Impact of an enhanced recovery after surgery program with a multimodal analgesia care pathway on opioid prescribing and clinical outcomes for patients undergoing colorectal surgery.

Background: Opioids are a mainstay for acute pain management, but their side effects can adversely impact patient recovery. Multimodal analgesia (MMA) is recommended for treatment of postoperative pain and has been incorporated in enhanced recovery after surgery (ERAS) protocols. The objective of this quality improvement study was to implement an MMA care pathway as part of an ERAS program for colorectal surgery and to measure the effect of this intervention on patient outcomes and costs. Methods: This pre-post study included 856 adult inpatients who underwent an elective colorectal surgery at three hospitals within an integrated healthcare system. The impact of ERAS program implementation on opioid prescribing practices, outcomes, and costs was examined after adjusting for clinical and demographic confounders. Results: Improvements were seen in MMA compliance (34.0% vs 65.5%, P < 0.0001) and ERAS compliance (50.4% vs 57.6%, P < 0.0001). Reductions in mean days on opioids (4.2 vs 3.2), daily (51.6 vs 33.4 mg) and total (228.8 vs 112.7 mg) morphine milligram equivalents given during hospitalization, and risk-adjusted length of stay (4.3 vs 3.6 days, P < 0.05) were also observed. Conclusions: Implementing ERAS programs that include MMA care pathways as standard of care may result in more judicious use of opioids and reduce patient recovery time.

The Texas Health Resources Clinical Scholars Program: Learning healthcare system workforce development through embedded translational research.

Introduction: Texas Health Resources (THR), a large, nonprofit health care system based in the Dallas-Fort Worth area, has collaborated with the University of Texas Southwestern Medical Center (UTSW) to develop and operate a unique, integrated approach for Learning Health System (LHS) workforce development. This training model centers on academic health system faculty members conducting later-stage translational research within a partnering regional care delivery organization. Methods: The THR Clinical Scholars Program engages early career UTSW faculty members to conduct studies that are likely to have an impact on care delivery at the health system level. Interested candidates submit formal applications to the program. A joint committee comprised of senior research faculty from UTSW and THR clinical leadership reviews proposals with a focus on the shared LHS needs of both institutions-developing high quality research output that can be applied to enhance care delivery. A key prioritization criterion for funding is the degree to which the research addresses a question relevant to THR as a high-volume network with multiple channels for consumers to access care. The program emphasis is on supporting embedded research initiatives using health system data to generate knowledge that will improve the quality and efficiency of care for the patient populations served by the participant organizations. Results: We discuss specific strategic and tactical components of the THR Clinical Scholars Program including an overview of the academic affiliation agreement between the collaborating organizations, criteria for successful program applications, data sharing, and funding. We also share project summaries from selected clinical scholars as examples of the LHS research done in the program to date. Conclusion: This experience report provides an implementation framework for other academic health systems interested in adopting similar LHS workforce training models with community partners.

Retrospective observational study of asthma and chronic obstructive pulmonary disease prevalence and associated healthcare resource utilization in a large, integrated healthcare system.

Limited data exist on asthma and chronic obstructive pulmonary disease (COPD) management-major drivers of healthcare resource utilization (HCRU) in the USA. We describe prevalence and exacerbation rates, therapeutic interventions, and HCRU for asthma and/or COPD within a large, integrated healthcare system. Patients with asthma, COPD, and asthma + COPD were identified from retrospective electronic health record data (2016-2018) of >1.7 million patients. Descriptive analysis of disease prevalence and exacerbation frequencies, pharmacotherapies, and HCRU was performed. Time-to-event analysis of time to first exacerbation was performed in patients with asthma and/or COPD. Exacerbation rates, pharmacotherapies, and HCRU were examined by exploratory analysis in an outpatient subset. Overall, 149,086 unique patients (8.6%) had encounters for asthma, COPD, or asthma + COPD. Acute care utilization was high, including emergency department visits (asthma, 52.9%; COPD, 35.1%) and hospitalizations (asthma, 26.7%; COPD, 65.7%). Many patients were prescribed short-acting therapies (asthma, 45.3%; COPD, 40.0%; asthma + COPD, 54.7%). Prescription rates for maintenance therapies were low (17.1%, 20.8%, 31.7%) and annual exacerbation rates were 0.65, 0.80, and 1.33. This analysis showed a substantive prevalence of pulmonary disease, variability between documented prescriptions and pharmacotherapy guidelines, and high HCRU. Appropriate tailoring of pharmacotherapies and management of asthma and COPD over a continuum are opportunities to improve patient care.

Implementation and Routinization of the ABCDE Bundle: A Mixed Methods Evaluation.

BACKGROUND: The ABCDE (Awakening and Breathing Coordination, Delirium monitoring and management, and Early exercise/mobility) bundle has been associated with reductions in delirium incidence and improved patient outcomes but has not been widely adopted. OBJECTIVE: The objective of this study was to determine how to facilitate ABCDE bundle adoption by examining the impact of different implementation strategies on bundle adherence rates and assessing clinicians' perceptions of the bundle and implementation efforts. METHODS: This study examined the effect of 2 bundle implementation strategies on patient care in 8 adult intensive care units. The basic strategy included electronic health record (EHR) modification, whereas the enhanced strategy included EHR modification plus additional bundle training, clinical champions, and staff engagement. A total of 84 nurses, physicians, and therapists participated in interviews and a survey to assess bundle implementation. RESULTS: Respondents indicated bundle use resulted in "best care" through care standardization and coordination and improved patient outcomes. Intensive care units in both intervention groups had significant improvements in bundle adherence after implementation efforts, but intensive care units in the basic intervention group outperformed other sites after initiating their own implementation strategies. Successful implementation tactics included incorporating the bundle into multidisciplinary rounds and providing ongoing support, training, and routine auditing and feedback. DISCUSSION: The ABCDE bundle can improve quality of care and outcomes, and implementation can be accelerated through EHR tools, trainings, and performance feedback.

Evaluating the Cost-Effectiveness of the ABCDE Bundle: Impact of Bundle Adherence on Inpatient and 1-Year Mortality and Costs of Care.

OBJECTIVES: Growing evidence supports the Awakening and Breathing Coordination, Delirium monitoring/management, and Early exercise/mobility (ABCDE) bundle processes as improving a number of short- and long-term clinical outcomes for patients requiring ICU care. To assess the cost-effectiveness of this intervention, we determined the impact of ABCDE bundle adherence on inpatient and 1-year mortality, quality-adjusted life-years, length of stay, and costs of care. DESIGN: We conducted a 2-year, prospective, cost-effectiveness study in 12 adult ICUs in six hospitals belonging to a large, integrated healthcare delivery system. SETTING: Hospitals included a large, urban tertiary referral center and five community hospitals. ICUs included medical/surgical, trauma, neurologic, and cardiac care units. PATIENTS: The study included 2,953 patients, 18 years old or older, with an ICU stay greater than 24 hours, who were on a ventilator for more than 24 hours and less than 14 days. INTERVENTION: ABCDE bundle. MEASUREMENTS AND MAIN RESULTS: We used propensity score-adjusted regression models to determine the impact of high bundle adherence on inpatient mortality, discharge status, length of stay, and costs. A Markov model was used to estimate the potential effect of improved bundle adherence on healthcare costs and quality-adjusted life-years in the year following ICU admission. We found that patients with high ABCDE bundle adherence (≥ 60%) had significantly decreased odds of inpatient mortality (odds ratio 0.28) and significantly higher costs ($3,920) of inpatient care. The incremental cost-effectiveness ratio of high bundle adherence was $15,077 (95% CI, $13,675-$16,479) per life saved and $1,057 per life-year saved. High bundle adherence was associated with a 0.12 increase in quality-adjusted life-years, a $4,949 increase in 1-year care costs, and an incremental cost-effectiveness ratio of $42,120 per quality-adjusted life-year. CONCLUSIONS: The ABCDE bundle appears to be a cost-effective means to reduce in-hospital and 1-year mortality for patients with an ICU stay.

Innovative Data Science to Transform Health Care: All the Pieces Matter.

This issue of eGEMS focuses on application of data science as a driver of health care transformation. Importantly, quantitative or qualitative analysis with a particular method is only one downstream step in the process of leveraging data. Effective analytics occurs on a continuum with multiple complementary phases, categorized here as data acquisition, ensuring or enhancing data access and usability, data analysis, and dissemination. Each of these activities is encompassed in the series of papers presented.

Haloperidol and Ziprasidone for Treatment of Delirium in Critical Illness.

BACKGROUND: There are conflicting data on the effects of antipsychotic medications on delirium in patients in the intensive care unit (ICU). METHODS: In a randomized, double-blind, placebo-controlled trial, we assigned patients with acute respiratory failure or shock and hypoactive or hyperactive delirium to receive intravenous boluses of haloperidol (maximum dose, 20 mg daily), ziprasidone (maximum dose, 40 mg daily), or placebo. The volume and dose of a trial drug or placebo was halved or doubled at 12-hour intervals on the basis of the presence or absence of delirium, as detected with the use of the Confusion Assessment Method for the ICU, and of side effects of the intervention. The primary end point was the number of days alive without delirium or coma during the 14-day intervention period. Secondary end points included 30-day and 90-day survival, time to freedom from mechanical ventilation, and time to ICU and hospital discharge. Safety end points included extrapyramidal symptoms and excessive sedation. RESULTS: Written informed consent was obtained from 1183 patients or their authorized representatives. Delirium developed in 566 patients (48%), of whom 89% had hypoactive delirium and 11% had hyperactive delirium. Of the 566 patients, 184 were randomly assigned to receive placebo, 192 to receive haloperidol, and 190 to receive ziprasidone. The median duration of exposure to a trial drug or placebo was 4 days (interquartile range, 3 to 7). The median number of days alive without delirium or coma was 8.5 (95% confidence interval [CI], 5.6 to 9.9) in the placebo group, 7.9 (95% CI, 4.4 to 9.6) in the haloperidol group, and 8.7 (95% CI, 5.9 to 10.0) in the ziprasidone group (P=0.26 for overall effect across trial groups). The use of haloperidol or ziprasidone, as compared with placebo, had no significant effect on the primary end point (odds ratios, 0.88 [95% CI, 0.64 to 1.21] and 1.04 [95% CI, 0.73 to 1.48], respectively). There were no significant between-group differences with respect to the secondary end points or the frequency of extrapyramidal symptoms. CONCLUSIONS: The use of haloperidol or ziprasidone, as compared with placebo, in patients with acute respiratory failure or shock and hypoactive or hyperactive delirium in the ICU did not significantly alter the duration of delirium. (Funded by the National Institutes of Health and the VA Geriatric Research Education and Clinical Center; MIND-USA ClinicalTrials.gov number, NCT01211522 .).

Association of Opioid-Related Adverse Drug Events With Clinical and Cost Outcomes Among Surgical Patients in a Large Integrated Health Care Delivery System.

Importance: Opioids are commonly used for pain control during and after invasive procedures. However, opioid-related adverse drug events (ORADEs) are common and have been associated with worse patient outcomes. Objectives: To examine the incidence of ORADEs in patients undergoing hospital-based surgical and endoscopic procedures and to evaluate the association of ORADEs with clinical and cost outcomes. Design, Setting, and Participants: In this retrospective study of clinical and administrative data, ORADEs were identified using International Classification of Diseases, Ninth Revision diagnosis codes for known adverse effects of opioids or by opioid antagonist use. Multivariable regression analysis was used to measure the association of ORADEs with outcomes after adjusting for potential confounding factors. The setting was 21 acute care hospitals in a large integrated health care delivery system. Participants were 135 379 patients (aged ≥18 years, admitted from January 1, 2013, to September 30, 2015) who underwent surgical and endoscopic procedures and were given opioids. Exposure: Opioid use, reported as morphine milligram equivalent doses. Main Outcomes and Measures: Opioid-related adverse drug events and their association with inpatient mortality, discharge to another care facility, length of stay, cost of hospitalization, and 30-day readmission. Results: Among 135 379 adult patients in this study (67.5% female), 14 386 (10.6%) experienced at least one ORADE. Patients with ORADEs were more likely to be older, of white race/ethnicity, and male and have more comorbidities. Patients with ORADEs received a higher total dose of opioids (median morphine milligram equivalent dose, 46.8 vs 30.0 mg; P < .001) and for a longer duration (median, 3.0 vs 2.0 days; P < .001). In adjusted analyses, ORADEs were associated with increased inpatient mortality (odds ratio [OR], 28.8; 95% CI, 24.0-34.5), greater likelihood of discharge to another care facility (OR, 2.9; 95% CI, 2.7-3.0), prolonged length of stay (OR, 3.1; 95% CI, 2.8-3.4), high cost of hospitalization (OR, 2.7; 95% CI, 2.4-3.0), and higher rate of 30-day readmission (OR, 1.3; 95% CI, 1.2-1.4). ORADEs were associated with a 2.9% increase in absolute mortality, an $8225 increase in cost for the index hospitalization, and a 1.6-day increase in length of stay for the index hospitalization. Conclusions and Relevance: Opioid-related adverse drug events were common among patients undergoing hospital-based invasive procedures and were associated with significantly worse clinical and cost outcomes. Hospital-acquired harm from ORADEs in the surgical patient population is an important opportunity for health systems to improve patient safety and reduce cost.

Long-Term Outcomes From Repeated Smoking Cessation Assistance in Routine Primary Care.

PURPOSE: To test the association between repeated clinical smoking cessation support and long-term cessation. DESIGN: Retrospective, observational cohort study using structured and free-text data from electronic health records. SETTING: Six diverse health systems in the United States. PARTICIPANTS: Patients aged ≥18 years who were smokers in 2007 and had ≥1 primary care visit in each of the following 4 years (N = 33 691). MEASURES: Primary exposure was a composite categorical variable (comprised of documentation of smoking cessation medication, counseling, or referral) classifying the proportions of visits for which patients received any cessation assistance (<25% (reference), 25%-49%, 50%-74%, and ≥75% of visits). The dependent variable was long-term quit (LTQ; yes/no), defined as no indication of being a current smoker for ≥365 days following a visit where nonsmoker or former smoker was indicated. ANALYSIS: Mixed effects logistic regression analysis adjusted for age, sex, race, and comorbidities, with robust standard error estimation to account for within site correlation. RESULTS: Overall, 20% of the cohort achieved LTQ status. Patients with ≥75% of visits with any assistance had almost 3 times the odds of achieving LTQ status compared to those with <25% visits with assistance (odds ratio = 2.84; 95% confidence interval: 1.50-5.37). Results were similar for specific assistance types. CONCLUSIONS: These findings provide support for the importance of repeated assistance at primary care visits to increase long-term smoking cessation.

Early inpatient calculation of laboratory-based 30-day readmission risk scores empowers clinical risk modification during index hospitalization.

Improving 30-day readmission continues to be problematic for most hospitals. This study reports the creation and validation of sex-specific inpatient (i) heart failure (HF) risk scores using electronic data from the beginning of inpatient care for effective and efficient prediction of 30-day readmission risk. METHODS: HF patients hospitalized at Intermountain Healthcare from 2005 to 2012 (derivation: n=6079; validation: n=2663) and Baylor Scott & White Health (North Region) from 2005 to 2013 (validation: n=5162) were studied. Sex-specific iHF scores were derived to predict post-hospitalization 30-day readmission using common HF laboratory measures and age. Risk scores adding social, morbidity, and treatment factors were also evaluated. RESULTS: The iHF model for females utilized potassium, bicarbonate, blood urea nitrogen, red blood cell count, white blood cell count, and mean corpuscular hemoglobin concentration; for males, components were B-type natriuretic peptide, sodium, creatinine, hematocrit, red cell distribution width, and mean platelet volume. Among females, odds ratios (OR) were OR=1.99 for iHF tertile 3 vs. 1 (95% confidence interval [CI]=1.28, 3.08) for Intermountain validation (P-trend across tertiles=0.002) and OR=1.29 (CI=1.01, 1.66) for Baylor patients (P-trend=0.049). Among males, iHF had OR=1.95 (CI=1.33, 2.85) for tertile 3 vs. 1 in Intermountain (P-trend <0.001) and OR=2.03 (CI=1.52, 2.71) in Baylor (P-trend < 0.001). Expanded models using 182-183 variables had predictive abilities similar to iHF. CONCLUSIONS: Sex-specific laboratory-based electronic health record-delivered iHF risk scores effectively predicted 30-day readmission among HF patients. Efficient to calculate and deliver to clinicians, recent clinical implementation of iHF scores suggest they are useful and useable for more precise clinical HF treatment.

The High Value Healthcare Collaborative: Observational Analyses of Care Episodes for Hip and Knee Arthroplasty Surgery.

BACKGROUND: Broader use of value-based reimbursement models will require providers to transparently demonstrate health care value. We sought to determine and report cost and quality data for episodes of hip and knee arthroplasty surgery among 13 members of the High Value Healthcare Collaborative (HVHC), a consortium of health care systems interested in improving health care value. METHODS: We conducted a retrospective, cross-sectional observational cohort study of 30-day episodes of care for hip and knee arthroplasty in fee-for-service Medicare beneficiaries aged 65 or older who had hip or knee osteoarthritis and used 1 of 13 HVHC member systems for uncomplicated primary hip arthroplasty (N = 8853) or knee arthroplasty (N = 16,434), respectively, in 2012 or 2013. At the system level, we calculated: per-capita utilization rates; postoperative complication rates; standardized total, acute, and postacute care Medicare expenditures for 30-day episodes of care; and the modeled impact of reducing episode expenditures or per-capita utilization rates. RESULTS: Adjusted per-capita utilization rates varied across HVHC systems and postacute care reimbursements varied more than 3-fold for both types of arthroplasty in both years. Regression analysis confirmed that total episode and postacute care reimbursements significantly differed across HVHC members after considering patient demographic differences. Potential Medicare cost savings were greatest for knee arthroplasty surgery and when lower total reimbursement targets were achieved. CONCLUSION: The substantial variation that we found offers opportunities for learning and collaboration to collectively improve outcomes, reduce costs, and enhance value. Ceteris paribus, reducing per-episode reimbursements would achieve greater Medicare cost savings than reducing per-capita rates.

A Review of Multifaceted Care Approaches for the Prevention and Mitigation of Delirium in Intensive Care Units.

OBJECTIVE: The objective of this review is to examine the effectiveness, implementation, and costs of multifaceted care approaches, including care bundles, for the prevention and mitigation of delirium in patients hospitalized in intensive care units (ICUs). DATA SOURCES: A systematic search using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines was conducted utilizing PubMed, EMBASE, and CINAHL. Searches were limited to studies published in English from January 1, 1988, to March 31, 2014. Randomized controlled trials and comparative studies of multifaceted care approaches with the reduction of delirium in ICU patients as an outcome and evaluations of the implementation or cost-effectiveness of these interventions were included. DATA EXTRACTION: Data on study methods including design, cohort size, interventions, and outcomes were abstracted, reviewed, and summarized. Given the variability in study design, populations, and interventions, a qualitative review of findings was conducted. DATA SYNTHESIS: In all, 14 studies met our inclusion criteria: 6 examined outcomes, 5 examined implementation, 2 examined outcomes and implementation, and 1 examined cost-effectiveness. The majority of studies indicated that multifaceted care approaches were associated with improved patient outcomes including reduced incidence and duration of delirium. Additionally, improvements in functional status and reductions in coma and ventilator days, hospital length of stay, and/or mortality rates were observed. Implementation strategies included structured quality improvement approaches with ongoing audit and feedback, multidisciplinary care teams, intensive training, electronic reporting systems, and local support teams. The cost-effectiveness analysis indicated an average reduction of $1000 in hospital costs for patients treated with a multifaceted care approach. CONCLUSION: Although multifaceted care approaches may reduce delirium and improve patient outcomes, greater improvements may be achieved by deploying a comprehensive bundle of care practices including awakening and breathing trials, delirium monitoring and treatment, and early mobility. Further research to address this knowledge gap is essential to providing best care for ICU patients.

Development and Validation of an Algorithm to Identify Planned Readmissions From Claims Data.

BACKGROUND: It is desirable not to include planned readmissions in readmission measures because they represent deliberate, scheduled care. OBJECTIVES: To develop an algorithm to identify planned readmissions, describe its performance characteristics, and identify improvements. DESIGN: Consensus-driven algorithm development and chart review validation study at 7 acute-care hospitals in 2 health systems. PATIENTS: For development, all discharges qualifying for the publicly reported hospital-wide readmission measure. For validation, all qualifying same-hospital readmissions that were characterized by the algorithm as planned, and a random sampling of same-hospital readmissions that were characterized as unplanned. MEASUREMENTS: We calculated weighted sensitivity and specificity, and positive and negative predictive values of the algorithm (version 2.1), compared to gold standard chart review. RESULTS: In consultation with 27 experts, we developed an algorithm that characterizes 7.8% of readmissions as planned. For validation we reviewed 634 readmissions. The weighted sensitivity of the algorithm was 45.1% overall, 50.9% in large teaching centers and 40.2% in smaller community hospitals. The weighted specificity was 95.9%, positive predictive value was 51.6%, and negative predictive value was 94.7%. We identified 4 minor changes to improve algorithm performance. The revised algorithm had a weighted sensitivity 49.8% (57.1% at large hospitals), weighted specificity 96.5%, positive predictive value 58.7%, and negative predictive value 94.5%. Positive predictive value was poor for the 2 most common potentially planned procedures: diagnostic cardiac catheterization (25%) and procedures involving cardiac devices (33%). CONCLUSIONS: An administrative claims-based algorithm to identify planned readmissions is feasible and can facilitate public reporting of primarily unplanned readmissions.

Documentation of the 5 as for smoking cessation by PCPs across distinct health systems.

OBJECTIVES: Physicians can help patients quit smoking using the 5 As of smoking cessation. This study aimed to (1) identify the proportion of known smokers that receive smoking cessation services in the course of routine clinical practice; (2) describe demographic and comorbidity characteristics of patients receiving the 5 As in these systems; and (3) evaluate differences in performance of the 5 As across health systems, gender, and age categories. STUDY DESIGN: Electronic medical records of 200 current smokers from 6 unique health systems (N = 1200) were randomly selected from 2006 to 2010. Primary care encounter progress notes were hand coded for occurrences of the 5 As. METHODS: Bivariate comparisons of delivery of the 3 smoking-cessation services by site, gender, and age category were analyzed using χ² tests. RESULTS: About 50% of smokers were advised to quit smoking, 39% were assessed for their readiness to quit, and 54% received some type of assistance to help them quit smoking. Only 2% had a documented plan for follow-up regarding their quitting efforts (arrange). Significant differences were found among sites for documentation of receiving the 5 As and between age groups receiving assistance with quitting. There was no statistically significant difference between genders in receipt of the 5 As. CONCLUSIONS: Documentation of adherence to the 5 As varied by site and some demographics. Adjustments to protocols for addressing cessation and readiness to quit may be warranted. Health systems could apply the methodology described in this paper to assess their own performance, and then use that as a basis to guide improvement initiatives.

Modifying the electronic health record to facilitate the implementation and evaluation of a bundled care program for intensive care unit delirium.

CONTEXT: Electronic health records (EHRs) have been promoted as a key driver of improved patient care and outcomes and as an essential component of learning health systems. However, to date, many EHRs are not optimized to support delivery of quality and safety initiatives, particularly in Intensive Care Units (ICUs). Delirium is a common and severe problem for ICU patients that may be prevented or mitigated through the use of evidence-based care processes (daily awakening and breathing trials, formal delirium screening, and early mobility-collectively known as the "ABCDE bundle"). This case study describes how an integrated health care delivery system modified its inpatient EHR to accelerate the implementation and evaluation of ABCDE bundle deployment as a safety and quality initiative. CASE DESCRIPTION: In order to facilitate uptake of the ABCDE bundle and measure delivery of the care processes within the bundle, we worked with clinical and technical experts to create structured data fields for documentation of bundle elements and to identify where these fields should be placed within the EHR to streamline staff workflow. We created an "ABCDE" tab in the existing patient viewer that allowed providers to easily identify which components of the bundle the patient had and had not received. We examined the percentage of ABCDE bundle elements captured in these structured data fields over time to track compliance with data entry procedures and to improve documentation of care processes. MAJOR THEMES: Modifying the EHR to support ABCDE bundle deployment was a complex and time-consuming process. We found that it was critical to gain buy-in from senior leadership on the importance of the ABCDE bundle to secure information technology (IT) resources, understand the different workflows of members of multidisciplinary care teams, and obtain continuous feedback from staff on the EHR revisions during the development cycle. We also observed that it was essential to provide ongoing training to staff on proper use of the new EHR documentation fields. Lastly, timely reporting on ABCDE bundle performance may be essential to improved practice adoption and documentation of care processes. CONCLUSION: The creation of learning health systems is contingent on an ability to modify EHRs to meet emerging care delivery and quality improvement needs. Although this study focuses on the prevention and mitigation of delirium in ICUs, our process for identifying key data elements and making modifications to the EHR, as well as the lessons learned from the IT components of this program, are generalizable to other health care settings and conditions.

Challenges in using electronic health record data for CER: experience of 4 learning organizations and solutions applied.

OBJECTIVE: To document the strengths and challenges of using electronic health records (EHRs) for comparative effectiveness research (CER). METHODS: A replicated case study of comparative effectiveness in hypertension treatment was conducted across 4 health systems, with instructions to extract data and document problems encountered using a specified list of required data elements. Researchers at each health system documented successes and challenges, and suggested solutions for addressing challenges. RESULTS: Data challenges fell into 5 categories: missing data, erroneous data, uninterpretable data, inconsistencies among providers and over time, and data stored in noncoded text notes. Suggested strategies to address these issues include data validation steps, use of surrogate markers, natural language processing, and statistical techniques. DISCUSSION: A number of EHR issues can hamper the extraction of valid data for cross-health system comparative effectiveness studies. Our case example cautions against a blind reliance on EHR data as a single definitive data source. Nevertheless, EHR data are superior to administrative or claims data alone, and are cheaper and timelier than clinical trials or manual chart reviews. All 4 participating health systems are pursuing pathways to more effectively use EHR data for CER.A partnership between clinicians, researchers, and information technology specialists is encouraged as a way to capitalize on the wealth of information contained in the EHR. Future developments in both technology and care delivery hold promise for improvement in the ability to use EHR data for CER.

Comparative effectiveness research using electronic health records: impacts of oral antidiabetic drugs on the development of chronic kidney disease.

PURPOSE: Little is known about the comparative effects of common oral antidiabetic drugs ([OADs] metformin, sulfonylureas, or thiazolidinediones [THZs]) on chronic kidney disease (CKD) outcomes in patients newly diagnosed with type 2 diabetes (T2DM) and followed in community primary care practices. Electronic health records (EHRs) were used to evaluate the relationships between OAD class use and incident proteinuria and prevention of glomerular filtration rate decline. METHODS: A retrospective cohort study on newly diagnosed T2D cases requiring OADs documented in the EHRs of two primary care networks between 1998 and 2009 was conducted. CKD outcomes were new-onset proteinuria and estimated GFR (eGFR) falling below 60 ml/min/1.73 m(2). OAD exposures defined cohorts. Hazard ratios represent differential CKD outcome risk per year of OAD class use. RESULTS: A total of 798 and 977 patients qualified for proteinuria and eGFR outcome analyses, respectively. With metformin as the reference group, sulfonylurea exposure trended toward association with an increased risk of developing proteinuria ([adjusted hazard ratio; 95% CI] 1.27; 0.93, 1.74); proteinuria risk associated with THZ exposure (1.00; 0.70, 1.42) was similar to metformin. Compared with metformin, sulfonylurea exposure was associated with an increased risk of eGFR reduction to <60 ml/min/1.73 m(2) (1.41; 1.05, 1.91). THZ exposure (1.04; 0.71, 1.50) was not associated with change in the risk of eGFR decline. CONCLUSIONS: In a primary care population, metformin appeared to decrease the risk of CKD development compared with sulfonlyureas; risks of CKD development between metformin and THZs were similar. EHR use in pharmacotherapy comparative effectiveness research creates specific challenges and study limitations.