John W. Sharp

Development and Validation of an Electronic Health Record–Based Chronic Kidney Disease Registry

BACKGROUND AND OBJECTIVES Chronic kidney disease (CKD) is increasing, and outcomes-related research from diverse health care settings is needed to target appropriate efforts and interventions. We developed an electronic health record (EHR)-based CKD registry at the Cleveland Clinic and validated comorbid conditions. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS Patients who had at least one face-to-face outpatient encounter with a Cleveland Clinic health care provider and (1) had two estimated GFR values <60 ml/min per 1.73 m(2) >90 days apart as of January 1, 2005 and/or (2) were patients with International Classification of Diseases-9 (ICD-9) diagnosis codes for kidney disease were included. RESULTS Our registry includes 57,276 patients (53,399 patients met estimated GFR criteria and 3877 patients met ICD-9 diagnosis code criteria) as of March 2010. Mean age was 69.5 ± 13.4 years, with 55% women and 12% African Americans. Medicare is the primary insurer for more than one half of the study cohort. The κ statistics to assess the extent of agreement between the administrative dataset extracted from the EHR and actual EHR chart review showed substantial agreement (>0.80) for all conditions except for coronary artery disease and hypertension, which had moderate agreement (<0.60). CONCLUSIONS Development of an EHR-based CKD registry is feasible in a large health system, and the comorbid conditions included in the registry are reliable. In addition to conducting research studies, such a registry could help to improve the quality of care delivered to CKD patients and complement the ongoing nationwide efforts to develop a CKD surveillance project.

Implications of the CKD-EPI GFR estimation equation in clinical practice.

BACKGROUND AND OBJECTIVES Chronic kidney disease (CKD) is a significant public health problem whose diagnosis and staging relies upon GFR-estimating equations, including the new CKD-EPI equation. CKD-EPI demonstrated superior performance compared with the existing MDRD equation but has not been applied to a healthcare system. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS We identified 53,759 patients with stages 3 to 5 CKD on the basis of either MDRD or CKD-EPI equations using two eGFR values <60 ml/min per 1.73 m² > 90 days apart from an outpatient setting. We compared patient characteristics, presence of related diagnosis codes, and time CKD classification between equations. RESULTS The number of patients identified with CKD decreased 10% applying CKD-EPI versus MDRD. Changes varied substantially by patient characteristics including a 35% decrease among patients < 60 years and a 10% increase among patients > 90 years. Women, non-African Americans, nondiabetics, and obese patients were less likely to be classified on the basis of CKD-EPI. Time to CKD classification was significantly longer with CKD-EPI among younger patients. 14% of patients identified with CKD on the basis of either estimating equation also had a related ICD-9 diagnosis, ranging from 19% among patients < 60 years to 7% among patients > 90 years. CONCLUSIONS Consistent with findings in the general population, CKD-EPI resulted in substantial declines in equation-based CKD diagnoses in a large healthcare system. Further research is needed to determine whether widespread use of CKD-EPI with current guidelines could lead to delayed needed care among younger patients or excessive referrals among older patients.

Expanding the definition of quality of life for prostate cancer

Background. Quality of life in prostate cancer is a multidimensional concept. From a social work perspective, three quality‐of‐life issues require additional consideration. These are: the impact of the disease and its treatment on family caregivers, the possibility of age bias and ethical dilemmas in treatment decisions, and the specific concerns of black men in whom the disease is more common.

Electronic health records: a new tool to combat chronic kidney disease?

Electronic health records (EHRs) were first developed in the 1960s as clinical information systems for document storage and retrieval. Adoption of EHRs has increased in the developed world and is increasing in developing countries. Studies have shown that quality of patient care is improved among health centers with EHRs. In this article, we review the structure and function of EHRs along with an examination of its potential application in CKD care and research. Well-designed patient registries using EHRs data allow for improved aggregation of patient data for quality improvement and to facilitate clinical research. Preliminary data from the United States and other countries have demonstrated that CKD care might improve with use of EHRs-based programs. We recently developed a CKD registry derived from EHRs data at our institution and complimented the registry with other patient details from the United States Renal Data System and the Social Security Death Index. This registry allows us to conduct a EHRs-based clinical trial that examines whether empowering patients with a personal health record or patient navigators improves CKD care, along with identifying participants for other clinical trials and conducting health services research. EHRs use have shown promising results in some settings, but not in others, perhaps attributed to the differences in EHRs adoption rates and varying functionality. Thus, future studies should explore the optimal methods of using EHRs to improve CKD care and research at the individual patient level, health system and population levels.

Chronic kidney disease in an electronic health record problem list: quality of care, ESRD, and mortality.

Background: Whether chronic kidney disease (CKD) recognition in an electronic health record (EHR) problem list improves processes of care or clinical outcomes of end-stage renal disease (ESRD) and death is unclear. Methods: We identified patients who had at least 1 year of follow-up (2005-2009) in our EHR-based CKD registry (n = 25,742). CKD recognition was defined by having ICD-9 codes for CKD, diabetic kidney disease, or hypertensive kidney disease in the problem list. We calculated proportions of patients with and without CKD recognition and examined differences by demographics, clinical factors, and development of ESRD or mortality. We evaluated differences in the proportion of patients with CKD-specific laboratory results checked before and after recognition among cases and propensity-matched controls. Results: Only 11% (n = 2,735) had CKD recognition in the problem list and they were younger (68 vs. 71 years), a higher proportion were male (61 vs. 37%) and African-American (21 vs. 10%) compared to those unrecognized. CKD-specific laboratory results for patients with estimated glomerular filtration rate (eGFR) 30-59 including intact parathyroid hormone (23 vs. 6%), vitamin D (22 vs. 18%), phosphorus (29 vs. 7%), and a urine check for proteinuria (55 vs. 36%) were significantly more likely to be done among those with CKD recognition (all p < 0.05). Similar results were found for eGFR <30 except for proteinuria and in our propensity score-matched control analysis. There was no independent association of CKD recognition with ESRD or mortality. Conclusions: CKD recognition in the EHR problem list was low, but translated into more CKD-specific processes of care; however ESRD or mortality were not affected.

Hospital Utilization for AIDS: Are All Hospital Days Necessary?

This study examined hospital utilization and, specifically, unnecessary hospital days for patients with acquired immunodeficiency syndrome (AIDS) in a Midwest regional referral center as of June 1987. In 1990 a follow-up study was conducted to measure changes in length of stay (LOS) and unnecessary days. Results show a mean LOS consistent with other studies and a pattern of unnecessary days comprising 14% to 18% respectively of the mean LOS. Admissions in which the patient died and those considered outliers (LOS greater than 36 days) had a trend toward a higher percentage of unnecessary days. Hospital utilization and unnecessary days for patients with AIDS should be an ongoing quality indicator for hospitals experiencing a high volume of persons with AIDS admissions.

Practice patterns of phosphate binder use and their associations with mortality in chronic kidney disease

BACKGROUND Higher serum phosphorus is associated with an increased mortality among those with chronic kidney disease (CKD). We examined the practice patterns of phosphate binder use to lower serum phosphorus levels and their associations with mortality in the non-dialysisdependent CKD population. METHODS We examined the factors associated with the use of calcium and non-calcium phosphate binders in those with stage 3 and 4 CKD (eGFR 15 - 59 mL/min/1.73 m2) using logistic regression models. The associations between phosphate binder use and mortality were studied using propensity based analysis. RESULTS Out of 57,928 patients with eGFR 15 - 59 mL/min/1.73 m2, 13,325 (23%) patients had serum phosphorus levels measured. 945 patients were prescribed phosphate binders, with 238 (25%) of them prescribed non-calcium-based phosphate binders and the rest calcium-based phosphate binders. Higher BMI, higher serum phosphorus, and higher serum calcium were associated with higher odds of being prescribed a non-calcium-based binder. Phosphate binder use was not significantly associated with mortality in either the entire cohort or the matched cohort in the analysis limited to those who were treated for at least 6 months. In the matched cohort, those who were treated for 1 year with a phosphate binder had a non-significant lower mortality rate (hazard ratio (HR): 0.85, 95% CI 0.66, 1.10). CONCLUSIONS Phosphate binder use for 6 months and 1 year was not associated with reduced mortality in those with stage 3 and stage 4 CKD.

Pragmatic Randomized, Controlled Trial of Patient Navigators and Enhanced Personal Health Records in CKD

BACKGROUND AND OBJECTIVES Patient navigators and enhanced personal health records improve the quality of health care delivered in other disease states. We aimed to develop a navigator program for patients with CKD and an electronic health record-based enhanced personal health record to disseminate CKD stage-specific goals of care and education. We also conducted a pragmatic randomized clinical trial to compare the effect of a navigator program for patients with CKD with enhanced personal health record and compare their combination compared with usual care among patients with CKD stage 3b/4. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS Two hundred and nine patients from six outpatient clinics (in both primary care and nephrology settings) were randomized in a 2×2 factorial design into four-study groups: (1) enhanced personal health record only, (2) patient navigator only, (3) both, and (4) usual care (control) group. Primary outcome measure was the change in eGFR over a 2-year follow-up period. Secondary outcome measures included acquisition of appropriate CKD-related laboratory measures, specialty referrals, and hospitalization rates. RESULTS Median age of the study population was 68 years old, and 75% were white. At study entry, 54% of patients were followed by nephrologists, and 88% were on renin-angiotensin system blockers. After a 2-year follow-up, rate of decline in eGFR was similar across the four groups (P=0.19). Measurements of CKD-related laboratory parameters were not significantly different among the groups. Furthermore, referral for dialysis education and vascular access placement, emergency room visits, and hospitalization rates were not statistically significant different between the groups. CONCLUSIONS We successfully developed a patient navigator program and an enhanced personal health record for the CKD population. However, there were no differences in eGFR decline and other outcomes among the study groups. Larger and long-term studies along with cost-effectiveness analyses are needed to evaluate the role of patient navigators and patient education through an enhanced personal health record in those with CKD.

The Broken Health Information Technology Innovation Pipeline: A Perspective from the NODE Health Consortium

Background: The Network of Digital Evidence (NODE) was formed to further advance the field of health information technology (HIT) and evidence-based digital medicine at different healthcare institutions nationwide. As the NODE network reviewed the state of the field, it was noted that despite substantial financial and human capital investments, the processes and results of HIT innovation seem chaotic and subpar, especially in comparison to the more well-established drug and device industries. During the course of this white paper, we will explore the causes for this observed phenomenon as well as propose possible solutions to improve the state of HIT. Methods: We compared the entire process of discovery, proof of concept, Food and Drug Administration (FDA) review, and postmarket monitoring and distribution/implementation of HIT innovations to the equivalent processes for drugs and devices. Whereas drug and device innovations are subject to a standardized pipeline of production, HIT innovations are not held to equivalent standards. Conclusions: As a result, HIT lags behind the more mature drug and device industries in producing effective and reliable products. This leads to an inefficient use of already scarce healthcare resources. The authors believe that the HIT industry must adopt many of the mechanisms implemented by the drug and device industries as dictated by their innovation pipelines of discovery, proof of concept, FDA review, and postmarket monitoring and distribution/implementation. We propose an eight-point plan to fundamentally evolve the HIT lifecycle, including reforms for institutions such as neutral government agencies, new health system boards and management systems, modified incentive structures, improved relationships with financial investors and start-ups, patient engagement, and enhanced mechanisms to improve HIT adoption.