Screening for acquired cystic kidney disease: A decision analytic perspective

Screening for acquired cystic kidney disease: A decision analytic perspective. Acquired cystic kidney disease (ACKD) increases the risk of renal malignancy, and many authors suggest routine screening of dialysis patients for ACKD and renal tumors. However, they have defined neither the target population, the optimal screening strategy, the magnitude of its benefit, nor its risk. We used decision analysis to evaluate strategies of performing either computed tomography (CT) or ultrasound every three years on all dialysis patients and annually on patients found to have cysts. We compared these strategies to a strategy of seeking cysts and cancer only if these are clinically suspected. The baseline analysis shows that both CT and ultrasound may decrease cancer deaths by half for patients with a life expectancy of 25 years. Screening for ACKD offers these patients as much as a 1.6 year gain in life expectancy. However, for the majority of patients beginning renal replacement therapy, age or comorbid disease substantially limits life expectancy. For such patients, the gain in life expectancy from an ACKD screening program is measured in days. Sensitivity analyses show that the benefit of screening depends on the rate of malignant transformation, which needs better definition. The gain in life expectancy does not appear to be large enough to justify an ACKD screening program for the entire ESRD population. However, for the youngest and healthiest patients, a screening program would be of benefit. The magnitude of this benefit is uncertain, because the analysis was consistently biased in favor of the screening strategies

Evaluation of the long-term efficacy and safety of an imidacloprid 10%/flumethrin 4.5% polymer matrix collar (Seresto®) in dogs and cats naturally infested with fleas and/or ticks in multicentre clinical field studies in Europe

<p>Abstract</p> <p>Background</p> <p>The objective of these two GCP multicentre European clinical field studies was to evaluate the long-term efficacy and safety of a new imidacloprid/flumethrin collar (Seresto^®, Bayer AnimalHealth, Investigational Veterinary Product(IVP)) in dogs and cats naturally infested with fleas and/or ticks in comparison to a dimpylat collar ("Ungezieferband fuer Hunde/fuer Katzen", Beaphar, Control Product (CP)).</p> <p>Methods</p> <p>232 (IVP) and 81 (CP) cats and 271(IVP) and 129 (CP) dogs were treated with either product according to label claims and formed the safety population. Flea and tick counts were conducted in monthly intervals for up to 8 months in the efficacy subpopulation consisting of 118 (IVP) + 47 (CP) cats and 197 (IVP) + 94 (CP) dogs. Efficacy was calculated as reduction of infestation rate within the same treatment group and statistically compared between the two treatment groups.</p> <p>Results</p> <p>Preventive efficacy against fleas in cats/dogs varied in the IVP group between 97.4%/94.1% and 100%/100% (overall mean: 98.3%/96.7%) throughout the 8 month period and in the CP group between 57.1%/28.2% and 96.1%/67.8% (overall mean: 79.3%/57.9%). Preventive efficacy against ticks in cats/dogs varied in the IVP group between 94.0%/91.2% and 100%/100% (overall mean: 98.4%/94.7%) throughout the 8 month period and in the CP group between 90.7%/79.9% and 100%/88.0% (overall mean: 96.9%/85.6%). The IVP group was statistically non-inferior to the CP group, and on various assessment days, statistical superiority was proven for flea and tick count reduction in dogs and cats. Both treatments proved to be safe in dogs and cats with mainly minor local observations at the application site. There was moreover, no incidence of any mechanical problem with the collar in dogs and cats during the entire study period.</p> <p>Conclusions</p> <p>The imidacloprid/flumethrin collar proved to reduce tick counts by at least 90% and flea counts by at least 95% for a period of at least 7-8 months in cats and dogs under field conditions. Therefore, it can be used as sustainable long-term preventative, covering the whole flea and tick season.</p

Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure &lt; 100 mmHg (n = 1127), estimated glomerular filtration rate &lt; 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

Improving CKD-Specific Patient-Reported Measures of Health-Related Quality of Life

BACKGROUND: Patient-reported outcome measures that are more practical and clinically useful are needed for patients with CKD. We compared a new CKD-specific quality-of-life impact scale (CKD-QOL) with currently used measures. METHODS: Patients (n=485) in different treatment groups (nondialysis stages 3-5, on dialysis, or post-transplant) completed the kidney-specific CKD-QOL and Kidney Disease Quality of Life-36 (KDQOL-36) forms and the generic SF-12 Health Survey at baseline and 3 months. New items summarizing quality of life (QOL) impact attributed to CKD across six QOL domains yielded single impact scores from a six-item static (fixed-length) form and from computerized adaptive tests (CATs) with three to six items. Validity tests compared the CKD-QOL, KDQOL-36 (Burden, Effects, and Symptoms/Problems subscales), and generic SF-12 measures across groups in four tests of clinical status and clinician assessment of change (CKD-specific tests), and number of comorbidities. ANOVA was used to test for group mean differences, variances in each measure explained by groups, and relative validity (RV) in comparison with the referent KDQOL-36 Burden subscale. RESULTS: KDQOL-36 and CKD-QOL measures generally discriminated better than generic SF-12v2 measures. The pattern of variances across CKD-specific tests comparing validity favored CKD-QOL two-fold over KDQOL-36. Two RV test results confirmed CKD-QOL improvements over the referent KDQOL scale. Results for static and CAT CKD-QOL forms were similar. SF-12 Physical and KDQOL-36 Symptoms scores worsened with increasing comorbid condition counts. CONCLUSIONS: Overall, compared with the KDQOL-36, the new approach to summarizing CKD-specific QOL impact performed better across multiple tests of validity. CAT surveys were more efficient than static surveys

Hemodialysis patient characteristics associated with better experience as measured by the In-center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) survey

Abstract Background Patient experience in hemodialysis (HD) is measured twice yearly in all in-center HD patients in the United States using the In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) survey. Survey scores are publically available and incorporated into the dialysis payment system. Despite its importance, little is known about factors associated with better experience scores. We studied the association between patient-level characteristics and experience scores in a large real-world cohort of HD patients. Methods This is a cross-sectional analysis of ICH CAHPS administration in 2012. All in-center HD patients in Dialysis Clinic, Incorporated facilities nationally over 18 years old and receiving HD at their facility for at least 3 months were eligible. Predictors include patient demographic, clinical, and treatment-related characteristics. Outcomes include high global rating scores across three domains (Nephrologist, Dialysis Staff, Dialysis Center) and high composite scores across three domains (Nephrologists’ Communication and Caring, Quality of Dialysis Center Care and Operations, and Providing Information to Patients). Results Among 3369 respondents, older age and telephone (vs. mail) administration of the survey were associated with higher global ratings, while shortened HD treatments were associated with lower global ratings. Lower education and telephone administration were associated with higher composite scores, while older age, and shortened HD treatments were associated with lower composite scores. Conclusions Several patient characteristics and mode of survey administration are associated with higher experience scores. Future research should assess HD facility characteristics associated with higher scores and interventions that might improve experience accounting for these associations