John J. Lefante

A comparison of hospital adverse events identified by three widely used detection methods

OBJECTIVE Determine the degree of congruence between several measures of adverse events. DESIGN Cross-sectional study to assess frequency and type of adverse events identified using a variety of methods. SETTING Mayo Clinic Rochester hospitals. PARTICIPANTS All inpatients discharged in 2005 (n = 60 599). INTERVENTIONS Adverse events were identified through multiple methods: (i) Agency for Healthcare Research and Quality-defined patient safety indicators (PSIs) using ICD-9 diagnosis codes from administrative discharge abstracts, (ii) provider-reported events, and (iii) Institute for Healthcare Improvement Global Trigger Tool with physician confirmation. PSIs were adjusted to exclude patient conditions present at admission. MAIN OUTCOME MEASURE Agreement of identification between methods. RESULTS About 4% (2401) of hospital discharges had an adverse event identified by at least one method. Around 38% (922) of identified events were provider-reported events. Nearly 43% of provider-reported adverse events were skin integrity events, 23% medication events, 21% falls, 1.8% equipment events and 37% miscellaneous events. Patients with adverse events identified by one method were not usually identified using another method. Only 97 (6.2%) of hospitalizations with a PSI also had a provider-reported event and only 10.5% of provider-reported events had a PSI. CONCLUSIONS Different detection methods identified different adverse events. Findings are consistent with studies that recommend combining approaches to measure patient safety for internal quality improvement. Potential reported adverse event inconsistencies, low association with documented harm and reporting differences across organizations, however, raise concerns about using these patient safety measures for public reporting and organizational performance comparison.

Use of the SF-8 to assess health-related quality of life for a chronically ill, low-income population participating in the Central Louisiana Medication Access Program (CMAP)

Objectives: The utility of the SF-8 for assessing health-related quality of life (HRQL) is demonstrated. Race and gender differences in physical component (PCS) and mental component (MCS) summary scores among participants in the CENLA Medication Access Program (CMAP), along with comparisons to the United States population are made. Methods: Age-adjusted multiple linear regression analyses were used to compare 1687 CMAP participants to the US population. Internal race and gender comparisons, adjusting for age and the number of self reported diagnoses, were also obtained. The paired t-test was used to assess 6-month change in PCS and MCS scores for a subset of 342 participants. Results: CMAP participants have PCS and MCS scores that are significantly 10–12 points lower than the US population, indicating lower self-reported HRQL. Females have significantly higher PCS and significantly lower MCS than males. African–Americans have significantly higher MCS than Caucasians. Significant increases in both PCS and MCS were observed for the subset of participants after 6 months of intervention. Conclusions: The expected lower baseline PCS and MCS measures and the expected associations with age and number of diagnoses indicate that the SF-8 survey is an effective tool for measuring the HRQL of participants in this program. Preliminary results indicate significant increases in both PCS and MCS 6 months after intervention.

Effect of Blood Pressure on Early Decline in Kidney Function Among Hypertensive Men

Abstract—Few cohort studies have examined the longitudinal association between change in blood pressure and decline in kidney function among treated hypertensive patients without chronic kidney disease. We conducted a nonconcurrent cohort study to examine the effects of blood pressure on estimated glomerular filtration rate and early kidney function decline (rise in serum creatinine ≥0.6 mg/dL during follow-up) among 504 African-American and 218 white hypertensive patients. Our results showed that each standard deviation higher treated systolic (18 mm Hg) and diastolic (10 mm Hg) blood pressure was associated with an average annual decline (95% confidence interval [CI]) in estimated glomerular filtration rate of −0.92 ([−1.49 to −0.36]P =0.001) and −0.83 ([−1.38 to −0.28]P =0.003) mL · min−1 · 1.73 m−2, respectively, after adjustment for race, age, education, income, use of antihypertensive drugs, body mass index, and history of diabetes and dyslipidemia. Likewise, each standard deviation higher systolic and diastolic blood pressure was associated with relative risks (95% CIs) of 1.81 ([1.29 to 2.55]P <0.001) and 1.55 ([1.08 to 2.22]P =0.046), respectively, for early kidney function decline. Compared with patients with a blood pressure level <140/90 mm Hg, those with a blood pressure level ≥160/95 mm Hg had a −2.67 ([−4.01 to −1.32]P <0.001) mL · min−1 · 1.73 m−2 greater annual decline in estimated glomerular filtration rate and a 5.21-fold ([2.06 to 13.21]P <0.001) greater risk of early kidney function decline. Our study found that higher levels of treated blood pressure were positively and significantly related to early decline in kidney function among hypertensive men. These results indicate that better blood pressure control might prevent the onset of chronic kidney disease among hypertensives.

Effect of illness severity and comorbidity on patient safety and adverse events.

The objective was to investigate the effect of admission health status on hospital adverse events and added costs. Secondary data were from merged administrative and clinical sources for Mayo Clinic Rochester, Minnesota hospital discharges in 2005 (N = 60 599). This was a retrospective cross-sectional study of the effect of demographics, diagnosis group, comorbidity, and admission illness severity on adverse events, incremental costs, and length of stay (LOS) using the Agency for Healthcare Research and Quality Patient Safety Indicators and provider-reported events with harm. Estimates are derived from generalized linear models. Admission severity increased the likelihood of all types of adverse events (7.2% per unit acute physiology score for any event); 7 specific comorbidities were associated with increased events and 2 with decreased events. High admission severity increased incremental costs and LOS. Selected comorbidities increased incremental LOS but had no significant effect on incremental costs. Adverse event reporting should incorporate comorbidity and admission severity. Reimbursement incentives to improve patient safety should consider adjustment for admission health status.

Short-term Outdoor Temperature Change and Emergency Department Visits for Asthma Among Children: A Case-Crossover Study

Although weather changes are known to cause asthma symptoms, their impact on asthma-related health-care utilization is poorly understood. The objective of the present study was to determine the association between short-term outdoor temperature change and asthma-related emergency department (ED) visits among children 3-18 years of age in Detroit, Michigan, in 2000-2001. Descriptive analyses of patient and ED visit characteristics were performed. A case-crossover study utilizing time-stratified controls was conducted to determine the impact of maximum temperature change and change rate measured during 4-, 8-, 12-, and 24-hour periods. Multivariable conditional logistic regression demonstrated the relation between ED visits and temperature change after controlling for other weather and pollutant measures. There were 4,804 asthma-related ED visits during the study period, and they occurred most frequently in the fall and during morning hours. The case-crossover study showed a statistically significant inverse relation between ED visits and maximum 24-hour temperature change after adjustment for climatic factors (for temperature change, odds ratio = 0.992, P = 0.04; for temperature change rate, odds ratio 0.972, P = 0.01). The association persisted after air pollutant measures were added to the model, although the association was not significant. Despite the finding that a greater 24-hour temperature change decreased the risk of asthma-related ED visits, the overall results suggested a negligible association with short-term temperature change.

Sample size determination and the effect of censoring when estimating the arithmetic mean of a lognormal distribution

This article presents several formulas to approximate the required sample size to estimate the arithmetic mean of a lognormal distribution with desired accuracy and confidence under and without the presence of type I censoring to the left. We present tables of exact sample sizes which are based on Lands exact confidence interval of the lognormal mean. In the case of non censoring, Box-Cox transformations were used to derive formulae for approximating these exact sample sizes and new formulae, adjusting the classic central limit approach, were derived. Each of these formulas as well as other existing formulas (the classical central limit approach.

Asthma severity, not asthma control, is worse in atopic compared with nonatopic adolescents with asthma

BACKGROUND The effects of atopic and nonatopic asthma phenotypes on asthma morbidity are unclear. Moreover, asthma morbidity in patients without atopy might be mediated by immunoglobulin E (IgE). OBJECTIVE To determine differences in morbidity in patients with asthma with and without atopy in a population of inner-city adolescents with asthma and to assess the impact of total IgE (tIgE) in this population. METHODS Data were obtained from 546 inner-city adolescents in the Asthma Control Evaluation study. A positive skin prick test reaction to 14 aeroallergens and specific IgE to 5 aeroallergens determined atopic status. High (≥75th percentile) and low (≤25th percentile) tIgE levels were categorized. Asthma control (Asthma Control Test) and asthma severity (Composite Asthma Severity Index [CASI]) were measured at multiple time points over 1 year. Fractional exhaled nitric oxide (FeNO) and measurements of morbidity also were collected. Multivariable and repeated measures analyses modeled the relation between atopic status and morbidity. RESULTS Baseline CASI scores increased 0.90 point (P < .05) and FeNO increased 0.85 natural logarithmic unit (P < .001) in participants with vs without atopy. Repeated measures analyses showed consistent results. Participants without atopy and increased tIgE had FeNO 0.73 natural log unit higher (P < .01) than low tIgE and a nonsignificant increase in CASI. The CASI score and FeNO levels were higher for high than for low tIgE in participants with atopy. CONCLUSION In this population, participants with atopic asthma had worse asthma severity and higher FeNO compared with those with nonatopic asthma, but no difference in control. In all participants, higher tIgE indicated worse severity and higher FeNO. In this population, asthma severity and FeNO might be mediated by IgE in the 2 asthma phenotypes.

Exposures to Thoracic Particulate Matter, Endotoxin, and Glucan During Post-Hurricane Katrina Restoration Work, New Orleans 2005–2012

In the aftermath of Hurricane Katrina, which devastated the city of New Orleans in August 2005, restoration workers were at risk for respiratory illness from exposure to airborne particles and microbial agents. In support of an epidemiologic investigation of this risk, an exposure assessment for restoration work activities (demolition, trash & debris management, landscape restoration, sewer/waterline repair, and mold remediation) was performed from 2005 to 2012. For 2005 and 2006, Occupational Safety and Health Administration (OSHA) data (n = 730) for personal and area monitoring of total and respirable dust exposures of restoration workers were accessed and analyzed. The most significant exposures were for demolition work, with average respirable dust exposures in 2005 above the action level of 2.5 mg/m3 and 17.6% of exposures exceeding the permissible exposure limit (PEL) (5 mg/m3). Additional personal and area monitoring for thoracic particulate matter was performed from 2007 to 2012 (n = 774) and samples were assayed for endotoxin and (1→3, 1→6)-β-D-glucan (n = 202). In order to integrate the OSHA data with the later monitoring data, three independent predictive models were developed to convert total and respirable dust measures into the equivalent thoracic dust. The three models were not statistically different and the modeling results were in good agreement with an overall coefficient of variation of 16% for the thoracic dust means across work activities estimated by each of the three models. Overall, thoracic dust exposure levels decreased by about an order of magnitude within the first year after Katrina and then more gradually declined and stabilized through 2012. Estimated average exposures to endotoxin and microbial glucan in 2005 were as high as 256 EU/m3 and 118 μg/m3, respectively, and likewise were seen to decrease dramatically and stabilize after 2005. The results of this exposure assessment support previously published reports of respiratory illness including sinusitis, toxic pneumonitis, and Katrina Cough among restoration workers in the years immediately after the hurricane.

Age, Race, Weight and Gender Impact Normative Values of Bone Mineral Density

BACKGROUND Osteoporosis and fractures represent a major public health issue. Accurate normative reference bone mineral density (BMD) values are vital for diagnosing osteoporosis. The generalizability of the T-score method across gender, race, and age in clinic decision-making has been debated. Our aim was to identify the best statistical model to derive normative BMD values in both men and women in the multiethnic United States population. METHODS The Third National Health and Nutrition Examination Survey was used as a data source. Gender- and race/ethnicity-stratified data analyses and modeling were conducted on 9779 persons (ages 20 to 65 years) who reported no conditions or medications likely to affect bone metabolism. Sampling and design effects were addressed using STATA 10. Model comparisons were conducted by partial F tests and residual plots. RESULTS Polynomial regression provided a statistically significant better fit than linear regression in predicting normative BMD in both men and women. Age-centered polynomial models provided the best model for predicting normative BMD values. CONCLUSION The gender- and race-specific lower limit of normal values obtained created a new classification method of low BMD, which might mitigate some of the T-score limitations in men and minority populations.

Respiratory Health Effects Associated with Restoration Work in Post-Hurricane Katrina New Orleans

Background. This study examines prevalence of respiratory conditions in New Orleans-area restoration workers after Hurricane Katrina. Methods. Between 2007 and 2010, spirometry and respiratory health and occupational questionnaire were administered to 791 New Orleans-area adults who mostly worked in the building construction and maintenance trades or custodial services. The associations between restoration work hours and lung function and prevalence of respiratory symptoms were examined by multiple linear regression, χ 2, or multiple logistic regression. Results. 74% of participants performed post-Katrina restoration work (median time: 620 hours). Symptoms reported include episodes of transient fever/cough (29%), sinus symptoms (48%), pneumonia (3.7%), and new onset asthma (4.5%). Prevalence rate ratios for post-Katrina sinus symptoms (PRR = 1.3; CI: 1.1, 1.7) and fever and cough (PRR = 1.7; CI: 1.3, 2.4) were significantly elevated overall for those who did restoration work and prevalence increased with restoration work hours. Prevalence rate ratios with restoration work were also elevated for new onset asthma (PRR = 2.2; CI: 0.8, 6.2) and pneumonia (PRR = 1.3; CI: 0.5, 3.2) but were not statistically significant. Overall, lung function was slightly depressed but was not significantly different between those with and without restoration work exposure. Conclusions. Post-Katrina restoration work is associated with moderate adverse effects on respiratory health, including sinusitis and toxic pneumonitis.