Publications by authors named "Suetonia C Palmer"

161 Publications

Acute Decompensated Heart Failure and the Kidney: Physiological, Histological and Transcriptomic Responses to Development and Recovery.

J Am Heart Assoc 2021 Sep 17;10(18):e021312. Epub 2021 Sep 17.

Department of Medicine University of OtagoChristchurch Christchurch New Zealand.

BACKGROUND Acute decompensated heart failure (ADHF) is associated with deterioration in renal function-an important risk factor for poor outcomes. Whether ADHF results in permanent kidney damage/dysfunction is unknown. METHODS AND RESULTS We investigated for the first time the renal responses to the development of, and recovery from, ADHF using an ovine model. ADHF development induced pronounced hemodynamic changes, neurohormonal activation, and decline in renal function, including decreased urine, sodium and urea excretion, and creatinine clearance. Following ADHF recovery (25 days), creatinine clearance reductions persisted. Kidney biopsies taken during ADHF and following recovery showed widespread mesangial cell prominence, early mild acute tubular injury, and medullary/interstitial fibrosis. Renal transcriptomes identified altered expression of 270 genes following ADHF development and 631 genes following recovery. A total of 47 genes remained altered post-recovery. Pathway analysis suggested gene expression changes, driven by a network of inflammatory cytokines centered on IL-1β (interleukin 1β), lead to repression of reno-protective eNOS (endothelial nitric oxide synthase) signaling during ADHF development, and following recovery, activation of glomerulosclerosis and reno-protective pathways and repression of proinflammatory/fibrotic pathways. A total of 31 dysregulated genes encoding proteins detectable in urine, serum, and plasma identified potential candidate markers for kidney repair (including [cyclic nucleotide gated channel subunit alpha 3] and [oncoprotein induced transcript 3]) or long-term renal impairment in ADHF (including [actin gamma 2, smooth muscle] and [angiopoietin like 4]). CONCLUSIONS In an ovine model, we provide the first direct evidence that an episode of ADHF leads to an immediate decline in kidney function that failed to fully resolve after ≈4 weeks and is associated with persistent functional/structural kidney injury. We identified molecular pathways underlying kidney injury and repair in ADHF and highlighted 31 novel candidate biomarkers for acute kidney injury in this setting.
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http://dx.doi.org/10.1161/JAHA.121.021312DOI Listing
September 2021

Incidence and Outcomes of COVID-19 in People With CKD: A Systematic Review and Meta-analysis.

Am J Kidney Dis 2021 Aug 5. Epub 2021 Aug 5.

Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy; Sydney School of Public Health, The University of Sydney, Sydney, Australia.

Rationale & Objective: Coronavirus disease 2019 (COVID-19) disproportionately affects people with chronic diseases such as chronic kidney disease (CKD). We assessed the incidence and outcomes of COVID-19 in people with CKD.

Study Design: Systematic review and meta-analysis by searching MEDLINE, EMBASE, and PubMed through February 2021.

Setting & Study Populations: People with CKD with or without COVID-19.

Selection Criteria For Studies: Cohort and case-control studies.

Data Extraction: Incidence of COVID-19, death, respiratory failure, dyspnea, recovery, intensive care admission, hospital admission, need for supplemental oxygen, hospital discharge, sepsis, short-term dialysis, acute kidney injury, and fatigue.

Analytical Approach: Random-effects meta-analysis and evidence certainty adjudicated using an adapted version of GRADE (Grading of Recommendations Assessment, Development and Evaluation).

Results: 348 studies (382,407 participants with COVID-19 and CKD; 1,139,979 total participants with CKD) were included. Based on low-certainty evidence, the incidence of COVID-19 was higher in people with CKD treated with dialysis (105 per 10,000 person-weeks; 95% CI, 91-120; 95% prediction interval [PrI], 25-235; 59 studies; 468,233 participants) than CKD not requiring kidney replacement therapy (16 per 10,000 person-weeks; 95% CI, 4-33; 95% PrI, 0-92; 5 studies; 70,683 participants) and kidney or pancreas-kidney transplant recipients (23 per 10,000 person-weeks; 95% CI, 18-30; 95% PrI, 2-67; 29 studies; 120,281 participants). Based on low-certainty evidence, the incidence of death in people with CKD and COVID-19 was 32 per 1000 person-weeks (95% CI, 30-35; 95% PrI, 4-81; 229 studies; 70,922 participants), which may be higher compared to people with CKD without COVID-19 (incidence rate ratio, 10.26; 95% CI, 6.78-15.53; 95% PrI, 2.62-40.15; 4 studies; 18,347 participants).

Limitations: Analyses were generally based on low-certainty evidence. Few studies reported outcomes in people with CKD without COVID-19 to calculate the excess risk attributable to COVID-19 and potential confounders were not adjusted for in most studies.

Conclusions: The incidence of COVID-19 may be higher in people receiving maintenance dialysis compared to those with CKD not requiring kidney replacement therapy or those who are kidney or pancreas-kidney transplant recipients. People with CKD and COVID-19 may have a higher incidence of death than people with CKD without COVID-19.
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http://dx.doi.org/10.1053/j.ajkd.2021.07.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8339603PMC
August 2021

Reported sources of health inequities in Indigenous Peoples with chronic kidney disease: a systematic review of quantitative studies.

BMC Public Health 2021 07 23;21(1):1447. Epub 2021 Jul 23.

Department of Medicine, University of Otago Christchurch, Christchurch, New Zealand.

Background: To summarise the evidentiary basis related to causes of inequities in chronic kidney disease among Indigenous Peoples.

Methods: We conducted a Kaupapa Māori meta-synthesis evaluating the epidemiology of chronic kidney diseases in Indigenous Peoples. Systematic searching of MEDLINE, Google Scholar, OVID Nursing, CENTRAL and Embase was conducted to 31 December 2019. Eligible studies were quantitative analyses (case series, case-control, cross-sectional or cohort study) including the following Indigenous Peoples: Māori, Aboriginal and Torres Strait Islander, Métis, First Nations Peoples of Canada, First Nations Peoples of the United States of America, Native Hawaiian and Indigenous Peoples of Taiwan. In the first cycle of coding, a descriptive synthesis of the study research aims, methods and outcomes was used to categorise findings inductively based on similarity in meaning using the David R Williams framework headings and subheadings. In the second cycle of analysis, the numbers of studies contributing to each category were summarised by frequency analysis. Completeness of reporting related to health research involving Indigenous Peoples was evaluated using the CONSIDER checklist.

Results: Four thousand three hundred seventy-two unique study reports were screened and 180 studies proved eligible. The key finding was that epidemiological investigators most frequently reported biological processes of chronic kidney disease, particularly type 2 diabetes and cardiovascular disease as the principal causes of inequities in the burden of chronic kidney disease for colonised Indigenous Peoples. Social and basic causes of unequal health including the influences of economic, political and legal structures on chronic kidney disease burden were infrequently reported or absent in existing literature.

Conclusions: In this systematic review with meta-synthesis, a Kaupapa Māori methodology and the David R Williams framework was used to evaluate reported causes of health differences in chronic kidney disease in Indigenous Peoples. Current epidemiological practice is focussed on biological processes and surface causes of inequity, with limited reporting of the basic and social causes of disparities such as racism, economic and political/legal structures and socioeconomic status as sources of inequities.
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http://dx.doi.org/10.1186/s12889-021-11180-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8299576PMC
July 2021

Implementing an indigenous model of practice.

Clin Teach 2021 Oct 15;18(5):502-504. Epub 2021 Jul 15.

Maori/Indigenous Health Institute, University of Otago Christchurch, Christchurch, New Zealand.

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http://dx.doi.org/10.1111/tct.13395DOI Listing
October 2021

Values, preferences and burden of treatment for the initiation of GLP-1 receptor agonists and SGLT-2 inhibitors in adult patients with type 2 diabetes: a systematic review.

BMJ Open 2021 07 9;11(7):e049130. Epub 2021 Jul 9.

Plataforma INVEST Medicina UANL-KER Unit Mayo Clinic (KER Unit Mexico), Universidad Autonoma de Nuevo Leon Facultad de Medicina, Monterrey, Nuevo León, Mexico

Objectives: Assess values, preferences and burden of treatment that patients with type 2 diabetes consider when initiating glucagon-like peptide-1 receptor agonists (GLP-1 RA) or sodium-glucose cotransporter-2 inhibitors (SGLT-2i) compared with other glucose-lowering options.

Methods: Paired reviewers independently included studies reporting quantitative or qualitative methods to assess values, preferences and burden of treatment reported by patients with type 2 diabetes regarding the initiation of GLP-1 RA or SGLT-2i over other alternatives. A systematic search in MEDLINE, Scopus, EMBASE, Web of Science and Cochrane Central Register of Controlled Trials from inception until May 2020 was performed by an experienced librarian. Risk of bias was assessed with a specifically designed tool for values and preferences studies.

Results: 17 studies (7296 patients) proved eligible. Studies fulfilling criteria for SGLT-2i were not identified. Five studies (2662 patients) evaluated preferences for GLP-1 RA compared with other glucose-lowering medications. 12 studies (4634 patients) evaluated preferences between, at least, two kinds of GLP-1 RA or their injection devices based on the following attributes: efficacy, dose, application frequency, device characteristics. Among studies comparing GLP-1 RA to other glucose-lowering medications, some preferences were observed for dypeptil peptidase-4 inhibitors compared with once daily liraglutide. Comparing different attributes of GLP-1 RA drugs and devices, cardiovascular risk reduction, glucose lowering potential, once weekly and simple administered regimens were the most preferred.

Conclusions: As no evidence for preferences on SGLT-2i was available, only preferences for GLP-1 RA were assessed; however, evidence is still limited for the latter. Studies comparing preferences for GLP1-RA to other glucose-lowering alternatives only included twice daily or once daily injection regimens of GLP-1 RA drugs. According to our findings, once weekly alternatives are widely preferred than the formers. The extent to which patients with type 2 diabetes value reduced adverse cardiovascular and kidney outcomes, weighed benefits against harms and burden of treatment is limited and with very low certainty.

Prospero Registration Number: CRD42020159284.
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http://dx.doi.org/10.1136/bmjopen-2021-049130DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8273479PMC
July 2021

Calcifediol supplementation in adults on hemodialysis: a randomized controlled trial.

J Nephrol 2021 Jun 26. Epub 2021 Jun 26.

Faculty of Medicine and Health, Sydney School of Public Health, University of Sydney, Sydney, Australia.

Background: Vitamin D deficiency is associated with increased risks of mortality in people with chronic kidney disease. The benefits and harm of vitamin D supplementation on cardiovascular outcomes and mortality are unknown. We aimed to assess the effectiveness of calcifediol in reducing mortality in patients with vitamin D insufficiency on hemodialysis compared to no additional therapy.

Methods: A phase III, multicenter, randomized, open-label trial was conducted including 284 adults with vitamin D insufficiency undergoing hemodialysis who were randomly assigned to receive oral calcifediol or standard care for 24 months.

Results: Two hundred eighty-four participants were enrolled (143 assigned to the calcifediol group and 141 to the no additional therapy group). The primary outcome (mortality) occurred in 34 and 31 participants in the calcifediol and control group, respectively [hazard ratio (HR) 1.03; 95% confidence interval (CI) 0.63-1.67]. Calcifediol had no detectable effects on cardiovascular death (HR 1.06; 95% CI 0.41-2.74), non-cardiovascular death (HR 1.13; 95% CI 0.62-2.04), nonfatal myocardial infarction (HR 0.20; 95% CI 0.02-1.67) or nonfatal stroke (HR could not be estimated). The incidence of hypercalcemia and hyperphosphatemia was similar between groups. None of the participants underwent parathyroidectomy.

Conclusions: In adults treated with hemodialysis and who had vitamin D insufficiency, calcifediol supplementation for 24 months had inconclusive effects on mortality and cardiovascular outcomes.

Trial Registration Number: NCT01457001.
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http://dx.doi.org/10.1007/s40620-021-01104-zDOI Listing
June 2021

SGLT-2 inhibitors or GLP-1 receptor agonists for adults with type 2 diabetes: a clinical practice guideline.

BMJ 2021 05 11;373:n1091. Epub 2021 May 11.

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada

Clinical Question: What are the benefits and harms of sodium-glucose cotransporter 2 (SGLT-2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists when added to usual care (lifestyle interventions and/or other diabetes drugs) in adults with type 2 diabetes at different risk for cardiovascular and kidney outcomes?

Current Practice: Clinical decisions about treatment of type 2 diabetes have been led by glycaemic control for decades. SGLT-2 inhibitors and GLP-1 receptor agonists are traditionally used in people with elevated glucose level after metformin treatment. This has changed through trials demonstrating atherosclerotic cardiovascular disease (CVD) and chronic kidney disease (CKD) benefits independent of medications' glucose-lowering potential.

Recommendations: The guideline panel issued risk-stratified recommendations concerning the use of SGLT-2 inhibitors or GLP-1 receptor agonists in adults with type 2 diabetes• Three or fewer cardiovascular risk factors without established CVD or CKD: Weak recommendation against starting SGLT-2 inhibitors or GLP-1 receptor agonists.• More than three cardiovascular risk factors without established CVD or CKD: Weak recommendation for starting SGLT-2 inhibitors and weak against starting GLP-1 receptor agonists.• Established CVD or CKD: Weak recommendation for starting SGLT-2 inhibitors and GLP-1 receptor agonists.• Established CVD and CKD: Strong recommendation for starting SGLT-2 inhibitors and weak recommendation for starting GLP-1 receptor agonists.• For those committed to further reducing their risk for CVD and CKD outcomes: Weak recommendation for starting SGLT-2 inhibitors rather than GLP-1 receptor agonists.

How This Guideline Was Created: An international panel including patients, clinicians, and methodologists created these recommendations following standards for trustworthy guidelines and using the GRADE approach. The panel applied an individual patient perspective.

The Evidence: A linked systematic review and network meta-analysis (764 randomised trials included 421 346 participants) of benefits and harms found that SGLT-2 inhibitors and GLP-1 receptor agonists generally reduce overall death, and incidence of myocardial infarctions, and end-stage kidney disease or kidney failure (moderate to high certainty evidence). These medications exert different effects on stroke, hospitalisations for heart failure, and key adverse events in different subgroups. Absolute effects of benefit varied widely based on patients' individual risk (for example, from five fewer deaths in the lowest risk to 48 fewer deaths in the highest risk, for 1000 patients treated over five years). A prognosis review identified 14 eligible risk prediction models, one of which (RECODe) informed most baseline risk estimates in evidence summaries to underpin the risk-stratified recommendations. Concerning patients' values and preferences, the recommendations were supported by evidence from a systematic review of published literature, a patient focus group study, a practical issues summary, and a guideline panel survey.

Understanding The Recommendation: We stratified the recommendations by the levels of risk for CVD and CKD and systematically considered the balance of benefits, harms, other considerations, and practical issues for each risk group. The strong recommendation for SGLT-2 inhibitors in patients with CVD and CKD reflects what the panel considered to be a clear benefit. For all other adults with type 2 diabetes, the weak recommendations reflect what the panel considered to be a finer balance between benefits, harms, and burdens of treatment options. Clinicians using the guideline can identify their patient's individual risk for cardiovascular and kidney outcomes using credible risk calculators such as RECODe. Interactive evidence summaries and decision aids may support well informed treatment choices, including shared decision making.
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http://dx.doi.org/10.1136/bmj.n1091DOI Listing
May 2021

KIM-1 mediates fatty acid uptake by renal tubular cells to promote progressive diabetic kidney disease.

Cell Metab 2021 May;33(5):1042-1061.e7

Division of Renal Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA. Electronic address:

Tubulointerstitial abnormalities are predictive of the progression of diabetic kidney disease (DKD), and their targeting may be an effective means for prevention. Proximal tubular (PT) expression of kidney injury molecule (KIM)-1, as well as blood and urinary levels, are increased early in human diabetes and can predict the rate of disease progression. Here, we report that KIM-1 mediates PT uptake of palmitic acid (PA)-bound albumin, leading to enhanced tubule injury with DNA damage, PT cell-cycle arrest, interstitial inflammation and fibrosis, and secondary glomerulosclerosis. Such injury can be ameliorated by genetic ablation of the KIM-1 mucin domain in a high-fat-fed streptozotocin mouse model of DKD. We also identified TW-37 as a small molecule inhibitor of KIM-1-mediated PA-albumin uptake and showed in vivo in a kidney injury model in mice that it ameliorates renal inflammation and fibrosis. Together, our findings support KIM-1 as a new therapeutic target for DKD.
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http://dx.doi.org/10.1016/j.cmet.2021.04.004DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8132466PMC
May 2021

Dietary intake in adults on hemodialysis compared with guideline recommendations.

J Nephrol 2021 Feb 16. Epub 2021 Feb 16.

Faculty of Medicine and Health, Sydney School of Public Health, University of Sydney, Sydney, Australia.

Background: Clinical practice guidelines of dietary management are designed to promote a balanced diet and maintain health in patients undergoing haemodialysis but they may not reflect patients' preferences. We aimed to investigate the consistency between the dietary intake of patients on maintenance haemodialysis and guideline recommendations.

Methods: Cross-sectional analysis of the DIET-HD study, which included 6,906 adults undergoing haemodialysis in 10 European countries. Dietary intake was determined using the Global Allergy and Asthma European Network (GALEN) Food Frequency Questionnaire (FFQ), and compared with the European Best Practice Guidelines. Consistency with guidelines was defined as achieving the minimum daily recommended intake for energy (≥ 30 kcal/kg) and protein (≥ 1.1 g/kg), and not exceeding the maximum recommended daily intake for phosphate (≤ 1000 mg), potassium (≤ 2730 mg), sodium (≤ 2300 mg) and calcium (≤ 800 mg).

Results: Overall, patients' dietary intakes of phosphate and potassium were infrequently consistent with guidelines (consistent in 25% and 25% of patients, respectively). Almost half of the patients reported that energy (45%) and calcium intake (53%) was consistent with the guidelines, while the recommended intake of sodium and protein was consistent in 85% and 67% of patients, respectively. Results were similar across all participating countries. Intake was consistent with all six guideline recommendations in only 1% of patients.

Conclusion: Patients on maintenance haemodialysis usually have a dietary intake which is inconsistent with current recommendations, especially for phosphate and potassium.
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http://dx.doi.org/10.1007/s40620-020-00962-3DOI Listing
February 2021

Sodium-glucose cotransporter protein-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists for type 2 diabetes: systematic review and network meta-analysis of randomised controlled trials.

BMJ 2021 01 13;372:m4573. Epub 2021 Jan 13.

School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.

Objective: To evaluate sodium-glucose cotransporter-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists in patients with type 2 diabetes at varying cardiovascular and renal risk.

Design: Network meta-analysis.

Data Sources: Medline, Embase, and Cochrane CENTRAL up to 11 August 2020.

Eligibility Criteria For Selecting Studies: Randomised controlled trials comparing SGLT-2 inhibitors or GLP-1 receptor agonists with placebo, standard care, or other glucose lowering treatment in adults with type 2 diabetes with follow up of 24 weeks or longer. Studies were screened independently by two reviewers for eligibility, extracted data, and assessed risk of bias.

Main Outcome Measures: Frequentist random effects network meta-analysis was carried out and GRADE (grading of recommendations assessment, development, and evaluation) used to assess evidence certainty. Results included estimated absolute effects of treatment per 1000 patients treated for five years for patients at very low risk (no cardiovascular risk factors), low risk (three or more cardiovascular risk factors), moderate risk (cardiovascular disease), high risk (chronic kidney disease), and very high risk (cardiovascular disease and kidney disease). A guideline panel provided oversight of the systematic review.

Results: 764 trials including 421 346 patients proved eligible. All results refer to the addition of SGLT-2 inhibitors and GLP-1 receptor agonists to existing diabetes treatment. Both classes of drugs lowered all cause mortality, cardiovascular mortality, non-fatal myocardial infarction, and kidney failure (high certainty evidence). Notable differences were found between the two agents: SGLT-2 inhibitors reduced mortality and admission to hospital for heart failure more than GLP-1 receptor agonists, and GLP-1 receptor agonists reduced non-fatal stroke more than SGLT-2 inhibitors (which appeared to have no effect). SGLT-2 inhibitors caused genital infection (high certainty), whereas GLP-1 receptor agonists might cause severe gastrointestinal events (low certainty). Low certainty evidence suggested that SGLT-2 inhibitors and GLP-1 receptor agonists might lower body weight. Little or no evidence was found for the effect of SGLT-2 inhibitors or GLP-1 receptor agonists on limb amputation, blindness, eye disease, neuropathic pain, or health related quality of life. The absolute benefits of these drugs vary substantially across patients from low to very high risk of cardiovascular and renal outcomes (eg, SGLT-2 inhibitors resulted in 5 to 48 fewer deaths in 1000 patients over five years; see interactive decision support tool (https://magicevidence.org/match-it/200820dist/#!/) for all outcomes.

Conclusions: In patients with type 2 diabetes, SGLT-2 inhibitors and GLP-1 receptor agonists reduced cardiovascular and renal outcomes, with notable differences in benefits and harms. Absolute benefits are determined by individual risk profiles of patients, with clear implications for clinical practice, as reflected in the Rapid Recommendations directly informed by this systematic review.

Systematic Review Registration: PROSPERO CRD42019153180.
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http://dx.doi.org/10.1136/bmj.m4573DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7804890PMC
January 2021

Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease.

Cochrane Database Syst Rev 2020 10 27;10:CD007004. Epub 2020 Oct 27.

Sydney School of Public Health, The University of Sydney, Sydney, Australia.

Background: Treatment with angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) is used to reduce proteinuria and retard the progression of chronic kidney disease (CKD). However, resolution of proteinuria may be incomplete with these therapies and the addition of an aldosterone antagonist may be added to further prevent progression of CKD. This is an update of a Cochrane review first published in 2009 and updated in 2014.

Objectives: To evaluate the effects of aldosterone antagonists (selective (eplerenone), non-selective (spironolactone or canrenone), or non-steroidal mineralocorticoid antagonists (finerenone)) in adults who have CKD with proteinuria (nephrotic and non-nephrotic range) on: patient-centred endpoints including kidney failure (previously know as end-stage kidney disease (ESKD)), major cardiovascular events, and death (any cause); kidney function (proteinuria, estimated glomerular filtration rate (eGFR), and doubling of serum creatinine); blood pressure; and adverse events (including hyperkalaemia, acute kidney injury, and gynaecomastia).

Search Methods: We searched the Cochrane Kidney and Transplant Register of Studies up to 13 January 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.

Selection Criteria: We included randomised controlled trials (RCTs) and quasi-RCTs that compared aldosterone antagonists in combination with ACEi or ARB (or both) to other anti-hypertensive strategies or placebo in participants with proteinuric CKD.

Data Collection And Analysis: Two authors independently assessed study quality and extracted data. Data were summarised using random effects meta-analysis. We expressed summary treatment estimates as a risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, or standardised mean difference (SMD) when different scales were used together with their 95% confidence interval (CI). Risk of bias were assessed using the Cochrane tool. Evidence certainty was evaluated using GRADE.

Main Results: Forty-four studies (5745 participants) were included. Risk of bias in the evaluated methodological domains were unclear or high risk in most studies. Adequate random sequence generation was present in 12 studies, allocation concealment in five studies, blinding of participant and investigators in 18 studies, blinding of outcome assessment in 15 studies, and complete outcome reporting in 24 studies. All studies comparing aldosterone antagonists to placebo or standard care were used in addition to an ACEi or ARB (or both). None of the studies were powered to detect differences in patient-level outcomes including kidney failure, major cardiovascular events or death. Aldosterone antagonists had uncertain effects on kidney failure (2 studies, 84 participants: RR 3.00, 95% CI 0.33 to 27.65, I² = 0%; very low certainty evidence), death (3 studies, 421 participants: RR 0.58, 95% CI 0.10 to 3.50, I² = 0%; low certainty evidence), and cardiovascular events (3 studies, 1067 participants: RR 0.95, 95% CI 0.26 to 3.56; I² = 42%; low certainty evidence) compared to placebo or standard care. Aldosterone antagonists may reduce protein excretion (14 studies, 1193 participants: SMD -0.51, 95% CI -0.82 to -0.20, I² = 82%; very low certainty evidence), eGFR (13 studies, 1165 participants, MD -3.00 mL/min/1.73 m², 95% CI -5.51 to -0.49, I² = 0%, low certainty evidence) and systolic blood pressure (14 studies, 911 participants: MD -4.98 mmHg, 95% CI -8.22 to -1.75, I² = 87%; very low certainty evidence) compared to placebo or standard care. Aldosterone antagonists probably increase the risk of hyperkalaemia (17 studies, 3001 participants: RR 2.17, 95% CI 1.47 to 3.22, I² = 0%; moderate certainty evidence), acute kidney injury (5 studies, 1446 participants: RR 2.04, 95% CI 1.05 to 3.97, I² = 0%; moderate certainty evidence), and gynaecomastia (4 studies, 281 participants: RR 5.14, 95% CI 1.14 to 23.23, I² = 0%; moderate certainty evidence) compared to placebo or standard care. Non-selective aldosterone antagonists plus ACEi or ARB had uncertain effects on protein excretion (2 studies, 139 participants: SMD -1.59, 95% CI -3.80 to 0.62, I² = 93%; very low certainty evidence) but may increase serum potassium (2 studies, 121 participants: MD 0.31 mEq/L, 95% CI 0.17 to 0.45, I² = 0%; low certainty evidence) compared to diuretics plus ACEi or ARB. Selective aldosterone antagonists may increase the risk of hyperkalaemia (2 studies, 500 participants: RR 1.62, 95% CI 0.66 to 3.95, I² = 0%; low certainty evidence) compared ACEi or ARB (or both). There were insufficient studies to perform meta-analyses for the comparison between non-selective aldosterone antagonists and calcium channel blockers, selective aldosterone antagonists plus ACEi or ARB (or both) and nitrate plus ACEi or ARB (or both), and non-steroidal mineralocorticoid antagonists and selective aldosterone antagonists.

Authors' Conclusions: The effects of aldosterone antagonists when added to ACEi or ARB (or both) on the risks of death, major cardiovascular events, and kidney failure in people with proteinuric CKD are uncertain. Aldosterone antagonists may reduce proteinuria, eGFR, and systolic blood pressure in adults who have mild to moderate CKD but may increase the risk of hyperkalaemia, acute kidney injury and gynaecomastia when added to ACEi and/or ARB.
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http://dx.doi.org/10.1002/14651858.CD007004.pub4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8094274PMC
October 2020

Patients' and caregivers' expectations and experiences of remote monitoring for peritoneal dialysis: A qualitative interview study.

Perit Dial Int 2020 11 21;40(6):540-547. Epub 2020 Oct 21.

Department of Medicine, 2495University of Otago Christchurch, Christchurch, New Zealand.

Background: Peritoneal dialysis (PD) can offer more flexibility and independence compared with hemodialysis, yet uptake of PD remains low. Barriers to PD include the fear of dialyzing without medical assistance and uncertainty about recognizing and managing complications. There is increasing use of remote monitoring in automated peritoneal dialysis (APD), but little is known about its acceptability by patients and caregivers. We aimed to describe patients' and caregivers' expectations and experiences of remote monitoring for APD.

Methods: Qualitative study design, using semi-structured face-to-face interviews of patients who either receiving PD or were considered eligible for PD, and their caregivers. Transcripts were analyzed using thematic analysis.

Results: Of the 34 participants, 27 were patients and the remainder caregivers. Four themes (with subthemes) were identified reducing patient burden (seeking reassurance and shared responsibility, convenience and accuracy); strengthening partnerships in care (empowering knowledge and understanding, increased accountability to dialysis team); improving access to treatment (saving time and money, providing timely care and avoiding hospital); and preserving quality patient-provider interactions (enhancing face-to-face contact, clarifying expectations of access and use of data).

Conclusions: Remote monitoring may increase patient knowledge about their kidney disease and its treatment, encourage accountability to the clinical team, enhance partnerships with clinicians, and improve access to treatment and timely care. It is also important to ensure that remote monitoring does not replace face-to-face clinical contact with clinicians.
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http://dx.doi.org/10.1177/0896860820927528DOI Listing
November 2020

Patients' Experiences of Community House Hemodialysis: A Qualitative Study.

Kidney Med 2019 Nov-Dec;1(6):338-346. Epub 2019 Sep 24.

Department of Medicine, University of Otago, Christchurch, New Zealand.

Rationale & Objective: Community house hemodialysis is a submodality of home hemodialysis that enables patients to perform hemodialysis independent of nursing or medical supervision in a shared house. This study describes the perspectives and experiences of patients using community house hemodialysis in New Zealand to explore ways this dialysis modality may support the wider delivery of independent hemodialysis care.

Study Design: Qualitative semi-structured in-depth interview study.

Setting & Participants: 25 patients who had experienced community house hemodialysis. Participants were asked about why they chose community house hemodialysis and their experiences and perspectives of this.

Analytical Approach: Thematic analysis using an inductive approach.

Results: 25 patients were interviewed (14 men and 11 women, aged 31-65 years). Most were of Māori or Pacific ethnicity and in part- or full-time employment. More than two-thirds dialyzed for 20 hours a week or more. We identified 4 themes that described patients' experiences and perspectives of choosing and using community house hemodialysis: reducing burden on family (when home is not an option, minimizing family exposure to dialysis, maintaining privacy and self-identity, reducing the costs of home hemodialysis, and gaining a reprieve from home), offering flexibility and freedom (having a normal life, maintaining employment, and facilitating travel), control of my health (building independence and self-efficacy, a place of wellness, avoiding institutionalization, and creating a culture of extended-hour dialysis), and community support (building social inclusion and supporting peers).

Limitations: Non-Māori and non-Pacific patient experiences of community house hemodialysis could not be explored.

Conclusions: Community house hemodialysis is a dialysis modality that overcomes many of the socioeconomic barriers to home hemodialysis, is socially and culturally acceptable to Māori and Pacific people, and supports extended-hour hemodialysis and thereby promotes more equitable access to best practice services. It is therefore a significant addition to independent hemodialysis options available for patients.
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http://dx.doi.org/10.1016/j.xkme.2019.07.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7380439PMC
September 2019

Comparative Efficacy and Safety of BP-Lowering Pharmacotherapy in Patients Undergoing Maintenance Dialysis: A Network Meta-Analysis of Randomized, Controlled Trials.

Clin J Am Soc Nephrol 2020 08 16;15(8):1129-1138. Epub 2020 Jul 16.

The George Institute for Global Health, Faculty of Medicine, The University of New South Wales, Sydney, New South Wales, Australia

Background And Objectives: Elevated BP is an important risk factor for cardiovascular disease, with a prevalence of over 80% in patients undergoing maintenance dialysis. We assessed the comparative BP-lowering efficacy and the safety of BP-lowering drugs in patients undergoing maintenance dialysis.

Design, Settings, Participants, & Measurements: We performed a frequentist random effects network meta-analysis of randomized, controlled trials evaluating BP-lowering agents in adult patients undergoing maintenance dialysis. Electronic databases (CENTRAL, MEDLINE, and Embase) were systematically searched (up to August 2018) for relevant trials. The main outcome was systolic BP reduction.

Results: Forty trials (4283 participants) met our inclusion criteria. Angiotensin-converting enzyme inhibitors, -blockers, calcium-channel blockers, and aldosterone antagonists lowered systolic BP to a greater extent than placebo, with effect sizes ranging from -10.8 mm Hg (95% confidence interval, -14.8 to -6.7 mm Hg) for the aldosterone antagonists to -4.3 mm Hg (95% confidence interval, -7.2 to -1.5 mm Hg) for angiotensin-converting enzyme inhibitors. Aldosterone antagonists and -blockers were superior to angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, calcium-channel blockers, and renin inhibitors at lowering systolic BP. Compared with angiotensin-converting enzyme inhibitors, aldosterone antagonists and -blockers lowered systolic BP by 6.4 mm Hg (95% confidence interval, -11.4 to -1.4 mm Hg) and 4.4 mm Hg (95% confidence interval, -7.4 to -1.3 mm Hg), respectively. Systolic BP reduction was not different with angiotensin receptor blockers, -blockers, and calcium-channel blockers compared with angiotensin-converting enzyme inhibitors. Renin inhibitors were less effective. Angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and aldosterone antagonists incurred risks of drug discontinuation due to adverse events and hypotension.

Conclusions: BP-lowering agents significantly reduced systolic BP in patients undergoing maintenance dialysis. -Blockers and aldosterone antagonists may confer larger reductions, although treatment with aldosterone antagonists may be limited by adverse events.
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http://dx.doi.org/10.2215/CJN.12201019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7409758PMC
August 2020

Potassium binders for chronic hyperkalaemia in people with chronic kidney disease.

Cochrane Database Syst Rev 2020 Jun 26;6:CD013165. Epub 2020 Jun 26.

Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.

Background: Hyperkalaemia is a common electrolyte abnormality caused by reduced renal potassium excretion in patients with chronic kidney diseases (CKD). Potassium binders, such as sodium polystyrene sulfonate and calcium polystyrene sulfonate, are widely used but may lead to constipation and other adverse gastrointestinal (GI) symptoms, reducing their tolerability. Patiromer and sodium zirconium cyclosilicate are newer ion exchange resins for treatment of hyperkalaemia which may cause fewer GI side-effects. Although more recent studies are focusing on clinically-relevant endpoints such as cardiac complications or death, the evidence on safety is still limited. Given the recent expansion in the available treatment options, it is appropriate to review the evidence of effectiveness and tolerability of all potassium exchange resins among people with CKD, with the aim to provide guidance to consumers, practitioners, and policy-makers.

Objectives: To assess the benefits and harms of potassium binders for treating chronic hyperkalaemia among adults and children with CKD.

Search Methods: We searched the Cochrane Kidney and Transplant Register of Studies up to 10 March 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.

Selection Criteria: Randomised controlled trials (RCTs) and quasi-randomised controlled studies (quasi-RCTs) evaluating potassium binders for chronic hyperkalaemia administered in adults and children with CKD.

Data Collection And Analysis: Two authors independently assessed risks of bias and extracted data. Treatment estimates were summarised by random effects meta-analysis and expressed as relative risk (RR) or mean difference (MD), with 95% confidence interval (CI). Evidence certainty was assessed using GRADE processes.

Main Results: Fifteen studies, randomising 1849 adult participants were eligible for inclusion. Twelve studies involved participants with CKD (stages 1 to 5) not requiring dialysis and three studies were among participants treated with haemodialysis. Potassium binders included calcium polystyrene sulfonate, sodium polystyrene sulfonate, patiromer, and sodium zirconium cyclosilicate. A range of routes, doses, and timing of drug administration were used. Study duration varied from 12 hours to 52 weeks (median 4 weeks). Three were cross-over studies. The mean study age ranged from 53.1 years to 73 years. No studies evaluated treatment in children. Some studies had methodological domains that were at high or unclear risks of bias, leading to low certainty in the results. Studies were not designed to measure treatment effects on cardiac arrhythmias or major GI symptoms. Ten studies (1367 randomised participants) compared a potassium binder to placebo. The certainty of the evidence was low for all outcomes. We categorised treatments in newer agents (patiromer or sodium zirconium cyclosilicate) and older agents (calcium polystyrene sulfonate and sodium polystyrene sulfonate). Patiromer or sodium zirconium cyclosilicate may make little or no difference to death (any cause) (4 studies, 688 participants: RR 0.69, 95% CI 0.11, 4.32; I = 0%; low certainty evidence) in CKD. The treatment effect of older potassium binders on death (any cause) was unknown. One cardiovascular death was reported with potassium binder in one study, showing that there was no difference between patiromer or sodium zirconium cyclosilicate and placebo for cardiovascular death in CKD and HD. There was no evidence of a difference between patiromer or sodium zirconium cyclosilicate and placebo for health-related quality of life (HRQoL) at the end of treatment (one study) in CKD or HD. Potassium binders had uncertain effects on nausea (3 studies, 229 participants: RR 2.10, 95% CI 0.65, 6.78; I = 0%; low certainty evidence), diarrhoea (5 studies, 720 participants: RR 0.84, 95% CI 0.47, 1.48; I = 0%; low certainty evidence), and vomiting (2 studies, 122 participants: RR 1.72, 95% CI 0.35 to 8.51; I = 0%; low certainty evidence) in CKD. Potassium binders may lower serum potassium levels (at the end of treatment) (3 studies, 277 participants: MD -0.62 mEq/L, 95% CI -0.97, -0.27; I = 92%; low certainty evidence) in CKD and HD. Potassium binders had uncertain effects on constipation (4 studies, 425 participants: RR 1.58, 95% CI 0.71, 3.52; I = 0%; low certainty evidence) in CKD. Potassium binders may decrease systolic blood pressure (BP) (2 studies, 369 participants: MD -3.73 mmHg, 95%CI -6.64 to -0.83; I = 79%; low certainty evidence) and diastolic BP (one study) at the end of the treatment. No study reported outcome data for cardiac arrhythmias or major GI events. Calcium polystyrene sulfonate may make little or no difference to serum potassium levels at end of treatment, compared to sodium polystyrene sulfonate (2 studies, 117 participants: MD 0.38 mEq/L, 95% CI -0.03 to 0.79; I = 42%, low certainty evidence). There was no evidence of a difference in systolic BP (one study), diastolic BP (one study), or constipation (one study) between calcium polystyrene sulfonate and sodium polystyrene sulfonate. There was no difference between high-dose and low-dose patiromer for death (sudden death) (one study), stroke (one study), myocardial infarction (one study), or constipation (one study). The comparative effects whether potassium binders were administered with or without food, laxatives, or sorbitol, were very uncertain with insufficient data to perform meta-analysis.

Authors' Conclusions: Evidence supporting clinical decision-making for different potassium binders to treat chronic hyperkalaemia in adults with CKD is of low certainty; no studies were identified in children. Available studies have not been designed to measure treatment effects on clinical outcomes such as cardiac arrhythmias or major GI symptoms. This review suggests the need for a large, adequately powered study of potassium binders versus placebo that assesses clinical outcomes of relevance to patients, clinicians and policy-makers. This data could be used to assess cost-effectiveness, given the lack of definitive studies and the clinical importance of potassium binders for chronic hyperkalaemia in people with CKD.
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http://dx.doi.org/10.1002/14651858.CD013165.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7386867PMC
June 2020

Effects of Allopurinol on the Progression of Chronic Kidney Disease.

N Engl J Med 2020 06;382(26):2504-2513

From the Department of Renal Medicine, St. George Hospital (S.V.B., A.T.), the Renal and Metabolic Division, George Institute for Global Health (S.V.B., A.T., V.P.), and St. Vincent's Clinical School (R.O.D., G.R.D.J.), University of New South Wales Medicine, the Departments of Clinical Pharmacology and Toxicology (R.O.D.) and Chemical Pathology, SydPath (G.R.D.J.), St. Vincent's Hospital, the Centre for Transplant and Renal Research, Westmead Institute for Medical Research, University of Sydney (D.C.H., G.K.R.), the Department of Renal Medicine, Westmead Hospital, Western Sydney Local Health District (D.C.H., G.K.R.), and the Department of Nephrology, the Royal North Shore Hospital (V.P.), Sydney, the Australasian Kidney Trials Network, University of Queensland (S.V.B., E.M.P., N.B., C.M.H., D.R., L.R., D.W.J.), the Department of Nephrology, Princess Alexandra Hospital, (B.D., C.M.H., D.W.J.), and the Translational Research Institute (D.W.J.), Brisbane, QLD, the Medical School, University of Western Australia, Perth (N.B.), the Department of Nephrology, Monash University at Monash Medical Centre, Melbourne, VIC (F.G.B., J.K.), Menzies School of Health Research, Charles Darwin University, Darwin, NT (A.C.), the University of Adelaide and Central Northern Adelaide Renal and Transplantation Services, Adelaide, SA (R.F.), and the Australian National University Medical School and the Department of Nephrology, Canberra Hospital, Canberra, ACT (G.W.) - all in Australia; the Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom (P.C.); and the Department of Medicine, University of Auckland (N.D., J.R.Z.), and the Renal Service, Waitemata District Health Board (J.R.Z.), Auckland, the Department of Medicine, University of Otago Christchurch, Christchurch (S.C.P.), and Dunedin School of Medicine, University of Otago, Dunedin (R.J.W.) - all in New Zealand.

Background: Elevated serum urate levels are associated with progression of chronic kidney disease. Whether urate-lowering treatment with allopurinol can attenuate the decline of the estimated glomerular filtration rate (eGFR) in patients with chronic kidney disease who are at risk for progression is not known.

Methods: In this randomized, controlled trial, we randomly assigned adults with stage 3 or 4 chronic kidney disease and no history of gout who had a urinary albumin:creatinine ratio of 265 or higher (with albumin measured in milligrams and creatinine in grams) or an eGFR decrease of at least 3.0 ml per minute per 1.73 m of body-surface area in the preceding year to receive allopurinol (100 to 300 mg daily) or placebo. The primary outcome was the change in eGFR from randomization to week 104, calculated with the Chronic Kidney Disease Epidemiology Collaboration creatinine equation.

Results: Enrollment was stopped because of slow recruitment after 369 of 620 intended patients were randomly assigned to receive allopurinol (185 patients) or placebo (184 patients). Three patients per group withdrew immediately after randomization. The remaining 363 patients (mean eGFR, 31.7 ml per minute per 1.73 m; median urine albumin:creatinine ratio, 716.9; mean serum urate level, 8.2 mg per deciliter) were included in the assessment of the primary outcome. The change in eGFR did not differ significantly between the allopurinol group and the placebo group (-3.33 ml per minute per 1.73 m per year [95% confidence interval {CI}, -4.11 to -2.55] and -3.23 ml per minute per 1.73 m per year [95% CI, -3.98 to -2.47], respectively; mean difference, -0.10 ml per minute per 1.73 m per year [95% CI, -1.18 to 0.97]; P = 0.85). Serious adverse events were reported in 84 of 182 patients (46%) in the allopurinol group and in 79 of 181 patients (44%) in the placebo group.

Conclusions: In patients with chronic kidney disease and a high risk of progression, urate-lowering treatment with allopurinol did not slow the decline in eGFR as compared with placebo. (Funded by the National Health and Medical Research Council of Australia and the Health Research Council of New Zealand; CKD-FIX Australian New Zealand Clinical Trials Registry number, ACTRN12611000791932.).
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http://dx.doi.org/10.1056/NEJMoa1915833DOI Listing
June 2020

Cardiac Rehabilitation Programs for Chronic Heart Disease: A Bayesian Network Meta-analysis.

Can J Cardiol 2021 01 19;37(1):162-171. Epub 2020 Feb 19.

Department of Gerontology, the Second Affiliated Hospital of Chongqing Medical University, Chongqing, China. Electronic address:

Background: Cardiac rehabilitation is a medically supervised program after coronary events that involves exercise and dietary modification. We evaluated the comparative benefits and harms of cardiac rehabilitation strategies via a network meta-analysis.

Methods: We followed a pre-specified protocol (PROSPERO: CRD42018094998). We searched Embase, MEDLINE, and Cochrane Central Register of Randomized Trials databases for randomized controlled trials that evaluated cardiac rehabilitation vs a second form of rehabilitation or standard/usual care in adults after myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention, or angiography. Risk of bias and evidence quality was evaluated using the Cochrane tool and Grading of Recommendations Assessment, Development and Evaluation (GRADE), respectively. Pairwise and Bayesian network meta-analyses were performed for 11 clinical outcomes.

Results: We included 134 randomized controlled trials involving 62,322 participants. Compared with standard care, exercise-only cardiac rehabilitation reduced the odds of cardiovascular mortality (odds ratio [OR], 0.70; 95% credibility interval [CrI], 0.51-0.96; moderate-quality evidence), major adverse cardiovascular events (OR, 0.57; 95% CrI, 0.40-0.78; low-quality evidence), nonfatal myocardial infarction (OR, 0.71; 95% CrI, 0.54-0.93; moderate-quality evidence), all-cause hospitalization (OR, 0.74; 95% CrI, 0.54-0.98; moderate-quality evidence), and cardiovascular hospitalization (OR, 0.69; 95% CrI, 0.51-0.88; moderate-quality evidence). Exercise-only cardiac rehabilitation was associated with lower cardiovascular hospitalization risk relative to cardiac rehabilitation without exercise (OR, 0.68; 95% CrI, 0.48-0.97; moderate-quality evidence).

Conclusions: Cardiac rehabilitation programs containing exercise might provide broader cardiovascular benefits compared with those without exercise.
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http://dx.doi.org/10.1016/j.cjca.2020.02.072DOI Listing
January 2021

Comparative Effectiveness of Calcimimetic Agents for Secondary Hyperparathyroidism in Adults: A Systematic Review and Network Meta-analysis.

Am J Kidney Dis 2020 09 28;76(3):321-330. Epub 2020 May 28.

Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy; Sydney School of Public Health, The University of Sydney, NSW, Australia. Electronic address:

Rationale & Objective: Comparative benefits and harms of calcimimetic agents used for the treatment of secondary hyperparathyroidism have not been well characterized. We sought to compare the effectiveness of 3 calcimimetic agents using published data.

Study Design: Systematic review of randomized controlled trials and network meta-analysis.

Setting & Study Population: Adults with chronic kidney disease enrolled in a clinical trial of a calcimetic agent.

Search Strategy & Sources: MEDLINE, EMBASE, CENTRAL (from February 7, 2013, to November 21, 2019), and a published meta-analysis.

Data Extraction: Two reviewers independently extracted the study data, assessed risk of bias, and rated evidence certainty using Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria.

Analytical Approach: Frequentist network meta-analysis was conducted. The primary review outcomes were achievement of a target reduction in serum parathyroid hormone (PTH) levels and hypocalcemia. Additional outcomes were nausea, vomiting, serious adverse events, all-cause mortality, cardiovascular mortality, heart failure, and fracture.

Results: 36 trials (11,247 participants) were included. All except 4 trials involved dialysis patients. Median follow-up was 26 weeks (range, 1 week to 21.2 months). Compared with placebo, calcimimetic agents had higher odds of achieving target PTH levels with high or moderate certainty. Etelcalcetide had the highest odds of achieving a PTH target compared with evocalcet (OR, 4.93; 95% CI, 1.33-18.2) and cinacalcet (OR, 2.78; 95% CI, 1.19-6.67). Etelcalcetide appeared to cause more hypocalcemia than cinacalcet and evocalcet. Cinacalcet and to a lesser extent etelcalcetide appeared to cause more nausea than placebo. Differences in risk for mortality, cardiovascular end points, or fractures across calcimimetic agents could not be discerned with sufficient certainty.

Limitations: Lack of longer-term data; heterogeneous end point definitions.

Conclusions: Evidence of the benefits of calcimimetic therapy is limited to short-term assessment of a putative surrogate outcome (serum PTH). Although etelcalcetide was associated with the largest reduction in PTH levels, side-effect profiles differed across the 3 calcimimetic agents, making it not possible to identify 1 preferred agent.
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http://dx.doi.org/10.1053/j.ajkd.2020.02.439DOI Listing
September 2020

Interventions for Preventing Bone Disease in Kidney Transplant Recipients: Editorial Summary of a Cochrane Review.

Am J Kidney Dis 2020 05 16;75(5):807-809. Epub 2020 Mar 16.

Department of Emergency and Transplantation, University of Bari, Italy; Sydney School of Public Health, University of Sydney, Australia. Electronic address:

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May 2020

Immunosuppressive agents for treating IgA nephropathy.

Cochrane Database Syst Rev 2020 03 12;3:CD003965. Epub 2020 Mar 12.

University of Bari, Department of Emergency and Organ Transplantation, Bari, Italy.

Background: IgA nephropathy is the most common glomerulonephritis world-wide. IgA nephropathy causes end-stage kidney disease (ESKD) in 15% to 20% of affected patients within 10 years and in 30% to 40% of patients within 20 years from the onset of disease. This is an update of a Cochrane review first published in 2003 and updated in 2015.

Objectives: To determine the benefits and harms of immunosuppression strategies for the treatment of IgA nephropathy.

Search Methods: We searched the Cochrane Kidney and Transplant Register of Studies up to 9 September 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.

Selection Criteria: We included randomised controlled trials (RCTs) and quasi-RCTs of treatment for IgA nephropathy in adults and children and that compared immunosuppressive agents with placebo, no treatment, or other immunosuppressive or non-immunosuppressive agents.

Data Collection And Analysis: Two authors independently assessed study risk of bias and extracted data. Estimates of treatment effect were summarised using random effects meta-analysis. Treatment effects were expressed as relative risk (RR) and 95% confidence intervals (95% CI) for dichotomous outcomes and mean difference (MD) and 95% CI for continuous outcomes. Risks of bias were assessed using the Cochrane tool. Evidence certainty was evaluated using GRADE methodology.

Main Results: Fifty-eight studies involving 3933 randomised participants were included. Six studies involving children were eligible. Disease characteristics (kidney function and level of proteinuria) were heterogeneous across studies. Studies evaluating steroid therapy generally included patients with protein excretion of 1 g/day or more. Risk of bias within the included studies was generally high or unclear for many of the assessed methodological domains. In patients with IgA nephropathy and proteinuria > 1 g/day, steroid therapy given for generally two to four months with a tapering course probably prevents the progression to ESKD compared to placebo or standard care (8 studies; 741 participants: RR 0.39, 95% CI 0.23 to 0.65; moderate certainty evidence). Steroid therapy may induce complete remission (4 studies, 305 participants: RR 1.76, 95% CI 1.03 to 3.01; low certainty evidence), prevent doubling of serum creatinine (SCr) (7 studies, 404 participants: RR 0.43, 95% CI 0.29 to 0.65; low certainty evidence), and may lower urinary protein excretion (10 studies, 705 participants: MD -0.58 g/24 h, 95% CI -0.84 to -0.33;low certainty evidence). Steroid therapy had uncertain effects on glomerular filtration rate (GFR), death, infection and malignancy. The risk of adverse events with steroid therapy was uncertain due to heterogeneity in the type of steroid treatment used and the rarity of events. Cytotoxic agents (azathioprine (AZA) or cyclophosphamide (CPA) alone or with concomitant steroid therapy had uncertain effects on ESKD (7 studies, 463 participants: RR 0.63, 95% CI 0.33 to 1.20; low certainty evidence), complete remission (5 studies; 381 participants: RR 1.47, 95% CI 0.94 to 2.30; very low certainty evidence), GFR (any measure), and protein excretion. Doubling of serum creatinine was not reported. Mycophenolate mofetil (MMF) had uncertain effects on the progression to ESKD, complete remission, doubling of SCr, GFR, protein excretion, infection, and malignancy. Death was not reported. Calcineurin inhibitors compared with placebo or standard care had uncertain effects on complete remission, SCr, GFR, protein excretion, infection, and malignancy. ESKD and death were not reported. Mizoribine administered with renin-angiotensin system inhibitor treatment had uncertain effects on progression to ESKD, complete remission, GFR, protein excretion, infection, and malignancy. Death and SCr were not reported. Leflunomide followed by a tapering course with oral prednisone compared to prednisone had uncertain effects on the progression to ESKD, complete remission, doubling of SCr, GFR, protein excretion, and infection. Death and malignancy were not reported. Effects of other immunosuppressive regimens (including steroid plus non-immunosuppressive agents or mTOR inhibitors) were inconclusive primarily due to insufficient data from the individual studies in low or very low certainty evidence. The effects of treatments on death, malignancy, reduction in GFR at least of 25% and adverse events were very uncertain. Subgroup analyses to determine the impact of specific patient characteristics such as ethnicity or disease severity on treatment effectiveness were not possible.

Authors' Conclusions: In moderate certainty evidence, corticosteroid therapy probably prevents decline in GFR or doubling of SCr in adults and children with IgA nephropathy and proteinuria. Evidence for treatment effects of immunosuppressive agents on death, infection, and malignancy is generally sparse or low-quality. Steroid therapy has uncertain adverse effects due to a paucity of studies. Available studies are few, small, have high risk of bias and generally do not systematically identify treatment-related harms. Subgroup analyses to identify specific patient characteristics that might predict better response to therapy were not possible due to a lack of studies. There is no evidence that other immunosuppressive agents including CPA, AZA, or MMF improve clinical outcomes in IgA nephropathy.
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http://dx.doi.org/10.1002/14651858.CD003965.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7066485PMC
March 2020

A Coaching Program to Improve Dietary Intake of Patients with CKD: ENTICE-CKD.

Clin J Am Soc Nephrol 2020 03 28;15(3):330-340. Epub 2020 Feb 28.

Faculty of Health Science and Medicine and.

Background And Objectives: The dietary self-management of CKD is challenging. Telehealth interventions may provide an effective delivery method to facilitate sustained dietary change.

Design, Setting, Participants, & Measurements: This pilot, randomized, controlled trial evaluated secondary and exploratory outcomes after a dietitian-led telehealth coaching intervention to improve diet quality in people with stage 3-4 CKD. The intervention group received phone calls every 2 weeks for 3 months (with concurrent, tailored text messages for 3 months), followed by 3 months of tailored text messages without telephone coaching, to encourage a diet consistent with CKD guidelines. The control group received usual care for 3 months, followed by nontailored, educational text messages for 3 months.

Results: Eighty participants (64% male), aged 62±12 years, were randomized to the intervention or control group. Telehealth coaching was safe, with no adverse events or changes to serum biochemistry at any time point. At 3 months, the telehealth intervention, compared with the control, had no detectable effect on overall diet quality on the Alternative Health Eating Index (3.2 points, 95% confidence interval, -1.3 to 7.7), nor at 6 months (0.5 points, 95% confidence interval, -4.6 to 5.5). There was no change in clinic BP at any time point in any group. There were significant improvements in several exploratory diet and clinical outcomes, including core food group consumption, vegetable servings, fiber intake, and body weight.

Conclusions: Telehealth coaching was safe, but appeared to have no effect on the Alternative Healthy Eating Index or clinic BP. There were clinically significant changes in several exploratory diet and clinical outcomes, which require further investigation.

Clinical Trial Registry Name And Registration Number: Evaluation of Individualized Telehealth Intensive Coaching to Promote Healthy Eating and Lifestyle in CKD (ENTICE-CKD), ACTRN12616001212448.
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http://dx.doi.org/10.2215/CJN.12341019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7057309PMC
March 2020

Pharmacological interventions for heart failure in people with chronic kidney disease.

Cochrane Database Syst Rev 2020 Feb 27;2:CD012466. Epub 2020 Feb 27.

University of Calgary, Department of Community Health Sciences, 3330 Hospital Drive NW, Calgary, Alberta, Canada, T2N 4N1.

Background: Approximately half of people with heart failure have chronic kidney disease (CKD). Pharmacological interventions for heart failure in people with CKD have the potential to reduce death (any cause) or hospitalisations for decompensated heart failure. However, these interventions are of uncertain benefit and may increase the risk of harm, such as hypotension and electrolyte abnormalities, in those with CKD.

Objectives: This review aims to look at the benefits and harms of pharmacological interventions for HF (i.e., antihypertensive agents, inotropes, and agents that may improve the heart performance indirectly) in people with HF and CKD.

Search Methods: We searched the Cochrane Kidney and Transplant Register of Studies through 12 September 2019 in consultation with an Information Specialist and using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.

Selection Criteria: We included randomised controlled trials of any pharmacological intervention for acute or chronic heart failure, among people of any age with chronic kidney disease of at least three months duration.

Data Collection And Analysis: Two authors independently screened the records to identify eligible studies and extracted data on the following dichotomous outcomes: death, hospitalisations, worsening heart failure, worsening kidney function, hyperkalaemia, and hypotension. We used random effects meta-analysis to estimate treatment effects, which we expressed as a risk ratio (RR) with 95% confidence intervals (CI). We assessed the risk of bias using the Cochrane tool. We applied the GRADE methodology to rate the certainty of evidence.

Main Results: One hundred and twelve studies met our selection criteria: 15 were studies of adults with CKD; 16 studies were conducted in the general population but provided subgroup data for people with CKD; and 81 studies included individuals with CKD, however, data for this subgroup were not provided. The risk of bias in all 112 studies was frequently high or unclear. Of the 31 studies (23,762 participants) with data on CKD patients, follow-up ranged from three months to five years, and study size ranged from 16 to 2916 participants. In total, 26 studies (19,612 participants) reported disaggregated and extractable data on at least one outcome of interest for our review and were included in our meta-analyses. In acute heart failure, the effects of adenosine A1-receptor antagonists, dopamine, nesiritide, or serelaxin on death, hospitalisations, worsening heart failure or kidney function, hyperkalaemia, hypotension or quality of life were uncertain due to sparse data or were not reported. In chronic heart failure, the effects of angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) (4 studies, 5003 participants: RR 0.85, 95% CI 0.70 to 1.02; I = 78%; low certainty evidence), aldosterone antagonists (2 studies, 34 participants: RR 0.61 95% CI 0.06 to 6.59; very low certainty evidence), and vasopressin receptor antagonists (RR 1.26, 95% CI 0.55 to 2.89; 2 studies, 1840 participants; low certainty evidence) on death (any cause) were uncertain. Treatment with beta-blockers may reduce the risk of death (any cause) (4 studies, 3136 participants: RR 0.69, 95% CI 0.60 to 0.79; I = 0%; moderate certainty evidence). Treatment with ACEi or ARB (2 studies, 1368 participants: RR 0.90, 95% CI 0.43 to 1.90; I = 97%; very low certainty evidence) had uncertain effects on hospitalisation for heart failure, as treatment estimates were consistent with either benefit or harm. Treatment with beta-blockers may decrease hospitalisation for heart failure (3 studies, 2287 participants: RR 0.67, 95% CI 0.43 to 1.05; I = 87%; low certainty evidence). Aldosterone antagonists may increase the risk of hyperkalaemia compared to placebo or no treatment (3 studies, 826 participants: RR 2.91, 95% CI 2.03 to 4.17; I = 0%; low certainty evidence). Renin inhibitors had uncertain risks of hyperkalaemia (2 studies, 142 participants: RR 0.86, 95% CI 0.49 to 1.49; I = 0%; very low certainty). We were unable to estimate whether treatment with sinus node inhibitors affects the risk of hyperkalaemia, as there were few studies and meta-analysis was not possible. Hyperkalaemia was not reported for the CKD subgroup in studies investigating other therapies. The effects of ACEi or ARB, or aldosterone antagonists on worsening heart failure or kidney function, hypotension, or quality of life were uncertain due to sparse data or were not reported. Effects of anti-arrhythmic agents, digoxin, phosphodiesterase inhibitors, renin inhibitors, sinus node inhibitors, vasodilators, and vasopressin receptor antagonists were very uncertain due to the paucity of studies.

Authors' Conclusions: The effects of pharmacological interventions for heart failure in people with CKD are uncertain and there is insufficient evidence to inform clinical practice. Study data for treatment outcomes in patients with heart failure and CKD are sparse despite the potential impact of kidney impairment on the benefits and harms of treatment. Future research aimed at analysing existing data in general population HF studies to explore the effect in subgroups of patients with CKD, considering stage of disease, may yield valuable insights for the management of people with HF and CKD.
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http://dx.doi.org/10.1002/14651858.CD012466.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7044419PMC
February 2020

Clinicians' experiences with remote patient monitoring in peritoneal dialysis: A semi-structured interview study.

Perit Dial Int 2020 03 17;40(2):202-208. Epub 2020 Jan 17.

Department of Medicine, University of Otago, Christchurch, New Zealand.

Background: Fear of catastrophic events and uncertainty about safety at home are barriers to choosing peritoneal dialysis (PD). Remote monitoring may address these concerns and is increasingly being used in patients on automated peritoneal dialysis (APD). This study aims to describe clinicians' perspectives and experiences of remote monitoring in caring for patients on PD.

Methods: We conducted semi-structured interviews with nephrologists and dialysis nurses across nine dialysis units in New Zealand who had experience using remote monitoring with patients on APD. Interviews were transcribed and analysed using thematic analysis.

Results: Thirteen registered nurses and 12 nephrologists or nephrologists-in-training (total = 25) participated. Four themes were identified: promoting and maintaining PD (providing reassurance to patients through continual surveillance, supporting confidence at home and sustaining PD as the patient-preferred treatment); enabling data-driven decisions (using comprehensive clinical data in providing timely and accessible care, and identifying and supporting patient adherence); establishing boundaries for use (negotiating privacy and independence, clarifying clinician and patient responsibilities and strengthening nursing innovation and capability); and enhancing patient-focused care (developing empathy for patients, enabling self-management and reducing time and financial burden in accessing care).

Conclusions: Remote monitoring is valued by clinicians in promoting and maintaining patients on PD and enabling data-driven decisions. Remote monitoring enhances patient-focused care, but clinicians also emphasise the need to protect patient privacy and establish boundaries for use. Remote monitoring that supports the clinicians' role and adheres to principles of data security maintains patient privacy may enhance care and outcomes for patients on PD.
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http://dx.doi.org/10.1177/0896860819887638DOI Listing
March 2020

Experiences, perspectives and values of Indigenous peoples regarding kidney transplantation: systematic review and thematic synthesis of qualitative studies.

Int J Equity Health 2019 12 30;18(1):204. Epub 2019 Dec 30.

Research and Innovation Centre, Eastern Institute of Technology, Napier, 4112, New Zealand.

Background: Kidney transplantation is considered best practice treatment for end stage kidney disease (ESKD), however Indigenous patients are substantially less likely to receive either a deceased or live donor kidney transplant than non-Indigenous patients. We describe Indigenous peoples' experiences and perspectives including traditional values around kidney transplantation to inform international transplant programs.

Methods: We conducted a systematic review of qualitative studies involving Indigenous adults who have experience with or perceptions of kidney transplantation. We searched MEDLINE, Embase, PsychINFO, and CINAHL, in conjunction with analysis of Google Scholar and reference lists of related studies till July 2019. We utilised thematic synthesis to analyse data. Completeness of reporting in studies was evaluated using the Consolidated Criteria for Reporting Qualitative Studies (COREQ) framework.

Results: Eight studies involving 225 Indigenous participants were included. Five themes were identified: strong desire for transplantation (seeking normality and freedom from dialysis, wanting to reduce burden of disease within community); lack of partnership in shared decision-making (receiving inadequate information, ineffective communication); barriers to live kidney donation (difficulty asking, apprehension about impact on donor, avoiding additional financial burden and fear of complications); cultural considerations (influence of traditional values and beliefs, reconciling traditional values with pragmatic need); and experiencing lack of cultural competence in clinical care (struggling with prejudice and ignorance, mistrust of clinicians and health system).

Conclusion: Indigenous participants had a strong desire for a kidney transplant and recognised the need for more readily available kidney transplants for others in their communities with ESKD. However, they faced prejudice and a lack of cultural competence by health workers as well as wider barriers to transplantation in systems that did not support effective and culturally appropriate delivery of information and care. Traditional cultural values also influenced decisions regarding kidney transplantation but such values were moderated when considering transplantation. Transplantation programs need to identify and mitigate barriers, such as the financial burden, promote cultural safety and incorporate traditional values into the promotion of transplantation in order to address inequitable transplantation rates.

Registration: Not applicable.
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http://dx.doi.org/10.1186/s12939-019-1115-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6937677PMC
December 2019

Physical activity for people with chronic kidney disease: an international survey of nephrologist practice patterns and research priorities.

BMJ Open 2019 12 18;9(12):e032322. Epub 2019 Dec 18.

Department of Medicine, University of Alberta, Edmonton, Alberta, Canada

Objectives: People with chronic kidney diseases (CKD) have identified exercise as a research priority. To inform the research agenda, we surveyed nephrologists on their practice patterns, available resources and research priorities for exercise and physical activity (PA) in CKD.

Design: Cross-sectional international survey.

Setting And Participants: 19-item electronic survey was administered to practising nephrologists with publicly available email addresses in Canada (n=354) and Australia and New Zealand (ANZ) and via newsletters for the Australian and New Zealand Society of Nephrology (n=598).

Outcomes: Frequency and predictors of exercise and PA counselling in practice and research priorities.

Results: 189 respondents (20% response) completed the survey. Eighty-one per cent of ANZ and 42% of Canadian respondents reported that their renal programmes did not have any exercise programmes or resources. The most frequently reported barrier for exercise programme implementation was a lack of funding (77%). Ninety per cent of respondents thought regular exercise provides 'health benefits' for all CKD stages; 59% reported that exercise counselling was within the nephrologists' scope of practice and 47% reported 'frequently' or 'always' counselling patients. In multivariable analysis, female gender (OR 2.31; 95% CI 1.16 to 4.58) and older age (OR 1.94 per age category increase; 95% CI 1.15 to 3.26) were associated with exercise counselling. Out of 194 research priorities, 65 (34%) were clinical outcomes (cardiovascular parameters) and 30% were patient-reported outcomes (quality of life).

Conclusions: Most nephrologists consider exercise and PA counselling as within their scope of practice and beneficial but, due to competing priorities, do not regularly counsel patients. This suggests a need for the evaluation of effective and efficient counselling strategies and a role for the routine involvement of exercise specialists in kidney care. Cardiovascular parameters and quality of life were identified as important outcomes for future exercise trials.
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http://dx.doi.org/10.1136/bmjopen-2019-032322DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6936996PMC
December 2019

Psychosocial interventions for preventing and treating depression in dialysis patients.

Cochrane Database Syst Rev 2019 12 2;12:CD004542. Epub 2019 Dec 2.

University of Bari, Department of Emergency and Organ Transplantation, Bari, Italy.

Background: People with end-stage kidney disease (ESKD) treated with dialysis are frequently affected by major depression. Dialysis patients have prioritised depression as a critically important clinical outcome in nephrology trials. Psychological and social support are potential treatments for depression, although a Cochrane review in 2005 identified zero eligible studies. This is an update of the Cochrane review first published in 2005.

Objectives: To assess the effect of using psychosocial interventions versus usual care or a second psychosocial intervention for preventing and treating depression in patients with ESKD treated with dialysis.

Search Methods: We searched Cochrane Kidney and Transplant's Register of Studies up to 21 June 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.

Selection Criteria: We included randomised controlled trials (RCTs) and quasi-RCTs of psychosocial interventions for prevention and treatment of depression among adults treated with long-term dialysis. We assessed effects of interventions on changes in mental state (depression, anxiety, cognition), suicide, health-related quality of life (HRQoL), withdrawal from dialysis treatment, withdrawal from intervention, death (any cause), hospitalisation and adverse events.

Data Collection And Analysis: Two authors independently selected studies for inclusion and extracted study data. We applied the Cochrane 'Risk of Bias' tool and used the GRADE process to assess evidence certainty. We estimated treatment effects using random-effects meta-analysis. Results for continuous outcomes were expressed as a mean difference (MD) or as a standardised mean difference (SMD) when investigators used different scales. Dichotomous outcomes were expressed as risk ratios. All estimates were reported together with 95% confidence intervals (CI).

Main Results: We included 33 studies enrolling 2056 participants. Twenty-six new studies were added to this 2019 update. Seven studies originally excluded from the 2005 review were included as they met the updated review eligibility criteria, which have been expanded to include RCTs in which participants did not meet criteria for depression as an inclusion criterion. Psychosocial interventions included acupressure, cognitive-behavioural therapy, counselling, education, exercise, meditation, motivational interviewing, relaxation techniques, social activity, spiritual practices, support groups, telephone support, visualisation, and voice-recording of a psychological intervention. The duration of study follow-up ranged between three weeks and one year. Studies included between nine and 235 participants. The mean study age ranged between 36.1 and 73.9 years. Random sequence generation and allocation concealment were at low risk of bias in eight and one studies respectively. One study reported low risk methods for blinding of participants and investigators, and outcome assessment was blinded in seven studies. Twelve studies were at low risk of attrition bias, eight studies were at low risk of selective reporting bias, and 21 studies were at low risk of other potential sources of bias. Cognitive behavioural therapy probably improves depressive symptoms measured using the Beck Depression Inventory (4 studies, 230 participants: MD -6.10, 95% CI -8.63 to -3.57), based on moderate certainty evidence. Cognitive behavioural therapy compared to usual care probably improves HRQoL measured either with the Kidney Disease Quality of Life Instrument Short Form or the Quality of Life Scale, with a 0.5 standardised mean difference representing a moderate effect size (4 studies, 230 participants: SMD 0.51, 95% CI 0.19 to 0.83) , based on moderate certainty evidence. Cognitive behavioural therapy may reduce major depression symptoms (one study) and anxiety, and increase self-efficacy (one study). Cognitive behavioural therapy studies did not report hospitalisation. We found low-certainty evidence that counselling may slightly reduce depressive symptoms measured with the Beck Depression Inventory (3 studies, 99 participants: MD -3.84, 95% CI -6.14 to -1.53) compared to usual care. Counselling reported no difference in HRQoL (one study). Counselling studies did not measure risk of major depression, suicide, or hospitalisation. Exercise may reduce or prevent major depression (3 studies, 108 participants: RR 0.47, 95% CI 0.27 to 0.81), depression of any severity (3 studies, 108 participants: RR 0.69, 95% CI 0.54 to 0.87) and improve HRQoL measured with Quality of Life Index score (2 studies, 64 participants: MD 3.06, 95% CI 2.29 to 3.83) compared to usual care with low certainty. With moderate certainty, exercise probably improves depression symptoms measured with the Beck Depression Inventory (3 studies, 108 participants: MD -7.61, 95% CI -9.59 to -5.63). Exercise may reduce anxiety (one study). No exercise studies measured suicide risk or withdrawal from dialysis. We found moderate-certainty evidence that relaxation techniques probably reduce depressive symptoms measured with the Beck Depression Inventory (2 studies, 122 participants: MD -5.77, 95% CI -8.76 to -2.78). Relaxation techniques reported no difference in HRQoL (one study). Relaxation studies did not measure risk of major depression or suicide. Spiritual practices have uncertain effects on depressive symptoms measured either with the Beck Depression Inventory or the Brief Symptom Inventory (2 studies, 116 participants: SMD -1.00, 95% CI -3.52 to 1.53; very low certainty evidence). No differences between spiritual practices and usual care were reported on anxiety (one study), and HRQoL (one study). No study of spiritual practices evaluated effects on suicide risk, withdrawal from dialysis or hospitalisation. There were few or no data on acupressure, telephone support, meditation and adverse events related to psychosocial interventions.

Authors' Conclusions: Cognitive behavioural therapy, exercise or relaxation techniques probably reduce depressive symptoms (moderate-certainty evidence) for adults with ESKD treated with dialysis. Cognitive behavioural therapy probably increases health-related quality of life. Evidence for spiritual practices, acupressure, telephone support, and meditation is of low certainty . Similarly, evidence for effects of psychosocial interventions on suicide risk, major depression, hospitalisation, withdrawal from dialysis, and adverse events is of low or very low certainty.
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http://dx.doi.org/10.1002/14651858.CD004542.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6886341PMC
December 2019

Diagnostic performance of non-invasive imaging for stable coronary artery disease: A meta-analysis.

Int J Cardiol 2020 02 6;300:276-281. Epub 2019 Nov 6.

Department of Emergency and Organ Transplantation, University of Bari, Italy; School of Public Health, University of Sydney, Australia; Diaverum Medical Scientific Office, Lund, Sweden.

Background: To determine diagnostic performance of non-invasive tests using invasive fractional flow reserve (FFR) as reference standard for coronary artery disease (CAD).

Methods: Medline, Embase, and citations of articles, guidelines, and reviews for studies were used to compare non-invasive tests with invasive FFR for suspected CAD published through March 2017.

Results: Seventy-seven studies met inclusion criteria. The diagnostic test with the highest sensitivity to detect a functionally significant coronary lesion was coronary computed tomography (CT) angiography [88%(85%-90%)], followed by FFR derived from coronary CT angiography (FFR) [85%(81%-88%)], positron emission tomography (PET) [85%(82%-88%)], stress cardiac magnetic resonance (stress CMR) [81%(79%-84%)], stress myocardial CT perfusion combined with coronary CT angiography [79%(74%-83%)], stress myocardial CT perfusion [77%(73%-80%)], stress echocardiography (Echo) [72%(64%-78%)] and stress single-photon emission computed tomography (SPECT) [64%(60%-68%)]. Specificity to rule out CAD was highest for stress myocardial CT perfusion added to coronary CT angiography [91%(88%-93%)], stress CMR [91%(90%-93%)], and PET [87%(86%-89%)].

Conclusion: A negative coronary CT angiography has a higher test performance than other index tests to exclude clinically-important CAD. A positive stress myocardial CT perfusion added to coronary CT angiography, stress cardiac MR, and PET have a higher test performance to identify patients requiring invasive coronary artery evaluation.
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http://dx.doi.org/10.1016/j.ijcard.2019.10.046DOI Listing
February 2020

Fruit and Vegetable Intake and Mortality in Adults undergoing Maintenance Hemodialysis.

Clin J Am Soc Nephrol 2019 02 31;14(2):250-260. Epub 2019 Jan 31.

Diaverum Medical-Scientific Office, Diaverum, Lund, Sweden.

Background And Objectives: Higher fruit and vegetable intake is associated with lower cardiovascular and all-cause mortality in the general population. It is unclear whether this association occurs in patients on hemodialysis, in whom high fruit and vegetable intake is generally discouraged because of a potential risk of hyperkalemia. We aimed to evaluate the association between fruit and vegetable intake and mortality in hemodialysis.

Design, Setting, Participants, & Measurements: Fruit and vegetable intake was ascertained by the Global Allergy and Asthma European Network food frequency questionnaire within the Dietary Intake, Death and Hospitalization in Adults with ESKD Treated with Hemodialysis study, a multinational cohort study of 9757 adults on hemodialysis, of whom 8078 (83%) had analyzable dietary data. Adjusted Cox regression analyses clustered by country were conducted to evaluate the association between tertiles of fruit and vegetable intake with all-cause, cardiovascular, and noncardiovascular mortality. Estimates were calculated as hazard ratios with 95% confidence intervals (95% CIs).

Results: During a median follow up of 2.7 years (18,586 person-years), there were 2082 deaths (954 cardiovascular). The median (interquartile range) number of servings of fruit and vegetables was 8 (4-14) per week; only 4% of the study population consumed at least four servings per day as recommended in the general population. Compared with the lowest tertile of servings per week (0-5.5, median 2), the adjusted hazard ratios for the middle (5.6-10, median 8) and highest (>10, median 17) tertiles were 0.90 (95% CI, 0.81 to 1.00) and 0.80 (95% CI, 0.71 to 0.91) for all-cause mortality, 0.88 (95% CI, 0.76 to 1.02) and 0.77 (95% CI, 0.66 to 0.91) for noncardiovascular mortality and 0.95 (95% CI, 0.81 to 1.11) and 0.84 (95% CI, 0.70 to 1.00) for cardiovascular mortality, respectively.

Conclusions: Fruit and vegetable intake in the hemodialysis population is low and a higher consumption is associated with lower all-cause and noncardiovascular death.
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http://dx.doi.org/10.2215/CJN.08580718DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6390927PMC
February 2019

Reported Māori consumer experiences of health systems and programs in qualitative research: a systematic review with meta-synthesis.

Int J Equity Health 2019 10 28;18(1):163. Epub 2019 Oct 28.

Māori and Indigenous Health Institute, University of Otago Christchurch, 45 Cambridge Terrace, Christchurch, 8140, New Zealand.

Background: Persistent inequities in health experiences and outcomes are observed for Māori compared to non-Māori in Aotearoa New Zealand. We conceptualised factors associated with Māori consumer experiences of health programs and services and characterise how the recommendations arising from qualitative research inform strategies to address inequities.

Methods: In this systematic review, electronic literature searching was conducted in February 2018. Qualitative studies reporting Māori consumer experiences of health services and programs in Aotearoa New Zealand were eligible. Māori consumer experiences of health services were mapped to the WHO Commission of Social Determinants of Health (CSDH) conceptual framework on health inequities as related to: (i) the socioeconomic and political context; (ii) socioeconomic positioning; or (iii) intermediary factors that increase exposure to health-compromising conditions. Recommendations to improve consumer experiences were mapped to the CSDH framework for tackling social determinants of health inequities as policy directions on: (i) unequal consequences of illness (individual interaction); (ii) risks of exposure to health-damaging factors (community); (iii) exposures to health-damaging factors (public policies); and (iv) mitigating effects of socioeconomic and political stratification (environment).

Results: Fifty-four studies were included. Māori consumer experiences mapped to social determinants of health inequities were most frequently related to direct interactions with health services and programs, particularly patient-clinician interactions (communication, relationships) and cultural competencies of clinicians and the system. Key recommendations by researchers mapped to potential strategies to address inequity were identified at all levels of the political, social and health system from individual interactions, community change, and broader public and system-level strategies. Recommendations were predominantly focused on actions to reduce risks of exposure to health-damaging factors including health literacy interventions, increased resources in cultural competencies and Māori capacity in health service development and workforce.

Conclusions: Māori consumer experiences of health services and programs are an important informer of variables that impact health inequity. Strategies to tackle health inequities informed by Māori consumer experiences can be drawn from existing empirical research. Future qualitative exploration of how socioeconomic, political and public policies influence Māori consumer experiences of health services and programs could inform a broader range of structural policies to address health inequities.
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http://dx.doi.org/10.1186/s12939-019-1057-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6816189PMC
October 2019

Interventions for preventing bone disease in kidney transplant recipients.

Cochrane Database Syst Rev 2019 Oct 22;10:CD005015. Epub 2019 Oct 22.

Department of Medicine, University of Otago Christchurch, 2 Riccarton Ave, PO Box 4345, Christchurch, New Zealand, 8140.

Background: People who have chronic kidney disease (CKD) have important changes to bone structure, strength, and metabolism. Children experience bone deformity, pain, and delayed or impaired growth. Adults experience limb and vertebral fractures, avascular necrosis, and pain. The fracture risk after kidney transplantation is four times that of the general population and is related to Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) occurring with end-stage kidney failure, steroid-induced bone loss, and persistent hyperparathyroidism after transplantation. Fractures may reduce quality of life and lead to being unable to work or contribute to community roles and responsibilities. Earlier versions of this review have found low certainty evidence for effects of treatment. This is an update of a review first published in 2005 and updated in 2007.

Objectives: This review update evaluates the benefits and harms of interventions for preventing bone disease following kidney transplantation.

Search Methods: We searched the Cochrane Kidney and Transplant Register of Studies up to 16 May 2019 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.

Selection Criteria: RCTs and quasi-RCTs evaluating treatments for bone disease among kidney transplant recipients of any age were eligible.

Data Collection And Analysis: Two authors independently assessed trial risks of bias and extracted data. Statistical analyses were performed using random effects meta-analysis. The risk estimates were expressed as a risk ratio (RR) for dichotomous variables and mean difference (MD) for continuous outcomes together with the corresponding 95% confidence interval (CI). The primary efficacy outcome was bone fracture. The primary safety outcome was acute graft rejection. Secondary outcomes included death (all cause and cardiovascular), myocardial infarction, stroke, musculoskeletal disorders (e.g. skeletal deformity, bone pain), graft loss, nausea, hyper- or hypocalcaemia, kidney function, serum parathyroid hormone (PTH), and bone mineral density (BMD).

Main Results: In this 2019 update, 65 studies (involving 3598 participants) were eligible; 45 studies contributed data to our meta-analyses (2698 participants). Treatments included bisphosphonates, vitamin D compounds, teriparatide, denosumab, cinacalcet, parathyroidectomy, and calcitonin. Median duration of follow-up was 12 months. Forty-three studies evaluated bone density or bone-related biomarkers, with more recent studies evaluating proteinuria and hyperparathyroidism. Bisphosphonate therapy was usually commenced in the perioperative transplantation period (within 3 weeks) and regardless of BMD. Risks of bias were generally high or unclear leading to lower certainty in the results. A single study reported outcomes among 60 children and adolescents. Studies were not designed to measure treatment effects on fracture, death or cardiovascular outcomes, or graft loss.Compared to placebo, bisphosphonate therapy administered over 12 months in transplant recipients may prevent fracture (RR 0.62, 95% CI 0.38 to 1.01; low certainty evidence) although the 95% CI included the possibility that bisphosphonate therapy might make little or no difference. Fracture events were principally vertebral fractures identified during routine radiographic surveillance. It was uncertain whether any other drug class decreased fracture (low or very low certainty evidence). It was uncertain whether interventions for bone disease in kidney transplantation reduce all-cause or cardiovascular death, myocardial infarction or stroke, or graft loss in very low certainty evidence. Bisphosphonate therapy may decrease acute graft rejection (RR 0.70, 95% CI 0.55 to 0.89; low certainty evidence), while it is uncertain whether any other treatment impacts graft rejection (very low certainty evidence). Bisphosphonate therapy may reduce bone pain (RR 0.20, 95% CI 0.04 to 0.93; very low certainty evidence), while it was very uncertain whether bisphosphonates prevent spinal deformity or avascular bone necrosis (very low certainty evidence). Bisphosphonates may increase to risk of hypocalcaemia (RR 5.59, 95% CI 1.00 to 31.06; low certainty evidence). It was uncertain whether vitamin D compounds had any effect on skeletal, cardiovascular, death, or transplant function outcomes (very low certainty or absence of evidence). Evidence for the benefits and harms of all other treatments was of very low certainty. Evidence for children and young adolescents was sparse.

Authors' Conclusions: Bisphosphonate therapy may reduce fracture and bone pain after kidney transplantation, however low certainty in the evidence indicates it is possible that treatment may make little or no difference. It is uncertain whether bisphosphonate therapy or other bone treatments prevent other skeletal complications after kidney transplantation, including spinal deformity or avascular bone necrosis. The effects of bone treatment for children and adolescents after kidney transplantation are very uncertain.
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http://dx.doi.org/10.1002/14651858.CD005015.pub4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6803293PMC
October 2019
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