Last data update: Jul 11, 2025. (Total: 49561 publications since 2009)
Records 1-26 (of 26 Records) |
Query Trace: Miele K[original query] |
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Birth Outcomes Among Women With Syphilis During Pregnancy in Six U.S. States, 2018-2021
Carlson JM , Sancken CL , Nguyen K , Lewis EL , Praag A , Pulliam K , Willabus T , Bakwa ZE , Longcore ND , O'Callaghan KP , Miele K , Fountain A , Tong VT , Woodworth KR . Obstet Gynecol 2025 146 (1) 121-128 OBJECTIVE: To describe the association between syphilis treatment status and adverse pregnancy and neonatal outcomes among pregnancies complicated by syphilis. METHODS: Six jurisdictions that participated in SET-NET (Surveillance for Emerging Threats to Mothers and Babies Network) reported data on women with syphilis during pregnancy and outcomes that occurred during 2018-2021. Frequencies of adverse outcomes were reported by syphilis treatment status during pregnancy as defined by the 2021 Sexually Transmitted Infections Treatment Guidelines (inadequate, adequate, and no treatment). Adjusted risk ratios (aRRs) were modeled for each outcome comparing adequate treatment with no treatment and with inadequate treatment, controlling for the pregnant woman's age at infection, education level, insurance status, reported substance use, number of prenatal visits, and stage of syphilis. RESULTS: As of June 7, 2024, 1,682 singleton pregnancies complicated by syphilis were reported, with more than half of pregnant women adequately treated for syphilis (57.6%). Pregnant women with no or inadequate treatment had higher relative frequencies of adverse outcomes (stillbirth, prematurity, low birth weight [LBW], and neonatal intensive care unit [NICU] admission) than those with adequate treatment. The aRRs for stillbirth (9.9% vs 1.4%, aRR 3.72, 95% CI, 1.73-8.03), LBW (30.1% vs 9.9%, aRR 1.51, 95% CI, 1.07-2.14), and NICU admission (66.7% vs 27.0%, aRR 1.60, 95% CI, 1.28-1.98) were higher in pregnant women with no treatment compared with those with adequate treatment. Inadequate treatment was associated with LBW and NICU admission (24.9% vs 9.9%, aRR 1.81, 95% CI, 1.29-2.52; and 57.2% vs 27.0%, aRR 1.61, 95% CI, 1.31-1.99, respectively) compared with adequate treatment. CONCLUSION: The high relative frequencies of adverse pregnancy and neonatal outcomes associated with inadequately treated or untreated syphilis during pregnancy reinforce the importance of adequate treatment in mitigating the effects of syphilitic infection. Increased attention and systematic strategies are needed to address gaps in screening and treatment before and during pregnancy to reduce adverse pregnancy and neonatal outcomes. |
The Impact of the COVID-19 Pandemic on the Care of Pregnant Women with a Focus on Those who Use Substances: Lessons for the Future
Green C , Board A , Squire C , Adams ET , Kim SY , Brown JA , Williams P , Malik R , Polen K , Gilboa SM , Miele K . Disaster Med Public Health Prep 2025 19 e154 OBJECTIVES: About 13% of pregnant women with substance use disorder (SUD) receive treatment and many may encounter challenges in accessing perinatal care, making it critical for this population to receive uninterrupted care during a global pandemic. METHODS: From October 2021-January 2022, we conducted an online survey of pregnant and postpartum women and interviews with clinicians who provide care to this population. The survey was administered to pregnant and postpartum women who used substances or received SUD treatment during the COVID-19 pandemic. RESULTS: Two hundred and ten respondents completed the survey. All respondents experienced pandemic-related barriers to routine health care services, including delays in prenatal care and SUD treatment. Disruptions in treatment were due to patient factors (38.2% canceled an appointment) and clinic factors (25.5% had a clinic cancel their appointment). Respondents were generally satisfied with telehealth (M = 3.97, SD = 0.82), though half preferred a combination of in-person and telehealth visits. Clinicians reported telehealth improved health care access for patients, however barriers were still observed. CONCLUSIONS: Although strategies were employed to mitigate barriers in care during COVID-19, pregnant and postpartum women who used substances still experienced barriers in receiving consistent care. Telehealth may be a useful adjunct to enhance care access for pregnant and postpartum women during public health crises. |
The Return of an Old Foe: Syphilis Among Women
Duggal R , Hufstetler K , Miele K . Clin Obstet Gynecol 2025 Over 10 years, the reported incidence of primary and secondary syphilis increased among women at 6 times the rate compared with men (636% vs. 103%). Untreated syphilis can lead to life-altering complications including permanent vision and hearing loss, congenital syphilis, and increased HIV acquisition. Syphilis diagnosis and staging require current and prior laboratory results, physical examination, and history. The preferred treatment for syphilis is long-acting penicillin G benzathine. Partner testing and treatment are critical to prevent re-infection and further community transmission. Innovative strategies are needed to prevent and treat syphilis among women, especially those without regular access to health care. |
Adverse childhood experiences and adult alcohol use during pregnancy - 41 U.S. jurisdictions, 2019-2023
Thomas SA , Deputy NP , Board A , Denny CH , Guinn AS , Miele K , Dunkley J , Kim SY . Prev Med 2025 108219 INTRODUCTION: Adverse childhood experiences (ACEs) are preventable, potentially traumatic events that occur in childhood. Alcohol use during pregnancy can result in miscarriage, stillbirth, preterm birth, and a range of lifelong behavioral, intellectual, and physical disabilities in the child. Limited research has examined the relationship between ACEs and alcohol use in pregnancy; available studies might not reflect current trends in this relationship. METHODS: Using 2019-2023 Behavioral Risk Factor Surveillance System data from 41 U.S. jurisdictions, the prevalence of self-reported current alcohol use among pregnant persons aged 18-49 years (N = 2371) was estimated by ACEs and selected characteristics. We calculated unadjusted and adjusted prevalence ratios (aPR) for the relationship between ACEs and alcohol use during pregnancy. RESULTS: The prevalence of current alcohol use was 16.2 % (95 % CI = 11.5-20.9) among pregnant persons who reported experiencing four or more ACEs, and 8.6 % (95 % CI = 5.7-11.5) among those who reported no ACEs. When adjusting for sociodemographic characteristics, pregnant persons who reported four or more ACEs were more likely to report current alcohol use compared to those who reported no ACEs (aPR = 1.8, 95 % CI = 1.1-2.9). Individually, pregnant persons who experienced emotional abuse (aPR = 1.9, 95 % CI = 1.3-2.7) and witnessed intimate partner violence (aPR = 1.6, 95 % CI = 1.1-2.4) were more likely to use alcohol during pregnancy compared to pregnant persons who did not report experiencing these ACEs. CONCLUSIONS: Higher ACE exposure was associated with alcohol use during pregnancy. Steps can be taken to mitigate their potential harms. Clinical and community-level interventions can address ACEs, which might reduce alcohol use during pregnancy. |
Patterns of medication for opioid use disorder during pregnancy, 7 clinical sites, MATernaL and Infant clinical NetworK (MAT-LINK), 2014-2021
Tran EL , Dorsey AN , Miele K , Gilboa SM , Gosdin L , Terplan M , Sanjuan PM , Seligman NS , Wright T , Wachman EM , Smid M , Henninger M , Leeman L , Schneider PD , Rood K , Louis JM , Caveglia S , Davidson A , Shakib J , Shrestha H , Meaney-Delman DM , Kim SY . J Addict Med 2024 OBJECTIVES: To describe patterns of medication for opioid use disorder (MOUD) during pregnancies in the opioid use disorder (OUD) cohort of MAT-LINK, a sentinel surveillance network of pregnancies at US clinical sites. METHODS: Seven clinical sites providing care for pregnant people with OUD collected electronic health record data. Pregnancies were included in this analysis if (1) the pregnancy outcome occurred between January 2014 and August 2021, (2) the person had OUD, and (3) there was any electronic health record-documented MOUD during pregnancy. Analyses describing MOUD type, demographic characteristics, and timing during pregnancy were performed. RESULTS: Among 3911 pregnancies with any documented MOUD, more than 90% of pregnancies with methadone were to publicly insured people, which was greater than percentages for pregnancies with other MOUD. Buprenorphine with naloxone and naltrexone were two MOUD types that were increasingly common among pregnant people in recent years. In most pregnancies, prenatal care and MOUD were first documented in the same trimester. During the first, second, and third trimesters, there were 37%, 61%, and 91% of pregnancies with MOUD, respectively. Approximately 87% (n = 3412) had only 1 documented MOUD type, versus 2 or 3 types. However, discontinuity in MOUD across trimesters was still observed. CONCLUSIONS: In MAT-LINK's OUD cohort, the overall frequency of MOUD improved over the course of pregnancy. Contextual factors, such as insurance status and year of pregnancy outcome, might influence MOUD type. Prenatal care and MOUD might be facilitators for one another; however, there are still opportunities to improve early linkage and continuous access to both prenatal care and MOUD during pregnancy. |
Using ICD codes alone may misclassify overdoses among perinatal people
Board A , Vivolo-Kantor A , Kim SY , Tran EL , Thomas SA , Terplan M , Smid MC , Sanjuan PM , Wright T , Davidson A , Wachman EM , Rood KM , Morse D , Chu E , Miele K . Am J Prev Med 2024 INTRODUCTION: As perinatal drug overdoses continue to rise, reliable approaches are needed to monitor overdose trends during pregnancy and postpartum. This analysis aimed to determine the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ICD-9/10-CM codes for drug overdose events among people in the MATernaL and Infant clinical NetworK (MAT-LINK) with medication for opioid use disorder (MOUD) during pregnancy. METHODS: People included in this analysis had electronic health record (EHR) documentation of MOUD and a known pregnancy outcome from January 1, 2014 through August 31, 2021. Data were analyzed during pregnancy through one year postpartum. CDC's drug overdose case definitions were used to categorize overdose based on ICD-9/10-CM codes. These codes were compared to abstracted EHR data of any drug overdose. Analyses were conducted between May 2023 and May 2024. RESULTS: Among 3,911 pregnancies with EHR-documented MOUD, the sensitivity of ICD-9/10-CM codes for capturing drug overdose during pregnancy was 32.7%, while specificity was 98.5%, PPV was 23.4%, and NPV was 99.0%. The sensitivity of ICD-9/10-CM codes for capturing drug overdose postpartum was 30.9%, while specificity was 98.4%, PPV was 25.9%, and NPV was 98.8%. CONCLUSIONS: The sensitivity and PPV of ICD-9/10-CM codes for capturing drug overdose compared to abstracted EHR data during the perinatal period was low in this cohort of people with MOUD during pregnancy, though the specificity and NPV were high. Incorporating other data from EHRs and outside the healthcare system might provide more comprehensive insights on nonfatal drug overdose in this population. |
Naloxone use during pregnancy-data from 26 US jurisdictions, 2019-2020
Board A , D'Angelo DV , Miele K , Asher A , Salvesen von Essen B , Denny CH , Terplan M , Dunkley J , Kim SY . J Addict Med 2024 OBJECTIVES: We aimed to determine the prevalence of self-reported naloxone use during pregnancy among people in the United States with a recent live birth. A secondary objective was to characterize people at increased risk of overdose who did and did not use naloxone. METHODS: We analyzed data from the Pregnancy Risk Assessment Monitoring System from 26 US jurisdictions that conducted an opioid supplement survey from 2019 to 2020. Respondents with increased risk of experiencing an opioid overdose were identified based on self-reported use of illicit amphetamines, heroin, cocaine, or receiving medication for opioid use disorder (MOUD) during pregnancy. Weighted prevalence estimates and 95% confidence intervals were calculated for reported naloxone use at any point during pregnancy among people with an increased risk of overdose. RESULTS: Naloxone use during pregnancy was reported by <1% of the overall study population (unweighted N = 88/34,528). Prevalence of naloxone use was 5.0% (95% CI: 0.0-10.6) among respondents who reported illicit amphetamine use, 15.2% (1.8-28.6) among those who reported heroin use, and 17.6% (0.0-38.1) among those who reported cocaine use. Naloxone use was 14.5% (8.4-20.6) among those who reported taking MOUD. Among people with increased risk of overdose, no significant differences in naloxone use were observed by age, race/ethnicity, education level, residential metropolitan status, or insurance status. CONCLUSIONS: Prevalence of naloxone use among people with an increased risk of overdose during pregnancy ranged from 5.0% to 17.6%. Access to naloxone, overdose prevention education, and treatment for substance use disorders may help reduce morbidity and mortality. |
Clinical updates in sexually transmitted infections, 2024
Hufstetler K , Llata E , Miele K , Quilter LAS . J Womens Health (Larchmt) 2024 Sexually transmitted infections (STIs) continue to increase in the United States with more than 2.5 million cases of gonorrhea, chlamydia, and syphilis reported to the Centers for Disease Control and Prevention in 2022. Untreated STIs in women can lead to adverse outcomes, including pelvic inflammatory disease, infertility, chronic pelvic pain, and pregnancy complications such as ectopic pregnancy, early pregnancy loss, stillbirth, and neonatal transmission. STI-related guidelines can be complex and are frequently updated, making it challenging to stay informed on current guidance. This article provides high-yield updates to support clinicians managing STIs by highlighting changes in screening, diagnosis, and treatment. One important topic includes new guidance on syphilis screening, including a clarified description of high community rates of syphilis based on Healthy People 2030 goals, defined as a case rate of primary or secondary syphilis > 4.6 per 100,000. Reproductive aged persons living in counties above this threshold should be offered syphilis screening. Additionally, American College of Obstetricians & Gynecologists now recommends syphilis screening three times during pregnancy regardless of risk-at the first prenatal visit, during the third trimester, and at delivery. In addition, new guidance to support consideration for extragenital screening for gonorrhea and chlamydia in women at sites such as the anus and pharynx is discussed. Other topics include the most recent chlamydia, gonorrhea, trichomoniasis, and pelvic inflammatory disease treatment recommendations; screening and treatment guidance for Mycoplasma genitalium; genital herpes screening indications and current diagnostic challenges; and the diagnosis and management of mpox in women and during pregnancy. |
Syphilis treatment among people who are pregnant in six U.S. states, 2018-2021
Tannis A , Miele K , Carlson JM , O'Callaghan KP , Woodworth KR , Anderson B , Praag A , Pulliam K , Coppola N , Willabus T , Mbotha D , Abetew D , Currenti S , Longcore ND , Akosa A , Meaney-Delman D , Tong VT , Gilboa SM , Olsen EO . Obstet Gynecol 2024 OBJECTIVE: To describe syphilis treatment status and prenatal care among people with syphilis during pregnancy to identify missed opportunities for preventing congenital syphilis. METHODS: Six jurisdictions that participated in SET-NET (Surveillance for Emerging Threats to Pregnant People and Infants Network) conducted enhanced surveillance among people with syphilis during pregnancy based on case investigations, medical records, and linkage of laboratory data with vital records. Unadjusted risk ratios (RRs) were used to compare demographic and clinical characteristics by syphilis stage (primary, secondary, or early latent vs late latent or unknown) and treatment status during pregnancy (adequate per the Centers for Disease Control and Prevention's "Sexually Transmitted Infections Treatment Guidelines, 2021" vs inadequate or not treated) and by prenatal care (timely: at least 30 days before pregnancy outcome; nontimely: less than 30 days before pregnancy outcome; and no prenatal care). RESULTS: As of September 15, 2023, of 1,476 people with syphilis during pregnancy, 855 (57.9%) were adequately treated and 621 (42.1%) were inadequately treated or not treated. Eighty-two percent of the cohort received timely prenatal care. Although those with nontimely or no prenatal care were more likely to receive inadequate or no treatment (RR 2.50, 95% CI, 2.17-2.88 and RR 2.73, 95% CI, 2.47-3.02, respectively), 32.1% of those with timely prenatal care were inadequately or not treated. Those with reported substance use or a history of homelessness were nearly twice as likely to receive inadequate or no treatment (RR 2.04, 95% CI, 1.82-2.28 and RR 1.83, 95% CI, 1.58-2.13, respectively). CONCLUSION: In this surveillance cohort, people without timely prenatal care had the highest risk for syphilis treatment inadequacy; however, almost a third of people who received timely prenatal care were not adequately treated. These findings underscore gaps in syphilis screening and treatment for pregnant people, especially those experiencing substance use and homelessness, and the need for systems-based interventions, such as treatment outside of traditional prenatal care settings. |
CDC's new hepatitis C virus testing recommendations for perinatally exposed infants and children: A step towards hepatitis C elimination
Panagiotakopoulos L , Miele K , Cartwright EJ , Kamili S , Furukawa N , Woodworth K , Tong VT , Kim SY , Wester C , Sandul AL . J Womens Health (Larchmt) 2024 New U.S. Centers for Disease Control and Prevention (CDC) guidelines for hepatitis C virus (HCV) testing of perinatally exposed infants and children released in 2023 recommend a nucleic acid test (NAT) for detection of HCV ribonucleic acid (i.e., NAT for HCV RNA) at 2-6 months of age to facilitate early identification and linkage to care for children with perinatally acquired HCV infection. Untreated hepatitis C can lead to cirrhosis, liver cancer, and premature death and is caused by HCV, a blood-borne virus transmitted most often among adults through injection drug use in the United States. Perinatal exposure from a birth parent with HCV infection is the most frequent mode of HCV transmission among infants and children. New HCV infections have been increasing since 2010, with the highest rates of infection among people aged 20-39 years, leading to an increasing prevalence of HCV infection during pregnancy. In 2020, the CDC recommended one-time HCV screening for all adults aged 18 years and older and for all pregnant persons during each pregnancy. Detecting HCV infection during pregnancy is key for the identification of pregnant persons, linkage to care for postpartum treatment, and identification of infants with perinatal exposure for HCV testing. It was previously recommended that children who were exposed to HCV during pregnancy receive an antibody to HCV (anti-HCV) test at 18 months of age; however, most children were lost to follow-up before testing occurred, leaving children with perinatal infection undiagnosed. The new strategy of testing perinatally exposed children at age 2-6 months was found to be cost-effective in increasing the identification of infants who might develop chronic hepatitis C. This report describes the current perinatal HCV testing recommendations and how they advance national hepatitis C elimination efforts by improving the health of pregnant and postpartum people and their children. |
Understanding the impact of Mpox on sexual health clinical services: A national knowledge, attitudes, and practices survey-United States, 2022
Schubert SL , Miele K , Quilter LAS , Agnew-Brune C , Coor A , Kachur R , Lewis F , Ard KL , Wendel K , Anderson T , Nagendra G , Tromble E . Sex Transm Dis 2024 51 (1) 38-46 BACKGROUND: During the 2022 mpox outbreak, most cases were associated with sexual contact, and many people with mpox sought care from sexual health clinics and programs. The National Network of STD Clinical Prevention Training Centers, in partnership with the Centers for Disease Control and Prevention, conducted a survey of US sexual health clinics and programs to assess knowledge, practices, and experiences around mpox to inform a future public health response. METHODS: Between August 31 and September 13, 2022, the National Network of STD Clinical Prevention Training Centers facilitated a web-based survey. Descriptive statistics were generated in R. RESULTS: Among 168 responses by clinicians (n = 131, 78%) and program staff (n = 37, 22%), more than half (51%) reported at least somewhat significant mpox-related clinical disruptions including burdensome paperwork requirements for mpox testing (40%) and tecovirimat use (88%). Long clinic visits (51%) added additional burden, and the median mpox-related visit lasted 1 hour. Few clinicians felt comfortable with advanced pain management, and clinicians felt most uninformed about preexposure (19%) and postexposure (24%) prophylaxis. Of 89 respondents involved in vaccination, 61% reported using equity strategies; however, accounts of these strategies revealed a focus on guideline or risk factor-based screenings instead of equity activities. CONCLUSIONS: These findings highlight the substantial impact of the 2022 mpox outbreak on sexual health care in the United States. Critical gaps and barriers were identified that may inform additional mpox training and technical assistance, including challenges with testing, diagnosis, and management as well as a disconnect between programs' stated goal of equity and operationalization of strategies to achieve equity. |
Notes from the field: Undiagnosed tuberculosis during pregnancy resulting in a neonatal death - United States, 2021
Miele K , Rock RB , LaCourse SM , Ashkin D , Armitige LY , Pomputius W , Goswami ND . MMWR Morb Mortal Wkly Rep 2023 72 (49) 1331-1332 In 2022, the World Health Organization reported 10.6 million new cases of tuberculosis (TB) globally. One third of these new cases were reported in women; however, pregnancy status was not included in these data.* CDC recently added pregnancy status to national TB reporting in the United States; however, because the number of U.S. TB cases during pregnancy is presumed to be low, adverse effects of TB on pregnancy and postpartum outcomes are likely not well characterized.† A 2017 meta-analysis of 13 studies that included approximately 123,000 pregnancies from several countries found that TB disease during pregnancy was associated with increased odds of maternal morbidity and mortality, including hospital admission, anemia of pregnancy, cesarean birth, miscarriage, preterm birth, low birthweight, and neonatal TB (1). TB diagnosis during pregnancy might be delayed because of overlap in symptoms of TB with those of pregnancy, as well as clinician reluctance to use chest radiography during pregnancy.§ Perinatal TB is a life-threatening illness, with a congenital and neonatal TB mortality rate of approximately 50% (2), highlighting the importance of diagnosing and treating TB before and during pregnancy. This report describes a case of fatal neonatal TB after successful in vitro fertilization in 2021. |
Rising stillbirth rates related to congenital syphilis in the United States from 2016 to 2022
Machefsky A , Hufstetler K , Bachmann L , Barbee L , Miele K , O'Callaghan K . Obstet Gynecol 2024 OBJECTIVE: To identify trends in stillbirth rates attributed to congenital syphilis in the United States by describing congenital syphilis-related stillbirths and comparing characteristics of pregnant people who had congenital syphilis-related stillbirths with those of people who had preterm and full-term liveborn neonates with congenital syphilis. METHODS: Cases of congenital syphilis reported to the Centers for Disease Control and Prevention during 2016-2022 were analyzed and categorized as stillbirth, preterm live birth (before 37 weeks of gestation), or term live birth (37 weeks or later). Cases with unknown vital status or gestational age were excluded. Frequencies were calculated by pregnancy outcome, including pregnant person demographics; receipt of prenatal care; syphilis stage and titer; and timing of prenatal care, testing, and treatment. RESULTS: Overall, 13,393 congenital syphilis cases with vital status and gestational age were reported; of these, 853 (6.4%) were stillbirths. The number of congenital syphilis-related stillbirths increased each year (from 44 to 231); the proportion of congenital syphilis cases resulting in stillbirth ranged from 5.2% to 7.5%. Median gestational age at delivery for stillborn fetuses was 30 weeks (interquartile range 26-33 weeks). People with congenital syphilis-related stillbirths were more likely to have titers at or above 1:32 (78.9% vs 45.5%; P<.001) and to have received no prenatal care (58.4% vs 33.1%; P<.001) than people with liveborn neonates with congenital syphilis. The risk of stillbirth was twice as high in persons with secondary syphilis compared with those with primary syphilis (11.5% vs 5.7%, risk ratio 2.00; 95% CI, 1.27-3.13). Across all congenital syphilis cases, 34.2% of people did not have a syphilis test at their first prenatal visit. CONCLUSION: Stillbirths occurred in more than 1 in 20 pregnancies complicated by congenital syphilis. Risk factors for stillbirth included high titers, secondary stage, and lack of prenatal care. If the prevalence of congenital syphilis continues to rise, there will be a corresponding increase in the overall stillbirth rate nationally. |
Polysubstance use during pregnancy: The importance of screening, patient education, and integrating a harm reduction perspective
Board A , D'Angelo DV , Salvesen von Essen B , Denny CH , Miele K , Dunkley J , Baillieu R , Kim SY . Drug Alcohol Depend 2023 247 109872 BACKGROUND: Substance use during pregnancy is associated with poor health outcomes. This study assessed substance use, polysubstance use, and use of select prescription medications during pregnancy. METHODS: We analyzed 2019 data from the Pregnancy Risk Assessment Monitoring System in 25 United States jurisdictions that included questions on prescription medications, tobacco, and illicit substance use during pregnancy. Alcohol and electronic cigarette use were assessed during the last three months of pregnancy, and all other substances and medications were assessed throughout pregnancy. Weighted prevalence estimates and 95% confidence intervals (CIs) were calculated. RESULTS: Nearly one-fifth of respondents who reported use of any substance reported use of at least one other substance during pregnancy. Cigarettes (8.1%; 95% CI 7.6-8.7%) and alcohol (7.4%; 95% CI 6.7-8.1%) were the most frequently reported substances, followed by cannabis (4.3%; 95% CI 3.9-4.7%). Substance use was higher among individuals who reported having depression or using antidepressants during pregnancy compared with those who did not report depression or antidepressant use. Illicit drug use prevalence was low (0.5%, 95% CI 0.4-0.7%); however, respondents reporting heroin use also frequently reported use of illicit stimulants (amphetamines: 51.7%, 95% CI 32.1-71.3% or cocaine: 26.5%, 95% CI 11.9-41.1%). Although prenatal clinician screening for alcohol and cigarette use was approximately 95%, fewer respondents (82.1%) reported being screened for cannabis or illicit substance use during pregnancy. CONCLUSIONS: One in five individuals who reported use of any substance during pregnancy engaged in polysubstance use, highlighting the importance of comprehensive screening and evidence-based interventions including harm reduction. |
Medication for opioid use disorder during pregnancy - Maternal and Infant Network to Understand Outcomes Associated with Use of Medication for Opioid Use Disorder During Pregnancy (MAT-LINK), 2014-2021
Miele K , Kim SY , Jones R , Rembert JH , Wachman EM , Shrestha H , Henninger ML , Kimes TM , Schneider PD , Sivaloganathan V , Sward KA , Deshmukh VG , Sanjuan PM , Maxwell JR , Seligman NS , Caveglia S , Louis JM , Wright T , Bennett CC , Green C , George N , Gosdin L , Tran EL , Meaney-Delman D , Gilboa SM . MMWR Surveill Summ 2023 72 (3) 1-14 PROBLEM: Medication for opioid use disorder (MOUD) is recommended for persons with opioid use disorder (OUD) during pregnancy. However, knowledge gaps exist about best practices for management of OUD during pregnancy and these data are needed to guide clinical care. PERIOD COVERED: 2014-2021. DESCRIPTION OF THE SYSTEM: Established in 2019, the Maternal and Infant Network to Understand Outcomes Associated with Medication for Opioid Use Disorder During Pregnancy (MAT-LINK) is a surveillance network of seven clinical sites in the United States. Boston Medical Center, Kaiser Permanente Northwest, The Ohio State University, and the University of Utah were the initial clinical sites in 2019. In 2021, three clinical sites were added to the network (the University of New Mexico, the University of Rochester, and the University of South Florida). Persons receiving care at the seven clinical sites are diverse in terms of geography, urbanicity, race and ethnicity, insurance coverage, and type of MOUD received. The goal of MAT-LINK is to capture demographic and clinical information about persons with OUD during pregnancy to better understand the effect of MOUD on outcomes and, ultimately, provide information for clinical care and public health interventions for this population. MAT-LINK maintains strict confidentiality through robust information technology architecture. MAT-LINK surveillance methods, population characteristics, and evaluation findings are described in this inaugural surveillance report. This report is the first to describe the system, presenting detailed information on funding, structure, data elements, and methods as well as findings from a surveillance evaluation. The findings presented in this report are limited to selected demographic characteristics of pregnant persons overall and by MOUD treatment status. Clinical and outcome data are not included because data collection and cleaning have not been completed; initial analyses of clinical and outcome data will begin in 2023. RESULTS: The MAT-LINK surveillance network gathered data on 5,541 reported pregnancies with a known pregnancy outcome during 2014-2021 among persons with OUD from seven clinical sites. The mean maternal age was 29.7 (SD = ±5.1) years. By race and ethnicity, 86.3% of pregnant persons were identified as White, 25.4% as Hispanic or Latino, and 5.8% as Black or African American. Among pregnant persons, 81.6% had public insurance, and 84.4% lived in urban areas. Compared with persons not receiving MOUD during pregnancy, those receiving MOUD during pregnancy were more likely to be older and White and to have public insurance. The evaluation of the surveillance system found that the initial four clinical sites were not representative of demographics of the South or Southwest regions of the United States and had low representation from certain racial and ethnic groups compared with the overall U.S. population; however, the addition of three clinical sites in 2021 made the surveillance network more representative. Automated extraction and processing improved the speed of data collection and analysis. The ability to add new clinical sites and variables demonstrated the flexibility of MAT-LINK. INTERPRETATION: MAT-LINK is the first surveillance system to collect comprehensive, longitudinal data on pregnant person-infant dyads with perinatal outcomes associated with MOUD during pregnancy from multiple clinical sites. Analyses of clinical site data demonstrated different sociodemographic characteristics between the MOUD and non-MOUD treatment groups. PUBLIC HEALTH ACTIONS: MAT-LINK is a timely and flexible surveillance system with data on approximately 5,500 pregnancies. Ongoing data collection and analyses of these data will provide information to support clinical and public health guidance to improve health outcomes among pregnant persons with OUD and their children. |
The postpartum period: An opportunity for alcohol screening and counseling to reduce adverse health impacts
Board A , D'Angelo DV , von Essen BS , Denny CH , Miele K , Dunkley J , Park Y , Kim SY . J Addict Med 2023 17 (5) 528-535 OBJECTIVES: The postpartum period presents an opportunity to engage in discussions about alcohol consumption and related health harms. This study examined the prevalence of alcohol consumption among a sample of postpartum persons with a recent live birth and screening and brief intervention (alcohol SBI) or counseling by their providers. METHODS: We analyzed 2019 data from a telephone survey conducted 9 to 10 months postpartum among individuals who responded to the standard Pregnancy Risk Assessment Monitoring System survey in 6 states. Weighted prevalence estimates were calculated for alcohol consumption and alcohol SBI after birth through up to 10 months postpartum. RESULTS: Among 1790 respondents, 53.1% reported consuming alcohol postpartum. Among those who drank postpartum, 70.8% reported being asked about alcohol use by a healthcare provider. Slightly more than half of respondents who drank postpartum and were trying to get pregnant (52.4%) or were not using birth control at the time of the survey (59.8%) reported being asked about alcohol use. Approximately 25% of respondents who drank alcohol postpartum were advised about risky alcohol levels by a healthcare provider. Small proportions of individuals who drank alcohol postpartum and were pregnant or trying to get pregnant at the time of the survey were advised to reduce or stop drinking alcohol (10.6% and 2.3%, respectively). CONCLUSIONS: These findings suggest missed opportunities to promote health and prevent adverse alcohol-related health outcomes during the postpartum period through evidence-based tools such as alcohol SBI. |
Substance use among persons with syphilis during pregnancy - Arizona and Georgia, 2018-2021
Carlson JM , Tannis A , Woodworth KR , Reynolds MR , Shinde N , Anderson B , Hobeheidar K , Praag A , Campbell K , Carpentieri C , Willabus T , Burkhardt E , Torrone E , O'Callaghan KP , Miele K , Meaney-Delman D , Gilboa SM , Olsen EO , Tong VT . MMWR Morb Mortal Wkly Rep 2023 72 (3) 63-67 Despite universal prenatal syphilis screening recommendations and availability of effective antibiotic treatment, syphilis prevalence during pregnancy and the incidence of congenital syphilis have continued to increase in the United States (1,2). Concurrent increases in methamphetamine, injection drug, and heroin use have been described in women with syphilis (3). CDC used data on births that occurred during January 1, 2018-December 31, 2021, from two states (Arizona and Georgia) that participate in the Surveillance for Emerging Threats to Pregnant People and Infants Network (SET-NET) to describe the prevalence of substance use among pregnant persons with syphilis by congenital syphilis pregnancy outcome (defined as delivery of a stillborn or live-born infant meeting the surveillance case definition for probable or confirmed congenital syphilis). The prevalence of substance use (e.g., tobacco, alcohol, cannabis, illicit use of opioids, and other illicit, nonprescription substances) in persons with a congenital syphilis pregnancy outcome (48.1%) was nearly double that among those with a noncongenital syphilis pregnancy outcome (24.6%). Persons with a congenital syphilis pregnancy outcome were six times as likely to report illicit use of opioids and four times as likely to report using other illicit, nonprescription substances during pregnancy than were persons with a noncongenital syphilis pregnancy outcome. Approximately one half of persons who used substances during pregnancy and had a congenital syphilis pregnancy outcome had late or no prenatal care. Tailored interventions should address barriers and facilitators to accessing screening and treatment for syphilis among persons who use substances. The need for syphilis screening and treatment should be addressed at any health care encounter during pregnancy, especially among persons who use substances. |
Public health actions to control measles among Afghan evacuees during Operation Allies Welcome - United States, September-November 2021
Masters NB , Mathis AD , Leung J , Raines K , Clemmons NS , Miele K , Balajee SA , Lanzieri TM , Marin M , Christensen DL , Clarke KR , Cruz MA , Gallagher K , Gearhart S , Gertz AM , Grady-Erickson O , Habrun CA , Kim G , Kinzer MH , Miko S , Oberste MS , Petras JK , Pieracci EG , Pray IW , Rosenblum HG , Ross JM , Rothney EE , Segaloff HE , Shepersky LV , Skrobarcek KA , Stadelman AM , Sumner KM , Waltenburg MA , Weinberg M , Worrell MC , Bessette NE , Peake LR , Vogt MP , Robinson M , Westergaard RP , Griesser RH , Icenogle JP , Crooke SN , Bankamp B , Stanley SE , Friedrichs PA , Fletcher LD , Zapata IA , Wolfe HO , Gandhi PH , Charles JY , Brown CM , Cetron MS , Pesik N , Knight NW , Alvarado-Ramy F , Bell M , Talley LE , Rotz LD , Rota PA , Sugerman DE , Gastañaduy PA . MMWR Morb Mortal Wkly Rep 2022 71 (17) 592-596 On August 29, 2021, the United States government oversaw the emergent establishment of Operation Allies Welcome (OAW), led by the U.S. Department of Homeland Security (DHS) and implemented by the U.S. Department of Defense (DoD) and U.S. Department of State (DoS), to safely resettle U.S. citizens and Afghan nationals from Afghanistan to the United States. Evacuees were temporarily housed at several overseas locations in Europe and Asia* before being transported via military and charter flights through two U.S. international airports, and onward to eight U.S. military bases,(†) with hotel A used for isolation and quarantine of persons with or exposed to certain infectious diseases.(§) On August 30, CDC issued an Epi-X notice encouraging public health officials to maintain vigilance for measles among Afghan evacuees because of an ongoing measles outbreak in Afghanistan (25,988 clinical cases reported nationwide during January-November 2021) (1) and low routine measles vaccination coverage (66% and 43% for the first and second doses, respectively, in 2020) (2). |
Congenital syphilis-related stillbirths in the United States from 2015 to 2019
Machefsky Aliza , Miele Kathryn , Kimball Anne , Thorpe Phoebe , Bachmann Laura , Bowen Virginia . Am J Obstet Gynecol 2022 226 (2) 303-304 Objectives | Given recent increases in congenital syphilis (CS) in the United States, we describe national trends in the number of CS-related stillbirths, describe CS-related stillbirths by gestational age, and compare characteristics of women delivering CS-related stillbirths to those delivering full term and preterm liveborn CS infants to provide important clinical insight. | | Methods | CS is nationally notifiable with case reports submitted to Centers for Disease Control and Prevention (CDC). We analyzed reported cases of CS born during 20152019, categorizing birth outcomes as stillbirth, preterm <37 weeks, or full term 37 weeks; cases with unknown vital status or gestational age were excluded. We calculated frequencies of maternal clinical characteristics by birth outcome, including receipt of prenatal care, stage of syphilis, and highest reported titer during pregnancy. | | Results | Of the 5,269 CS cases reported to CDC for 20152019, 5,127 (97.3%) had known vital status and gestational age. Among these, 307 (6.0%) were stillbirths. While the number of CS-related stillbirths increased each year during 20152019 (from 2994), the proportion of CS cases reported as stillbirths did not vary considerably across the period (range: 5.1%7.3%). Median gestational age at delivery for CS-related stillbirths was 30 weeks (interquartile range: 2733 weeks). Most CS cases were born to mothers with early latent (31.4%) or late/unknown duration (59.7%) syphilis, though mothers of stillborn infants were 2.3 times as likely as mothers of full term liveborn infants to have secondary syphilis (10.8% vs. 4.6%). Adverse pregnancy outcomes were more likely to have a high maternal syphilis titer; 80.8% of stillbirth, 58.1% of preterm, and 40.2% of full-term deliveries occurred among women with a titer 1:32 during pregnancy. Among women delivering a CS-related stillbirth, 33 (10.7%) had evidence of syphilis seroconversion during pregnancy. Most mothers delivering a CS-related stillbirth (53.4%) did not receive prenatal care, compared to mothers delivering full term liveborn CS infants (18.4%). | | Conclusions | Increases in CS-related stillbirths in the United States reflect increases in CS cases; without prevention efforts, CS could become a larger contributor to overall U.S. stillbirth levels. Understanding when CS-related stillbirths occur, as well as the differences between women delivering CS-related stillbirths and women delivering liveborn CS infants (higher titer, syphilis stage, and prenatal care) may aid with stillbirth prevention. Overcoming barriers to prenatal care is essential for preventing CS stillbirths. Low rates of prenatal care also highlight the importance of syphilis testing outside traditional settings and at the time of stillbirth delivery. Delivery may provide a rare interaction with the healthcare system enabling syphilis testing and treatment, and prevention of future CS-related adverse outcomes. |
Congenital syphilis diagnosed beyond the neonatal period in the United States: 2014-2018
Kimball A , Bowen VB , Miele K , Weinstock H , Thorpe P , Bachmann L , McDonald R , Machefsky A , Torrone E . Pediatrics 2021 148 (3) BACKGROUND AND OBJECTIVES: During 2014-2018, reported congenital syphilis (CS) cases in the United States increased 183%, from 462 to 1306 cases. We reviewed infants diagnosed with CS beyond the neonatal period (>28 days) during this time. METHODS: We reviewed surveillance case report data for infants with CS delivered during 2014-2018 and identified those diagnosed beyond the neonatal period with reported signs or symptoms. We describe these infants and identify possible missed opportunities for earlier diagnoses. RESULTS: Of the 3834 reported cases of CS delivered during 2014-2018, we identified 67 symptomatic infants diagnosed beyond the neonatal period. Among those with reported findings, 67% had physical examination findings of CS, 69% had abnormal long-bone radiographs consistent with CS, and 36% had reactive syphilis testing in the cerebrospinal fluid. The median serum nontreponemal titer was 1:256 (range: 1:1-1:2048). The median age at diagnosis was 67 days (range: 29-249 days). Among the 66 mothers included, 83% had prenatal care, 26% had a syphilis diagnosis during pregnancy or at delivery, and 42% were not diagnosed with syphilis until after delivery. Additionally, 24% had an initial negative test result and seroconverted during pregnancy. CONCLUSIONS: Infants with CS continue to be undiagnosed at birth and present with symptoms after age 1 month. Pediatric providers can diagnose and treat infants with CS early by following guidelines, reviewing maternal records and confirming maternal syphilis status, advocating for maternal testing at delivery, and considering the diagnosis of CS, regardless of maternal history. |
COVID-19 and family planning service delivery: Findings from a survey of U.S. physicians.
Zapata LB , Curtis KM , Steiner RJ , Reeves JA , Nguyen AT , Miele K , Whiteman MK . Prev Med 2021 150 106664 Equitable access to contraception is critical for reproductive autonomy. Using cross-sectional data from the DocStyles survey administered September-October 2020 (68% response rate), we compared changes in family planning-related clinical services and healthcare delivery strategies before and during the COVID-19 pandemic and assessed service provision issues among 1063 U.S. physicians whose practice provided family planning services just before the pandemic. About one-fifth of those whose practices provided the following services or strategies just before the pandemic discontinued these services during the pandemic: long-acting reversible contraception (LARC) placement (16%); LARC removal (17%); providing or prescribing emergency contraceptive pills (ECPs) in advance (18%); and reminding patients about contraception injections or LARC removal or replacement (20%). Many practices not providing the following services or strategies just before the pandemic initiated these services during the pandemic: telehealth for contraception initiation (43%); telehealth for contraception continuation (48%); and renewing contraception prescriptions without requiring an office visit (36%). While a smaller proportion of physicians reported service provision issues in the month before survey completion than at any point during the pandemic, about one-third still reported fewer adult females seeking care (37%) and technical challenges with telehealth (32%). Discontinuation of key family planning services during the COVID-19 pandemic may limit contraception access and impede reproductive autonomy. Implementing healthcare service delivery strategies that reduce the need for in-person visits (e.g., telehealth for contraception, providing or prescribing ECPs in advance) may decrease disruptions in care. Resources exist for public health and clinical efforts to ensure contraception access during the pandemic. |
Lifetime medical costs of genital herpes in the United States: Estimates from insurance claims
Eppink ST , Kumar S , Miele K , Chesson H . Sex Transm Dis 2021 48 (4) 266-272 BACKGROUND: The purpose of this study was to estimate the lifetime direct medical costs per incident case of genital herpes in the United States. METHODS: We used medical claims data to construct a cohort of people continuously enrolled in insurance for at least 48 consecutive months between 2010 and 2018. From this cohort, we identified initial genital herpes diagnoses as well as the cost of related clinical visits and medication during the 36 months following an initial diagnosis. Lifetime costs beyond 36 months were estimated based on treatment use patterns observed in the 36 months of follow-up. RESULTS: The present value of lifetime direct medical costs of genital herpes was estimated to be $972 per treated case or $165 per infection (2019 dollars), not including costs associated with prevention or treatment of neonatal herpes. The clinical visit at which genital herpes was first diagnosed accounted for 27% of lifetime costs. Subsequent clinical visits and medications related to genital herpes accounted for an additional 13% and 60% of lifetime costs, respectively. CONCLUSIONS: The results from this study can inform cost-effectiveness analysis of GH control interventions as well as help quantify the cost burden of sexually transmitted infections in the United States. |
Missed opportunities for prevention of congenital syphilis - United States, 2018
Kimball A , Torrone E , Miele K , Bachmann L , Thorpe P , Weinstock H , Bowen V . MMWR Morb Mortal Wkly Rep 2020 69 (22) 661-665 Congenital syphilis is an infection with Treponema pallidum in an infant or fetus, acquired during pregnancy from a mother with untreated or inadequately treated syphilis. Congenital syphilis can cause miscarriage, stillbirth, or early infant death, and infected infants can experience lifelong physical and neurologic problems. Although timely identification and treatment of maternal syphilis during pregnancy can prevent congenital syphilis (1,2), the number of reported congenital syphilis cases in the United States increased 261% during 2013-2018, from 362 to 1,306. Among reported congenital syphilis cases during 2018, a total of 94 resulted in stillbirths or early infant deaths (3). Using 2018 national congenital syphilis surveillance data and a previously developed framework (4), CDC identified missed opportunities for congenital syphilis prevention. Nationally, the most commonly missed prevention opportunities were a lack of adequate maternal treatment despite the timely diagnosis of syphilis (30.7%) and a lack of timely prenatal care (28.2%), with variation by geographic region. Congenital syphilis prevention involves syphilis prevention for women and their partners and timely identification and treatment of pregnant women with syphilis. Preventing continued increases in congenital syphilis requires reducing barriers to family planning and prenatal care, ensuring syphilis screening at the first prenatal visit with rescreening at 28 weeks' gestation and at delivery, as indicated, and adequately treating pregnant women with syphilis (2). Congenital syphilis prevention strategies that implement tailored public health and health care interventions to address missed opportunities can have substantial public health impact. |
Tuberculosis in pregnancy
Miele K , Bamrah Morris S , Tepper NK . Obstet Gynecol 2020 135 (6) 1444-1453 Tuberculosis (TB) in pregnancy poses a substantial risk of morbidity to both the pregnant woman and the fetus if not diagnosed and treated in a timely manner. Assessing the risk of having Mycobacterium tuberculosis infection is essential to determining when further evaluation should occur. Obstetrician-gynecologists are in a unique position to identify individuals with infection and facilitate further evaluation and follow up as needed. A TB evaluation consists of a TB risk assessment, medical history, physical examination, and a symptom screen; a TB test should be performed if indicated by the TB evaluation. If a pregnant woman has signs or symptoms of TB or if the test result for TB infection is positive, active TB disease must be ruled out before delivery, with a chest radiograph and other diagnostics as indicated. If active TB disease is diagnosed, it should be treated; providers must decide when treatment of latent TB infection is most beneficial. Most women will not require latent TB infection treatment while pregnant, but all require close follow up and monitoring. Treatment should be coordinated with the TB control program within the respective jurisdiction and initiated based on the woman's risk factors including social history, comorbidities (particularly human immunodeficiency virus [HIV] infection), and concomitant medications. |
Preexposure prophylaxis for prevention of HIV acquisition among adolescents: Clinical considerations, 2020
Tanner MR , Miele P , Carter W , Valentine SS , Dunville R , Kapogiannis BG , Smith DK . MMWR Recomm Rep 2020 69 (3) 1-12 Preexposure prophylaxis (PrEP) with antiretroviral medication has been proven effective in reducing the risk for acquiring human immunodeficiency virus (HIV). The fixed-dose combination tablet of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) was approved by the U.S. Food and Drug Administration (FDA) for use as PrEP for adults in 2012. Since then, recognition has been increasing that adolescents at risk for acquiring HIV can benefit from PrEP. In 2018, FDA approved revised labeling for TDF/FTC that expanded the indication for PrEP to include adolescents weighing at least 77 lb (35 kg) who are at risk for acquiring HIV. In 2019, FDA approved the combination product tenofovir alafenamide (TAF)/FTC as PrEP for adolescents and adults weighing at least 77 lb (35 kg), excluding those at risk for acquiring HIV through receptive vaginal sex. This exclusion is due to the lack of clinical data regarding the efficacy of TAF/FTC in cisgender women.Clinical providers who evaluate adolescents for PrEP use must consider certain topics that are unique to the adolescent population. Important considerations related to adolescents include PrEP safety data, legal issues about consent for clinical care and confidentiality, the therapeutic partnership with adolescents and their parents or guardians, the approach to the adolescent patient's clinical visit, and medication initiation, adherence, and persistence during adolescence. Overall, data support the safety of PrEP for adolescents. PrEP providers should be familiar with the statutes and regulations about the provision of health care to minors in their states. Providers should partner with the adolescent patient for PrEP decisions, recognizing the adolescent's autonomy to the extent allowable by law and including parents in the conversation about PrEP when it is safe and reasonable to do so. A comprehensive approach to adolescent health is recommended, including considering PrEP as one possible component of providing medical care to adolescents who inject drugs or engage in sexual behaviors that place them at risk for acquiring HIV. PrEP adherence declined over time in the studies evaluating PrEP among adolescents, a trend that also has been observed among adult patients. Clinicians should implement strategies to address medication adherence as a routine part of prescribing PrEP; more frequent clinical follow-up is one possible approach.PrEP is an effective HIV prevention tool for protecting adolescents at risk for HIV acquisition. For providers, unique considerations that are part of providing PrEP to adolescents include the possible need for more frequent, supportive interactions to promote medication adherence. Recommendations for PrEP medical management and additional resources for providers are available in the U.S. Public Health Service clinical practice guideline Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2017 Update and the clinical providers' supplement Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2017 Update: Clinical Providers' Supplement (https://www.cdc.gov/hiv/clinicians/prevention/prep.html). |
Clinical development of therapeutic agents for hospitalized patients with influenza: Challenges and innovations
King JC , Beigel JH , Ison MG , Rothman RE , Uyeki TM , Walker RE , Neaton JD , Tegeris JS , Zhou JA , Armstrong KL , Carter W , Miele PS , Willis MS , Dugas AF , Tracy LA , Vock DM , Bright RA . Open Forum Infect Dis 2019 6 (4) ofz137 Background: Since 1999, the US Food and Drug Administration approved neuraminidase and endonuclease inhibitors to treat uncomplicated outpatient influenza but not severe hospitalized influenza. After the 2009 pandemic, several influenza hospital-based clinical therapeutic trials were unsuccessful, possibly due to certain study factors. Therefore, in 2014, the US Health and Human Services agencies formed a Working Group (WG) to address related clinical challenges. Methods: Starting in 2014, the WG obtained retrospective data from failed hospital-based influenza therapeutic trials and nontherapeutic hospital-based influenza studies. These data allowed the WG to identify factors that might improve hospital-based therapeutic trials. These included primary clinical endpoints, increased clinical site enrollment, and appropriate baseline enrollment criteria. Results: During 2018, the WG received retrospective data from a National Institutes of Health hospital-based influenza therapeutic trial that demonstrated time to resolution of respiratory status, which was not a satisfactory primary endpoint. The WG statisticians examined these data and believed that ordinal outcomes might be a more powerful primary endpoint. Johns Hopkins' researchers provided WG data from an emergency-department (ED) triage study to identify patients with confirmed influenza using molecular testing. During the 2013-2014 influenza season, 4 EDs identified 1074 influenza-patients, which suggested that triage testing should increase enrollment by hospital-based clinical trial sites. In 2017, the WG received data from Northwestern Memorial Hospital researchers regarding 703 influenza inpatients over 5 seasons. The WG applied National Early Warning Score (NEWS) at patient baseline to identify appropriate criteria to enroll patients into hospital-based therapeutic trials. Conclusions: Data received by the WG indicated that hospital-based influenza therapeutic trials could use ordinal outcome analyses, ED triage to identify influenza patients, and NEWS for enrollment criteria. |
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