Development and validation of an end stage kidney disease awareness survey: Item difficulty and discrimination indices.

INTRODUCTION: Lack of awareness for chronic kidney disease (CKD), including end stage kidney disease (ESKD) and their management options is a major impediment to patients being able to select and use home dialysis therapies. While some instruments have been developed to measure CKD awareness, we lack validated instruments to evaluate patients' awareness of ESKD and dialysis modalities. This study is part of multipart project for developing and validating an ESKD-centric disease awareness questionnaire. METHODS: A team of specialty renal care experts developed a 45-items questionnaire encompassing the subdomains of General Kidney Knowledge, CKD Knowledge, and ESKD Knowledge. Item reduction analysis-specifically, calculation of item difficulty and item discrimination index scores-was used to items for further review and potential removal. RESULTS: Index scores were reviewed in conjunction with consideration of theoretical and substantive item content to reduce the number of items in the questionnaire, resulting in a 32-item questionnaire, retaining 5/10 items in the general kidney knowledge subdomain, 14/21 items in the CKD knowledge subdomain, and 13/14 items in the ESKD knowledge subdomain. Retained items ranged from 0.19 to 0.79 on the difficulty index, and from 0.31 to 0.81 on the discrimination index. Scores for percent correct on the reduced questionnaire spanned 0% to 87.5% correct on the full scale, 0% to 100% correct on the General Knowledge subdomain, 0% to 100% on the CKD Knowledge subdomain, and 0% to 92.3% on ESKD Knowledge subdomain. CONCLUSIONS: The questionnaire developed and refined in this study constitutes a patient disease awareness instrument that spans a range of difficulty, and yet shows strong ability to distinguish between patients with varying levels of disease awareness. This study is the first in part of a multistep project to addresses a gap in measuring ESKD specific knowledge. Accurate assessment of patients' disease awareness through a validated instrument can allow identification of knowledge domains leading to positive impacts on their healthcare decisions and improve targeted patient education efforts.

What do the US advanced kidney disease patients want? Comprehensive pre-ESRD Patient Education (CPE) and choice of dialysis modality.

Improvement in Home Dialysis (HoD) utilizations as a mean to improve the patient reported and health services outcomes, has been a long-held goal of the providers and healthcare system in United States. However, measures to improve HoD rates have yielded limited success so far. Lack of patient awareness of chronic kidney disease (CKD) and its management options, is one of the important barriers against patient adoption of HoD. Despite ample evidence that Comprehensive pre-ESERD Patient Education (CPE) improves patient awareness and informed HoD choice, use of CPE among US advanced CKD patients is low. Need for significant resources, lack of validated data showing unequivocal and reproducible benefits, and the lack of validated CPE protocols proven to have consistent efficacy in improving not only patient awareness but also HoD rates in US population, are major limitations deterring adoption of CPE in routine clinical practice. We recently demonstrated that if a structured, protocol based CPE is integrated within the routine nephrology care for patients with advanced CKD, it substantially improves informed HoD choice and utilizations. However, this requires establishing CPE resources within each nephrology practice. Efficacy of a stand-alone CPE model, independent of clinical care, has not been examined till date. In this report we report the efficacy of our structured CPE protocol, delivered outside the realm of routine nephrology care-as a stand-alone patient education program, in a geographically distant region, and show that: when provided opportunity for informed dialysis choice, a majority of advanced CKD patients in US would prefer HoD. We also show that initiating CPE leads to accelerated growth in HoD utilizations and reduces disparities in HoD utilizations, goals for system improvements. Finally, the reproducibility of our structured CPE protocol with consistent efficacy data suggest that initiating such programs at institutional levels has the potential to improve informed dialysis selection and HoD rates across any similar large healthcare institute within US.

The utility of trough mycophenolic acid levels for the management of lupus nephritis.

Background: Monitoring of mycophenolic acid (MPA) levels may be useful for effective mycophenolate mofetil (MMF) dosing. However, whether commonly obtained trough levels are an acceptable method of surveillance remains debatable. We hypothesized that trough levels of MPA would be a poor predictor of area under the curve (AUC) for MPA. Methods: A total of 51 patients with lupus nephritis who were on MMF 1500 mg twice a day and had a 4-h AUC done were included in this study. MPA levels were measured prior to (C0) and at 1 (C1), 2 (C2) and 4 (C4) h, followed by 1500 mg of MMF. The MPA AUC values were calculated using the linear trapezoidal rule. Regression analysis was used to examine the relationship between the MPA trough and AUC. Differences in the MPA trough and AUC between different clinical and demographic categories were compared using t-tests. Results: When grouped by tertiles there was significant overlap in MPA, AUC 0-4 and MPA trough in all tertiles. Although there was a statistically significant correlation between MPA trough levels and AUC, this association was weak and accounted for only 30% of the variability in MPA trough levels. This relationship might be even more unreliable in men than women. The use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers was associated with increased MPA trough levels and AUC at 0-4 h (AUC0-4). Conclusion: Trough levels of MPA do not show a strong correlation with AUC. In clinical situations where MPA levels are essential to guide therapy, an AUC0-4 would be a better indicator of the adequacy of treatment.