From Pruritus to Cholestasis: Building a Statistical Model and Online Application to Predict a Diagnosis Prior to Bile Acid Determination.

OBJECTIVE: This study aimed to create a statistical model using clinical and laboratory parameters to predict which patients presenting with pruritus in pregnancy will have elevated total bile acids (TBA) and thus, have a high risk of intrahepatic cholestasis of pregnancy (ICP). STUDY DESIGN: Retrospective cohort study of patients presenting with pruritus in pregnancy and had TBA sent from a single public hospital from January 1, 2017, to December 31, 2017. Primary outcome is TBA ≥ 10 µmol/L. Multivariate logistic regression with stepwise and backward variable selection were used to create predictive models. Four models were compared using Akaike information criterion (AIC), C-statistic, and the DeLong nonparametric approach to test for differences between area under the curve (AUC) of receiver operating characteristic (ROC) curves. Internal validation was performed via fivefold cross-validation technique on the best-fitting, most parsimonious model. RESULTS: Of the 320 patients with pruritus, 153 (47.8%) had elevated bile acid levels ≥10 µmol/L. Sixty-nine variables were assessed for association with the primary outcome. Five variables were significantly associated with elevated TBA: pruritus of palms and soles (adjusted odds ratio [aOR]: 2.35 [95% confidence interval, CI: 1.22, 4.54]), gestational hypertension (aOR: 0.10 [95% CI: 0.02, 0.60]), log of total bilirubin (aOR: 4.71 [95% CI: 2.28, 9.75]), systolic blood pressure (aOR: 0.97 [95% CI: 0.94, 0.99]), and alanine aminotransferase (aOR: 1.05 [95% CI: 1.02, 1.07]). The final model was chosen for being parsimonious while having the lowest AIC with highest AUC (0.85; 95% CI: 0.81, 0.89). Internal validation using a probability threshold of 50% demonstrated a sensitivity of 65.5%, specificity of 83.5%, and accuracy of 75.1%. CONCLUSION: We provide a predictive model using five simple variables to determine the probability that a patient presenting with pruritus in pregnancy carries the diagnosis of ICP. This tool, available via a web app, is designed to aid providers and enhance clinical judgment in difficult triage situations. KEY POINTS: · Currently, no standard method to triage pruritus in pregnancy exists.. · We present a predictive statistical model using five readily available clinical variables.. · Final calculator yields probability of having intrahepatic cholestasis of pregnancy..

Burden of Future Liver Abnormalities in Patients With Intrahepatic Cholestasis of Pregnancy.

INTRODUCTION: There are limited data on the incidence, predictors, and time to future liver abnormalities in patients with intrahepatic cholestasis of pregnancy (ICP). METHODS: Single-center retrospective study of pregnant women with and without ICP who delivered from 2005 to 2009 evaluating incidence and time to future liver abnormalities. Women returning for care with liver function tests at a minimum of 6 months postpartum were included. Liver disease diagnoses and liver functions test abnormalities were compared. Time to development of alanine aminotransferase (ALT) >25 U/L, alkaline phosphatase (ALP) >140 U/L, and diagnosis of liver disease (through imaging or clinical evaluation) were compared between women with and without ICP using Kaplan-Meier methods and Cox regression models. RESULTS: A total of 255 women with ICP and 131 age-matched control subjects with delivery during the same period were identified. Subjects in both groups were similar in follow-up time, age at pregnancy, prepregnancy body mass index, and ethnicity (≥75% were Hispanic in both groups). On univariate analyses, ICP was associated with increased incidence of ALT >25 U/L P < 0.01 ALP >140 U/L (P < 0.01) and liver disease (P = 0.03). Adjusting for metabolic factors, ICP diagnosis was associated with risk of future liver abnormalities: postpartum ALT >25 U/L (hazard ratio [HR] 1.9, P < 0.01), ALP >140 U/L (HR 3.4, P < 0.01), and liver disease (HR 1.5, P = 0.05). DISCUSSION: In our cohort of urban women, ICP diagnosis predicted risk of future liver disease and abnormal liver tests. Women with pregnancies complicated by ICP may benefit from surveillance for postpartum liver abnormalities.

Treatment tolerability and outcomes in elderly patients with head and neck cancer.

PURPOSE: The number of elderly patients with head and neck squamous cell carcinoma (HNSCC) continues to grow. Management of this cohort remains poorly defined. We investigated treatment tolerability and clinical outcomes in this underrepresented population. METHODS: We identified patients aged ≥70 with nonrecurrent, nonmetastatic HNSCC treated curatively from 2007-2018 and analyzed clinical covariates. RESULTS: Two hundred and twenty patients with a median age of 75 (interquartile range:72-80) were identified. Age and comorbidities were not correlated with toxicity (P ≥ .05). Patients who experienced a treatment interruption had significantly greater weight loss (P = .042) and worse overall survival (OS) (P < .001), but not worse disease-specific survival (P = .45), or locoregional control (P = .21). CONCLUSIONS: Treatment interruptions were associated with weight loss and worse OS, but not disease related outcomes, suggesting an interruption in the elderly may be a surrogate for another issue. In sum, our data should guide clinical trial design to benefit this growing, neglected cohort.

Cancer screening information at community health fairs: What the participants do with information they receive.

BACKGROUND: To assess participants' reasons for seeking cancer screening information at community health fairs and what they do with the information they receive. DESIGN AND METHODS: Mixed quantitative and qualitative approach was used. Community health fairs are organized in underserved New York City neighbourhoods. From June 14, 2016 to August 26, 2016, cancer prevention tables providing information about various cancer screenings were established at 12 local community health fairs in New York City. In-person and follow up telephone surveys assessing interest in the cancer prevention table, personal cancer screening adherence rates, information-sharing behaviours and demographic variables have been taken into account. Statistical analyses were performed using IBM SPSS 22.0: frequencies, descriptive, cross tabulations. All qualitative data was coded by theme so that it could be analysed through SPSS. For example, Were you interested in a specific cancer? may be coded as 2 for yes, breast cancer. RESULTS: One hundred and sixteen patrons participated in the initial survey. Of those, 88 (78%) agreed to give their contact information for the follow-up survey and 60 follow-up surveys were completed (68%). Of those who reported reading the material, 45% shared the information; 15% subsequently spoke to a provider about cancer screenings and 40% intended to speak to a provider. CONCLUSIONS: Participants disseminated information without prompting; suggesting the reach of these fairs extends beyond the people who visit our table. Future studies should look at whether patrons would share information at higher rates when they are explicitly encouraged to share the information.