Racial and Ethnic Disparities in Infant Mortality in North Carolina, 2008-2009.

BACKGROUND: This study was designed to investigate whether racial and ethnic disparities in infant mortality still exist in North Carolina and to examine predictors of infant mortality using the North Carolina Vital Statistics Dataverse. METHODS: This was a retrospective, cross-sectional, observational study that included all 257,543 births in North Carolina in 2008-2009. Infant mortality was assessed based on birth records included in the database. Infant births and deaths were summarized by demographic and maternal/infant characteristics. A multivariate logistic regression model was constructed to jointly assess predictors of infant mortality. RESULTS: The overall infant mortality rate in North Carolina was 0.8%. Adjusting for confounders through the construction and assessment of a multivariate logistic regression model, statistically significant associations were found between infant mortality and each of the following: maternal race (both black and 'other' versus white), infant sex, both premature and preterm gestation (versus full term), birth weight (both low and high versus normal), maternal education (both less than high school graduate and more than high school versus college graduate), prenatal care (both intermediate and inadequate versus adequate), and maternal tobacco use. LIMITATIONS: Maternal race was limited to white, black, and other. Data on socioeconomic status, maternal medical risk factors, and quality of prenatal care were not available. At the time of the analysis, data for years beyond 2009 were limited. CONCLUSIONS: Racial disparities in infant mortality persist in North Carolina; specifically, infants of nonwhite mothers have a higher mortality rate than do infants of white mothers. Other factors that continue to play a significant role in infant mortality in North Carolina include preterm and premature births, male infant sex, low birth weight, maternal education less than college graduate, maternal tobacco use, and less than adequate prenatal care.

Impact of genotype-guided dosing on anticoagulation visits for adults starting warfarin: a randomized controlled trial.

AIM: This study aimed to assess the effectiveness of genotype-guided warfarin dosing. PATIENTS & METHODS: A total of 109 adults were randomized to receive initial dosing as determined by an algorithm containing genetic (VKORC1 and CYP2C9) plus clinical information or only clinical information. Primary end points were the number of anticoagulation visits and the time in therapeutic range (TTR) over 90 days. Secondary end points included time to therapeutic dose, International Normalized Ratios of >4, emergency visits, hospitalizations, hemorrhagic events, thrombotic events and mortality. RESULTS: Neither primary end point was significantly different between groups (anticoagulation visits: 6.96 vs 6.37, p = 0.51; TTR: 0.40 vs 0.43, p = 0.59). Fewer emergency visits, hospitalizations, major hemorrhagic events, thrombotic events and deaths occurred in the genetic plus clinical group than in the clinical only group, but these differences were not statistically significant. CONCLUSION: Genotype-guided dosing did not decrease the number of anticoagulation visits or improve TTR. Our trial was not powered to detect anything but large differences for utilization and health outcomes.

The Adverse Drug Event Collaborative: a joint venture to measure medication-related patient harm.

AIM: To measure the extent of patient harm caused by medications (rate of Adverse Drug Events) in three DHBs, using a standardised trigger tool method. METHODS: Counties Manukau, Capital and Coast and Canterbury DHBs decided to work collaboratively to implement the ADE Trigger Tool (TT). Definitions of ADE were agreed on and triggers refined. A random sample of closed charts (from March 2010 to February 2011) was obtained excluding patients who were admitted for <48 hours, children under the age of 18 and psychiatric admissions. In each DHB trained reviewers scanned these in a structured way to identify any of the 19 triggers. If triggers were identified, a more detailed, though time-limited review of the chart was done to determine whether an ADE had occurred. The severity of patient harm was categorised using the National Coordinating Council for Medication Error Reporting and Prevention Index. No attempt was made to determine preventability of harm and ADEs from acts of omission were excluded. RESULTS: The ADE TT was applied to 1210 charts and 353 ADE were identified, with an average rate of 28.9/100 admissions and 38/1,000 bed days. 94.5% of the ADE identified were in the lower severity scales with temporary harm, however in 5 patients it was considered that the ADE contributed to their death, 9 required an intervention to sustain life and 4 suffered permanent harm. The most commonly implicated drugs were morphine and other opioids, anticoagulants, antibiotics, Non Steroidal Anti-Inflammatory Drugs (NSAIDs) and diuretics. Patients who suffered an ADE were more likely to be female, older with more complex medical illnesses, and have a longer length of stay. CONCLUSION: The rate of medication-related harm identified by the ADE TT is considerably higher than that identified through traditional voluntary reporting mechanisms. The ADE TT provides a standardised measure of harm over time that can be used to determine trends and the effect of medication safety improvement programmes. This study not only shows the problem of medication-related patient harm, but it also shows the utility of informal collaboratives as a mechanism for change.

Comparison of subject-specific and population averaged models for count data from cluster-unit intervention trials.

Maximum likelihood estimation techniques for subject-specific (SS) generalized linear mixed models and generalized estimating equations for marginal or population-averaged (PA) models are often used for the analysis of cluster-unit intervention trials. Although both classes of procedures account for the presence of within-cluster correlations, the interpretations of fixed effects including intervention effect parameters differ in SS and PA models. Furthermore, closed-form mathematical expressions relating SS and PA parameters from the two respective approaches are generally lacking. This paper investigates the special case of correlated Poisson responses where, for a log-linear model with normal random effects, exact relationships are available. Equivalent PA model representations of two SS models commonly used in the analysis of nested cross-sectional cluster trials with count data are derived. The mathematical results are illustrated with count data from a large non-randomized cluster trial to reduce underage drinking. Knowledge of relationships among parameters in the respective mean and covariance models is essential to understanding empirical comparisons of the two approaches.

Prevalence of partner violence in same-sex romantic and sexual relationships in a national sample of adolescents.

PURPOSE: To present the first national prevalence estimates of psychological and physical intimate partner violence between adolescents in same-sex relationships. METHODS: Analyses focus on 117 adolescents aged 12-21 years (50% female) from Wave II of the National Longitudinal Study of Adolescent Health who reported exclusively same-sex romantic or sexual relationships in the 18 months before interview. Items from the Conflict Tactics Scale were used to measure partner violence victimization. Data analysis included computation of prevalence estimates and a logistic regression analysis to assess associations between sociodemographic characteristics and violence victimization. RESULTS: Almost one-quarter of adolescents with same-sex romantic or sexual partners reported some type of partner violence victimization; about 1 in 10 reported physical victimization. Significant sex differences were found (OR = .29, CI = 0.08, 1.00), with males being less likely than females to report "any violence." Of six other sociodemographic characteristics examined, importance of religion (OR = .27, CI = 0.07-1.07) and school size (OR = .32, CI = 0.09-1.11) were associated with victimization at the p < .10 level. Adolescents who reported that religion was important to them and adolescents who attended larger schools were at lower risk of "any violence." CONCLUSIONS: As with opposite-sex relationships, psychological and minor physical violence victimization is common among adolescents involved in same-sex intimate relationships. Males reporting exclusively same-sex relationships were less likely than females to report experiencing the violence behaviors examined.

Blinded review of Papanicolaou smears in the context of litigation.

BACKGROUND: Blinded review has been endorsed by several cytology and pathology organizations as the most appropriate method for the review of cervicovaginal specimens in the context of litigation. Methods for determining the statistical validity of this method were evaluated. METHODS: First, the authors calculated the sample size needed to detect various differences in case difficulty or ease of interpretation, in which ease of interpretation is defined as the percentage of the time a case could be identified as abnormal by routine screening. Very easy cases could be identified most reliably, whereas more difficult cases were detected less regularly and less reliably. Using construct sample sizes, the authors calculated the number of abnormal reviews that may be helpful to conclude that the case's difficulty or ease of interpretation was statistically significantly different from another case of a specified difficulty. Finally, they examined the effect of using two separate cutoff parameters to make these distinctions. RESULTS: Depending on the threshold chosen, it was determined that improvements in the statistically meaningful distinctions may be made using 15 or 20 reviews. To distinguish between routine false-negative cases (ease of detection, 40%) and routine cases (ease of detection, 80%), the thresholds may be set at 5 of 10 reviews (a case that would not be detected regularly and reliably in any given laboratory) and 7 of 10 reviews (defining a case that would be identified regularly and reliably), respectively. CONCLUSIONS: The authors provide data that can be used to interpret the results of a blinded review in a statistically appropriate manner. To improve the utility of blinded reviews, the standards are defined explicitly.

An integrated population-averaged approach to the design, analysis and sample size determination of cluster-unit trials.

While the mixed model approach to cluster randomization trials is relatively well developed, there has been less attention given to the design and analysis of population-averaged models for randomized and non-randomized cluster trials. We provide novel implementations of familiar methods to meet these needs. A design strategy that selects matching control communities based upon propensity scores, a statistical analysis plan for dichotomous outcomes based upon generalized estimating equations (GEE) with a design-based working correlation matrix, and new sample size formulae are applied to a large non-randomized study to reduce underage drinking. The statistical power calculations, based upon Wald tests for summary statistics, are special cases of a general power method for GEE.

How many cases need to be reviewed to compare performance in surgical pathology?

Recent studies have shown increased interest in measuring error rates in surgical pathology. We sought to determine how many surgical pathology cases need to be reviewed to show a significant difference from published error rates for review of routine or biopsy cases. Results of 4 series with this type of diagnostic material involving a total of 11,683 cases were reviewed to determine the range of published false-negative, false-positive, typing error, threshold error, and clinically significant error rates. Error rates ranged from 0.00% to 2.36%; clinically significant error rates ranged from 0.34% to 1.19%. Assuming a power of 0.80 and a 1-sided alpha of 0.05, the number of cases needed to be reviewed to show that a laboratory with either twice or one half the published error rate was significantly different from the range of published error rates varied from 3.30 to 50, 158. For clinically significant errors, the number of cases varied from 665 to 5,886. Because the published error rates are low, a relatively large number of cases need to be reviewed and a relatively great difference in error rate needs to exist to show a significant difference in performance in surgical pathology.

Blinded review as a method for quality improvement in surgical pathology.

CONTEXT: Several studies have shown that blinded review, because it is less biased and may improve vigilance, is an excellent method for detecting errors and improving performance in gynecologic cytology. The value of blinded review in surgical pathology is not known. OBJECTIVE: To determine the value of blinded review in surgical pathology. METHODS: Five hundred ninety-two biopsy cases were reviewed without knowledge of the original diagnosis or history, and the results were compared with those of the original diagnosis. RESULTS: Complete agreement was obtained in 567 (96%) of 592 cases. The technique of blinded review of biopsy material had a sensitivity of 98%, failing to identify a lesion in 7 cases; no cases of malignancy were missed. The specificity was 100%. Differences in diagnostic threshold were the most common source of disagreement. False-negative cases were identified by the technique and were clinically significant. Power studies show that the number of cases requiring review to identify significant errors are large, but potentially achievable by blinded review. CONCLUSION: Blinded review is a sensitive and effective method for identifying areas of disagreement, including false-negative cases, and for decreasing errors in surgical pathology biopsy material.

Quantifying the value of in-house consultation in surgical pathology.

In-house consultation is a well-known method to improve diagnostic accuracy and agreement, but the technique has not been well studied. We reviewed the results of in-house consultation in a large private hospital practice setting for a 1-month period and determined its effect on diagnostic accuracy using the final sign-out as the "gold standard." During this 1-month period, 352 cases were reviewed as in-house consultations. Initial complete agreement was found in 315 (89.5%) cases. Using the initial diagnosis as the test case and the final sign-out as the gold standard, of the 37 discrepant cases, 4 (1.1%) were thought to represent false-negative results, (0.3%) a false-positive result, 3 (0.9%) differences in type, and 29 (8.2%) differences in diagnostic threshold. Disagreements in 10 cases were thought to be potentially clinically significant. Internal consultation was obtained on approximately 20% of all cases seen in the laboratory and disagreements were found in 2% of all cases. Internal consultation has a significant and measurable impact on the practice of surgical pathology.

Recurrence of chronic venous ulcers on the basis of clinical, etiologic, anatomic, and pathophysiologic criteria and air plethysmography.

INTRODUCTION: Leg ulcers associated with chronic venous insufficiency (CVI) frequently recur after healing. The risk of recurrence has not been well defined for patients in different anatomic and hemodynamic groups. We reviewed the risk of ulcer recurrence on the basis of clinical, etiologic, anatomic, and pathophysiologic criteria and hemodynamic characteristics of the affected limb as assessed with air plethysmography (APG). METHODS: Ninety-nine limbs with class 6 CVI were assessed clinically and with standing duplex ultrasound scanning and APG for the definition of clinical, etiologic, anatomic, and pathophysiologic criteria. Leg ulcers were treated with high-pressure compression protocols. Surgical correction of venous abnormalities was offered to patients with appropriate conditions. After ulcer healing, the limbs were placed in compressive garments and followed at 6-month intervals for ulcer recurrence. RESULTS: The mean patient age was 54.3 years, and 46% of the patients were female. Corrective venous surgery was performed in 37 limbs. The mean follow-up time for all 99 limbs was 28 months. The ulcer recurrence rate with life table was 37% +/- 6% at 3 years and 48% +/- 10% at 5 years. The patients who underwent venous surgery had a significantly lower recurrence rate (27% +/- 9% at 48 months) than did those patients who had not undergone surgery (67% +/- 8% at 48 months; P =.005). The patients with deep venous insufficiency (DVI; n = 51) had significantly higher recurrence rates (66% +/- 8% at 48 months) than did the patients without DVI (n = 48; 29% +/- 9% at 48 months; P =.006). This difference was significant even after accounting for the effects of surgery (P =.03). The hazard ratio of ulcer recurrence increases by 14% for every unit increase in the venous filling index (VFI; P =.001). This remains significant even after accounting for the effects of surgery (P =.001). The combination of DVI and a VFI of more than 4 mL/s yields a risk of ulcer recurrence of 43% +/- 9% at 1 year and 60% +/- 10% at 2 years. CONCLUSION: Leg ulcers associated with CVI have a high rate of recurrence. Ulcer recurrence is significantly increased in patients with DVI and in patients who do not have venous abnormalities corrected surgically. The VFI obtained from APG is useful in the prediction of increased risk for recurrence, particularly in association with anatomic data.