biochemical and mortality end points. Intervention Drug interventions with effects on serum PTH, phosphorus, and calcium levels, including vitamin D compounds, phosphate binders, cinacalcet, bisphosphonates, and calcitonin. Outcomes Correlation between drug effects on biochemical and all-cause and cardiovascular mortality. Results 28 studies (6,999 participants) reported both biochemical and mortality outcomes and were eligible for analysis. Associations between drug effects on surrogate biochemical end points and corresponding effects on mortality were weak and imprecise. All correlation coefficients were less than 0.70, and 95% credible intervals were generally wide and overlapped with zero, consistent with the possibility of no association. The exception was an inverse correlation between drug effects on serum PTH levels and all-cause mortality, which was nominally significant (−0.64; 95% credible interval, −0.85 to −0.15), but the strength of this association was very imprecise. Risk of bias within available trials was generally high, further reducing confidence in the summary correlations. Findings were robust to adjustment for age, baseline serum PTH level, allocation concealment, CKD stage, and drug class. Limitations Low power in analyses and combining evidence from many different drug comparisons with incomplete data across studies. Conclusions Drug effects on serum PTH, phosphorus, and calcium levels are weakly and imprecisely correlated with all-cause and cardiovascular death in the setting of CKD. Risks of mortality (patient-level outcome) cannot be inferred from treatment-induced changes in biochemical outcomes in people with CKD. Similarly, existing data do not exclude a mortality benefit with treatment. Trials need to address patient-centered outcomes to evaluate drug effectiveness in this setting

Antiplatelet agents for chronic kidney disease

To evaluate the benefits and harms of antiplatelet therapy in patients with any form of kidney disease, including patients with CKD not receiving renal replacement therapy (RRT), patients receiving any form of dialysis, and kidney transplant recipients