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Background and Aims: To validate a set of indicators for monitoring the quality of care of patients with diabetes in 'real-life' practice through its relationship with measurable clinical outcomes and healthcare costs., Methods and Results: A population-based cohort study was carried out by including the 20,635 patients, residents in the Lombardy Region (Italy), who in the year 2012 were newly taken-in-care for diabetes. Adherence with clinical recommendations (i.e., controls for glycated haemoglobin, lipid profile, urine albumin excretion and serum creatinine) was recorded during the first year after the patient was taken-in-care, and categorized according whether he/she complied with none or almost none (0 or 1), just some (2) or all or almost all (3 or 4) the recommendations, respectively denoted as poor, intermediate and high adherence. Short- and long-term complications of diabetes, and healthcare cost incurred by the National Health Service, were assessed during follow-up. Compared with patients with poor adherence, those with intermediate and high adherence respectively showed (i) a delay in outcome occurrence of 13 days (95% CI, -2 to 27) and 23 days (9-38), and (ii) a lower healthcare cost of 54 € and 77 €. In average, a gain of 18 Euros and 15 Euros for each day free from diabetic complication by increasing adherence respectively from poor to intermediate and from poor to high were observed., Conclusion: Close control of patients with diabetes through regular clinical examinations must be considered the cornerstone of national guidance, national audits, and quality improvement incentive schemes., Competing Interests: Declaration of competing interest Giovanni Corrao received research support from the European Community (EC), the Italian Agency of Drug (AIFA), and the Italian Ministry of Education, University and Research (MIUR). He took part to a variety of projects that were funded by pharmaceutical companies (i.e., Novartis, GSK, Roche, AMGEN and BMS). He also received honoraria as member of Advisory Board from Roche. Giuseppe Mancia received honoraria for participation as speaker/chairman in national/international meetings from Bayer, Boehringer Ingelheim, CVRx, Daiichi Sankyo, Ferrer, Medtronic, Menarini Int., Merck, Novartis, Recordati and Servier. Other authors declare that they have no conflict of interest to disclose., (Copyright © 2021 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

Background: Kidney disease is a major global public health problem, and laboratory testing of kidney health measures is essential for diagnosis and monitoring. The availability and affordability of kidney health laboratory tests across countries has not been systematically described., Methods: The International Society of Nephrology (ISN), in partnership with leaders of a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference, surveyed a representative subset of ISN-Global Kidney Health Atlas (ISN-GKHA) respondents from April to June 2020. We assessed the association between country gross national income (GNI) per capita and laboratory testing availability and affordability., Results: Of 33 regional expert nephrologists invited, 24 (73%) responded, representing all 10 ISN regions around the world. Availability of kidney health laboratory tests was as follows: serum Cr (100%), serum cystatin C (67%), urine albumin (96%), urine Cr (100%), and dipstick urinalysis (100%). Median (IQR) reimbursement values in international dollars were as follows: serum Cr Int$ 6.61 (3.42-8.84), serum cystatin C Int$ 31.51 (17.36-46.25), urine albumin Int$ 10.22 (5.90-15.42), urine Cr Int$ 7.50 (1.66-8.84), and dipstick urinalysis Int$ 6.26 (2.56-8.40). Reimbursement values did not differ significantly by World Bank income group or by GNI per capita., Conclusion: There was widespread availability of kidney health laboratory tests and substantial variation in reimbursement values. To achieve meaningful progress across nations in mitigating the growth of kidney disease, access to affordable diagnostic technology is essential. Our results are highly relevant to policymakers and researchers as countries increasingly consider national strategies for kidney disease detection and management., (© 2020 S. Karger AG, Basel.)

Purpose: To quantify the financial implications of eliminating the need for renal function screening before contrast-enhanced MRI., Methods: A HIPAA-complaint, institutional review board-exempt retrospective analysis was conducted of all MRI examinations performed at our quaternary care center over a 12-month period (41,336 examinations; 28,970 with contrast). Examination volume-related data, labor costs, and material costs were assessed and applied to a base case model. Univariate sensitivity analyses were conducted to evaluate the impact of individual components on total cost. Bivariate and multivariate sensitivity analyses were then performed. Medicare data were utilized for reimbursement and net cost analysis., Results: The annual base case cost estimate for point-of-care estimated glomerular filtration rate testing before contrast-enhanced MRI was $126,058. Assuming 100% Medicare reimbursement for point-of-care testing, the net departmental cost was still $78,330. In univariate sensitivity analyses, MRI technologist time and i-Stat cartridge (Abbott Laboratories, Lake Bluff, Illinois) pricing were the biggest cost drivers for labor and materials costs, respectively. In multivariate sensitivity analyses, the lowest cost estimate was $6,845 and the highest cost estimate was $787,257., Conclusion: Recent changes to screening guidelines for group II gadolinium-based contrast agents by the ACR will likely have major financial implications., (Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) estimations of glomerular filtration rate (eGFR), compared to modification of diet in renal disease (MDRD), have superior performance in predicting renal, cardiovascular and mortality events. Cystatin-C further improves prediction. Our primary aim was to assess the change in prevalence and classification of CKD in converting from MDRD to CKD-EPI in an unselected primary care CKD population. Our secondary aims were to determine the eligibility for cystatin-C testing based on National Institute for Health and Care Excellence guidance and the associated costs., Methods: eGFR data from an unselected UK primary care CKD cohort was studied to assess reclassification of CKD stages from MDRD to CKD-EPI, suitability for cystatin-C testing and its associated cost., Results: A total number of 24,660 individuals had ≥2 MDRD eGFR results <60 mL/min/1.73 m2 >3 months apart (7.0% of adult population). The mean age was 75.2 (SD 11.4 years) with 15,265 (61.9%) females. Mean eGFR was 2.88 mL/min/1.73 m2 lower with CKD-EPI eGFR versus MDRD eGFR (49.7 vs. 46.8, t test p < 0.0001, 95% CI 2.85-2.91). 12.0% of individuals were re-categorised to a more or less advanced CKD stage, and 1.3% to a less advanced stage. The percentage of the population categorised as 3a-A1 CKD-EPI and therefore potentially suitable for cystatin-C was 2.8%. The estimated initial cost is €67.5 (£57.2) million with annual costs of €2.7 (£2.3) million for the United Kingdom., Conclusions: The mean eGFR was lower with the CKD-EPI formula and individuals were more likely to be reclassified to more advanced CKD. This may be related to the higher mean age of this unselected population compared to previous studies. Refinements of eGFR formulae, CKD definitions and cystatin-C eligibility in unselected populations are required., (© 2018 S. Karger AG, Basel.)

Aim: No evidence-based approach to the evaluation of CKD has been established. We sought to identify clinical criteria to guide a rational diagnostic approach for the initial evaluation of CKD., Methods: We conducted a retrospective cohort study of 1487 patients presenting for initial evaluation of CKD over 3 years (1/2010-1/2013) to academic nephrology clinics. We utilized the electronic medical record to determine tests ordered, abnormal results and testing that affected diagnosis and/or management. Diagnostic and management yield of testing was defined as the percentage of tests that affected diagnosis and/or management. High yield for a given test was defined as an increased likelihood of the test affecting diagnosis and/or management., Results: We identified clinical criteria predictive of high yield for paraprotein-related testing (one of the following: history of monoclonal disease, high risk of CKD progression, hypercalcemia or haemoglobin < 10.6), and clinical criteria predictive of high yield for glomerulonephritis testing (one of the following: abnormal urine sediment, 3+ or greater hematuria or proteinuria > 500 mg/gm). A prior history of hydronephrosis and renal artery stenosis was predictive of high yield of abnormal renal ultrasound. Higher yield of testing was associated with higher risk progression categories for ANA, SPEP, urine sediment, calcium, PTH, haemoglobin, iron and ferritin. We estimate that initial CKD evaluation costs range from $28 to $109 million/year in US-Medicare expenditure., Conclusion: Numerous tests without significant clinical utility are obtained in initial CKD evaluation. Identifying criteria that can guide diagnostic testing may lead to a more informed and cost-effective approach to evaluation., (© 2015 Asian Pacific Society of Nephrology.)

Purpose: To determine the financial implications of switching technetium (Tc)-99m mercaptoacetyltriglycine (MAG-3) to Tc-99m diethylene triamine penta-acetic acid (DTPA) at certain renal function thresholds before renal scintigraphy., Methods: Institutional review board approval was obtained, and informed consent was waived for this HIPAA-compliant, retrospective, cohort study. Consecutive adult subjects (27 inpatients; 124 outpatients) who underwent MAG-3 renal scintigraphy, in the period from July 1, 2012 to June 30, 2013, were stratified retrospectively by hypothetical serum creatinine and estimated glomerular filtration rate (eGFR) thresholds, based on pre-procedure renal function. Thresholds were used to estimate the financial effects of using MAG-3 when renal function was at or worse than a given cutoff value, and DTPA otherwise. Cost analysis was performed with consideration of raw material and preparation costs, with radiotracer costs estimated by both vendor list pricing and proprietary institutional pricing. The primary outcome was a comparison of each hypothetical threshold to the clinical reality in which all subjects received MAG-3, and the results were supported by univariate sensitivity analysis., Results: Annual cost savings by serum creatinine threshold were as follows (threshold given in mg/dL): $17,319 if ≥1.0; $33,015 if ≥1.5; and $35,180 if ≥2.0. Annual cost savings by eGFR threshold were as follows (threshold given in mL/min/1.73 m(2)): $21,649 if ≤60; $28,414 if ≤45; and $32,744 if ≤30. Cost-savings inflection points were approximately 1.25 mg/dL (serum creatinine) and 60 mL/min/1.73m(2) (eGFR). Secondary analysis by proprietary institutional pricing revealed similar trends, and cost savings of similar magnitude. Sensitivity analysis confirmed cost savings at all tested thresholds., Conclusions: Reserving MAG-3 utilization for patients who have impaired renal function can impart substantial annual cost savings to a radiology department., (Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.)

Background: The prevalence of chronic kidney disease (CKD) is high in general populations around the world. Targeted testing and screening for CKD are often conducted to help identify individuals that may benefit from treatment to ameliorate or prevent their disease progression., Aims: This systematic review examines the methods used in economic evaluations of testing and screening in CKD, with a particular focus on whether test accuracy has been considered, and how analysis has incorporated issues that may be important to the patient, such as the impact of testing on quality of life and the costs they incur., Methods: Articles that described model-based economic evaluations of patient testing interventions focused on CKD were identified through the searching of electronic databases and the hand searching of the bibliographies of the included studies., Results: The initial electronic searches identified 2,671 papers of which 21 were included in the final review. Eighteen studies focused on proteinuria, three evaluated glomerular filtration rate testing and one included both tests. The full impact of inaccurate test results was frequently not considered in economic evaluations in this setting as a societal perspective was rarely adopted. The impact of false positive tests on patients in terms of the costs incurred in re-attending for repeat testing, and the anxiety associated with a positive test was almost always overlooked. In one study where the impact of a false positive test on patient quality of life was examined in sensitivity analysis, it had a significant impact on the conclusions drawn from the model., Conclusion: Future economic evaluations of kidney function testing should examine testing and monitoring pathways from the perspective of patients, to ensure that issues that are important to patients, such as the possibility of inaccurate test results, are properly considered in the analysis.

Purpose: To assess whether selective use of estimated glomerular filtration rate (eGFR) in patients with risk factors for kidney disease is more cost-effective than measuring eGFR in all patients undergoing contrast-enhanced computed tomography (CECT)., Methods: Risk factors and costs were assessed in consecutive patients. eGFR was evaluated in all patients, considering a tenability of 12 months. For the three-month tenability and the pre-selection strategy based on risk factors for kidney disease, we extrapolated data by assuming equal distribution of patient characteristics., Results: We included 1001 patients, mean age 59.9 ± 13.6 years. Strategy with eGFR in all patients: eGFR measurements specifically performed for CECT in 645/1001 (in 356 patients the eGFR was already known). The total cost including costs of an extra visit to the hospital (49 patients) and absence from work (11 patients) were € 6037.20. Considering a tenability of 3 months, eGFR had to be measured in 786 patients, 60 would have paid an extra visit and 14 would have been absent from work: total cost € 7443.54. Pre-selection strategy: 807 patients had risk factors, necessitating eGFR measurement and an extra visit would be paid by 61. Fourteen patients would have been absent from work: total cost € 7585.16. Of the patients with an eGFR <60 ml/min/1.73 m(2), 94.8% were identified including all with an eGFR <45 ml/min/1.73 m(2)., Conclusion: Determining eGFR based on risk factors for kidney disease is not more cost-effective than eGFR testing in all patients if the eGFR is tenable for 12 months or for 3 months.

Background: In 2008, several Nigerian children developed acute kidney injury (AKI) after ingesting teething syrup contaminated with diethylene glycol (DEG). Because there are limited diagnostic facilities in resource-constrained countries, this study investigated whether AKI associated with DEG could be identified by other means., Methods: This was a multicenter study. Information was obtained from hospital records. Clinicopathological features of all children with AKI over a 6-month period were reviewed., Results: Sixty (50.4%) of 119 children ingested "My pikin" teething syrup. Compared to children who had not ingested it, they were significantly (p < 0.05) younger (11.95 vs. 31 months), more were anuric (98.3 vs. 74.6%), hypertensive (84 vs. 52%), had severe metabolic acidosis (46.7 vs. 20.5%), and died (96.6 vs. 71.2%). They developed increasing metabolic acidosis and multiorgan dysfunction despite peritoneal dialysis. Late presentation, financial difficulties, inadequate facilities for toxicology, and hemodialysis complicated management., Conclusions: Identifying AKI associated with DEG is difficult. Detailed drug history, increasing metabolic acidosis, and multiorgan deterioration despite peritoneal dialysis should arouse suspicion. Simple diagnostic tests need to be developed and facilities for hemodialysis of infants and financial support provided. Recurrences can be prevented by creating awareness, improving manufacturing practices, field-testing of drugs, and international monitoring of pharmaceuticals imported for manufacture.

Background: Clinical practice guidelines were established to improve the diagnosis and management of chronic kidney disease (CKD), but the extent, determinants, and cost implications of guideline adherence and variation in adherence have not been evaluated., Study Design: Cross-sectional survey., Settings & Participants: The questionnaire was sent (on paper or through the internet) to a nationally representative sample of 1,200 US primary care physicians and nephrologists., Predictor: Provider and patient characteristics., Outcomes & Measurements: Guideline adherence was assessed as present if physicians recommended at least 5 of 6 clinical tests prescribed by the National Kidney Foundation's Kidney Disease Outcomes and Quality Initiative guidelines for a hypothetical patient with newly identified CKD. We also assessed patterns and costs of additional nonrecommended tests for the initial clinical evaluation of CKD., Results: Of the 301 (86 family medicine, 89 internal medicine, and 126 nephrology) eligible physicians who responded to the survey (response rate, 32%), most practiced longer than 10 years (54%), were in nonacademic practices (76%), spent greater than 80% of their time performing clinical duties (77%), and correctly estimated kidney function (73%). Overall, 35% of participants were guideline adherent. Compared with nephrologists, internal medicine and family physicians had lower odds of adherence for all recommended testing (odds ratio, 0.6; 95% confidence interval, 0.3 to 1.1; and odds ratio, 0.3; 95% confidence interval, 0.1 to 0.6, respectively). Participants practicing longer than 10 years had lower odds of ordering all recommended testing compared with participants practicing fewer than 10 years (odds ratio, 0.5; 95% confidence interval, 0.3 to 0.9). Eighty-five percent of participants recommended additional tests, which resulted in a 23% increased total per-patient cost of the clinical evaluation., Limitations: Recommendations for a hypothetical case scenario may differ from those of actual patients., Conclusions: Adherence to recommended clinical testing for the diagnosis and management of CKD was poor, and additional testing was associated with substantially increased cost of the clinical evaluation. Improved clarity, dissemination, and uptake of existing guidelines are needed to improve quality and decrease costs of care for patients with CKD.

Background and Objectives: The prevalence of chronic kidney disease (CKD) has increased over the past two decades. The sensitivity of serum creatinine (sCr) to identify CKD is low. As a result, many healthcare centers report estimated GFR (eGFR) with routine blood work. The aim of this study was to determine the cost-effectiveness of automatic eGFR reporting compared with reporting sCr alone., Design, Setting, Participants, & Measurements: A Markov model was designed to evaluate the cost-effectiveness of reporting eGFR compared with reporting sCr alone in a hypothetical cohort of 60-yr-old individuals undergoing annual blood chemistry testing over 18 yr. Paths and path probabilities were identical between the two arms, except for the sensitivity and specificity of eGFR and sCr to detect CKD., Results: eGFR reporting was dominant with a cost/effectiveness ratio of $16,751/quality-adjusted life year (QALY) versus $16,779/QALY for sCr reporting. Monte Carlo microsimulations in a hypothetical cohort of 10,000 patients demonstrated that over 18 yr, an average of 13 fewer deaths, 29 fewer ESRD events, and 11,348 more false positive CKD (FP-CKD) cases occurred with eGFR reporting. A sensitivity analysis revealed that decreasing the FP-CKD quality of life by > 2% rendered sCr reporting more cost-effective than eGFR reporting. If FP-CKD reduced quality of life by 5%, the incremental cost-effectiveness ratio for sCr reporting versus eGFR reporting would be $4367/QALY., Conclusion: A decision analysis suggests that reporting eGFR may be beneficial, but this limited benefit was reversed with virtually any reduction in quality of life caused by incorrect diagnosis of CKD.

Assessment of glomerular filtration rate (GFR) in heart transplant (HTx) patients is based on serum creatinine (sCr), the endogenous creatinine clearance (C(Cr)) and radionuclide GFR (rGFR); however, the latter is expensive and time consuming. We reviewed the data of 32 adult HTx patients to determine the correlation between sCr, C(Cr), the calculated C(Cr) (Calc.C(Cr); based on gender, age, weight and sCr) and rGFR in long-term (>1 year) HTx patients receiving calcineurin inhibitors. The Calc.C(Cr) was found to have the best correlation with rGFR (r(2) = 0.65), followed by C(Cr) (r(2) = 0.53) and sCr (r(2) = 0.38). The use of Calc.C(Cr) to estimate GFR may be cost-effective in assessing renal function after HTx.

Objective: The authors' goal was to determine the extent and pattern of blood serum monitoring of mood stabilizers in Medicaid patients with bipolar disorder., Method: Data were drawn from a Medicaid medical claims data set from Pittsburgh and the surrounding region. The authors identified bipolar patients using lithium, valproate, and carbamazepine (N = 718) and then examined the patient demographic, diagnostic, and service use variables associated with therapeutic drug monitoring., Results: A substantial proportion of lithium users (36.5%), valproate users (42.4%), and carbamazepine users (42.2%) with bipolar disorder diagnoses did not receive therapeutic drug level testing during the 12-month study period. Carbamazepine users who were male or in the 30-49-year age range were significantly less likely to be tested for serum drug level. Lithium users who did not receive partial-hospitalization psychiatric services and valproate users who received mental health case management were also less likely to be tested for serum drug level. Over one-half of the lithium users (54.1%) did not receive thyroid function tests, and few (4.2%) received renal function tests. Patients who did receive tests for serum drug level were likely to receive the other recommended tests., Conclusions: Many Medicaid patients with bipolar disorder received no therapeutic drug monitoring. Patient sociodemographic characteristics contributed little to explaining this omission, although some types of service utilization were related to rates of serum drug level testing.

Traditional measurements of glomerular filtration rate (GFR) in clinical practice include the measurement of serum creatinine or creatinine clearance. Increasing evidence concerning the limitation of these measurements in clinical practice and clinical trials has resulted in efforts to develop technologies that improve measurement of GFR. Recent efforts in that regard have used radioisotopic labeling of markers of GFR, such as 125I-iothalamate, and 51Cr-ethylenediaminetetraacetic acid. Limitations of these technologies include radiation exposure as well as cost considerations for the management of radioisotopes, including safety, disposal, mailing, and deteriorating activity that results in short shelf life. We report a test that used 0.5 mL Conray dye injected subcutaneously and subsequent measurement of the nonisotopic (cold) iothalamate by capillary electrophoresis in blood and urine. GFR using cold iothalamate compared with standard clearance using 125I-iothalamate was 0.99. The method is cost-effective and allows for avoiding exposure to isotopes, as well as problems such as the disposal and short shelf life of isotopes. This technology could allow for replacement of 125I-iothalamate as a marker for GFR.

This paper deals with the examination of urine and blood specimens and the renal function test specifically as they relate to the diagnosis of tubulointerstitial nephropathy. The diagnostic significance of urinalysis, measurement of creatinine, creatinine clearance, fractional excretion, beta 2-microglobulin, alpha 1-microglobulin, N-acetyl-glucosaminidase and free water clearance, the Fishberg concentration test and the ammonium chloride loading test is discussed in the evaluation of tubulointerstitial disorder. Physicians must choose the most appropriate ones among the many examinations and tests also from the viewpoints of minimal invasiveness and cost-effectiveness.

Test programmes for early detection of renal dysfunction are urgently needed. They should be adapted to the population under investigation, whether the general population or an occupationally or medically exposed population. At present, there is no clinically relevant definition of renal dysfunction on the basis of pathological test results. Due to the complex function and structure of the kidney, measurement of a single parameter is not sufficient for early detection of renal dysfunction. However, any prophylactic and prospective protocol should take into account the sensitivity and specificity of the applied tests, the amount of work involved and the possible positive effects for the population at risk.