Stewardship Prompts to Improve Antibiotic Selection for Pneumonia: The INSPIRE Randomized Clinical Trial.

Importance: Pneumonia is the most common infection requiring hospitalization and is a major reason for overuse of extended-spectrum antibiotics. Despite low risk of multidrug-resistant organism (MDRO) infection, clinical uncertainty often drives initial antibiotic selection. Strategies to limit empiric antibiotic overuse for patients with pneumonia are needed. Objective: To evaluate whether computerized provider order entry (CPOE) prompts providing patient- and pathogen-specific MDRO infection risk estimates could reduce empiric extended-spectrum antibiotics for non-critically ill patients admitted with pneumonia. Design, Setting, and Participants: Cluster-randomized trial in 59 US community hospitals comparing the effect of a CPOE stewardship bundle (education, feedback, and real-time MDRO risk-based CPOE prompts; n = 29 hospitals) vs routine stewardship (n = 30 hospitals) on antibiotic selection during the first 3 hospital days (empiric period) in non-critically ill adults (≥18 years) hospitalized with pneumonia. There was an 18-month baseline period from April 1, 2017, to September 30, 2018, and a 15-month intervention period from April 1, 2019, to June 30, 2020. Intervention: CPOE prompts recommending standard-spectrum antibiotics in patients ordered to receive extended-spectrum antibiotics during the empiric period who have low estimated absolute risk (<10%) of MDRO pneumonia, coupled with feedback and education. Main Outcomes and Measures: The primary outcome was empiric (first 3 days of hospitalization) extended-spectrum antibiotic days of therapy. Secondary outcomes included empiric vancomycin and antipseudomonal days of therapy and safety outcomes included days to intensive care unit (ICU) transfer and hospital length of stay. Outcomes compared differences between baseline and intervention periods across strategies. Results: Among 59 hospitals with 96 451 (51 671 in the baseline period and 44 780 in the intervention period) adult patients admitted with pneumonia, the mean (SD) age of patients was 68.1 (17.0) years, 48.1% were men, and the median (IQR) Elixhauser comorbidity count was 4 (2-6). Compared with routine stewardship, the group using CPOE prompts had a 28.4% reduction in empiric extended-spectrum days of therapy (rate ratio, 0.72 [95% CI, 0.66-0.78]; P < .001). Safety outcomes of mean days to ICU transfer (6.5 vs 7.1 days) and hospital length of stay (6.8 vs 7.1 days) did not differ significantly between the routine and CPOE intervention groups. Conclusions and Relevance: Empiric extended-spectrum antibiotic use was significantly lower among adults admitted with pneumonia to non-ICU settings in hospitals using education, feedback, and CPOE prompts recommending standard-spectrum antibiotics for patients at low risk of MDRO infection, compared with routine stewardship practices. Hospital length of stay and days to ICU transfer were unchanged. Trial Registration: ClinicalTrials.gov Identifier: NCT03697070.

Stewardship Prompts to Improve Antibiotic Selection for Urinary Tract Infection: The INSPIRE Randomized Clinical Trial.

Importance: Urinary tract infection (UTI) is the second most common infection leading to hospitalization and is often associated with gram-negative multidrug-resistant organisms (MDROs). Clinicians overuse extended-spectrum antibiotics although most patients are at low risk for MDRO infection. Safe strategies to limit overuse of empiric antibiotics are needed. Objective: To evaluate whether computerized provider order entry (CPOE) prompts providing patient- and pathogen-specific MDRO risk estimates could reduce use of empiric extended-spectrum antibiotics for treatment of UTI. Design, Setting, and Participants: Cluster-randomized trial in 59 US community hospitals comparing the effect of a CPOE stewardship bundle (education, feedback, and real-time and risk-based CPOE prompts; 29 hospitals) vs routine stewardship (n = 30 hospitals) on antibiotic selection during the first 3 hospital days (empiric period) in noncritically ill adults (≥18 years) hospitalized with UTI with an 18-month baseline (April 1, 2017-September 30, 2018) and 15-month intervention period (April 1, 2019-June 30, 2020). Interventions: CPOE prompts recommending empiric standard-spectrum antibiotics in patients ordered to receive extended-spectrum antibiotics who have low estimated absolute risk (<10%) of MDRO UTI, coupled with feedback and education. Main Outcomes and Measures: The primary outcome was empiric (first 3 days of hospitalization) extended-spectrum antibiotic days of therapy. Secondary outcomes included empiric vancomycin and antipseudomonal days of therapy. Safety outcomes included days to intensive care unit (ICU) transfer and hospital length of stay. Outcomes were assessed using generalized linear mixed-effect models to assess differences between the baseline and intervention periods. Results: Among 127 403 adult patients (71 991 baseline and 55 412 intervention period) admitted with UTI in 59 hospitals, the mean (SD) age was 69.4 (17.9) years, 30.5% were male, and the median Elixhauser Comorbidity Index count was 4 (IQR, 2-5). Compared with routine stewardship, the group using CPOE prompts had a 17.4% (95% CI, 11.2%-23.2%) reduction in empiric extended-spectrum days of therapy (rate ratio, 0.83 [95% CI, 0.77-0.89]; P < .001). The safety outcomes of mean days to ICU transfer (6.6 vs 7.0 days) and hospital length of stay (6.3 vs 6.5 days) did not differ significantly between the routine and intervention groups, respectively. Conclusions and Relevance: Compared with routine stewardship, CPOE prompts providing real-time recommendations for standard-spectrum antibiotics for patients with low MDRO risk coupled with feedback and education significantly reduced empiric extended-spectrum antibiotic use among noncritically ill adults admitted with UTI without changing hospital length of stay or days to ICU transfers. Trial Registration: ClinicalTrials.gov Identifier: NCT03697096.

Validation of an electronic algorithm for Hodgkin and non-Hodgkin lymphoma in ICD-10-CM.

PURPOSE: Lymphoma is a health outcome of interest for drug safety studies. Studies using administrative claims data require the accurate identification of lymphoma cases. We developed and validated an International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM)-based algorithm to identify lymphoma in healthcare claims data. METHODS: We developed a three-component algorithm to identify patients aged ≥15 years who were newly diagnosed with Hodgkin (HL) or non-Hodgkin (NHL) lymphoma from January 2016 through July 2018 among members of four Data Partners within the FDA's Sentinel System. The algorithm identified potential cases as patients with ≥2 ICD-10-CM lymphoma diagnosis codes on different dates within 183 days; ≥1 procedure code for a diagnostic procedure (e.g., biopsy, flow cytometry) and ≥1 procedure code for a relevant imaging study within 90 days of the first lymphoma diagnosis code. Cases identified by the algorithm were adjudicated via chart review and a positive predictive value (PPV) was calculated. RESULTS: We identified 8723 potential lymphoma cases via the algorithm and randomly sampled 213 for validation. We retrieved 138 charts (65%) and adjudicated 134 (63%). The overall PPV was 77% (95% confidence interval: 69%-84%). Most cases also had subtype information available, with 88% of cases identified as NHL and 11% as HL. CONCLUSIONS: Seventy-seven percent of lymphoma cases identified by an algorithm based on ICD-10-CM diagnosis and procedure codes and applied to claims data were true cases. This novel algorithm represents an efficient, cost-effective way to target an important health outcome of interest for large-scale drug safety and public health surveillance studies.

Prevalence of selected risk behaviors and chronic diseases and conditions-steps communities, United States, 2006-2007.

PROBLEM: At least one chronic disease or condition affects 45% of persons and account for seven of the 10 leading causes of death in the United States. Persons who suffer from chronic diseases and conditions, (e.g., obesity, diabetes, and asthma) experience limitations in function, health, activity, and work, affecting the quality of their lives as well as the lives of their family. Preventable health-risk factors (e.g., insufficient physical activity, poor nutrition, and tobacco use and exposure) contribute substantially to the development and severity of certain chronic diseases and conditions. REPORTING PERIOD COVERED: 2006-2007 DESCRIPTION OF THE SYSTEM: CDC's Healthy Communities Program funds communities to address chronic diseases and related risk factors through policy, systems, and environmental change strategies. As part of the Healthy Communities Program, 40 Steps communities were funded nationwide to address six focus areas: obesity, diabetes, asthma, physical inactivity, poor nutrition, and tobacco use and exposure. During 2006-2007, 38 and 39 of the 40 communities conducted a survey to collect adult health outcome data. The survey instrument was a modified version of the Behavioral Risk Factor Surveillance System (BRFSS) survey, a state-based, random-digit-dialed telephone survey. The survey instrument collected information on chronic diseases and conditions, health risk behaviors, and preventive health practices related to Steps community outcomes from noninstitutionalized community members aged ≥18 years. RESULTS: Prevalence estimates of chronic diseases and conditions and risk behaviors varied among Steps communities that reported data for 2006 and 2007. The proportion of the population that achieved Healthy People 2010 (HP 2010) objectives also varied among the communities. In 2006, the estimated prevalence of respondents aged ≥18 years being overweight or obese as calculated from self-reported weight and height ranged from 51.8% to 73.7%. The nationwide 2006 BRFSS median was 62.3%; a total of 20 communities exceeded this median. In 2007, the estimated prevalence being overweight or obese ranged from 50.5% to 77.2%. The nationwide 2007 BRFSS median was 63.0%; a total of 18 communities exceeded this median. In 2006, the estimated prevalence of diagnosed diabetes (excluding gestational diabetes) ranged from 3.7% to 19.7%. None of the communities achieved the HP 2010 objective of increasing to 91% the proportion of adults with diabetes who have at least an annual clinical foot examination. Six communities reached the HP 2010 objective of increasing to 76% the proportion of adults with diabetes who have an annual dilated eye examination; 20 communities reached the HP 2010 objective of increasing to 65% the proportion of adults who have a glycosylated hemoglobin measurement (A1c) at least once a year. In 2007, the estimated prevalence of diagnosed diabetes (excluding gestational diabetes) ranged from 4.4% to 17.9%. None of the communities achieved the HP 2010 objective of increasing to 91% the proportion of adults with diabetes who have at least an annual clinical foot examination, eight communities achieved the HP 2010 objective of increasing to 76% the proportion of adults with diabetes who have an annual dilated eye examination, and 16 communities achieved the HP 2010 objective of increasing to 65% the proportion of adults who have an A1c at least once a year. In 2006, the prevalence of reported asthma ranged from 6.5% to 18.9%. Among those who reported having asthma, the prevalence of having no symptoms of asthma during the preceding 30 days ranged from 11.5% to 29.5% for five communities with sufficient data for estimates. In 2007, the estimated prevalence of reported asthma ranged from 7.5% to 18.9%. Among those who reported having asthma, the prevalence of having no symptoms of asthma during the preceding 30 days ranged from 10.3% to 36.1% for 12 communities with sufficient data for estimates. In 2006, the prevalence of respondents who engaged in moderate physical activity for ≥30 minutes at least five times a week or who reported vigorous physical activity for ≥20 minutes at least three times a week ranged from 42.3% to 59.9%. The prevalence of consumption of fruits and vegetables at least five times/day ranged from 11.1% to 30.2%. In 2007, the prevalence of moderate or vigorous physical activity ranged from 40.6% to 69.8%; 25 communities reached the HP 2010 objective to increase the proportion of adults who engage in physical activity to 50%. The prevalence of consumption of fruits and vegetables ≥5 times/day ranged from 14.6% to 37.6%. In 2006, the estimated prevalence among respondents aged >18 years who reported having smoked >100 cigarettes in their lifetime and who were current smokers on every day or some days at the time of the survey ranged from 12.5% to 48.0%. Among smokers, the prevalence of having stopped smoking for ≥1 day because of trying to quit smoking during the previous 12 months ranged from 48.4% to 67.9% for 31 communities. No communities reached the HP 2010 target of increasing to 75% smoking cessation attempts by adult smokers. In 2007, the estimated prevalence of current smokers ranged from 11.2% to 33.7%. Two communities reached the HP 2010 objective to reduce the proportion of adults who smoke. Among smokers, the prevalence of having stopped smoking for ≥1 day because of trying to quit smoking during the preceding 12 months ranged from 50.8% to 69.6% for 26 communities. No communities reached the HP 2010 objective of increasing to 75% smoking cessation attempts by adult smokers. INTERPRETATION: The findings in this report indicate variations in health risk behaviors, chronic diseases and conditions, and use of preventive health screenings and health services among Steps communities. These findings underscore the continued need to evaluate prevention interventions at the community level and to design and implement policies to promote and encourage healthy behaviors. PUBLIC HEALTH ACTION: Steps BRFSS data monitored the prevalence of health behaviors, conditions, and use of preventive health services. CDC (at the national level), and Steps staff at state, local, and tribal levels can use BRFSS data to demonstrate accountability to stakeholders; monitor progress in meeting objectives; focus activities on policy, systems and environmental change strategies with the greatest promise of results; identify collaboration opportunities; and identify and disseminate successes and lessons learned.

Prevalence of selected risk behaviors and chronic diseases--Behavioral Risk Factor Surveillance System (BRFSS), 39 steps communities, United States, 2005.

PROBLEM: Behavioral risk factors (e.g., tobacco use, poor diet, and physical inactivity) can lead to chronic diseases. In 2005, of the 10 leading causes of death in the United States, seven (heart disease, cancer, stroke, chronic lower respiratory diseases, diabetes, Alzheimer's disease, and kidney disease) were attributable to chronic disease. Chronic diseases also adversely affect the quality of life of an estimated 90 million persons in the United States, resulting in illness, disability, extended pain and suffering, and major limitations in daily living. REPORTING PERIOD COVERED: 2005. DESCRIPTION OF THE SYSTEM: CDC's Steps Program funds 40 selected U.S. communities to address six leading causes of death and disability and rising health-care costs in the United States: obesity, diabetes, asthma, physical inactivity, poor nutrition, and tobacco use. In 2005, a total of 39 Steps communities conducted a survey to collect adult health outcome data. The survey instrument was a modified version of the Behavioral Risk Factor Surveillance System (BRFSS) survey, a community-based, random-digit--dialing telephone survey with a multistage cluster design. The survey instrument collected information on health risk behaviors and preventive health practices among noninstitutionalized adults aged >/=18 years. RESULTS: Prevalence estimates of risk behaviors and chronic conditions varied among the 39 Steps communities that reported data for 2005. The proportion of the population that achieved Healthy People 2010 (HP 2010) objectives also varied among the communities. The estimated prevalence of obesity (defined as having a body mass index [BMI] of >/=30.0 kg/m(2) as calculated from self-reported weight and height) ranged from 15.6% to 44.0%. No communities reached the HP2010 objective of reducing the proportion of adults who are obese to 15.0%. The prevalence of diagnosed diabetes (excluding gestational diabetes) ranged from 4.3% to 16.6%. Eighteen communities achieved the HP2010 objective to increase the proportion of adults with diabetes who have at least an annual foot examination to 75.0%; five communities achieved the HP2010 objective to increase the proportion of adults with diabetes who have an annual dilated eye examination to 75.0%. The prevalence of reported asthma ranged from 7.0% to 17.6%. Among those who reported having asthma, the prevalence of having no symptoms of asthma during the preceding 30 days ranged from 15.4% to 40.3% for 10 communities with sufficient data for estimates. The prevalence of respondents who engaged in moderate physical activity for >/=30 minutes at least five times a week or who reported vigorous physical activity for >/=20 minutes at least three times a week ranged from 42.0% to 62.2%. The prevalence of consumption of fruits and vegetables at least five times a day ranged from 15.6% to 30.3%. The estimated prevalence among respondents aged >/=18 years who reported having smoked >/=100 cigarettes in their lifetime and who were current smokers on every day or some days at the time of the survey ranged from 11.0% to 39.7%. One community achieved the HP2010 objective to reduce the proportion of adults who smoke to 12.0%. Among smokers, the prevalence of having stopped smoking for >/=1 day as a result of trying to quit smoking during the previous 12 months ranged from 47.8% to 63.3% for 31 communities. No communities reached the HP2010 objective of increasing smoking cessation attempts by adult smokers to 75%. INTERPRETATION: The findings in this report indicate variations in health risk behaviors, chronic conditions, and use of preventive health screenings and health services. These findings underscore the continued need to evaluate intervention programs at the community level and to design and implement policies to reduce morbidity and mortality caused by chronic disease. PUBLIC HEALTH ACTION: Steps BRFSS data can be used to monitor the prevalence of specific health behaviors, diseases, conditions, and use of preventive health services. Steps Program staff at the national, state, local, and tribal levels can use BRFSS data to demonstrate accountability to stakeholders, monitor progress in meeting program objectives, focus programs on activities with the greatest promise of results, identify opportunities for strategic collaboration, and identify and disseminate successes and lessons learned.