Continuous Atrial Fibrillation Monitoring From Photoplethysmography: Comparison Between Supervised Deep Learning and Heuristic Signal Processing.

BACKGROUND: Continuous monitoring for atrial fibrillation (AF) using photoplethysmography (PPG) from smartwatches or other wearables is challenging due to periods of poor signal quality during motion or suboptimal wearing. As a result, many consumer wearables sample infrequently and only analyze when the user is at rest, which limits the ability to perform continuous monitoring or to quantify AF. OBJECTIVES: This study aimed to compare 2 methods of continuous monitoring for AF in free-living patients: a well-validated signal processing (SP) heuristic and a convolutional deep neural network (DNN) trained on raw signal. METHODS: We collected 4 weeks of continuous PPG and electrocardiography signals in 204 free-living patients. Both SP and DNN models were developed and validated both on holdout patients and an external validation set. RESULTS: The results show that the SP model demonstrated receiver-operating characteristic area under the curve (AUC) of 0.972 (sensitivity 99.6%, specificity: 94.4%), which was similar to the DNN receiver-operating characteristic AUC of 0.973 (sensitivity 92.2, specificity: 95.5%); however, the DNN classified significantly more data (95% vs 62%), revealing its superior tolerance of tracings prone to motion artifact. Explainability analysis revealed that the DNN automatically suppresses motion artifacts, evaluates irregularity, and learns natural AF interbeat variability. The DNN performed better and analyzed more signal in the external validation cohort using a different population and PPG sensor (AUC, 0.994; 97% analyzed vs AUC, 0.989; 88% analyzed). CONCLUSIONS: DNNs perform at least as well as SP models, classify more data, and thus may be better for continuous PPG monitoring.

Implications of missingness in self-reported data for estimating racial and ethnic disparities in Medicaid quality measures.

OBJECTIVE: To assess the feasibility and implications of imputing race and ethnicity for quality and utilization measurement in Medicaid. DATA SOURCES AND STUDY SETTING: 2017 Oregon Medicaid claims from the Oregon Health Authority and electronic health records (EHR) from OCHIN, a clinical data research network, were used. STUDY DESIGN: We cross-sectionally assessed Hispanic-White, Black-White, and Asian-White disparities in 22 quality and utilization measures, comparing self-reported race and ethnicity to imputed values from the Bayesian Improved Surname Geocoding (BISG) algorithm. DATA COLLECTION: Race and ethnicity were obtained from self-reported data and imputed using BISG. PRINCIPAL FINDINGS: 42.5%/4.9% of claims/EHR were missing self-reported data; BISG estimates were available for >99% of each and had good concordance (0.87-0.95) with Asian, Black, Hispanic, and White self-report. All estimated racial and ethnic disparities were statistically similar in self-reported and imputed EHR-based measures. However, within claims, BISG estimates and incomplete self-reported data yielded substantially different disparities in almost half of the measures, with BISG-based Black-White disparities generally larger than self-reported race and ethnicity data. CONCLUSIONS: BISG imputation methods are feasible for Medicaid claims data and reduced missingness to <1%. Disparities may be larger than what is estimated using self-reported data with high rates of missingness.

Change in Gender on Record and Transgender Adults' Mental or Behavioral Health.

INTRODUCTION: Within gender-diverse populations, gender-affirming changes in gender on record may improve mental or behavioral health. This study uses claims data to investigate whether sex assigned at birth modifies the association between change in gender on record and mental or behavioral health. METHODS: Adult Oregon Medicaid beneficiaries with gender identity-related diagnoses and enrolled during 2010-2019 were included. Sex assigned at birth was inferred from medical and pharmacy claims and was categorized as assigned female, assigned male, or unknown sex assigned at birth. Self-reported gender ascertained at initial enrollment differing from sex assigned at birth indicated a change in gender on record. Multivariable logistic regression estimated the association between change in gender on record and mental (anxiety, depression, suicidal ideation, post-traumatic stress disorder) or behavioral (alcohol, substance, or tobacco use disorders) health. Analyses were conducted in February 2021. RESULTS: This study included 2,940 transgender and nonbinary adults. Of the 1,451 self-reporting female gender and 1,489 self-reporting male gender, 449 (30.9%) were assigned male at birth, and 303 (20.3%) were assigned female at birth, classified as changing their gender on record. Predicted probability of mental or behavioral conditions was significantly lower in those who changed their gender on record. Sex assigned at birth modified the association with mental health: assigned female at birth reporting female gender had the highest burdens, followed by assigned male at birth reporting male. Secondary analyses using a modified change in gender definition or alternative sex assigned at birth inference method found similar trends. CONCLUSIONS: Oregon Medicaid gender-diverse beneficiaries who changed their gender on record had a meaningfully lower probability of mental and behavioral health conditions. Those assigned female at birth reporting female gender had the highest burdens.

PrEP Use and Adherence Among Transgender Patients.

This cross-sectional study used 2012 to 2019 Oregon Medicaid claims to estimate the prevalence of PrEP use and identify determinants of high adherence across transgender and cisgender men and women. Gender identity (cisgender woman/man; transgender, assigned female sex at birth [AFAB]; transgender, assigned male sex at birth [AMAB]) was based on medical history and enrollment records. Proportion of days covered ≥ 0.80 was considered high adherence to PrEP. The association between gender identity and PrEP uptake or high adherence was estimated using multivariable logistic regression. 1555 PrEP users, including 171 (11.0%) cis women, 1171 (75.3%) cis men, 67 (4.3%) AFAB, and 146 (9.4%) AMAB individuals, were included. The probability of PrEP use per 10,000 people was highest in transgender groups (AMAB 546.8, 95% CI 462.4-631.3; AFAB 226.5, 95% CI 173.4-279.6), followed by cisgender men (20.6, 95% CI 19.4, 21.8) and women (2.6, 95% CI 2.2, 3.0). High adherence was significantly lower in AMAB recipients (72.6%) than cisgender women (86.0%) and cisgender men (82.2%). Among the 279 PrEP users with female on their enrollment record, 76 (27.2%) were AMAB, while among the 1276 PrEP users with male on their enrollment record, 35 (2.7%) were AFAB. This demonstrates the importance of surveillance methods that take gender identity into account in addition to sex assigned at birth. There were significant differences in PrEP use and adherence by gender identity. PrEP surveillance, outreach, and prescribing practices must consider gender identity-unique risk factors.

Using best subset regression to identify clinical characteristics and biomarkers associated with sepsis-associated acute kidney injury.

Sepsis-associated acute kidney injury (AKI) is a complex clinical disorder associated with inflammation, endothelial dysfunction, and dysregulated coagulation. With standard regression methods, collinearity among biomarkers may lead to the exclusion of important biological pathways in a single final model. Best subset regression is an analytic technique that identifies statistically equivalent models, allowing for more robust evaluation of correlated variables. Our objective was to identify common clinical characteristics and biomarkers associated with sepsis-associated AKI. We enrolled 453 septic adults within 24 h of intensive care unit admission. Using best subset regression, we evaluated for associations using a range of models consisting of 1-38 predictors (composed of clinical risk factors and plasma and urine biomarkers) with AKI as the outcome [defined as a serum creatinine (SCr) increase of ≥0.3 mg/dL within 48 h or ≥1.5× baseline SCr within 7 days]. Two hundred ninety-seven patients had AKI. Five-variable models were found to be of optimal complexity, as the best subset of five- and six-variable models were statistically equivalent. Within the subset of five-variable models, 46 permutations of predictors were noted to be statistically equivalent. The most common predictors in this subset included diabetes, baseline SCr, angiopoetin-2, IL-8, soluble tumor necrosis factor receptor-1, and urine neutrophil gelatinase-associated lipocalin. The models had a c-statistic of ∼0.70 (95% confidence interval: 0.65-0.75). In conclusion, using best subset regression, we identified common clinical characteristics and biomarkers associated with sepsis-associated AKI. These variables may be especially relevant in the pathogenesis of sepsis-associated AKI.

Coverage of immediate postpartum long-acting reversible contraception has improved birth intervals for at-risk populations.

BACKGROUND: In 2012, South Carolina revised the Medicaid policy to cover reimbursement for immediate postpartum long-acting reversible contraception. Immediate postpartum long-acting reversible contraception may improve health outcomes for populations at risk with a subsequent short-interval pregnancy. OBJECTIVES: We examined the impact of the Medicaid policy change on the initiation of long-acting and reversible contraception (immediate postpartum and postpartum) within key populations. We determined whether immediate postpartum long-acting and reversible contraception use varied by adequate prenatal care (>7 visits), metropolitan location, and medical comorbidities. We also tested the association of immediate postpartum and postpartum long-acting, reversible contraception on interpregnancy interval of less than 18 months. STUDY DESIGN: We conducted a historical cohort study of live births among Medicaid recipients in South Carolina between 2010 and 2017, 2 years before and 5 years after the policy change. We used birth certificate data linked with Medicaid claims. Our primary outcome was immediate postpartum long-acting and reversible contraception, and our secondary outcome was short interpregnancy interval. We characterize trends in long-acting and reversible contraception use and interpregnancy interval over the study period. We used logistic regression models to test the association of key factors (rural, inadequate prenatal care, and medical comorbidities) with immediate and outpatient postpartum long-acting and reversible contraception following the policy change and to test the association of immediate postpartum and postpartum long-acting and reversible contraception with short interpregnancy interval. RESULTS: Our sample included 187,438 births to 145,973 women. Overall, 44.7% of the sample was white, with a mean age of 25.0 years. A majority of the sample (61.5%) was multiparous and resided in metropolitan areas (79.5%). The odds of receipt of immediate postpartum long-acting and reversible contraception use increased after the policy change (adjusted odds ratio, 1.39, 95% confidence interval, 1.34-1.43). Women with inadequate prenatal care (adjusted odds ratio, 1.50, 95% confidence interval, 1.31-1.71) and medically complex pregnancies had higher odds of receipt of immediate postpartum long-acting and reversible contraception following the policy change (adjusted odds ratio, 1.47, 95% confidence interval, 1.29-1.67) compared with women with adequate prenatal care and normal pregnancies. Women residing in rural areas were less likely to receive immediate postpartum long-acting and reversible contraception (adjusted odds ratio, 0.36, 95% confidence interval, 0.30-0.44) than women in metropolitan areas. Utilization of immediate postpartum long-acting and reversible contraception was associated with a decreased odds of a subsequent short interpregnancy interval (adjusted odds ratio, 0.62, 95% confidence interval, 0.44-0.89). CONCLUSION: Women at risk of a subsequent pregnancy and complications (inadequate prenatal care and medical comorbidities) are more likely to receive immediate postpartum long-acting and reversible contraception following the policy change. Efforts are needed to improve access in rural areas.

Pharmacists expand access to reproductive heaLthcare: PEARL study protocol.

BACKGROUND: In 2016, Oregon became the first of eight states to allow pharmacists to directly prescribe hormonal contraception (HC), including the pill, patch, or ring, without a clinic visit. In the two years following this policy change, the majority of ZIP codes across the state of Oregon had a pharmacist certified to prescribe HC. METHODS: We will utilize complementary methodologies to evaluate the effect of this policy change on convenient access to contraception (cost, supply dispensed), safety, contraceptive continuation and unintended pregnancy rates. We will conduct a prospective clinical cohort study to directly measure the impact of provider type on contraceptive continuation and to understand who is accessing hormonal contraception directly from pharmacists. We will concurrently conduct a retrospective analysis using medical claims data to evaluate the state-level effect of the policy. We will examine contraceptive continuation rates, incident pregnancy, and safety measures. The combination of these methodologies allows us to examine key woman-level factors, such as pregnancy intention and usual place of care, while also estimating the impact of the pharmacist prescription policy at the state level. DISCUSSION: Pharmacist prescription of HC is emerging nationally as a strategy to reduce unintended pregnancy. This study will provide data on the effect of this practice on convenient access to care, contraceptive safety and continuation rates.

A systematic review of the economic and humanistic burden of illness in irritable bowel syndrome and chronic constipation.

BACKGROUND: Irritable bowel syndrome (IBS) and chronic constipation (CC) are common functional gastrointestinal disorders affecting 14% and 20% of the U.S. population, respectively. Reviews of the evidence on the burden of illness associated with IBS and CC have not been comprehensive in scope and have not provided an assessment of the distribution of health care costs across categories of resource use. OBJECTIVES: To (a) identify studies from any geographic region or country perspective that measure the economic burden of the disease; (b) analyze the direct (medical, drug, and other components) and indirect costs of illness; and (c) assess published evidence of the humanistic burden as measured by quality of life (QOL). METHODS: An electronic literature search was conducted using journal databases, including MEDLINE, The Cochrane Library, EconLit, CINAHL, and Digestive Disease Week meeting abstracts. Specific search terms used were "irritable bowel syndrome" and "chronic constipation." In databases that accommodated Boolean searches, terms related to economic and quality of life outcomes were incorporated. Studies were included if they evaluated patients with an IBS or CC diagnosis and quantitatively measured the economic or humanistic burden of disease. Results were descriptively analyzed. RESULTS: The search identified a total of 882 unique publications. Thirty-five articles and abstracts met the inclusion criteria. Studies included 1,706 IBS-C, 2,264 IBS-D, 2,892 IBS-A, 15,830 IBS unclassified, and 1,278 CC patients. Nineteen of 35 studies assessed cost-of-illness endpoints, and from the U.S. perspective, the direct cost per-patient for IBS ranged from $1,562 to $7,547 per year, while direct costs of CC ranged from $1,912 to $7,522 per year. From the U.S. perspective, the indirect costs of IBS ranged from $791 to $7,737 per year, and no study assessed the indirect costs of CC. For IBS, data on the distribution of costs attributable to categories of resource use varied widely, particularly outpatient costs (12.7% to > 50% of total costs), inpatient costs (6.2% to 40.8%), and pharmacy or drug costs (5.9% to 46.6%). Comparable data on CC were not identified. Nineteen studies of IBS patients measured the humanistic burden of disease; 14 studies utilized SF-36; and within-study domain scores were significantly lower in IBS patients compared with non-IBS controls. Only 1 study of CC patients reported humanistic burden of disease. CONCLUSIONS: The studies identified in the systematic review varied in the method used to identify patients with IBS and CC. Results were not typically reported by IBS subtype. We observed a large variation in attributable direct and indirect costs and drivers of these costs. Future research should refine burden of illness estimates to subtypes so that estimates associated with IBS-C and CC are differentiated.

Regulatory misconception muddies the ethical waters: challenges to a qualitative study.

In "Potential Subjects' Responses to an Ethics Questionnaire in a Phase I Study of Deep-Brain Stimulation in Early Parkinson's Disease," Finder, Bliton, Gill, Davis, Konrad, and Charles undertake informed consent research on what they describe as a Phase I trial of deep brain stimulation (DBS) for Parkinson's disease. We argue that the authors should have more carefully characterized the nature of the DBS study at the start of their clinical study.

Female genital cutting and other intra-vaginal practices: implications for TwoDay Method use.

This report examines the implications of female genital cutting and other intra-vaginal practices for offering the TwoDay Method® of family planning.This fertility awareness-based method relies on the identification of cervicovaginal secretions to identify the fertile window. Female genital cutting and traditional vaginal practices, such as the use of desiccants, may affect the presence or absence of secretions and therefore the woman's perception of her fertility. These issues and their implications for service delivery of the method are discussed.

Validation of a simple camera navigation trainer.

BACKGROUND: One laparoscopic skill that is rarely addressed is proper use of the 30-degree laparoscope. Lack of knowledge and training with an angled laparoscope can result in less than optimal visualization. The purpose of this study is to validate a simple and efficient camera navigation trainer. STUDY DESIGN: Thirty-four medical students from Baylor College of Medicine participated. Their use of a 30-degree laparoscope was assessed. In task A, subjects were asked to demonstrate a series of views corresponding to the position of the light cord. In task B, subjects had to correctly demonstrate views of a three-dimensional model of a liver, intestines, and abdominal wall. Subjects then underwent a brief training session, followed by a self-directed, 10-minute practice session. Last, they were retested in tasks A and B. RESULTS: Sixteen students (47.1%) had prior experience using a laparoscope. At baseline testing, 0 of 34 novices were able to demonstrate the intended views in task A, but at posttraining the mean success rate was 99.5% (p < 0.0001). There was also significant improvement in performance of task B, where pretest success was 5.9% and posttest success was 98.5% (p < 0.0001). CONCLUSIONS: After a simple and brief training session, novices were able to effectively use the 30-degree laparoscope using the established verbal cues. The simplicity of this training module provides an efficient method of training novice camera operators both within and outside the operating room.

Transgastric endoscopic rendezvous technique for removal of eroded Molina gastric band.

The application of the nonadjustable gastric band (NAGB) for the treatment of morbid obesity was common in the 1980s. However, it was associated with an unacceptable reoperative rate and numerous postoperative complications such as gastric erosion. Removing an eroded NAGB is fraught with difficulty secondary to the extensive inflammatory response around the proximal stomach and left lobe of the liver. To circumvent these difficulties, we have devised a transgastric endoscopic rendezvous (TGER) technique for the removal of eroded Molina NAGBs. A case series of 2 patients who had undergone the TGER technique for removal of an eroded Molina NAGB was undertaken. The outcomes assessed included preoperative morbidity, a description of the surgical procedure, and the postoperative course. Both patients presented with symptoms consistent with proximal gastric outlet obstruction. The TGER technique was effectively applied in removing the eroded NAGB in both patients with no intraoperative, perioperative, or postoperative complications at 6 months of follow-up. One patient requested additional treatment for morbid obesity and subsequently underwent successful placement of an adjustable gastric band. Our small series has demonstrated that the TGER technique is a safe and effective procedure applicable to the complicated case of an eroded NAGB. The use of a combined endoscopic/transgastric approach facilitates complete avoidance of the thick adhesion surrounding the previously banded stomach with the capability of securing a gastrotomy in virgin tissue rather than opening and then closing the dense perigastric pseudocapsule. Nevertheless, the true utility of the TGER technique is soundly dependent on the availability of adequate resources and experienced surgical assistance and needs to be explored further.

Prognostic significance of an elevated creatine kinase in the absence of an elevated troponin I during an acute coronary syndrome.

In patients with troponin-negative acute coronary syndromes, creatine kinase (CK)-MB elevation predicts a significantly higher risk of death and major acute cardiac events compared with CK-MB negative patients. This risk is accentuated in troponin-negative, CK-MB positive patients who do not demonstrate ST elevation by electrocardiogram.

Estrogen receptor alpha expression in normal human breast epithelium is consistent over time.

If increased expression of estrogen receptor alpha (ER) in benign breast epithelium increases susceptibility to breast cancer, such overexpression should be stable over time. There are no published data regarding this important aspect of ER expression in breast epithelium. We examined the temporal consistency of ER expression in the normal breast tissue of 28 women who had 2 separate breast surgical procedures, at least 6 months apart (mean interval, 2.8 years). Paraffin embedded breast tissue blocks containing an adequate sample of normal breast epithelium and no cancer, were sectioned and processed using the 6F11 antibody and standard immunohistochemical techniques. The ER labelling index (ER LI) was calculated by counting a mean of 2,000 epithelial cells. The median ER LI at first sampling was 13.6 and at second sample 15.5, with R(2) = 0.34 and p = 0.001. The ER LI was categorized into high and low values, using a threshold of 10. Twenty-four women (85.7%) showed concordance of high and low expression between the 2 samples (p = 0.002). There were 11 women who were premenopausal at both time points. Among them, much of the variation in ER LI was explained by differences in the menstrual cycle day at the time of sampling and adding the day of cycle to the regression model substantially improved the correlation between first and second labeling indices. These data suggest that ER expression of normal breast tissue is fairly consistent over time and support the notion that overexpression of ER in normal epithelium is a constant feature of the high risk breast.