Jacobs Institute of Women's Health
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Epidural Analgesia and the Risk of Obstetric Anal Sphincter Injury
No full textIMPORTANCE: There are conflicting data regarding the association between epidural analgesia and obstetric anal sphincter injuries (OASIs). There are also few predictive models that document assessment for multicollinearity among risk factors or precisely identify effect modifiers and confounders. OBJECTIVE: The objective of this study was to evaluate the association between epidural analgesia and OASIs, using rigorous statistical methods to identify effect modifiers and confounders in a diverse, urban population. STUDY DESIGN: This was a secondary analysis of a retrospective case-control study of women with singleton vaginal deliveries. Our primary analysis was to assess the association between epidural analgesia and OASIs, adjusting for modifiable and nonmodifiable risk factors. These risk factors were additionally assessed for effect modification and confounding effect. RESULTS: Our sample consisted of 1,326 women who had a vaginal delivery. Among the women with OASIs, 218 women (75.4%) had an epidural, and among those without OASIs, 620 women (59.8%) had an epidural (P \u3c 0.001). Epidural analgesia increased the odds of OASIs by 107% (odds ratio 2.07, 95% confidence interval [1.54 to 2.77]). Through further examination of the relationship between OASIs and epidurals, while considering multiple risk factors and addressing multicollinearity, effect modification, and confounding, we identified operative delivery and labor induction as confounding variables. Accounting for these factors mitigated the association between epidural use and OASIs (adjusted odds ratio 1.38, 95% confidence interval [1.00 to 1.91]). CONCLUSIONS: Initially, we found epidural analgesia to be associated with OASIs; however, after performing additional statistical analysis and accounting for additional risk factors, this association was no longer statistically significant
Differences between East and West may affect dementia studies: Thoughts from the KSA dementia prevalence study
No full textWhile science is the same in the East and West, certain personal characteristics may distort scientific results. This is more likely in the East. An example may be a recent project in the East that measured the prevalence of Alzheimer\u27s disease dementia in a very large group. They found it to be near 1%, which seems very low. Studies that show a low prevalence of Alzheimer\u27s disease dementia could be due to an examination of a very healthy group with very few older people, and/or poor/inaccurate testing (none of which were in this study). Another possibility is that the person, their family or their doctor aim at ignoring or hiding a diagnosis of dementia
Current Practices in Monitoring Children and Adults with X-linked Hypophosphatemia: A Global Survey of Expert Experience
No full textThis report provides recommendations for XLH monitoring based on current monitoring practices of experts in the management of XLH in children (\u3c18 years) and adults. We surveyed 43 experts to determine their monitoring practices for children and adults with XLH, including pregnant and lactating women. In the initial evaluation of children and adults with XLH, experts consistently obtain family history, fracture history and history of dental infections. They measure height, weight, blood pressure and conduct DNA analysis of multiple genes including the PHEX gene. For children follow-up, experts arrange follow-up every 3-6 months assessing height, weight, blood pressure and examining for skeletal deformities. Laboratory tests for children include serum phosphorus, corrected total/ionized calcium, alkaline phosphatase, renal function, parathyroid hormone and spot morning urine for calcium, creatinine and phosphorus. For adult follow-up, experts assess patients every 6-12-months including a clinical examination for skeletal deformities and joint involvment. The laboratory profile is completed at least once a year. In the presence of bone pain, experts conduct X-rays both in children and adults to evaluate for fractures or joint damage. With respect to nephrocalcinosis, renal ultrasound is suggested on an annual basis or less frequently when monitoring children and adults with XLH. Experts conduct a dental assessment at baseline and then every 6-12 months for all patients with XLH. The findings of the survey inform practice for assessing new patients with XLH, monitoring existing patients and identifying areas for future research. All recommendations based on these practices are weak with very low-quality evidence
Improving power in adaptive expansion of biomarker populations in phase 3 clinical trials
No full textWith the availability of unprecedented human genomic biomarker data, incorporating such biomarker data has received a lot of attention in phase 3 clinical trials. One particular enrichment design proposed recently in the literature is to recruit more biomarker positive patients in an all-comer study if the treatment effect in the biomarker negative group is less promising than expected. The intuition is to improve the chance of success of the trial since the success rate in the all-comer population may be low. We propose an enrichment design that unifies the existing biomarker adaptive designs for phase 3 clinical trials. In addition, we propose a new test accounting for the correlations among the test statistics based on different groups of patients, including all-comers, biomarker positive patients only, and biomarker negative patients only. We investigate the theoretical properties of the design and demonstrate the new test accurately controls the type I error rate and gains power over existing methods through extensive simulations. A computer program is developed for power calculations given a set of design parameters, including the proportion of biomarker positive patients, the distribution of the failure time in each treatment and biomarker group, and the number of patients in the first stage and the second stage (i.e. the enrichment stage), among others
Pediatric hepatobiliary scintigraphy: biliary atresia and beyond
No full textImaging is essential in evaluating pediatric patients with suspected hepatobiliary abnormalities. While anatomic imaging is commonly requested initially, in a variety of clinical scenarios, scintigraphy further refines the differential diagnosis and provides additional necessary functional information. The essential pathologies that benefit from scintigraphy in children encompass congenital disorders, such as biliary atresia and choledochal cysts, biliary stone diseases, functional gallbladder disorders, and suspected bile leaks. This manuscript reviews the proper technique of performing hepatobiliary scintigraphy in children and highlights the scintigraphic features of pediatric hepatobiliary pathologies
Relationship Between Parental Distress and Proxy Symptom Reports in Pediatric Palliative Care
No full textCONTEXT: In pediatric palliative care (PPC), patients often are not able to report symptoms so proxy reports from parents are used. Whether psychological distress in the proxies affects reports of patients\u27 symptoms is unknown. OBJECTIVE: To measure the influence of parents\u27 distress on proxy-reported scores regarding symptoms by analyzing pairs of parents reporting on the same child. METHODS: In a large prospective cohort study of PPC patients, we collected parents\u27 reports of child symptoms (Memorial Symptom Assessment Scale) and their own psychological distress (Kessler-6). In this quasi-experimental design study, we examined data from pairs of parents reporting symptoms for the same child. Using regression modelling, we estimated the association between parental distress scores and patient total symptom scores across the entire sample accounting for clustering within families, and then measured the association within-families of the absolute differences of the two parents\u27 distress and the difference in their symptom scores. RESULTS: Among 152 parents in 76 families, 50.0% were female, 80.9% were White, and the mean age was 36.4 (SD 9.0) years. Across the sample, each 1-point increase in reported parental distress was associated with a 1.07 (95% CI, 0.87-1.28; P \u3c 0.001) increase in proxy-reported patient symptom score. Within families, relative to the other parent, each 1-point increase in the difference of the distress scores was associated with a 0.33-point (95% CI, 0.32-0.35; P = 0.006) increase in the difference in symptom scores. CONCLUSION: Psychological distress appears to influence proxy reports of symptoms which has implications for future research and clinical practice
Evaluation of the Florida Newborn Screening Program Education Campaign
No full textFlorida\u27s Newborn Screening Program campaign aims to increase the awareness and participation of birthing facilities, providers, and parents. This evaluation aimed to determine the effectiveness and reach of the Newborn Screening Program (NBS) Statewide Educational Campaign to pregnant women through surveys and focus groups. The online survey, conducted throughout Florida in English, Spanish, and Haitian Creole, evaluated the reach and effectiveness of educational materials such as paid advertisements and brochures. The surveys also served to recruit participants for in-person focus groups throughout the state. The findings showed that 85.3% of the mothers had discussions with health professionals about the screening program, while others did not hear about it from health professionals. More than 50% of the respondents learned about the program through health facilities, with additional exposure from media platforms such as television, radio, and friends. This study shows the need for increased outreach of the campaign and better communication and education from medical professionals to increase awareness
The Psychometric Properties of Autism Mental Status Examination (AMSE) in Turkish Sample
No full textAutism Spectrum Disorder (ASD) is a prevalent neurodevelopmental disorder, and early diagnosis plays a pivotal role in prognosis and management. This study aims to examine the psychometric properties of the Autism Mental Status Exam (AMSE), a tool that shows great promise in terms of clinical utility, within the Turkish population. This study conducted in a cohort of 307 Turkish children aged 17 to 120 months with suspected ASD. Participants underwent a multidisciplinary assessment based on DSM-5 criteria for diagnosis and were categorized into ASD and non-ASD groups. Subsequently, the research team conducted blinded administrations of the AMSE and Childhood Autism Rating Scale (CARS). Additionally, a subset of 61 children underwent retesting for AMSE and CARS after three weeks for temporal stability. The results revealed an optimal cut-off score of 4 for AMSE, yielding sensitivity and specificity rates of 84% and 97%, respectively. Internal consistency, indicated by a Cronbach\u27s alpha of 0.80, was very good. The test-retest reliability, assessed using the Intraclass Correlation Coefficient (ICC), was excellent (ICC = 0.959). The inter-rater reliability also showed excellent agreement (ICC = 0.997). Furthermore, a significant correlation was observed between the AMSE and CARS scores (r = 0.94, p \u3c 0.001). Notably, the AMSE scores were significantly different between the ASD and non-ASD groups (p \u3c 0.001) with a large effect size (Cohen\u27s d = 1.40). The findings of this study underscore the utility of AMSE as a valid and reliable tool for Turkish children with robust psychometric properties
