Postoperative mortality risk prediction that incorporates intraoperative vital signs: development and internal validation in a historical cohort.

PURPOSE: Accurate risk reassessment after surgery is crucial for postoperative planning for monitoring and disposition. Existing postoperative mortality risk prediction models using preoperative features do not incorporate intraoperative hemodynamic derangements that may alter risk stratification. Intraoperative vital signs may provide an objective and readily available prognostic resource. Our primary objective was to derive and internally validate a logistic regression (LR) model by adding intraoperative features to established preoperative predictors to predict 30-day postoperative mortality. METHODS: Following Research Ethics Board approval, we analyzed a historical cohort that included patients aged ≥ 45 undergoing noncardiac surgery with an overnight stay at two tertiary hospitals (2013 to 2017). Features included intraoperative vital signs (blood pressure, heart rate, end-tidal carbon dioxide partial pressure, oxygen saturation, and temperature) by threshold and duration of exposure, as well as patient, surgical, and anesthetic factors. The cohort was divided temporally 75:25 into derivation and validation sets. We constructed a multivariable LR model with 30-day all-cause mortality as the outcome and evaluated performance metrics. RESULTS: There were 30,619 patients in the cohort (mean [standard deviation] age, 66 [11] yr; 50.2% female; 2.0% mortality). In the validation set, the primary LR model showed a c-statistic of 0.893 (99% confidence interval [CI], 0.853 to 0.927), a Nagelkerke R-squared of 0.269, a scaled Brier score of 0.082, and an area under precision-recall curve of 0.158 (baseline 0.017 for an uninformative model). The addition of intraoperative vital signs to preoperative factors minimally improved discrimination and calibration. CONCLUSION: We derived and internally validated a model that incorporated vital signs to improve risk stratification after surgery. Preoperative factors were strongly predictive of mortality risk, and intraoperative predictors only minimally improved discrimination. External and prospective validations are needed. STUDY REGISTRATION: www. CLINICALTRIALS: gov (NCT04014010); registered on 10 July 2019.

RéSUMé: OBJECTIF: Une réévaluation précise des risques après la chirurgie est cruciale pour la planification postopératoire du monitorage et du congé. Les modèles existants de prédiction du risque de mortalité postopératoire utilisant des caractéristiques préopératoires n'intègrent pas les perturbations hémodynamiques peropératoires, lesquelles pourraient modifier la stratification du risque. Les signes vitaux peropératoires peuvent fournir une ressource pronostique objective et facilement disponible. Notre objectif principal était de dériver et de valider en interne un modèle de régression logistique (RL) en ajoutant des caractéristiques peropératoires aux prédicteurs préopératoires établis pour prédire la mortalité postopératoire à 30 jours. MéTHODE: À la suite de l'approbation du Comité d'éthique de la recherche, nous avons analysé une cohorte historique qui comprenait des patients âgés de ≥ 45 ans bénéficiant d'une chirurgie non cardiaque avec un séjour d'une nuit dans deux hôpitaux tertiaires (2013 à 2017). Les caractéristiques comprenaient les signes vitaux peropératoires (tension artérielle, fréquence cardiaque, pression télé-expiratoire en CO2, saturation en oxygène et température) par seuil et durée d'exposition, ainsi que des facteurs propres au patient, chirurgicaux et anesthésiques. La cohorte a été divisée temporellement 75:25 en ensembles de dérivation et de validation. Nous avons élaboré un modèle de RL multivariée avec la mortalité toutes causes confondues à 30 jours comme critère, et évalué les mesures de performance. RéSULTATS: Il y avait 30 619 patients dans la cohorte (âge moyen [écart type], 66 [11] ans; 50,2 % de femmes; 2,0 % de mortalité). Dans l'ensemble de validation, le modèle de RL primaire a montré une statistique c de 0,893 (intervalle de confiance [IC] à 99 %, 0,853 à 0,927), un R carré de Nagelkerke de 0,269, un score de Brier mis à l'échelle de 0,082 et une aire sous la courbe de rappel et précision de 0,158 (ligne de base 0,017 pour un modèle non informatif). L'ajout de signes vitaux peropératoires aux facteurs préopératoires a amélioré de façon minimale la discrimination et l'étalonnage. CONCLUSION: Nous avons dérivé et validé en interne un modèle qui incorporait des signes vitaux pour améliorer la stratification des risques après la chirurgie. Les facteurs préopératoires étaient fortement prédictifs du risque de mortalité, et les prédicteurs peropératoires n'ont que que très peu amélioré la discrimination. Une validation externe et prospective est nécessaire. ENREGISTREMENT DE L'éTUDE: www.ClinicalTrials.gov (NCT04014010); enregistrée le 10 juillet 2019.

Association of cultural affinity and island food consumption in the Pacific Islander health study.

Objectives: The dietary patterns of Pacific Islander Americans are partially influenced by a rich cultural heritage. There is little known about how cultural affinity affects the dietary choices of this small, but quickly growing population. This analysis attempts to understand how the association of cultural affinity on island foods consumption (IFC) varies by key demographic characteristics.Design: A sample of 240 Samoan and Tongan adults in California from the Pacific Islander Health Study (PIHS) was used. Psychometric properties of a novel 11-item cultural affinity scale were assessed. Univariate and bivariate analyses of the cultural affinity scale were completed to understand the distribution of cultural affinity score. Separate multivariable Poisson regression was used to assess the effect of interactions between cultural affinity and five key demographic factors on IFC.Results: Psychometric analysis of the PIHS cultural affinity scale revealed two unique factors. Significant interactions were found between cultural affinity and ethnicity and birthplace: the association between cultural affinity and IFC was larger among Samoans compared to Tongans and Samoan or Tongan birthplace was found to have a weaker association between cultural affinity and IFC. Interactions between cultural affinity and age, financial insecurity, and educational attainment were not significant.Conclusion: Understanding how cultural affinity varies in its effect on IFC is a part of understanding overall dietary patterns in this population.

Hepatitis A Outbreaks Associated With the Opioid Epidemic in Kentucky Counties, 2017-2018.

Objectives. To describe county-level socioeconomic profiles associated with Kentucky's 2017-2018 hepatitis A outbreak that predominately affected communities affected by the opioid epidemic.Methods. We linked county-level characteristics on socioeconomic and housing variables to counties' hepatitis A rates. Principal component analysis identified county profiles of poverty, education, disability, income inequality, grandparent responsibility, residential instability, and marital status. We used Poisson regression to estimate adjusted relative risks (RRs) and 95% confidence intervals (CIs).Results. Counties with scores reflecting an extremely disadvantaged profile (RR = 1.21; 95% CI = 0.99, 1.48) and greater percentage of nonmarried men, residential instability, and income inequality (RR = 1.15; 95% CI = 0.94, 1.41) had higher hepatitis A rates. Counties with scores reflecting more married adults, residential stability, and lower income inequality despite disability, poverty, and low education (RR = 0.77; 95% CI = 0.59, 1.00) had lower hepatitis A rates. Counties with a higher percentage of workers in the manufacturing industry had slightly lower rates (RR = 0.97; 95% CI = 0.94, 1.00).Conclusions. As expected, impoverished counties had higher hepatitis A rates. Evaluation across the socioeconomic patterns highlighted community-level factors (e.g., residential instability, income inequality, and social structures) that can be collected to augment hepatitis A data surveillance and used to identify higher-risk communities for targeted immunizations.

Prognostic value of quantitative contrast-enhanced cardiovascular magnetic resonance for the evaluation of sudden death risk in patients with hypertrophic cardiomyopathy.

BACKGROUND: Hypertrophic cardiomyopathy (HCM) is the most common cause of sudden death in the young, although not all patients eligible for sudden death prevention with an implantable cardioverter-defibrillator are identified. Contrast-enhanced cardiovascular magnetic resonance with late gadolinium enhancement (LGE) has emerged as an in vivo marker of myocardial fibrosis, although its role in stratifying sudden death risk in subgroups of HCM patients remains incompletely understood. METHODS AND RESULTS: We assessed the relation between LGE and cardiovascular outcomes in 1293 HCM patients referred for cardiovascular magnetic resonance and followed up for a median of 3.3 years. Sudden cardiac death (SCD) events (including appropriate defibrillator interventions) occurred in 37 patients (3%). A continuous relationship was evident between LGE by percent left ventricular mass and SCD event risk in HCM patients (P=0.001). Extent of LGE was associated with an increased risk of SCD events (adjusted hazard ratio, 1.46/10% increase in LGE; P=0.002), even after adjustment for other relevant disease variables. LGE of ≥15% of LV mass demonstrated a 2-fold increase in SCD event risk in those patients otherwise considered to be at lower risk, with an estimated likelihood for SCD events of 6% at 5 years. Performance of the SCD event risk model was enhanced by LGE (net reclassification index, 12.9%; 95% confidence interval, 0.3-38.3). Absence of LGE was associated with lower risk for SCD events (adjusted hazard ratio, 0.39; P=0.02). Extent of LGE also predicted the development of end-stage HCM with systolic dysfunction (adjusted hazard ratio, 1.80/10% increase in LGE; P<0.03). CONCLUSIONS: Extensive LGE measured by quantitative contrast enhanced CMR provides additional information for assessing SCD event risk among HCM patients, particularly patients otherwise judged to be at low risk.

Electronic risk alerts to improve primary care management of chest pain: a randomized, controlled trial.

BACKGROUND: The primary care evaluation of chest pain represents a significant diagnostic challenge. OBJECTIVE: To determine if electronic alerts to physicians can improve the quality and safety of chest pain evaluations. DESIGN AND PARTICIPANTS: Randomized, controlled trial conducted between November 2008 and January 2010 among 292 primary care clinicians caring for 7,083 adult patients with chest pain and no history of cardiovascular disease. INTERVENTION: Clinicians received alerts within the electronic health record during office visits for chest pain. One alert recommended performance of an electrocardiogram and administration of aspirin for high risk patients (Framingham Risk Score (FRS) ≥ 10%), and a second alert recommended against performance of cardiac stress testing for low risk patients (FRS < 10%). MAIN MEASURES: The primary outcomes included performance of an electrocardiogram and administration of aspirin therapy for high risk patients; and avoidance of cardiac stress testing for low risk patients. KEY RESULTS: The majority (81%) of patients with chest pain were classified as low risk. High risk patients were more likely than low risk patients to be evaluated in the emergency department (11% versus 5%, p < 0.01) and to be hospitalized (7% versus 3%, p < 0.01). Acute myocardial infarction occurred among 26 (0.4%) patients, more commonly among high risk compared to low risk patients (1.1% versus 0.2%, p < 0.01). Among high risk patients, there was no difference between the intervention and control groups in rates of performing electrocardiograms (51% versus 48%, p = 0.33) or administering aspirin (20% versus 18%, p = 0.43). Among low risk patients, there was no difference between intervention and control groups in rates of cardiac stress testing (10% versus 9%, p = 0.40). CONCLUSIONS: Primary care management of chest pain is suboptimal for both high and low risk patients. Electronic alerts do not increase risk-appropriate care for these patients.

Development of a breast reconstruction satisfaction questionnaire (BRECON-31): principal components analysis and clinimetric properties.

BACKGROUND: A reliable, valid questionnaire is essential to assess patient satisfaction with breast reconstruction. METHODS: A 105-item pilot BRECON questionnaire was previously developed. One hundred eighty-one women with breast reconstruction were mailed the pilot BRECON, BREAST-Q, and EQ-5D questionnaires. Fifty women were re-mailed the BRECON. Based on the responses, the BRECON was refined using statistical means and principal components analysis (PCA). Reliability was assessed using the intraclass correlation coefficient (ICC) and Cronbach's alpha. Validity was assessed by comparing subscales of the BRECON to the BREAST-Q and comparing a summary score of the BRECON-31 to the EQ-5D using the Pearson's correlation coefficient (PCC). RESULTS: A total of 71% (128/181) of women completed the three questionnaires, and 86% (43/50) of women responded to the re-mailed BRECON. Statistical methods and PCA maintained 31 items covering eight components including self-image, arm concerns, intimacy, satisfaction, recovery, self-consciousness, expectations, and breast appearance. A 4-item "nipple" subscale and a 10-item "abdominal" subscale were developed for use where applicable. Measures of reliability and validity were high: Cronbach's alpha ranged from 0.67 to 0.91, ICC ranged from 0.55 to 0.85, and PCC ranged from 0.42 to 0.76. CONCLUSIONS: A reliable, valid 31-item breast reconstruction satisfaction questionnaire was developed.

Prevalence and phenotypes of APC and MUTYH mutations in patients with multiple colorectal adenomas.

CONTEXT: Patients with multiple colorectal adenomas may carry germline mutations in the APC or MUTYH genes. OBJECTIVES: To determine the prevalence of pathogenic APC and MUTYH mutations in patients with multiple colorectal adenomas who had undergone genetic testing and to compare the prevalence and clinical characteristics of APC and MUTYH mutation carriers. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional study conducted among 8676 individuals who had undergone full gene sequencing and large rearrangement analysis of the APC gene and targeted sequence analysis for the 2 most common MUTYH mutations (Y179C and G396D) between 2004 and 2011. Individuals with either mutation underwent full MUTYH gene sequencing. APC and MUTYH mutation prevalence was evaluated by polyp burden; the clinical characteristics associated with a pathogenic mutation were evaluated using logistic regression analyses. MAIN OUTCOME MEASURE: Prevalence of pathogenic mutations in APC and MUTYH genes. RESULTS: Colorectal adenomas were reported in 7225 individuals; 1457 with classic polyposis (≥100 adenomas) and 3253 with attenuated polyposis (20-99 adenomas). The prevalence of pathogenic APC and biallelic MUTYH mutations was 95 of 119 (80% [95% CI, 71%-87%]) and 2 of 119 (2% [95% CI, 0.2%-6%]), respectively, among individuals with 1000 or more adenomas, 756 of 1338 (56% [95% CI, 54%-59%]) and 94 of 1338 (7% [95% CI, 6%-8%]) among those with 100 to 999 adenomas, 326 of 3253 (10% [95% CI, 9%-11%]) and 233 of 3253 (7% [95% CI, 6%-8%]) among those with 20 to 99 adenomas, and 50 of 970 (5% [95% CI, 4%-7%]) and 37 of 970 (4% [95% CI, 3%-5%]) among those with 10 to 19 adenomas. Adenoma count was strongly associated with a pathogenic mutation in multivariable analyses. CONCLUSIONS: Among patients with multiple colorectal adenomas, pathogenic APC and MUTYH mutation prevalence varied considerably by adenoma count, including within those with a classic polyposis phenotype. APC mutations predominated in patients with classic polyposis, whereas prevalence of APC and MUTYH mutations was similar in attenuated polyposis. These findings require external validation.

Lack of association between migraine headache and patent foramen ovale: results of a case-control study.

BACKGROUND: Clinical observations of migraine headache symptoms in patients with a patent foramen ovale (PFO), both of which conditions are highly prevalent, have raised the question of a possible pathophysiological relationship. We sought to evaluate the assumption of an association between migraine headaches and the presence of PFO by use of a large case-control study. METHODS AND RESULTS: We conducted a case-control study to assess the prevalence of PFO in subjects with and without migraine. Case subjects were those with a history of migraine (diagnosed by neurologists at a specialty academic headache clinic). Control subjects were healthy volunteers without migraine 1:1 matched on the basis of age and sex with case subjects. Presence of PFO was determined by transthoracic echocardiogram with second harmonic imaging and transcranial Doppler ultrasonography during a standardized procedure of infused agitated saline contrast with or without Valsalva maneuver and a review of the results by experts blinded to case-control status. PFO was considered present if both studies were positive. Odds ratios were calculated with conditional logistic regression in the matched cohort (n=288). In the matched analysis, the prevalence of PFO was similar in case and control subjects (26.4% versus 25.7%; odds ratio 1.04, 95% confidence interval 0.62 to 1.74, P=0.90). There was no difference in PFO prevalence in those with migraine with aura and those without (26.8% versus 26.1%; odds ratio 1.03, 95% confidence interval 0.48 to 2.21, P=0.93). CONCLUSIONS: We found no association between migraine headaches and the presence of PFO in this large case-control study.

Outcomes of informed consent among parents of children in cancer clinical trials.

BACKGROUND: Clinical trials are central to pediatric oncology, yet the process and outcomes of informed consent are poorly understood. We evaluated correlates of understanding among parents of pediatric trial participants, and explored differences in the process and outcome of informed consent between parents and a comparison group of adult participants. PROCEDURE: We administered the Quality of Informed Consent (QuIC) to parents of children who were newly enrolled onto a cancer trial. We identified independent correlates of knowledge among parents, and compared parents' knowledge to that of a contemporaneous group of adult participants, using multiple linear regression models. RESULTS: Parents (n = 47) were less likely than adult participants (n = 204) to report having enough time to learn about the trial (64% vs. 87%, P = 0.001) or sufficient opportunity for questions (79% vs. 93%, P = 0.01), and reported lower overall satisfaction with the consent process (71% vs. 90%, P = 0.002). The mean parental knowledge score was 73.6 (95% confidence interval [CI] 69.5-77.8, theoretical maximum 100). Knowledge did not differ between parents and adult trial participants. In multivariate analysis, two predictors were significantly associated with higher parent knowledge scores: consent sought by the study's principal investigator (increment 13.6, CI 2.7-24.6) and physician-reported poor prognosis (increment 13.8, 95% CI 5.4-22.1). CONCLUSIONS: Although we observed no differences in knowledge between parents of pediatric cancer trial participants and their adult counterparts, parents report more problems with the informed consent process for their trials. The increased prevalence of problems is likely due to clinical and contextual differences between pediatric and adult trials.

Revised trauma scoring system to predict in-hospital mortality in the emergency department: Glasgow Coma Scale, Age, and Systolic Blood Pressure score.

INTRODUCTION: Our aim in this study was to assess whether the new Glasgow Coma Scale, Age, and Systolic Blood Pressure (GAP) scoring system, which is a modification of the Mechanism, Glasgow Coma Scale, Age, and Arterial Pressure (MGAP) scoring system, better predicts in-hospital mortality and can be applied more easily than previous trauma scores among trauma patients in the emergency department (ED). METHODS: This multicenter, prospective, observational study was conducted to analyze readily available variables in the ED, which are associated with mortality rates among trauma patients. The data used in this study were derived from the Japan Trauma Data Bank (JTDB), which consists of 114 major emergency hospitals in Japan. A total of 35,732 trauma patients in the JTDB from 2004 to 2009 who were 15 years of age or older were eligible for inclusion in the study. Of these patients, 27,154 (76%) with complete sets of important data (patient age, Glasgow Coma Scale (GCS) score, systolic blood pressure (SBP), respiratory rate and Injury Severity Score (ISS)) were included in our analysis. We calculated weight for the predictors of the GAP scores on the basis of the records of 13,463 trauma patients in a derivation data set determined by using logistic regression. Scores derived from four existing scoring systems (Revised Trauma Score, Triage Revised Trauma Score, Trauma and Injury Severity Score and MGAP score) were calibrated using logistic regression models that fit in the derivation set. The GAP scoring system was compared to the calibrated scoring systems with data from a total of 13,691 patients in a validation data set using c-statistics and reclassification tables with three defined risk groups based on a previous publication: low risk (mortality < 5%), intermediate risk, and high risk (mortality > 50%). RESULTS: Calculated GAP scores involved GCS score (from three to fifteen points), patient age < 60 years (three points) and SBP (> 120 mmHg, six points; 60 to 120 mmHg, four points). The c-statistics for the GAP scores (0.933 for long-term mortality and 0.965 for short-term mortality) were better than or comparable to the trauma scores calculated using other scales. Compared with existing instruments, our reclassification tables show that the GAP scoring system reclassified all patients except one in the correct direction. In most cases, the observed incidence of death in patients who were reclassified matched what would have been predicted by the GAP scoring system. CONCLUSIONS: The GAP scoring system can predict in-hospital mortality more accurately than the previously developed trauma scoring systems.

Altruism among participants in cancer clinical trials.

BACKGROUND: Patients' motivations for participation in cancer clinical trials are incompletely understood. Even less is known about the factors that influence participants' motivations for enrolling in trials. PURPOSE: We studied the reasons why adult patients and parents of pediatric patients agree to participate in cancer trials. We focused on the role of altruism across all phases of trial. METHODS: We surveyed adult patients and parents of pediatric patients participating in phase I, II, or III cancer clinical trials. We asked respondents why they agreed to enroll, and examined correlates of altruistic motivation using univariate and multivariate analyses. RESULTS: Among 205 adults and 48 parents of children participating in cancer trials, 47% reported that altruistic motivations were 'very important' to their decisions to enroll. In multivariate analysis with phase III trial participants as the reference group, phase I trial participants least often identified altruism as a 'very important' motivation for enrolling (phase I OR 0.4, 95% CI (confidence interval) 0.2-0.8; phase II OR 0.9, 95% CI 0.5-1.5, overall P = 0.017). Thirty-three respondents (13%) reported being motivated primarily by altruism. In multivariate analysis, participants with poor prognoses-defined as an expected 5-year disease-free survival of ≤ 10%-reported altruism as their primary motivation less often than those with better prognoses (OR 0.2, 95% CI 0.1-0.5, P = 0.001). Altruistic motivations did not differ between adult patients and parents of pediatric participants. LIMITATIONS: The data are derived from related academic medical centers in one city, and the study sample reflects limited sociodemographic diversity, thereby limiting generalizability to other settings. CONCLUSIONS: Although cancer trial participants commonly report that altruism contributed to their decision to enroll, it is rarely their primary motivation for study participation. Participants in early phase trials and those with poor prognoses are least often motivated by altruism.

Comparison of the utility of preoperative versus postoperative B-type natriuretic peptide for predicting hospital length of stay and mortality after primary coronary artery bypass grafting.

BACKGROUND: Preoperative B-type natriuretic peptide (BNP) is known to predict adverse outcomes after cardiac surgery. The value of postoperative BNP for predicting adverse outcomes is less well delineated. The authors hypothesized that peak postoperative plasma BNP (measured postoperative days 1-5) predicts hospital length of stay (HLOS) and mortality in patients undergoing primary coronary artery bypass grafting, even after adjusting for preoperative BNP and perioperative clinical risk factors. METHODS: This study is a prospective longitudinal study of 1,183 patients undergoing primary coronary artery bypass grafting surgery. Mortality was defined as all-cause death within 5 yr after surgery. Cox proportional hazards analyses were conducted to separately evaluate the associations between peak postoperative BNP and HLOS and mortality. Multivariable adjustments were made for patient demographics, preoperative BNP concentration, and clinical risk factors. BNP measurements were log10 transformed before analysis. RESULTS: One hundred fifteen deaths (9.7%) occurred in the cohort (mean follow-up = 4.3 yr, range = 2.38-5.0 yr). After multivariable adjustment for preoperative BNP and clinical covariates, peak postoperative BNP predicted HLOS (hazard ratio [HR] = 1.28, 95% CI = 1.002-1.64, P = 0.049) but not mortality (HR = 1.62, CI = 0.71-3.68, P = 0.25), whereas preoperative BNP independently predicted HLOS (HR = 1.09, CI = 1.01-1.18, P = 0.03) and approached being an independent predictor of mortality (HR = 1.36, CI = 0.96-1.94, P = 0.08). When preoperative and peak postoperative BNP were separately adjusted for within the clinical multivariable models, each independently predicted HLOS (preoperative BNP HR = 1.13, CI = 1.05-1.21, P = 0.0007; peak postoperative BNP HR = 1.44, CI = 1.15-1.81, P = 0.001) and mortality (preoperative BNP HR = 1.50, CI = 1.09-2.07, P = 0.01; peak postoperative BNP HR = 2.29, CI = 1.11-4.73, P = 0.02). CONCLUSIONS: Preoperative BNP may be better than peak postoperative BNP for predicting HLOS and longer term mortality after primary coronary artery bypass grafting surgery.

Development of a breast reconstruction satisfaction questionnaire (BRECON): dimensionality and clinical importance of breast symptoms, donor site issues, patient expectations, and relationships.

OBJECTIVES: To develop a valid, reliable and responsive, self-administered questionnaire to assess women's satisfaction with breast reconstruction. METHODS: Item generation: Three sources for item inventory were utilized: focus groups, expert panel, and literature review.Item reduction: Item impact scores were derived from patients and experts each ranking the importance and frequency of each item. Correlation between patient and expert scores was calculated. The highest impact questions were maintained. RESULTS: Four focus groups comprising 20 women generated 515 items, 10 experts developed 171 items, and literature review produced 227 items. These 913 potential items were reduced to 183 by combining redundancy. The 183 items underwent formal reduction by assessing importance and frequency of each item. Thirty-two of 40 reconstructed women and 19 of 19 experts responded to the mail-out. Seventy-seven items of the women's top 100 also made the experts' top 100 list. Intraclass correlation between patients and experts was 0.71 [0.62 0.77], indicating "good" but not "excellent" agreement, reinforcing the importance of patient involvement in questionnaire development. Women rated abdominal donor site issues higher than experts, and experts rated breast softness and symmetry higher than women. CONCLUSIONS: A 100-item pilot questionnaire for breast reconstruction satisfaction was developed for psychometric testing.

The Use of High-Risk Criteria to Assess Mortality Risk among Unsheltered Homeless Persons.

We assessed the ability of high-risk criteria developed by Boston Health Care for the Homeless Program to identify increased mortality during a 10-year cohort study (January 2000-December 2009) of 445 unsheltered adults. To qualify as high-risk for mortality, an individual slept unsheltered for six consecutive months or longer plus had one or more of the following characteristics: tri-morbidity, defined as co-occurring medical, psychiatric, and addiction diagnoses; one or more inpatient or respite admissions; three or more emergency department visits; 60 years old or older; HIV/AIDS; cirrhosis; renal failure; frostbite, hypothermia, or immersion foot. A total of 119 (26.7%) individuals met the high-risk criteria. The remaining 326 individuals in the cohort were considered lowerrisk. During the study, 134 deaths occurred; 52 (38.8%) were among high-risk individuals. Compared with sheltered individuals, the age-standardized mortality ratio for the high-risk group was 4.0 (95% confidence interval 3.0, 5.2) times higher and for the lower-risk group was 2.2 (1.8, 2.8) times higher. The hazard ratio, a measure of survival, for the high-risk group was 1.7 (1.2, 2.4) times that of the lower-risk group. High-risk criteria predicted an increased likelihood of mortality among unsheltered individuals. The lower-risk group also had high mortality rates compared with sheltered individuals.

A validated disease-specific symptom index for adults with celiac disease.

BACKGROUND & AIMS: Although the incidence of celiac disease (CD) is increasing, studies have been hampered by the lack of validated outcome measures. We sought to create a disease-specific Celiac Symptom Index (CSI) to reliably assess relevant symptoms. METHODS: A 36-item questionnaire was created after design by an expert committee and review/revision by patient focus groups. The survey, covering domains of CD-related symptoms and general health, was initially administered to 154 individuals with biopsy-proven CD; immunoglobulin (Ig)A tissue transglutaminase titers were determined, and gluten-free diet adherence was evaluated by a dietitian. The questionnaire was then revised to exclude questions with poor test characteristics and administered to a second, independent group of 52 individuals, to ensure validity. RESULTS: The subscales of "specific symptoms" and "general health" had excellent psychometric qualities that consisted of 11 and 5 items, respectively. The additive score based on these items was correlated with current general health, as measured by a visual analog scale and short form 36 general health subscale (P < or = .001 for both), as well as degree of adherence to the gluten-free diet (P = .008), lending external validity to the CSI. The resulting 16 questions make up the first CD-specific symptom index. CONCLUSIONS: The CSI allows for disease-specific monitoring of symptoms as an independent outcome measure or as part of a surrogate for disease activity in individuals with CD. The CSI might be an important tool for future clinical CD research.

Effectiveness of a barcode medication administration system in reducing preventable adverse drug events in a neonatal intensive care unit: a prospective cohort study.

OBJECTIVE: Patients are at risk of harm from medication errors. Barcode medication administration (BCMA) systems are recommended to mitigate preventable adverse drug events (ADEs). Our hypothesis was that a BCMA system would reduce preventable ADEs by 45% in a neonatal intensive care unit. STUDY DESIGN: We conducted a prospective, observational, cohort study of a BCMA system intervention in a neonatal intensive care unit. Participants were admitted neonates during 50 weeks. Medication errors and potential or preventable ADEs were detected by a daily structured audit of each subject's medical record, with assignment of an event as a preventable ADE made by blinded assessors. The generalized estimating equation method was used in modeling the targeted, preventable ADE rate with covariates. RESULTS: A total of 92,398 medication doses were administered to 958 subjects. The generalized estimating equation method yielded a relative risk of preventable ADE when the system was implemented of 0.53 (95% confidence limits 0.29 to 0.91, P = .04), adjusted for log(10)doses of medication/subject/day, a significant predictive covariate (P < .001), as well as for birth weight, sex, Caucasian race, birth cohort number, and nursing hours/subject/day. CONCLUSION: The BCMA system reduced the risk of targeted, preventable ADEs by 47%, controlling for the number of medication doses/subject/day, an important risk exposure.

Assessing cancer stage and screening disparities among Native American cancer patients.

OBJECTIVE: Disparities in cancer-related health outcomes exist among Native Americans. This article assesses barriers to timely and effective cancer care among Native American cancer patients. METHODS: We conducted a community-based participatory survey of newly diagnosed cancer patients to assess their basic knowledge of cancer screening and their beliefs about cancer management. Sociodemographic and cancer-related information was obtained from medical records. Mean scores for correct answers to the screening knowledge battery were tabulated and analyzed by race/ethnicity and sociodemographic characteristics. Multivariable regression models were used to adjust for sociodemographic characteristics in evaluating the association between screening knowledge and race/ethnicity. RESULTS: The survey response rate was 62%. Of 165 patients, 52 were Native American and 113 were white. Native Americans with cancers for which a screening test is available presented with significantly higher rates of advanced-stage cancer (p=0.04). Native Americans scored lower on the cancer screening knowledge battery (p=0.0001). In multivariable analyses adjusting for age, gender, income, education level, employment status, and geographic distance from the cancer center, Native American race/ethnicity was the only factor significantly predictive of lower screening knowledge. Native Americans expressed more negative attitudes toward cancer treatment in some of the items regarding impacts and burden of cancer treatment. CONCLUSIONS: Native American cancer patients presented with higher rates of advanced-stage disease for screening-detectable cancers, lower levels of basic cancer screening knowledge, and more negative attitudes about cancer treatment than white patients. Public health interventions regarding screening and cancer education are needed.

Medical mistrust and less satisfaction with health care among Native Americans presenting for cancer treatment.

PURPOSE: To assess barriers to cancer care among Native Americans, whose health outcomes compare unfavorably with those of the general U.S. population. METHODS AND PATIENTS: We undertook a comparative community-based participatory research project in which newly-diagnosed cancer patients were prospectively surveyed using novel scales for medical mistrust and satisfaction with health care. Socio-demographic information was obtained. Mean scale scores for mistrust and satisfaction were analyzed by race. Multivariable models were used to adjust for income, education level, and distance lived from cancer care institute. RESULTS: Participation refusal rate was 38%. Of 165 eligible patients, 52 were Native American and 113 where non-Hispanic White. Native Americans expressed significantly higher levels of mistrust (p=0001) and lower levels of satisfaction (p=.0001) with health care than Whites. In multivariable analyses, race was the only factor found to be significantly predictive of higher mistrust and lower satisfaction scores. CONCLUSION: Native Americans exhibit higher medical mistrust and lower satisfaction with health care.

Application of a decision support tool for anticoagulation in patients with non-valvular atrial fibrillation.

BACKGROUND: Atrial fibrillation affects more than two million Americans and results in a fivefold increased rate of embolic strokes. The efficacy of adjusted dose warfarin is well documented, yet many patients are not receiving treatment consistent with guidelines. The use of a patient-specific computerized decision support tool may aid in closing the knowledge gap regarding the best treatment for a patient. METHODS: This retrospective, observational cohort analysis of 6,123 Ohio Medicaid patients used a patient-specific computerized decision support tool that automated the complex risk-benefit analysis for anticoagulation. Adverse outcomes included acute stroke, major gastrointestinal bleeding, and intracranial hemorrhage. Cox proportional hazards models were developed to compare the group of patients who received warfarin treatment with those who did not receive warfarin treatment, stratified by the decision support tool's recommendation. RESULTS: Our decision support tool recommended warfarin for 3,008 patients (49%); however, only 9.9% received warfarin. In patients for whom anticoagulation was recommended by the decision support tool, there was a trend towards a decreased hazard for stroke with actual warfarin treatment (hazard ratio 0.90) without significant increase in gastrointestinal hemorrhage (0.87). In contrast, in patients for whom the tool recommended no anticoagulation, receipt of warfarin was associated with statistically significant increased hazard of gastrointestinal bleeding (1.54, p = 0.03). CONCLUSIONS: We have shown that our atrial fibrillation decision support tool is a useful predictor of those at risk of major bleeding for whom anticoagulation may not necessarily be beneficial. It may aid in weighing the benefits versus risks of anticoagulation treatment.

Evaluating uses of data mining techniques in propensity score estimation: a simulation study.

BACKGROUND: In propensity score modeling, it is a standard practice to optimize the prediction of exposure status based on the covariate information. In a simulation study, we examined in what situations analyses based on various types of exposure propensity score (EPS) models using data mining techniques such as recursive partitioning (RP) and neural networks (NN) produce unbiased and/or efficient results. METHOD: We simulated data for a hypothetical cohort study (n = 2000) with a binary exposure/outcome and 10 binary/continuous covariates with seven scenarios differing by non-linear and/or non-additive associations between exposure and covariates. EPS models used logistic regression (LR) (all possible main effects), RP1 (without pruning), RP2 (with pruning), and NN. We calculated c-statistics (C), standard errors (SE), and bias of exposure-effect estimates from outcome models for the PS-matched dataset. RESULTS: Data mining techniques yielded higher C than LR (mean: NN, 0.86; RPI, 0.79; RP2, 0.72; and LR, 0.76). SE tended to be greater in models with higher C. Overall bias was small for each strategy, although NN estimates tended to be the least biased. C was not correlated with the magnitude of bias (correlation coefficient [COR] = -0.3, p = 0.1) but increased SE (COR = 0.7, p < 0.001). CONCLUSIONS: Effect estimates from EPS models by simple LR were generally robust. NN models generally provided the least numerically biased estimates. C was not associated with the magnitude of bias but was with the increased SE.