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 Immuno-Oncology Biorepository, a statewide biospecimen collection and clinical informatics system to enable longitudinal tumor and immune profiling.

A detailed understanding of the molecular and immunological changes that occur longitudinally across tumors exposed to immune checkpoint inhibitors is a significant knowledge gap in oncology. To address this unmet need, we created a statewide biospecimen collection and clinical informatics system to enable longitudinal tumor and immune profiling and to enhance translational research. The Texas Immuno-Oncology Biorepository (TIOB) consents patients to collect, process, store, and analyze serial biospecimens of tissue, blood, urine, and stool from a diverse population of over 100,000 cancer patients treated each year across the Baylor Scott & White Health system. Here we sought to demonstrate that these samples were fit for purpose with regard to downstream multi-omic assays. Plasma, urine, peripheral blood mononuclear cells, and stool samples from 11 enrolled patients were collected from various cancer types. RNA isolated from extracellular vesicles derived from plasma and urine was sufficient for transcriptomics. Peripheral blood mononuclear cells demonstrated excellent yield and viability. Ten of 11 stool samples produced RNA quality to enable microbiome characterization. Sample acquisition and processing methods are known to impact sample quality and performance. We demonstrate that consistent acquisition methodology, sample preparation, and sample storage employed by the TIOB can produce high-quality specimens, suited for employment in a wide array of multi-omic platforms, enabling comprehensive immune and molecular profiling.

Daily Oxygenation Support for Patients Hospitalized With SARS-CoV-2 in an Integrated Health System.

BACKGROUND: Many COVID-19 studies are constructed to report hospitalization outcomes, with few large multi-center population-based reports on the time course of intra-hospitalization characteristics, including daily oxygenation support requirements. Comprehensive epidemiologic profiles of oxygenation methods used by day and by week during hospitalization across all severities are important to illustrate the clinical and economic burden of COVID-19 hospitalizations. METHODS: This was a retrospective, multi-center observational cohort study of 15,361 consecutive hospitalizations of patients with COVID-19 at 25 adult acute care hospitals in Texas participating in the Society of Critical Care Medicine Discovery Viral Respiratory Illness Universal Study COVID-19 registry. RESULTS: At initial hospitalization, the majority required nasal cannula (44.0%), with an increasing proportion of invasive mechanical ventilation in the first week and particularly the weeks to follow. After 4 weeks of acute illness, 69.9% of adults hospitalized with COVID-19 required intermediate (eg, high-flow nasal cannula, noninvasive ventilation) or advanced respiratory support (ie, invasive mechanical ventilation), with similar proportions that extended to hospitalizations that lasted ≥ 6 weeks. CONCLUSIONS: Data representation of intra-hospital processes of care drawn from hospitals with varied size, teaching and trauma designations is important to presenting a balanced perspective of care delivery mechanisms employed, such as daily oxygen method utilization.

Multi-center matched cohort study of convalescent plasma for hospitalized patients with COVID-19.

BACKGROUND: Although frequently used in the early pandemic, data on the effectiveness of COVID-19 convalescent plasma (CCP) remain mixed. We investigated the effectiveness and safety of CCP in hospitalized COVID-19 patients in real-world practices during the first two waves of the pandemic in a multi-hospital healthcare system in Texas. METHODS AND FINDINGS: Among 11,322 hospitalized patients with confirmed COVID-19 infection from July 1, 2020 to April 15, 2021, we included patients who received CCP and matched them with those who did not receive CCP within ±2 days of the transfusion date across sites within strata of sex, age groups, days and use of dexamethasone from hospital admission to the match date, and oxygen requirements 4-12 hours prior to the match date. Cox proportional hazards model estimated hazard ratios (HRs) and 95% confidence intervals (CIs) for effectiveness outcomes in a propensity score 1:1 matched cohort. Pre-defined safety outcomes were described. We included 1,245 patients each in the CCP treated and untreated groups. Oxygen support was required by 93% of patients at the baseline. The pre-defined primary effectiveness outcome of 28-day in-hospital all-cause mortality (HR = 0.85; 95%CI: 0.66,1.10) were similar between treatment groups. Sensitivity and stratified analyses found similar null results. CCP-treated patients were less likely to be discharged alive (HR = 0.82; 95%CI: 0.74, 0.91), and more likely to receive mechanical ventilation (HR = 1.48; 95%CI: 1.12, 1.96). Safety outcomes were rare and similar between treatment groups. CONCLUSION: The findings in this large, matched cohort of patients hospitalized with COVID-19 and mostly requiring oxygen support at the time of treatment, do not support a clinical benefit in 28-day in-hospital all-cause mortality for CCP. Future studies should assess the potential benefits with specifically high-titer units in perhaps certain subgroups of patients (e.g. those with early disease or immunocompromised).

Angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, and COVID-19-related outcomes: A patient-level analysis of the PCORnet blood pressure control lab.

SARS-CoV-2 accesses host cells via angiotensin-converting enzyme-2, which is also affected by commonly used angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), raising concerns that ACEI or ARB exposure may portend differential COVID-19 outcomes. In parallel cohort studies of outpatient and inpatient COVID-19-diagnosed adults with hypertension, we assessed associations between antihypertensive exposure (ACEI/ARB vs. non-ACEI/ARB antihypertensives, as well as between ACEI- vs. ARB) at the time of COVID-19 diagnosis, using electronic health record data from PCORnet health systems. The primary outcomes were all-cause hospitalization or death (outpatient cohort) or all-cause death (inpatient), analyzed via Cox regression weighted by inverse probability of treatment weights. From February 2020 through December 9, 2020, 11,246 patients (3477 person-years) and 2200 patients (777 person-years) were included from 17 health systems in outpatient and inpatient cohorts, respectively. There were 1015 all-cause hospitalization or deaths in the outpatient cohort (incidence, 29.2 events per 100 person-years), with no significant difference by ACEI/ARB use (adjusted HR 1.01; 95% CI 0.88, 1.15). In the inpatient cohort, there were 218 all-cause deaths (incidence, 28.1 per 100 person-years) and ACEI/ARB exposure was associated with reduced death (adjusted HR, 0.76; 95% CI, 0.57, 0.99). ACEI, versus ARB exposure, was associated with higher risk of hospitalization in the outpatient cohort, but no difference in all-cause death in either cohort. There was no evidence of effect modification across pre-specified baseline characteristics. Our results suggest ACEI and ARB exposure have no detrimental effect on hospitalizations and may reduce death among hypertensive patients diagnosed with COVID-19.

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.

The impact of patient education and shared decision making on hospital readmissions for COPD.

PURPOSE: Education on the self-management of COPD has been shown to improve patients' quality of life and reduce hospital admissions. This study aimed to assess the feasibility of a pilot, pragmatic COPD Chronic Care (CCC) education program led by registered respiratory therapists and determine the CCC's impact on hospital readmissions, patient activation, and health status. PATIENTS AND METHODS: This was a prospective, randomized, pilot study of inpatients with COPD admitted to a US community hospital between August 2014 and February 2016. In total, 308 patients were randomized 1:1 to receive standard care with or without the CCC program. Outcomes included the number of patients completing the program, frequency and time to first all-cause and COPD-related hospital readmissions, and changes in the Patient Activation Measure (PAM) and COPD Assessment Test (CAT). RESULTS: Overall, 37% (n=52) of patients in the CCC group and 29% (n=48) of patients in the control group remained in the study for 6 months and completed all follow-up phone calls. In total, 74% (n=105) of patients in the CCC group and 69% (n=115) of patients in the control group had at least one readmission (P=0.316). The time to first all-cause and COPD-related readmission appeared shorter for patients in the CCC group compared with the control group (mean [standard deviation]: 50.2 [54.5] vs 59.9 [63.1] days and 95.1 [80.2] vs 113.7 [82.4] days, respectively; both P=0.231). Patients experienced significant improvement from baseline in mean PAM (both groups) and CAT (CCC group) scores. CONCLUSION: Utilizing respiratory therapists to lead a chronic care education program for COPD in a community hospital was feasible. Although CCC patients showed improvements in perceived symptom severity, they were readmitted sooner than control group patients. However, the program did not impact the frequency of hospital readmissions. A more comprehensive disease management program may be needed to improve outcomes.

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.

Analytical Methods for a Learning Health System: 1. Framing the Research Question.

Learning health systems use routinely collected electronic health data (EHD) to advance knowledge and support continuous learning. Even without randomization, observational studies can play a central role as the nation's health care system embraces comparative effectiveness research and patient-centered outcomes research. However, neither the breadth, timeliness, volume of the available information, nor sophisticated analytics, allow analysts to confidently infer causal relationships from observational data. However, depending on the research question, careful study design and appropriate analytical methods can improve the utility of EHD. The introduction to a series of four papers, this review begins with a discussion of the kind of research questions that EHD can help address, noting how different evidence and assumptions are needed for each. We argue that when the question involves describing the current (and likely future) state of affairs, causal inference is not relevant, so randomized clinical trials (RCTs) are not necessary. When the question is whether an intervention improves outcomes of interest, causal inference is critical, but appropriately designed and analyzed observational studies can yield valid results that better balance internal and external validity than typical RCTs. When the question is one of translation and spread of innovations, a different set of questions comes into play: How and why does the intervention work? How can a model be amended or adapted to work in new settings? In these "delivery system science" settings, causal inference is not the main issue, so a range of quantitative, qualitative, and mixed research designs are needed. We then describe why RCTs are regarded as the gold standard for assessing cause and effect, how alternative approaches relying on observational data can be used to the same end, and how observational studies of EHD can be effective complements to RCTs. We also describe how RCTs can be a model for designing rigorous observational studies, building an evidence base through iterative studies that build upon each other (i.e., confirmation across multiple investigations).

Analytical Methods for a Learning Health System: 2. Design of Observational Studies.

The second paper in a series on how learning health systems can use routinely collected electronic health data (EHD) to advance knowledge and support continuous learning, this review summarizes study design approaches, including choosing appropriate data sources, and methods for design and analysis of natural and quasi-experiments. The primary strength of study design approaches described in this section is that they study the impact of a deliberate intervention in real-world settings, which is critical for external validity. These evaluation designs address estimating the counterfactual - what would have happened if the intervention had not been implemented. At the individual level, epidemiologic designs focus on identifying situations in which bias is minimized. Natural and quasi-experiments focus on situations where the change in assignment breaks the usual links that could lead to confounding, reverse causation, and so forth. And because these observational studies typically use data gathered for patient management or administrative purposes, the possibility of observation bias is minimized. The disadvantages are that one cannot necessarily attribute the effect to the intervention (as opposed to other things that might have changed), and the results do not indicate what about the intervention made a difference. Because they cannot rely on randomization to establish causality, program evaluation methods demand a more careful consideration of the "theory" of the intervention and how it is expected to play out. A logic model describing this theory can help to design appropriate comparisons, account for all influential variables in a model, and help to ensure that evaluation studies focus on the critical intermediate and long-term outcomes as well as possible confounders.

Analytical Methods for a Learning Health System: 3. Analysis of Observational Studies.

The third paper in a series on how learning health systems can use routinely collected electronic health data (EHD) to advance knowledge and support continuous learning, this review describes how analytical methods for individual-level electronic health data EHD, including regression approaches, interrupted time series (ITS) analyses, instrumental variables, and propensity score methods, can also be used to address the question of whether the intervention "works." The two major potential sources of bias in non-experimental studies of health care interventions are that the treatment groups compared do not have the same probability of treatment or exposure and the potential for confounding by unmeasured covariates. Although very different, the approaches presented in this chapter are all based on assumptions about data, causal relationships, and biases. For instance, regression approaches assume that the relationship between the treatment, outcome, and other variables is properly specified, all of the variables are available for analysis (i.e., no unobserved confounders) and measured without error, and that the error term is independent and identically distributed. The instrumental variables approach requires identifying an instrument that is related to the assignment of treatment but otherwise has no direct on the outcome. Propensity score methods approaches, on the other hand, assume that there are no unobserved confounders. The epidemiological designs discussed also make assumptions, for instance that individuals can serve as their own control. To properly address these assumptions, analysts should conduct sensitivity analyses within the assumptions of each method to assess the potential impact of what cannot be observed. Researchers also should analyze the same data with different analytical approaches that make alternative assumptions, and to apply the same methods to different data sets. Finally, different analytical methods, each subject to different biases, should be used in combination and together with different designs, to limit the potential for bias in the final results.

A Framework for Aligning Data from Multiple Institutions to Conduct Meaningful Analytics.

INTRODUCTION: Health systems can be supported by collaborative networks focused on data sharing and comparative analytics to identify and rapidly disseminate promising care practices. Standardized data collection, quality assessment, and cleansing is a necessary process to facilitate meaningful analytics for operations, quality improvement, and research. We developed a framework for aligning data from health care delivery systems using the High Value Healthcare Collaborative central registry. FRAMEWORK: The centralized data registry model allows for multiple layers of data quality assessment. Our framework uses an iterative approach, starting with clear specifications, maintaining ongoing dialogue with diverse stakeholders, and regular checkpoints to assess data conformance, completeness, and plausibility. LESSONS LEARNED: We found that an iterative communication process is critical for a central registry to ensure: 1) clarity of data specifications, 2) appropriate data quality, and 3) thorough understanding of data source, purpose, and context. Engaging teams from all participating institutions and incorporating diverse stakeholders of clinicians, information technologists, data analysts, operations managers, and health services researchers in all decision making processes supports development of high quality datasets for comparative analytics across multiple institutions. CONCLUSION: A standard data specification and submission process alone does not guarantee aligned data for a collaborative registry. Implementing an iterative data quality improvement framework with extensive communication proved to be effective for aligning data from multiple institutions to support meaningful analytics.

Multicenter validation of American Association for the Surgery of Trauma grading system for acute colonic diverticulitis and its use for emergency general surgery quality improvement program.

BACKGROUND: The American Association for the Surgery of Trauma (AAST) has developed a new grading system for uniform description of anatomic severity of emergency general surgery (EGS) diseases, ranging from Grade I (mild) to Grade V (severe). The purpose of this study was to determine the relationship of AAST grades for acute colonic diverticulitis with patient outcomes. A secondary purpose was to propose an EGS quality improvement program using risk-adjusted center outcomes, similar to National Surgical Quality Improvement Program and Trauma Quality Improvement Program methodologies. METHODS: This was a retrospective study of 1,105 patients (one death) from 13 centers. At each center, two reviewers (blinded to each other's assignments) assigned AAST grades. Interrater reliability was measured using κ coefficient. Relationship between AAST grade and clinical events (complications, intensive care unit use, surgical intervention, and 30-day readmission) as well as length of stay was measured using regression analyses to control for age, comorbidities, and physiologic status at the time of admission. Final model was also used to calculate observed-to-expected (O-E) ratios for adverse outcomes (death, complications, readmissions) for each center. RESULTS: Median age was 54 years, 52% were males, 43% were minorities, and 22% required a surgical intervention. Almost two thirds had Grade I or II disease. There was a high level of agreement for grades between reviewers (κ = 0.81). Adverse events increased from 13% for Grade I, to 18% for Grade II, 28% for Grade III, 44% for Grade IV, and 50% for Grade V. Regression analysis showed that higher disease grades were independently associated with all clinical events and length of stay, after adjusting for age, comorbidities, and physiology. O-E ratios showed statistically insignificant variations in risk of death, complications, or readmissions. CONCLUSION: AAST grades for acute colonic diverticulitis are independently associated with clinical outcomes and resource use. EGS quality improvement program methodology that incorporates AAST grade, age, comorbidities, and physiologic status may be used for measuring quality of EGS care. High-quality EGS registries are essential for developing meaningful quality metrics. LEVEL OF EVIDENCE: Prognostic study, level V.

Assessing Trends in Tobacco Cessation in Diverse Patient Populations.

INTRODUCTION: This study examined change in tobacco use over 4 years among the general population of patients in six diverse health care organizations using electronic medical record data. METHODS: The study cohort (N = 34 393) included all patients age 18 years or older who were identified as smokers in 2007, and who then had at least one primary care visit in each of the following 4 years. RESULTS: In the 4 years following 2007, this patient cohort had a median of 13 primary care visits, and 38.6% of the patients quit smoking at least once. At the end of the fourth follow-up year, 15.4% had stopped smoking for 1 year or more. Smokers were more likely to become long-term quitters if they were 65 or older (OR = 1.32, 95% CI = [1.16, 1.49]), or had a diagnoses of cancer (1.26 [1.12, 1.41]), cardiovascular disease (1.22 [1.09, 1.37]), asthma (1.15 [1.06, 1.25]), or diabetes (1.17 [1.09, 1.27]). Characteristics associated with lower likelihood of becoming a long-term quitter were female gender (0.90 [0.84, 0.95]), black race (0.84 [0.75, 0.94]) and those identified as non-Hispanic (0.50 [0.43, 0.59]). CONCLUSIONS: Among smokers who regularly used these care systems, one in seven had achieved long-term cessation after 4 years. This study shows the practicality of using electronic medical records for monitoring patient smoking status over time. Similar methods could be used to assess tobacco use in any health care organization to evaluate the impact of environmental and organizational programs.

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.

Validating a new grading scale for emergency general surgery diseases.

BACKGROUND: The American Association for the Surgery of Trauma (AAST) recently developed a grading scale for measuring anatomic severity of emergency general surgery (EGS) diseases. Grades were developed by expert consensus and have not been validated. The study purpose was to measure inter-rater reliability of the grading scale using colonic diverticulitis and to measure the association between disease grade and patient outcomes. METHODS: All charts were reviewed and independently assigned AAST grades based on specific disease criteria. Inter-rater reliability was measured using a kappa coefficient. Multivariate regression models were used to determine the relationship between AAST disease grade and patient outcomes adjusted for age, comorbidities, and patient physiology. RESULTS: Over 70% of patients demonstrated mild disease (grades I and II). No deaths were encountered. Inter-rater reliability for grade assignment was moderate (kappa coefficient, 0.43; 95% confidence interval, 0.31-0.56), with 67% concordance in grades. Compared to grade I, complications were similar in grade II but increased significantly with higher grades (grade III odds ratio [OR], 3.13 [1.32-7.41]; grade IV OR, 8.18 [2.09-32.0]; and grade V OR, 10.2 [2.68-38.90]). Compared to grade I, length of stay increased with higher grades (grade II incidence rate ratio [IRR], 1.30 [1.07-1.60]; grade III IRR, 2.4 [1.93-2.98]; grade IV IRR, 3.2 [2.27-4.60]; and grade V IRR, 2.6 [1.82-3.60]). CONCLUSIONS: The EGS grading scale for diverticulitis demonstrated moderate inter-rater reliability. Higher grades were independently associated with complications and length of stay. The findings provide a positive validation that the EGS scale is easily used and effective.

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.

Developing electronic data methods infrastructure to participate in collaborative research networks.

CONTEXT: Collaborative networks support the goals of a learning health system by sharing, aggregating, and analyzing data to facilitate identification of best practices care across delivery organizations. This case study describes the infrastructure and process developed by an integrated health delivery system to successfully prepare and submit a complex data set to a large national collaborative network. CASE DESCRIPTION: We submitted four years of data for a diverse population of patients in specific clinical areas: diabetes, chronic heart failure, sepsis, and hip, knee, and spine. The most recent submission included 19 tables, more than 376,000 unique patients, and almost 5 million patient encounters. Data was extracted from multiple clinical and administrative systems. LESSONS LEARNED: We found that a structured process with documentation was key to maintaining communication, timelines, and quality in a large-scale data submission to a national collaborative network. The three key components of this process were the experienced project team, documentation, and communication. We used a formal QA and feedback process to track and review data. Overall, the data submission was resource intensive and required an incremental approach to data quality. CONCLUSION: Participation in collaborative networks can be time and resource intense, however it can serve as a catalyst to increase the technical data available to the learning health system.

Exercise without weight loss does not reduce C-reactive protein: the INFLAME study.

PURPOSE: Numerous cross-sectional studies have observed an inverse association between C-reactive protein (CRP) and physical activity. Exercise training trials have produced conflicting results, but none of these studies was specifically designed to examine CRP. The objective of the Inflammation and Exercise (INFLAME) study was to examine whether aerobic exercise training without dietary intervention can reduce CRP in individuals with elevated CRP. METHODS: The study was a randomized controlled trial of 162 sedentary men and women with elevated CRP (> or = 2.0 mg·L(-1)). Participants were randomized into a nonexercise control group or an exercise group that trained for 4 months. The primary outcome was change in CRP. RESULTS: The study participants had a mean (SD) age of 49.7 (10.9) yr and a mean body mass index of 31.8 (4.0) kg·m(-2). The median (interquartile range (IQR)) and mean baseline CRP levels were 4.1 (2.5-6.1) and 4.8 (3.4) mg·L(-1), respectively. In the exercise group, median exercise compliance was 99.9%. There were no differences in median (IQR) change in CRP between the control and exercise groups (0.0 (-0.5 to 0.9) vs 0.0 (-0.8 to 0.7) mg·L(-1), P = 0.4). The mean (95% confidence interval) change in CRP adjusted for gender and baseline weight was similar in the control and exercise groups, with no significant difference between groups (0.5 (-0.4 to 1.3) vs 0.4 (-0.5 to 1.2) mg·L(-1), P = 0.9). Change in weight was correlated with change in CRP. CONCLUSIONS: Exercise training without weight loss is not associated with a reduction in CRP.

A randomized clinical trial to determine the efficacy of regimens containing clarithromycin, metronidazole, and amoxicillin among histologic subgroups for Helicobacter pylori eradication in a developing country.

BACKGROUND: Most treatments deemed effective for Helicobacter pylori eradication in developed countries are less effective in developing countries. Regimens containing clarithromycin, metronidazole, and amoxicillin seem efficacious despite antibiotic resistance, and may be a viable option in developing countries. MATERIALS AND METHODS: We evaluated the efficacy of a 14-day regimen with 500 mg clarithromycin b.i.d., 500 mg metronidazole t.i.d., and 500 mg amoxicillin t.i.d. (with and without a proton pump inhibitor), and a 10-day regimen containing 500 mg clarithromycin b.i.d., 1 g amoxicillin b.i.d., and 20 mg omeprazole b.i.d. in Pasto, Colombia, using a randomized, single-blind design stratified by presence of atrophic gastritis. RESULTS: H. pylori was eradicated in 86.8% and 85.3% of the participants randomized to a clarithromycin-metronidazole-amoxicillin and clarithromycin-amoxicillin-omeprazole regimens, respectively (p = .79). Per-protocol analyses indicated greater efficacy for the clarithromycin-metronidazole-amoxicillin regimen (97%) versus the clarithromycin-amoxicillin-omeprazole regimen (86%) (p = .04), particularly for participants with atrophic gastritis (clarithromycin-metronidazole-amoxicillin = 100%, clarithromycin-amoxicillin-omeprazole = 81%; p = .02). Adverse events were mild, but adverse event-related non-compliance was reported more often for regimens containing clarithromycin, metronidazole, and amoxicillin. CONCLUSIONS: Our results suggest that an eradication rate of > 85% can be achieved with 14-day clarithromycin, metronidazole, and amoxicillin and 10-day clarithromycin, amoxicillin, and omeprazole regimens in Pasto, Colombia. The regimens containing clarithromycin, metronidazole, and amoxicillin appear to be superior to the clarithromycin, amoxicillin, and omeprazole regimen for compliant participants and those with atrophic gastritis. Our findings provide treatment options for a population in a developing country with a high prevalence of H. pylori infections and antibiotic resistance.