Development of an international standard set of value-based outcome measures for patients with chronic kidney disease : a report of the International Consortium for Health Outcomes Measurement (ICHOM) CKD working group

Value-based health care is increasingly promoted as a strategy for improving care quality by benchmarking outcomes that matter to patients relative to the cost of obtaining those outcomes. To support the shift toward value-based health care in chronic kidney disease (CKD), the International Consortium for Health Outcomes Measurement (ICHOM) assembled an international working group of health professionals and patient representatives to develop a standardized minimum set of patient-centered outcomes targeted for clinical use. The considered outcomes and patient-reported outcome measures were generated from systematic literature reviews. Feedback was sought from patients and health professionals. Patients with very high-risk CKD (stages G3a/A3 and G3b/A2-G5, including dialysis, kidney transplantation, and conservative care) were selected as the target population. Using an online modified Delphi process, outcomes important to all patients were selected, such as survival and hospitalization, and to treatment-specific subgroups, such as vascular access survival and kidney allograft survival. Patient-reported outcome measures were included to capture domains of health-related quality of life, which were rated as the most important outcomes by patients. Demographic and clinical variables were identified to be used as case-mix adjusters. Use of these consensus recommendations could enable institutions to monitor, compare, and improve the quality of their CKD care

Rationale and design of a proof-of-concept trial investigating the effect of uninterrupted perioperative (par)enteral nutrition on amino acid profile, cardiomyocytes structure, and cardiac perfusion and metabolism of patients undergoing coronary artery bypass grafting

<p>Abstract</p> <p>Background</p> <p>Malnutrition is very common in patients undergoing cardiac surgery. Malnutrition can change myocardial substrate utilization which can induce adverse effects on myocardial metabolism and function. We aim to investigate the hypothesis that there is a disturbed amino acids profile in the cardiac surgical patient which can be normalized by (par)enteral nutrition before, during and after surgery, subsequently improving cardiomyocyte structure, cardiac perfusion and glucose metabolism.</p> <p>Methods/Design</p> <p>This randomized controlled intervention study investigates the effect of uninterrupted perioperative (par)enteral nutrition on cardiac function in 48 patients undergoing coronary artery bypass grafting. Patients are given enteral nutrition (n = 16) or parenteral nutrition (n = 16), at least two days before, during, and two days after coronary artery bypass grafting, or are treated according to the standard guidelines (control) (n = 16). We will illustrate the effect of (par)enteral nutrition on differences in concentrations of amino acids and asymmetric dimethylarginine and in activity of dimethylarginine dimethylaminohydrolase and arginase in cardiac tissue and blood plasma. In addition, cardiomyocyte structure by histological, immuno-histochemical and ultrastructural analysis will be compared between the (par)enteral and control group. Furthermore, differences in cardiac perfusion and global left ventricular function and glucose metabolism, and their changes after coronary artery bypass grafting are evaluated by electrocardiography-gated myocardial perfusion scintigraphy and ¹⁸F-fluorodeoxy-glucose positron emission tomography respectively. Finally, fat free mass is measured before and after intervention with bioelectrical impedance spectrometry in order to evaluate nutritional status.</p> <p>Trial registration</p> <p>Netherlands Trial Register (NTR): <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2183">NTR2183</a></p

Development of an International Standard Set of Value-Based Outcome Measures for Patients With Chronic Kidney Disease

Value-based health care is increasingly promoted as a strategy for improving care quality by benchmarking outcomes that matter to patients relative to the cost of obtaining those outcomes. To support the shift toward value-based health care in chronic kidney disease (CKD), the International Consortium for Health Outcomes Measurement (ICHOM) assembled an international working group of health professionals and patient representatives to develop a standardized minimum set of patient-centered outcomes targeted for clinical use. The considered outcomes and patient-reported outcome measures were generated from systematic literature reviews. Feedback was sought from patients and health professionals. Patients with very high-risk CKD (stages G3a/A3 and G3b/A2-G5, including dialysis, kidney transplantation, and conservative care) were selected as the target population. Using an online modified Delphi process, outcomes important to all patients were selected, such as survival and hospitalization, and to treatment-specific subgroups, such as vascular access survival and kidney allograft survival. Patient-reported outcome measures were included to capture domains of health-related quality of life, which were rated as the most important outcomes by patients. Demographic and clinical variables were identified to be used as case-mix adjusters. Use of these consensus recommendations could enable institutions to monitor, compare, and improve the quality of their CKD care

Hospital Utilization and Costs in Older Patients with Advanced Chronic Kidney Disease Choosing Conservative Care or Dialysis: A Retrospective Cohort Study

Background: Nondialytic conservative care has been recognized as a viable alternative to chronic dialysis in older patients with end-stage kidney disease, but little is known about its consequences on hospital utilization and costs. Methods: We performed a retrospective cohort study to compare outpatient and inpatient hospital utilization, place of death, and hospital costs in patients aged ≥70 years old who chose conservative care (n = 100) or dialysis (n = 162) after shared decision making in a nonacademic teaching hospital between 2008 and 2016. Results: Patients who chose conservative care were older than patients who chose dialysis (82.5 vs. 76.3 years). Comorbidity did not differ between the 2 patient groups. The incidence rates of outpatient visits per year were 7.1 in patients who chose conservative care and 10.7 in patients who chose dialysis (incidence rate ratio 0.67, 95% CI 0.55-0.81). The incidence rates of in-hospital days per year were, respectively, 6.0 and 9.8 (incidence rate ratio 0.50, 95% CI 0.29-0.88). Also in the final month of life, patients on conservative care had less outpatient visits, were less frequently hospitalized, and died less frequently in hospital than the dialysis patient group. The cost rates per year, measured from original treatment decision, were EUR 5,859 in conservative care patients and EUR 28,354 in patients who chose dialysis comprising both the predialysis and dialysis period (cost rate ratio 0.42, 95% CI 0.27-0.65). Patients who chose dialysis had higher costs on dialysis sessions, outpatient care, inpatient care, laboratory tests, and medical imaging. Conclusions: Patients who decided to forego dialysis and chose conservative care had less outpatient and inpatient hospital utilization than patients who chose dialysis, including less intensive hospital utilization near the end of life. Both overall and nondialysis-related costs were lower in patients on a conservative care pathway

Reanalysis of the physical and mental health summary scores of dialysis versus conservative care in older patients with advanced chronic kidney disease : A critical appraisal

Objective: Non-dialytic conservative care is argued to be a reasonable treatment alternative for dialysis in selected older patients with advanced chronic kidney disease. We evaluated patient-relevant outcomes including health-related quality of life in a previous study. However, the scoring algorithm we used to calculate the physical and mental component summary scores of the Short Form-36 (SF-36) turned out to differ from comparable studies on this topic. The aim of this critical appraisal was to reanalyze the SF-36 summary scores in our patient cohort (≥ 70 years) using the more widely used scoring algorithm. Results: Patients on conservative care (n = 23) had lower physical and mental component summary scores compared to patients not yet started on dialysis (n = 39), but similar compared to patients on dialysis (n = 34). These findings were similar to our original findings and did not change the conclusions. Several scoring algorithms are used for the SF-36 summary scores. Researchers should be aware of this fact and should use the same scoring algorithm across similar studies in a specific field to increase comparability. Using the more widely used scoring algorithm, the recalculated SF-36 summary scores of our patient cohort can now be compared to other studies

Older patients' experiences with a shared decision-making process on choosing dialysis or conservative care for advanced chronic kidney disease: a survey study

Background: Many older patients approaching end-stage kidney disease have to decide whether to go for dialysis or non-dialytic conservative care (CC). Shared decision-making is recommended to align the treatment plan with the patient's preferences and values. Little is known about older patients' experiences with shared decision-making on dialysis or CC. Methods: We performed a survey study, in collaboration with the Dutch Kidney Patients Association, in 99 patients aged ≥70 years who had chosen dialysis (n = 75) or CC (n = 24) after a shared decision-making process involving an experienced multidisciplinary team. Results: Patients stated to be overall satisfied with the shared decision-making process (% with score 6-10 on 11-point Likert scale, dialysis versus CC: 93% vs. 91%, P = 0.06), and treatment decision (87% vs. 91%, P = 0.03). However, patients also reported negative experiences, especially those who had chosen dialysis. Such negative experiences were related to the timing, informing, and level of decision-making being shared. More patients who selected dialysis indicated to have felt forced to make a decision, mostly due to the circumstances, such as their deteriorating health or kidney function, or by their nephrologist (31% vs. 5%, P = 0.01). Also, patients who selected dialysis mentioned a perceived lack of choice as most common reason for choosing dialysis, and 55% considered their own opinion as most important rather than their nephrologists' or relatives' opinion compared to 90% of the patients who had chosen CC (P = 0.02). A subset of patients who had chosen dialysis still doubted their treatment decision compared to no patient who had chosen CC (17% vs. 0%, P = 0.03). Conclusions: Older patients reported contrasting experiences with shared decision-making on dialysis or CC. Despite high overall satisfaction, the underlying negative experiences illustrate important but modifiable barriers to an optimal shared decision-making process

Value-based evaluation of dialysis versus conservative care in older patients with advanced chronic kidney disease: a cohort study

Abstract Background Conservative care is argued to be a reasonable treatment alternative for dialysis in older patients with advanced chronic kidney disease (CKD). However, comparisons are scarce and generally focus on survival only. Comparative data on more patient-relevant outcomes are needed to truly foster shared decision-making on an individual level, and cost comparison is needed to assess value of care. Methods We conducted a retrospective observational single-center cohort study in 366 patients aged ≥70 years with advanced CKD, who chose dialysis (n = 240) or conservative care (n = 126) after careful counselling by a multidisciplinary team in a non-academic teaching hospital in The Netherlands. Using a value-based health care approach (value = outcomes/cost): survival, health-related quality of life—cross-sectionally assessed with the Kidney Disease Quality of Life Short Form™—treatment burden, and treatment costs were evaluated. Results The overall survival benefit of patients on a dialysis pathway compared with patients on conservative care diminished or lost significance in patients aged ≥80 years or with severe comorbidity. There were no differences between patients managed conservatively and dialysis patients on physical and mental health summary scores (all P > 0.1). Patients on conservative care had 352.7 hospital free days per year versus 282.7 in patients on a dialysis pathway, calculated from treatment decision (adjusted incidence rate ratio: 1.15, 95% confidence interval: 1.09 to 1.21, P <  0.001). Annual treatment costs were lower in patients on conservative care (adjusted cost ratio: 0.43, 95% confidence interval: 0.28 to 0.67, P <  0.001). Conclusions In this study, conservative care is shown to be a viable treatment option in older patients with advanced CKD, particularly in the oldest old and those with severe comorbidity. By achieving similar outcomes at lower treatment burden and treatment costs, value was generated for older patients choosing conservative care and society

Differential Effects of Nonselective Versus Selective beta-Blockers on Cardiac Sympathetic Activity and Hemostasis in Patients with Heart Failure

<p>Carvedilol, a nonselective beta-blocker, may be more effective than the selective beta-blocker metoprolol in reducing the risk of thromboembolic events in heart failure. The aim of this study was, first, to assess whether there is a differential response in cardiac sympathetic activity by I-123-meta-iodobenzylguanidine (I-123-MIBG) imaging when either beta-blocker is used. Second, we assessed whether that response correlates with levels of various serum factors that serve as markers for coagulability. Methods: In this prospective, randomized, open-label crossover study with masked outcome assessments, stable heart failure patients (left ventricular ejection fraction <40%) homozygous for the Arg16/Gln27 (n = 13) or Gly16/Glu27 haplotype (n = 8) of the beta(2)-receptor were randomized to equipotent dosages of carvedilol or metoprolol for two 6-wk periods. Primary outcome was sympathetic activity as measured by I-123-MIBG myocardial washout. Secondary outcomes included markers of hemostasis. Results: I-123-MIBG cardiac washout was lower during carvedilol than metoprolol treatment (12.9% +/- 3.9% vs. 22.1% +/- 2.8%, respectively, P = 0.003), irrespective of beta(2)-adrenergic receptor haplotype. In addition, treatment with carvedilol resulted in a lower von Willebrand factor than did metoprolol (149% +/- 13% vs. 157% +/- 13%, respectively, P = 0.01), irrespective of beta(2)-adrenergic receptor haplotype. Conclusion: Compared with metoprolol, carvedilol resulted in greater reduction of sympathetic activity after 6 wk of treatment and lower von Willebrand factor concentrations in both Arg16/Gln27 and Gly16/Glu27 individuals. Therefore, carvedilol may reduce the risk of thromboembolic events in patients with heart failure, irrespective of beta(2)-receptor haplotype status.</p>

Brown adipose tissue volume in healthy lean south Asian adults compared with white Caucasians: a prospective, case-controlled observational study

Individuals of south Asian origin have a very high risk of developing type 2 diabetes compared with white Caucasians. We aimed to assess volume and activity of brown adipose tissue (BAT), which is thought to have a role in energy metabolism by combusting fatty acids and glucose to produce heat and might contribute to the difference in incidence of type 2 diabetes between ethnic groups. We enrolled Dutch nationals with south Asian ancestry and matched Caucasian participants at The Rijnland Hospital (Leiderdorp, Netherlands). Eligible participants were healthy lean men aged 18-28 years, and we matched groups for BMI. We measured BAT volume and activity with cold-induced (18)F-fluorodeoxyglucose ((18)F-FDG) PET CT scans, and assessed resting energy expenditure, non-shivering thermogenesis, and serum parameters. This study is registered with the Netherlands Trial Register, number 2473. Between March 1, 2013, and June 1, 2013, we enrolled 12 participants in each group; one Caucasian participant developed hyperventilation after (18)F-FDG administration, and was excluded from all cold-induced and BAT measurements. Compared with Caucasian participants, south Asian participants did not differ in age (mean 23.6 years [SD 2.8] for south Asians vs 24.6 years [2.8] for Caucasians) or BMI (21.5 kg/m(2) [2.0] vs 22.0 kg/m(2) [1.6]), but were shorter (1.74 m [0.06] vs 1.85 m [0.04]) and lighter (65.0 kg [8.5] vs 75.1 kg [7.2]). Thermoneutral resting energy expenditure was 1297 kcal per day (SD 123) in south Asian participants compared with 1689 kcal per day (193) in white Caucasian participants (difference -32%, p=0.0008). On cold exposure, shiver temperature of south Asians was 2.0°C higher than Caucasians (p=0.0067) and non-shivering thermogenesis was increased by 20% in white Caucasians (p <0.0001) but was not increased in south Asians. Although the maximum and mean standardised uptake values of (18)F-FDG in BAT did not differ between groups, total BAT volume was lower in south Asians (188 mL [SD 81]) than it was in Caucasians (287 mL [169]; difference -34%, p=0.04). Overall, BAT volume correlated positively with basal resting energy expenditure in all assessable individuals (β=0.44, p=0.04). Lower resting energy expenditure, non-shivering thermogenesis, and BAT volumes in south Asian populations might underlie their high susceptibility to metabolic disturbances, such as obesity and type 2 diabetes. Development of strategies to increase BAT volume and activity might help prevent and treat such disorders, particularly in south Asian individuals. Dutch Heart Foundation (2009T038) and Dutch Diabetes Research Foundation (2012.11.1500