Harnessing the power of the electronic health record for ALS research and quality improvement: CReATe CAPTURE-ALS and the ALS Toolkit.

The electronic health record (EHR) is designed principally to support the provision and documentation of clinical care, as well as billing and insurance claims. Broad implementation of the EHR, however, also yields an opportunity to use EHR data for other purposes, including research and quality improvement. Indeed, effective use of clinical data for research purposes has been a long-standing goal of physicians who provide care for patients with ALS, but the quality and completeness of clinical data, as well as the burden of double data entry into the EHR and into a research database, have been persistent barriers. These factors provided motivation for the development of the ALS Toolkit, a set of interactive digital forms within the EHR that enable easy, consistent, and structured capture of information relevant to ALS patient care (as well as research and quality improvement) during clinical encounters. Routine use of the ALS Toolkit within the context of the CReATe Consortium's institutional review board-approved Clinical Procedures to Support Research in ALS (CAPTURE-ALS) study protocol, permits aggregation of structured ALS patient data, with the goals of empowering research and driving quality improvement. Widespread use of the ALS Toolkit through the CAPTURE-ALS protocol will help to ensure that ALS clinics become a driving force for collecting and aggregating clinical data in a way that reflects the true diversity of the populations affected by this disease, rather than the restricted subset of patients that currently participate in dedicated research studies.

Meaningful variation in performance: what does variation in quality tell us about improving quality?

BACKGROUND: Variance reduction is sometimes considered as a goal of clinical quality improvement. Variance among physicians, hospitals, or health plans has been evaluated as the proportion of total variance (or intraclass correlation, ICC) in a quality measure; low ICCs have been interpreted to indicate low potential for quality improvement at that level. However, the absolute amount of variation, expressed in clinically meaningful units, is less frequently reported. Moreover, changes in variance components have not been studied as quality improves. OBJECTIVES: To examine changes in variance components at primary care physician and medical facility levels as performance improved for 4 quality indicators: systolic blood pressure levels in hypertension; low-density lipoprotein-cholesterol levels in hyperlipidemia; patient-reported care experience scores after primary care visits; and mammography screening rates. POPULATION: Adult members (n = 62,596-410,976) of Kaiser Permanente in Northern California, served by more than 1000 primary care physicians in 35 facilities, from 2001 to 2006. METHODS: Multilevel linear and logistic regression to examine the interphysician and interfacility variances in 4 quality indicators over 6 years, after case-mix adjustment. RESULTS: ICCs were low for all 4 indicators at both levels (0.0021-0.086). Nevertheless, variances at both levels were statistically and clinically significant. For systolic blood pressure and the care experience score, interfacility and interphysician variance as well as ICCs decreased further as quality improved; declines were greater at the facility level. For low-density lipoprotein-cholesterol, variability at both levels increased with quality improvement; and for screening mammography, small declines were not statistically significant for either physicians or facilities. CONCLUSIONS: Low proportions of variance do not predict low potential for quality improvement. Despite low ICCs for facilities, quality improvement efforts directed primarily at facilities improved quality for all 4 indicators.

Meaningful variation in performance: a systematic literature review.

BACKGROUND: Recommendations for directing quality improvement initiatives at particular levels (eg, patients, physicians, provider groups) have been made on the basis of empirical components of variance analyses of performance. OBJECTIVE: To review the literature on use of multilevel analyses of variability in quality. RESEARCH DESIGN: Systematic literature review of English-language articles (n = 39) examining variability and reliability of performance measures in Medline using PubMed (1949-November 2008). RESULTS: Variation was most commonly assessed at facility (eg, hospital, medical center) (n = 19) and physician (n = 18) levels; most articles reported variability as the proportion of total variation attributable to given levels (n = 22). Proportions of variability explained by aggregated levels were generally low (eg, <19% for physicians), and numerous authors concluded that the proportion of variability at a specific level did not justify targeting quality interventions to that level. Few articles based their recommendations on absolute differences among physicians, hospitals, or other levels. Seven of 12 articles that assessed reliability found that reliability was poor at the physician or hospital level due to low proportional variability and small sample sizes per unit, and cautioned that public reporting or incentives based on these measures may be inappropriate. CONCLUSIONS: The proportion of variability at levels higher than patients is often found to be "low." Although low proportional variability may lead to poor measurement reliability, a number of authors further suggested that it also indicates a lack of potential for quality improvement. Few studies provided additional information to help determine whether variation was, nevertheless, clinically meaningful.

Comparison of video- and EMG-based evaluations of the magnitude of children's emotion-modulated startle response.

We investigated the reliability and validity of a video-based method of measuring the magnitude of children's emotion-modulated startle response when electromyographic (EMG) measurement is not feasible. Thirty-one children between the ages of 4 and 7 years were videotaped while watching short video clips designed to elicit happiness or fear. Embedded in the audio track of the video clips were acoustic startle probes. A coding system was developed to quantify from the video record the strength of the eye-blink startle response to the probes. EMG measurement of the eye blink was obtained simultaneously. Intercoder reliability for the video coding was high (Cohen's kappa = .90). The average within-subjects probe-by-probe correlation between the EMG- and video-based methods was .84. Group-level correlations between the methods were also strong, and there was some evidence of emotion modulation of the startle response with both the EMG- and the video-derived data. Although the video method cannot be used to assess the latency, probability, or duration of startle blinks, the findings indicate that it can serve as a valid proxy of EMG in the assessment of the magnitude of emotion-modulated startle in studies of children conducted outside of a laboratory setting, where traditional psychophysiological methods are not feasible.

Developmental and contextual influences on autonomic reactivity in young children.

Studies of cardiovascular reactivity in young children have generally employed integrated, physiologically complex measures, such as heart rate and blood pressure, which are subject to the multiple influences of factors such as blood volume, hematologic status, thermoregulation, and autonomic nervous system (ANS) tone. Reactivity studies in children have rarely employed more differentiated, proximal measures of autonomic function capable of discerning the independent effects of sympathetic and parasympathetic responses. We describe 1) the development, validity, and reliability of a psychobiology protocol assessing autonomic reactivity to challenge in 3- to 8-year-old children; 2) the influences of age, gender, and study context on autonomic measures; and 3) the distributions of reactivity measures in a normative sample of children and the prevalences of discrete autonomic profiles. Preejection period (PEP) and respiratory sinus arrythmia (RSA) were measured as indices of sympathetic and parasympathetic nervous system reactivity, respectively, and autonomic profiles were created to offer summative indices of PEP and RSA response. Results confirmed the protocol's validity and reliability, and showed differences in autonomic reactivity by age and study context, but not by gender. The studies' findings offer guidelines for future research on autonomic reactivity in middle childhood and support the feasibility of examining sympathetic and parasympathetic responses to challenge in 3- to 8-year-old children.

Temperament, tympanum, and temperature: four provisional studies of the biobehavioral correlates of tympanic membrane temperature asymmetries.

Previous research in both humans and nonhuman primates suggests that subtle asymmetries in tympanic membrane (TM) temperatures may be related to aspects of cognition and socioaffective behavior. Such associations could plausibly reflect lateralities in cerebral blood flow that support side-to-side differences in regional cortical activation. Asymmetries in activation of the left and right frontal cortex, for example, are correlates of temperamental differences in child behavior and markers of risk status for affective and anxiety disorders. Tympanic membrane temperatures might thus reflect the neural asymmetries that subserve individual differences in temperament and behavior. This report merged findings from four geographically and demographically distinctive studies, which utilized identical thermometry methods to examine associations between TM temperature asymmetries and biobehavioral attributes of 4- to 8-year-old children (N = 468). The four studies produced shared patterns of associations that linked TM temperature lateralities to individual differences in behavior and socioaffective difficulties. Warmer left TMs were associated with "surgent," affectively positive behaviors, whereas warmer right TMs were related to problematic, affectively negative behaviors. Taken together, these findings suggest that asymmetries in TM temperatures could be associated with behavior problems that signal risk for developmental psychopathology.

Revealing the relation between temperament and behavior problem symptoms by eliminating measurement confounding: expert ratings and factor analyses.

This study examined the hypothesis that item overlap, or measurement confounding, accounts for the correlation between temperament and behavior problem symptoms in children. First, a conceptual approach was taken in which 41 experts rated temperament (Children's Behavior Questionnaire, CBQ) and behavior problem symptom items (Preschool Behavior Questionnaire, PBQ) for their fit to both constructs. With this approach, 10% of temperament and 38% of symptom items were confounded. Second, an empirical approach was taken and CBQ and PBQ items were factor analyzed with data from a multi-informant longitudinal study of 451 children. Using this method, 9% of temperament and 23% of symptom items were confounded. Most importantly, removing the confounded items from the CBQ and PBQ scales did not affect the relation between temperament and symptoms, suggesting that the associations were not due to measurement confounding. In addition, the predictive power of earlier temperament for DSM-IV symptoms (Health and Behavior Questionnaire) remained high with the purified CBQ scale. The findings of this study contribute to the understanding of the relation between normal-range temperament and extreme behavior.