Professionalism of Admitting and Consulting Services and Trauma Patient Outcomes.

OBJECTIVE: To determine whether trauma patients managed by an admitting or consulting service with a high proportion of physicians exhibiting patterns of unprofessional behaviors are at greater risk of complications or death. SUMMARY BACKGROUND DATA: Trauma care requires high-functioning interdisciplinary teams where professionalism, particularly modeling respect and communicating effectively, is essential. METHODS: This retrospective cohort study used data from 9 level I trauma centers that participated in a national trauma registry linked with data from a national database of unsolicited patient complaints. The cohort included trauma patients admitted January 1, 2012 through December 31, 2017. The exposure of interest was care by 1 or more high-risk services, defined as teams with a greater proportion of physicians with high numbers of patient complaints. The study outcome was death or complications within 30 days. RESULTS: Among the 71,046 patients in the cohort, 9553 (13.4%) experienced the primary outcome of complications or death, including 1875 of 16,107 patients (11.6%) with 0 high-risk services, 3788 of 28,085 patients (13.5%) with 1 high-risk service, and 3890 of 26,854 patients (14.5%) with 2+ highrisk services (P < 0.001). In logistic regression models adjusting for relevant patient, injury, and site characteristics, patients who received care from 1 or more high-risk services were at 24.1% (95% confidence interval 17.2% to 31.3%; P < 0.001) greater risk of experiencing the primary study outcome. CONCLUSIONS: Trauma patients who received care from at least 1 service with a high proportion of physicians modeling unprofessional behavior were at an increased risk of death or complications.

Unsolicited patient complaints among radiation, medical, and surgical oncologists.

BACKGROUND: Unsolicited patient complaints (UPCs) about physician practices are nonrandomly associated with malpractice claims and clinical quality. The authors evaluated the distributions and types of UPCs associated with oncologists by specialty and assessed oncologist characteristics associated with UPCs. METHODS: This retrospective study reviewed UPCs associated with US radiation oncologists (ROs), medical oncologists (MOs), and surgical oncologists (SOs) from 35 health care systems from 2015 to 2018. Average total UPCs were compared by specialty in addition to sex, medical school graduation year, degree, medical school location, residency location, practice setting, and practice region. For continuous variables, linear regression was used to test for an association with total complaints. RESULTS: The study included 1576 physicians: 318 ROs, 1020 MOs, and 238 SOs. The average number of UPCs per physician was different and depended on the oncologic specialty: ROs had significantly fewer complaints (1.28; 95% confidence interval [CI], 1.02-1.54) than MOs (3.81; 95% CI, 3.52-4.10) and SOs (6.89; 95% CI, 5.99-7.79; P < .0001). In a multivariable analysis, oncologic specialty, recency of graduation, and academic practice were predictive of higher total UPCs (P < .05). UPCs described concerns with care and treatment (42.8%), communication (26.4%), accessibility (17.5%), concern for patient (10.3%), and billing (2.9%). CONCLUSIONS: ROs had significantly fewer complaints than MOs and SOs and may have a lower risk of malpractice claims as a group. In addition to oncologic specialty, a more recent year of medical school graduation and working at an academic center were independent risk factors for UPCs. Further research is needed to clarify the reasons underlying these associations and to identify interventions that decrease UPCs and associated risks. LAY SUMMARY: This study of 1576 oncologists found that radiation oncologists had significantly fewer complaints than medical oncologists, who in turn had significantly fewer complaints than surgical oncologists. Other characteristics associated with more patient complaints included recency of medical school graduation and practice in an academic setting. Oncologists' patient complaints provide information that may have practical applications for patient safety and risk management. Understanding and addressing the characteristics that increase the risk for complaints could improve patients' experiences and outcomes.

Development and Validation of a Model to Predict Neonatal Abstinence Syndrome.

OBJECTIVES: To develop and validate clinical risk prediction tools for neonatal abstinence syndrome (NAS). STUDY DESIGN: We developed prediction models for NAS based on a set of 30 demographic and antenatal exposure covariates collected during pregnancy. Data (outpatient prescription, vital, and administrative records), were obtained from enrollees in the Tennessee Medicaid Program from 2009 to 2014. Models were created using logistic regression and backward selection based on improvement in the Akaike information criterion, and internally validated using bootstrap cross-validation. RESULTS: A total of 218 020 maternal and infant dyads met inclusion criteria, of whom 3208 infants were diagnosed with NAS. The general population model included age, hepatitis C virus infection, days of opioid used by type, number of cigarettes used daily, and the following medications used in the last 30 day of pregnancy: bupropion, antinausea medicines, benzodiazepines, antipsychotics, and gabapentin. Infant characteristics included birthweight, small for gestational age, and infant sex. A high-risk model used a smaller number of predictive variables. Both models discriminated well with an area under the curve of 0.89 and were well-calibrated for low-risk infants. CONCLUSIONS: We developed 2 predictive models for NAS based on demographics and antenatal exposure during the last 30 days of pregnancy that were able to risk stratify infants at risk of developing the syndrome.

Individual short-acting opioids and the risk of opioid-related adverse events in adolescents.

PURPOSE: Hydrocodone, codeine, oxycodone, and tramadol are frequently prescribed to adolescents for moderate pain related to minor trauma or dental, surgical, or medical procedures. Pharmacokinetic and pharmacodynamic differences between these opioids could affect their relative safety. We aimed to compare occurrence of opioid-related adverse events in adolescents without cancer or other severe conditions taking hydrocodone, codeine, oxycodone, and tramadol. METHODS: Retrospective cohort study of 201 940 Tennessee Medicaid enrollees 12 to 17 years of age without cancer, other severe conditions, or evidence of substance abuse with 529 731 filled prescriptions for study opioids. Adverse events were defined as an emergency department visit, hospital admission, or death related to opioid use, confirmed by medical record review. Serious events had opioid-related escalation of care, hospitalization, or death. Propensity-score adjusted hazard ratios (HRs) were calculated with hydrocodone as the reference category. RESULTS: The incidence of opioid-related adverse events per 10 000 person-years of opioid exposure was 97.5 for hydrocodone (127 events/13 026 person-years), 91.2 for codeine (58/6,359), 229.7 for oxycodone (43/1,872), and 317.7 for tramadol (47/1479). The HRs for tramadol in comparison with hydrocodone for all and serious events were 2.98 (2.03-4.39) and 2.94 (1.81-4.75), respectively. Increased risk for tramadol was consistently present when the adverse events were restricted to those with neurologic-respiratory depression/other symptoms of possible overdose. CONCLUSION: In adolescents without cancer or other severe conditions prescribed short-acting opioids, the incidence of both all opioid-related adverse events and more serious events with opioid-related escalation of care, hospitalization, or death was consistently greater for tramadol than for hydrocodone.

Association Between Maternal 2nd Trimester Plasma Folate Levels and Infant Bronchiolitis.

Objectives Viral bronchiolitis is the most common cause of infant hospitalization. Folic acid supplementation is important during the periconceptional period to prevent neural tube defects. An area of investigation is whether higher prenatal folate is a risk factor for childhood respiratory illnesses. We investigated the association between maternal 2nd trimester plasma folate levels and infant bronchiolitis. Methods We conducted a retrospective cohort analysis in a subset of mother-infant dyads (n = 676) enrolled in the Conditions Affecting Neurocognitive Development and Learning in Early Childhood study and Tennessee Medicaid. Maternal folate status was determined using 2nd trimester (16-28 weeks) plasma samples. Bronchiolitis diagnosis in the first year of life was ascertained using International Classification of Diagnosis-9 codes from Medicaid administrative data. We used multivariable logistic regression to assess the adjusted association of prenatal folate levels and infant bronchiolitis outcome. Results Half of the women in this lower-income and predominately African-American (84%) study population had high levels of folate (median 2nd trimester level 19.2 ng/mL) and 21% of infants had at least one bronchiolitis healthcare visit. A relationship initially positive then reversing between maternal plasma folate and infant bronchiolitis was observed that did not reach statistical significance (poverall = .112, pnonlinear effect = .088). Additional adjustment for dietary methyl donor intake did not significantly alter the association. Conclusions for Practice Results did not confirm a statistically significant association between maternal 2nd trimester plasma folate levels and infant bronchiolitis. Further work is needed to investigate the role of folate, particularly higher levels, in association with early childhood respiratory illnesses.

Barriers to accessing treatment for pregnant women with opioid use disorder in Appalachian states.

Background and aims: Opioid agonist therapies (OATs) are highly effective treatments for opioid use disorders (OUDs), especially for pregnant women; thus, improving access to OAT is an urgent public policy goal. Our objective was to determine if insurance and pregnancy status were barriers to obtaining access to OAT in 4 Appalachian states disproportionately impacted by the opioid epidemic. Methods: Between April and May 2017, we conducted phone surveys of OAT providers, opioid treatment programs (OTPs), and outpatient buprenorphine providers, in Kentucky, North Carolina, Tennessee, and West Virginia. Survey response rates were 59%. Logistic models for dichotomous outcomes (e.g., patient acceptance) and negative binomial models were created for count variables (e.g., wait time), overall and for pregnant women. Results: The majority of OAT providers were accepting new patients; however, providers were less likely to treat pregnant women (91% vs. 75%; p < .01). OTPs were more likely to accept new patients than waivered buprenorphine providers (97% vs. 83%; p = .01); rates of accepting pregnant patients were lower in both (91% and 53%; p < .01). OTPs and buprenorphine providers accepted cash payments for services at high rates (OTP: 100%; buprenorphine: 89.4%; p < .01); Medicaid and private insurance were accepted at lower rates. In adjusted models, providers were less likely to accept pregnant women if they took any insurance (adjusted odds ratio [aOR] = 0.15, 95% confidence interval [CI]: 0.03-0.68) or were a buprenorphine provider (aOR = 0.09, 95% CI: 0.02-0.37). Conclusions: We found that OAT providers frequently did not accept any insurance and frequently did not treat pregnant women in an area of the country disproportionately affected by the opioid epidemic. Policymakers could prioritize improvements in provider training (e.g., training of obstetricians to become buprenorphine prescribers) as a means to enhance access to pregnant women or enhancing reimbursement rates as a means of improving insurance acceptance for OAT.

Outpatient Pharmacotherapy for Neonatal Abstinence Syndrome.

OBJECTIVE: To determine differences in lengths of stay, length of therapy, emergency department (ED) utilization, and hospital readmissions between infants with neonatal abstinence syndrome (NAS) treated exclusively with inpatient pharmacotherapy compared with those discharged on outpatient pharmacotherapy. STUDY DESIGN: This retrospective cohort study of infants enrolled in the Tennessee Medicaid program used administrative and vital records data from 2009 to 2011. Medical record review was used to confirm cases of NAS and classify treatment type. Negative binomial regression was used to compare length of therapy and ordinal regression was used to determine frequency of ED visits and hospital readmissions. RESULTS: Among a cohort of 736 patients with confirmed NAS, 72.3% were treated with pharmacotherapy of which approximately one-half (45.5%) were discharged home on outpatient medications. For infants discharged on outpatient pharmacotherapy, initial hospital length of stay was shorter (11 vs 23 days; P < .001) and length of therapy was longer (60 vs 19 days; adjusted incidence rate ratio [aIRR] 2.84, 95%CI 2.31-3.52). After adjusting for potential confounders, infants discharged on outpatient pharmacotherapy had a greater number of ED visits within 6 months of discharge (adjusted odds ratio [aOR] 1.52, 95% CI 1.06-2.17) compared with those treated as inpatients alone. CONCLUSIONS: Outpatient pharmacotherapy for NAS was associated with higher length of therapy and higher rates of ED utilization when compared with infants treated exclusively as inpatients. Future research should focus on improving the efficiency of NAS management while minimizing postdischarge complications.

Unsolicited Patient Complaints Identify Physicians with Evidence of Neurocognitive Disorders.

OBJECTIVES: Determine whether words contained in unsolicited patient complaints differentiate physicians with and without neurocognitive disorders (NCD). METHODS: We conducted a nested case-control study using data from 144 healthcare organizations that participate in the Patient Advocacy Reporting System program. Cases (physicians with probable or possible NCD) and two comparison groups of 60 physicians each (matched for age/sex and site/number of unsolicited patient complaints) were identified from 33,814 physicians practicing at study sites. We compared the frequency of words in patient complaints related to an NCD diagnostic domain between cases and our two comparison groups. RESULTS: Individual words were all statistically more likely to appear in patient complaints for cases (73% of cases had at least one such word) compared to age/sex matched (8%, p < 0.001 using Pearson's χ2 test, χ2 = 30.21, df = 1) and site/complaint matched comparisons (18%, p < 0.001 using Pearson's χ2 test, χ2 = 17.51, df = 1). Cases were significantly more likely to have at least one complaint with any word describing NCD than the two comparison groups combined (conditional logistic model adjusted odds ratio 20.0 [95% confidence interval 4.9-81.7]). CONCLUSIONS: Analysis of words in unsolicited patient complaints found that descriptions of interactions with physicians with NCD were significantly more likely to include words from one of the diagnostic domains for NCD than were two different comparison groups. Further research is needed to understand whether patients might provide information for healthcare organizations interested in identifying professionals with evidence of cognitive impairment.

Unsolicited Patient Complaints in Ophthalmology: An Empirical Analysis from a Large National Database.

PURPOSE: The number of unsolicited patient complaints about a physician has been shown to correlate with increased malpractice risk. Using a large national patient complaint database, we evaluated the number and content of unsolicited patient complaints about ophthalmologists to identify significant risk factors for receiving a complaint. DESIGN: Retrospective cohort study. PARTICIPANTS: Ophthalmologists, nonophthalmic surgeons, nonophthalmic nonsurgeons. METHODS: We analyzed 2087 unsolicited or spontaneous complaints reported about 815 ophthalmologists practicing in 24 academic and nonacademic organizations using the Patient Advocacy Reporting System (PARS). Complaints against 5273 nonophthalmic surgeons and 19487 nonophthalmic nonsurgeons during the same period were used for comparison. Complaint type profiles were assigned using a previously validated standardized coding system. We (1) described the distribution of complaints against ophthalmologists; (2) compared the distribution and rates of patient complaints about ophthalmologists with those of nonophthalmic surgeons and nonophthalmic nonsurgeons in the database; (3) analyzed differences in complaint type profiles and quantity of complaints by ophthalmic subspecialty, practice setting, physician gender, medical school type, and graduation date; and (4) identified significant risk factors for high numbers of unsolicited patient complaints after adjusting for other covariates. MAIN OUTCOME MEASURES: Unsolicited patient complaints. RESULTS: Ophthalmologists had significantly fewer complaints per physician than other nonophthalmic surgeons and nonsurgeons. Sixty-three percent of ophthalmologists had 0 complaints, whereas 10% of ophthalmologists accounted for 61% of all complaints. Ophthalmologists from academic centers, female ophthalmologists, and younger ophthalmologists had significantly more complaints (P < 0.01), and general ophthalmologists had significantly fewer complaints than subspecialists (P < 0.05). After adjusting for covariates using multivariable analysis, working at an academic center was a statistically significant risk factor (adjusted relative risk, 1.82; 95% confidence interval, 1.36-2.43; P < 0.001). CONCLUSIONS: Ophthalmologists had significantly fewer complaints than nonophthalmic surgeons and nonophthalmic nonsurgeons, and by implication may have a lower malpractice risk as a group. Nevertheless, a small number of ophthalmologists generated a disproportionate number of complaints. Working at an academic center was a significant independent risk factor for having more patient complaints. Further research is needed to clarify the underlying reasons for this association and to identify interventions that may decrease this risk.

Trimethoprim-sulfonamide use during the first trimester of pregnancy and the risk of congenital anomalies.

BACKGROUND: Sulfonamide antibacterials are widely used in pregnancy, but evidence about their safety is mixed. The objective of this study was to assess the association between first-trimester sulfonamide exposure and risk of specific congenital malformations. METHODS: Mother-infant pairs were selected from a cohort of 1.2 million live-born deliveries (2001-2008) at 11 US health plans comprising the Medication Exposure in Pregnancy Risk Evaluation Program. Mothers with first-trimester trimethoprim-sulfonamide (TMP-SUL) exposures were randomly matched 1:1 to (i) a primary comparison group (mothers exposed to penicillins and/or cephalosporins) and (ii) a secondary comparison group (mothers with no dispensing of an antibacterial, antiprotozoal, or antimalarial medication during the same time period). The outcomes were cardiovascular abnormalities, cleft palate/lip, clubfoot, and urinary tract abnormalities. RESULTS: We first identified 7615 infants in the TMP-SUL exposure group, of which 7595 (99%) were exposed to a combination of TMP-SUL and the remaining 1% to sulfonamides alone. After matching (1:1) to the comparator groups and only including those with complete data on covariates, there were 20 064 (n = 6688 per group) in the primary analyses. Overall, cardiovascular defects (1.52%) were the most common and cleft lip/palate (0.10%) the least common that were evaluated. Compared with penicillin/cephalosporin exposure, and no antibacterial exposure, TMP-SUL exposure was not associated with statistically significant elevated risks for cardiovascular, cleft lip/palate, clubfoot, or urinary system defects. CONCLUSIONS: First-trimester TMP-SUL exposure was not associated with a higher risk of the congenital anomalies studied, compared with exposure to penicillins and/or cephalosporins, or no exposure to antibacterials.

Using Coworker Observations to Promote Accountability for Disrespectful and Unsafe Behaviors by Physicians and Advanced Practice Professionals.

BACKGROUND: Health care team members are well positioned to observe disrespectful and unsafe conduct-behaviors known to undermine team function. Based on experience in sharing patient complaints with physicians who subsequently achieved decreased complaints and malpractice risk, Vanderbilt University Medical Center developed and assessed the feasibility of the Co-Worker Observation Reporting System(SM) (CORS (SM)) for addressing coworkers' reported concerns. METHODS: VUMC leaders used a "Project Bundle" readiness assessment, which entailed identification and development of key people, organizational supports, and systems. Methods involved gaining leadership buy-in, recruiting and training key individuals, aligning the project with organizational values and policies, promoting reporting, monitoring reports, and employing a tiered intervention process to address reported coworker concerns. RESULTS: Peer messengers shared coworker reports with the physicians and advanced practice professionals associated with at least one report 84% of the time. Since CORS inception, 3% of the medical staff was associated with a pattern of CORS reports, and 71% of recipients of pattern-related interventions were not named in any subsequent reports in a one-year follow-up period. CONCLUSIONS: Systematic monitoring of documented co-worker observations about unprofessional conduct and sharing that information with involved professionals are feasible. Feasibility requires organizationwide implementation; co-workers willing and able to share respectful, nonjudgmental, timely feedback designed initially to encourage self-reflection; and leadership committed to be more directive if needed. Follow-up surveillance indicates that the majority of professionals "self-regulate" after receiving CORS data.

Maternal Folic Acid Supplementation During Pregnancy and Early Childhood Asthma.

BACKGROUND: Asthma is one of the most common chronic childhood diseases. While folic acid supplementation around conception helps prevent neural tube defects, an animal model suggests that it may be a risk factor for respiratory diseases, although epidemiologic studies have had conflicting results. We investigated the timing of folic acid-containing prescription filling during pregnancy and child asthma. METHODS: In a retrospective cohort study of 104,428 children, born 1996-2005, and their mothers enrolled in Tennessee Medicaid, we investigated the association of filling folic acid-containing prescriptions during pregnancy and childhood asthma at ages 4.5-6 years. We categorized women into exposure groups based on prescription filling centered around the first trimester: no folic acid prescription exposure, exposure in first trimester only, exposure after first trimester, and exposure in first trimester and beyond. We defined asthma using asthma-specific healthcare visits and medication fills. Using logistic regression models, we investigated the relationship adjusting for potential confounders. RESULTS: Overall 15% of children had asthma. Compared with children born to women with no folic acid prescription exposure, children born to women with exposures in the first trimester only or first trimester and later had increased relative odds of asthma (adjusted odds ratios = 1.2, 95% confidence interval = 1.1, 1.3, and 1.2, 95% confidence interval = 1.2, 1.3); no association was seen in children born to women exposed after the first trimester. CONCLUSION: Timing of folic acid-containing prescription filling during pregnancy was associated with childhood asthma. Our findings contribute to understanding of the role of prenatal nutritional supplements on child respiratory health.

Promise and peril: Dissemination of findings from studies of drugs used in pregnancy and their association with birth defects.

BACKGROUND: When and how to publish birth defects research can be complex, especially in the context of drugs used in pregnancy. Such research frequently involves multiple stakeholders, including regulatory agencies. Researchers must balance the potential peril of an unnecessarily panicked populace versus the benefit of protecting the public's health. METHODS: We use a case presentation and contemporary literature to highlight the potential tradeoffs that researchers must consider. We highlight important considerations including the public health impact, examining the likelihood of causality, understanding common considerations when using large data sources, the role of peer review and working in partnership with regulatory agencies. RESULTS: We suggest that plans for analyses, dissemination and risk communication are done best a priori and not post hoc. CONCLUSION: Rigorous research evaluating the impact of drugs used in pregnancy, coupled with effective dissemination strategies, has the potential improve outcomes for mothers and their infants for generations.

Beginning and duration of pregnancy in automated health care databases: review of estimation methods and validation results.

PURPOSE: To describe methods reported in the literature to estimate the beginning or duration of pregnancy in automated health care data, and to present results of validation exercises where available. METHODS: Papers reporting methods for determining the beginning or duration of pregnancy were identified based on Pubmed searches, by consulting investigators with expertise in the field and by reviewing conference abstracts and reference lists of relevant papers. From each paper or abstract, we extracted information to characterize the study population, data sources, and estimation algorithm. We then grouped these studies into categories reflecting their general methodological approach. RESULTS: Methods were classified into 5 categories: (i) methods that assign a uniform duration for all pregnancies, (ii) methods that assign pregnancy duration based on preterm-delivery or health care related codes, or codes for other pregnancy outcomes, (iii) methods based on the timing of prenatal care, (iv) methods based on birth weight, and (v) methods that combine elements from 2 and 3. Validation studies evaluating these methods used varied approaches, with results generally reporting on the mistiming of the start of pregnancy, incorrect estimation of the duration of pregnancy, or misclassification of drug exposure during pregnancy or early pregnancy. CONCLUSIONS: In the absence of accurate information on the beginning or duration of pregnancy, several methods of varying complexity are available to estimate them. Validation studies have been performed for many of them and can serve as a guide for method selection for a particular study.

Stuck in a moment: an ex ante analysis of patient complaints in plastic surgery, used to predict malpractice risk profiles, from a large cohort of physicians in the patient advocacy reporting system.

INTRODUCTION: Unsolicited patient complaints (UPCs) serve as a powerful predictor of increased risk of malpractice claims, and reductions in UPCs, through targeted physician interventions, lower incidence of lawsuits and decrease cost of risk management. We analyzed UPCs, verified by trained counselors in patient relations, to determine the malpractice risk of plastic surgeons, compared to dermatologists, all surgeons, and all physicians, from a national patient complaint registry. METHODS: We examined the patient complaint profiles and risk scores of 31,077 physicians (3935 surgeons, 338 plastic and reconstructive surgeons, and 519 dermatologists), who participated in the Patient Advocacy Reporting System, a national registry of UPCs. Patient complaint data were collected from 70 community and academic hospitals across 29 states, from 2009 to 2012. In addition to determining the specific complaint mix for plastic surgery compared to all physicians, each physician was assigned a patient complaint risk score, based on a proprietary weighted-sum algorithm, with a score higher than 70, indicative of high risk for malpractice claims. Patient complaint profiles and risk scores were compared between all groups, using Wilcoxon rank and χ analysis. P values less than 0.05 were assigned statistical significance. RESULTS: Over this 4-year period, the majority of plastic surgeons (50.8%) did not generate any patient complaints, but those who did received an average of 9.8 complaints from 4.8 patients. The percentage of physicians at high risk for malpractice claims, based upon the Patient Advocacy Reporting System index score of patient complaints, was as follows: all physicians, 2.0%; all surgeons, 4.1%; plastic and reconstructive surgeons, 2.4%; dermatologists, 1.4%. Physicians (from 2012 only) who were identified by their sponsoring institutions as "reconstructive" plastic surgeons (n = 41) were 5 times as likely to have a high risk score, compared to physicians who were identified as "plastic" surgeons (n = 233), and were more likely to practice within an academic health care system that had a level 1 trauma center and a plastic surgery residency program. The overall mix of patient complaints from plastic and reconstructive surgeons was nearly the same as the national cohort of all physicians: care and treatment, 49%; communication, 19%; accessibility and availability, 14%; money or payment issues, 9%; and concern for patient/family, 9%. CONCLUSIONS: "Reconstructive" plastic surgeons are at increased risk for UPCs, compared to most physicians, especially dermatologists. Because UPCs are a robust proxy for malpractice risk, targeted interventions to decrease patient complaints may improve patient satisfaction and reduce malpractice claims and risk management activity. Monitoring UPCs may permit early identification of high-risk surgeons before malpractice claims accumulate.

Association of folic acid supplementation during pregnancy and infant bronchiolitis.

Viral bronchiolitis affects 20%-30% of infants; because there is no known effective treatment, it is important to identify risk factors that contribute to its pathogenesis. Although adequate folate intake during the periconceptional period prevents neural tube defects, animal data suggest that higher supplementation may be a risk factor for child respiratory diseases. Using a population-based retrospective cohort of 167,333 women and infants, born in 1995-2007 and enrolled in the Tennessee Medicaid program, we investigated the association between the filling of folic acid-containing prescriptions and infant bronchiolitis. We categorized women into the following 4 groups in relation to the first trimester: "none" (no prescription filled), "first trimester only," "after first trimester," and "both" (prescriptions filled both during and after the first trimester). Overall, 21% of infants had a bronchiolitis diagnosis, and 5% were hospitalized. Most women filled their first prescriptions after the fifth to sixth weeks of pregnancy, and most prescriptions contained 1,000 µg of folic acid. Compared with infants born to women in the "none" group, infants born to women in the "first trimester only" group had higher relative odds of bronchiolitis diagnosis (adjusted odds ratio = 1.17, 95% confidence interval: 1.11, 1.22) and greater severity (adjusted odds ratio = 1.16, 95% confidence interval: 1.11, 1.22). This study's findings contribute to an understanding of the implications of prenatal nutritional supplement recommendations for infant bronchiolitis.

ADHD drugs and serious cardiovascular events in children and young adults.

BACKGROUND: Adverse-event reports from North America have raised concern that the use of drugs for attention deficit-hyperactivity disorder (ADHD) increases the risk of serious cardiovascular events. METHODS: We conducted a retrospective cohort study with automated data from four health plans (Tennessee Medicaid, Washington State Medicaid, Kaiser Permanente California, and OptumInsight Epidemiology), with 1,200,438 children and young adults between the ages of 2 and 24 years and 2,579,104 person-years of follow-up, including 373,667 person-years of current use of ADHD drugs. We identified serious cardiovascular events (sudden cardiac death, acute myocardial infarction, and stroke) from health-plan data and vital records, with end points validated by medical-record review. We estimated the relative risk of end points among current users, as compared with nonusers, with hazard ratios from Cox regression models. RESULTS: Cohort members had 81 serious cardiovascular events (3.1 per 100,000 person-years). Current users of ADHD drugs were not at increased risk for serious cardiovascular events (adjusted hazard ratio, 0.75; 95% confidence interval [CI], 0.31 to 1.85). Risk was not increased for any of the individual end points, or for current users as compared with former users (adjusted hazard ratio, 0.70; 95% CI, 0.29 to 1.72). Alternative analyses addressing several study assumptions also showed no significant association between the use of an ADHD drug and the risk of a study end point. CONCLUSIONS: This large study showed no evidence that current use of an ADHD drug was associated with an increased risk of serious cardiovascular events, although the upper limit of the 95% confidence interval indicated that a doubling of the risk could not be ruled out. However, the absolute magnitude of such an increased risk would be low. (Funded by the Agency for Healthcare Research and Quality and the Food and Drug Administration.).

The prevalence and trends of antiviral medication use during pregnancy in the US: a population-based study of 664,297 deliveries in 2001-2007.

To evaluate the prevalence, trends, timing and duration of exposure to antiviral medications during pregnancy within a US cohort of pregnant women and to evaluate the proportion of deliveries with a viral infection diagnosis among women given antiviral medication during pregnancy. Live-born deliveries between 2001 and 2007, to women aged 15-45 years, were included from the Medication Exposure in Pregnancy Risk Evaluation Program, a collaborative research program between the U.S. Food and Drug Administration and eleven health plans. They were evaluated for prevalence, timing, duration, and temporal trends of exposure to antiviral medications during pregnancy. We also calculated the proportion of deliveries with a viral infection diagnosis among those exposed to antiviral medications. Among 664,297 live births, the overall prevalence of antiviral exposure during pregnancy was 4 % (n = 25,155). Between 2001 and 2007, antiviral medication exposure during pregnancy doubled from 2.5 to 5 %. The most commonly used antiviral medication was acyclovir, with 3 % of the deliveries being exposed and most of the exposure occurring after the 1st trimester. Most deliveries exposed to antiviral medications were exposed for less than 30 days (2 % of all live births). Forty percent of the women delivering an infant exposed to antiviral medications had a herpes diagnosis. Our findings highlight the increased prevalence of women delivering an infant exposed to antiviral medications over time. These findings support the need for large, well-designed studies to assess the safety and effectiveness of these medications during pregnancy.

Antipsychotic Medications and Mortality in Children and Young Adults.

Importance: Dose-related effects of antipsychotic medications may increase mortality in children and young adults. Objective: To compare mortality for patients aged 5 to 24 years beginning treatment with antipsychotic vs control psychiatric medications. Design, Setting, and Participants: This was a US national retrospective cohort study of Medicaid patients with no severe somatic illness or schizophrenia or related psychoses who initiated study medication treatment. Study data were analyzed from November 2022 to September 2023. Exposures: Current use of second-generation antipsychotic agents in daily doses of less than or equal to 100-mg chlorpromazine equivalents or greater than 100-mg chlorpromazine equivalents vs that for control medications (α agonists, atomoxetine, antidepressants, and mood stabilizers). Main Outcome and Measures: Total mortality, classified by underlying cause of death. Rate differences (RDs) and hazard ratios (HRs) adjusted for potential confounders with propensity score-based overlap weights. Results: The 2 067 507 patients (mean [SD] age, 13.1 [5.3] years; 1 060 194 male [51.3%]) beginning study medication treatment filled 21 749 825 prescriptions during follow-up with 5 415 054 for antipsychotic doses of 100 mg or less, 2 813 796 for doses greater than 100 mg, and 13 520 975 for control medications. Mortality was not associated with antipsychotic doses of 100 mg or less (RD, 3.3; 95% CI, -5.1 to 11.7 per 100 000 person-years; HR, 1.08; 95% CI, 0.89-1.32) but was associated with doses greater than 100 mg (RD, 22.4; 95% CI, 6.6-38.2; HR, 1.37; 95% CI, 1.11-1.70). For higher doses, antipsychotic treatment was significantly associated with overdose deaths (RD, 8.3; 95% CI, 0-16.6; HR, 1.57; 95% CI, 1.02-2.42) and other unintentional injury deaths (RD, 12.3; 95% CI, 2.4-22.2; HR, 1.57; 95% CI, 1.12-2.22) but was not associated with nonoverdose suicide deaths or cardiovascular/metabolic deaths. Mortality for children aged 5 to 17 years was not significantly associated with either antipsychotic dose, whereas young adults aged 18 to 24 years had increased risk for doses greater than 100 mg (RD, 127.5; 95% CI, 44.8-210.2; HR, 1.68; 95% CI, 1.23-2.29). Conclusions and Relevance: In this cohort study of more than 2 million children and young adults without severe somatic disease or diagnosed psychosis, antipsychotic treatment in doses of 100 mg or less of chlorpromazine equivalents or in children aged 5 to 17 years was not associated with increased risk of death. For doses greater than 100 mg, young adults aged 18 to 24 years had significantly increased risk of death, with 127.5 additional deaths per 100 000 person-years.

Physician Specialty Differences in Unprofessional Behaviors Observed and Reported by Coworkers.

Importance: Because unprofessional behaviors are associated with patient complications, malpractice claims, and well-being concerns, monitoring concerns requiring investigation and individuals identified in multiple reports may provide important opportunities for health care leaders to support all team members. Objective: To examine the distribution of physicians by specialty who demonstrate unprofessional behaviors measured through safety reports submitted by coworkers. Design, Setting, and Participants: This retrospective cohort study was conducted among physicians who practiced at the 193 hospitals in the Coworker Concern Observation Reporting System (CORS), administered by the Vanderbilt Center for Patient and Professional Advocacy. Data were collected from January 2018 to December 2022. Exposure: Submitted reports concerning communication, professional responsibility, medical care, and professional integrity. Main Outcomes and Measures: Physicians' total number and categories of CORS reports. The proportion of physicians in each specialty (nonsurgeon nonproceduralists, emergency medicine physicians, nonsurgeon proceduralists, and surgeons) who received at least 1 report and who qualified for intervention were calculated; logistic regression was used to calculate the odds of any CORS report. Results: The cohort included 35 120 physicians: 18 288 (52.1%) nonsurgeon nonproceduralists, 1876 (5.3%) emergency medicine physicians, 6743 (19.2%) nonsurgeon proceduralists, and 8213 (23.4%) surgeons. There were 3179 physicians (9.1%) with at least 1 CORS report. Nonsurgeon nonproceduralists had the lowest percentage of physicians with at least 1 report (1032 [5.6%]), followed by emergency medicine (204 [10.9%]), nonsurgeon proceduralists (809 [12.0%]), and surgeons (1134 [13.8%]). Nonsurgeon nonproceduralists were less likely to be named in a CORS report than other specialties (5.6% vs 12.8% for other specialties combined; difference in percentages, -7.1 percentage points; 95% CI, -7.7 to -6.5 percentage points; P < .001). Pediatric-focused nonsurgeon nonproceduralists (2897 physicians) were significantly less likely to be associated with a CORS report than nonpediatric nonsurgeon nonproceduralists (15 391 physicians) (105 [3.6%] vs 927 [6.0%]; difference in percentages, -2.4 percentage points, 95% CI, -3.2 to -1.6 percentage points; P < .001). Pediatric-focused emergency medicine physicians, nonsurgeon proceduralists, and surgeons had no significant differences in reporting compared with nonpediatric-focused physicians. Conclusions and Relevance: In this cohort study, less than 10% of physicians ever received a coworker report with a concern about unprofessional behavior. Monitoring reports of unprofessional behaviors provides important opportunities for health care organizations to identify and intervene as needed to support team members.