Publications by authors named "Gabriela Vazquez-Benitez"

66 Publications

Association of the COVID-19 Pandemic With Routine Childhood Vaccination Rates and Proportion Up to Date With Vaccinations Across 8 US Health Systems in the Vaccine Safety Datalink.

JAMA Pediatr 2021 Oct 7. Epub 2021 Oct 7.

HealthPartners Institute, Minneapolis, Minnesota.

Importance: The COVID-19 pandemic has affected routine vaccine delivery in the US and globally. The magnitude of these disruptions and their association with childhood vaccination coverage are unclear.

Objectives: To compare trends in pediatric vaccination before and during the pandemic and to evaluate the proportion of children up to date (UTD) with vaccinations by age, race, and ethnicity.

Design, Setting, And Participants: This surveillance study used a prepandemic-postpandemic control design with data from 8 health systems in California, Oregon, Washington, Colorado, Minnesota, and Wisconsin in the Vaccine Safety Datalink. Children from age groups younger than 24 months and 4 to 6, 11 to 13, and 16 to 18 years were included if they had at least 1 week of health system enrollment from January 5, 2020, through October 3, 2020, over periods before the US COVID-19 pandemic (January 5, 2020, through March 14, 2020), during age-limited preventive care (March 15, 2020, through May 16, 2020), and during expanded primary care (May 17, 2020, through October 3, 2020). These individuals were compared with those enrolled during analogous weeks in 2019.

Exposures: This study evaluated UTD status among children reaching specific ages in February, May, and September 2020, compared with those reaching these ages in 2019.

Main Outcomes And Measures: Weekly vaccination rates for routine age-specific vaccines and the proportion of children UTD for all age-specific recommended vaccines.

Results: Of 1 399 708 children in 2019 and 1 402 227 in 2020, 1 371 718 were female (49.0%) and 1 429 979 were male (51.0%); 334 216 Asian individuals (11.9%), 900 226 were Hispanic individuals (32.1%), and 201 619 non-Hispanic Black individuals (7.2%). Compared with the prepandemic period and 2019, the age-limited preventive care period was associated with lower weekly vaccination rates, with ratios of rate ratios of 0.82 (95% CI, 0.80-0.85) among those younger than 24 months, 0.18 (95% CI, 0.16-0.20) among those aged 4 to 6 years, 0.16 (95% CI, 0.14-0.17) among those aged 11 to 13 years, and 0.10 (95% CI, 0.08-0.13) among those aged 16 to 18 years. Vaccination rates during expanded primary care remained lower for most ages (ratios of rate ratios: <24 months, 0.96 [95% CI, 0.93-0.98]; 11-13 years, 0.81 [95% CI, 0.76-0.86]; 16-18 years, 0.57 [95% CI, 0.51-0.63]). In September 2020, 74% (95% CI, 73%-76%) of infants aged 7 months and 57% (95% CI, 56%-58%) of infants aged 18 months were UTD vs 81% (95% CI, 80%-82%) and 61% (95% CI, 60%-62%), respectively, in September 2019. The proportion UTD was lowest in non-Hispanic Black children across most age groups, both during and prior to the COVID-19 pandemic (eg, in May 2019, 70% [95% CI, 64%-75%] of non-Hispanic Black infants aged 7 months were UTD vs 82% [95% CI, 81%-83%] in all infants aged 7 months combined).

Conclusions And Relevance: As of September 2020, childhood vaccination rates and the proportion who were UTD remained lower than 2019 levels. Interventions are needed to promote catch-up vaccination, particularly in populations at risk for underimmunization.
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http://dx.doi.org/10.1001/jamapediatrics.2021.4251DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8498937PMC
October 2021

Association of Cardiovascular Outcomes and Mortality With Sustained Long-Acting Insulin Only vs Long-Acting Plus Short-Acting Insulin Treatment.

JAMA Netw Open 2021 Sep 1;4(9):e2126605. Epub 2021 Sep 1.

HealthPartners Institute, Minneapolis, Minnesota.

Importance: Cardiovascular events and mortality are the principal causes of excess mortality and health care costs for people with type 2 diabetes. No large studies have specifically compared long-acting insulin alone with long-acting plus short-acting insulin with regard to cardiovascular outcomes.

Objective: To compare cardiovascular events and mortality in adults with type 2 diabetes receiving long-acting insulin who do or do not add short-acting insulin.

Design, Setting, And Participants: This retrospective cohort study emulated a randomized experiment in which adults with type 2 diabetes who experienced a qualifying glycated hemoglobin A1c (HbA1c) level of 6.8% to 8.5% with long-acting insulin were randomized to continuing treatment with long-acting insulin (LA group) or adding short-acting insulin within 1 year of the qualifying HbA1c level (LA plus SA group). Retrospective data in 4 integrated health care delivery systems from the Health Care Systems Research Network from January 1, 2005, to December 31, 2013, were used. Analysis used inverse probability weighting estimation with Super Learner for propensity score estimation. Analyses took place from April 1, 2018, to June 30, 2019.

Exposures: Long-acting insulin alone or with added short-acting insulin within 1 year from the qualifying HbA1c level.

Main Outcomes And Measures: Mortality, cardiovascular mortality, acute myocardial infarction, stroke, and hospitalization for heart failure.

Results: Among 57 278 individuals (39 279 with data on cardiovascular mortality) with a mean (SD) age of 60.6 (11.5) years, 53.6% men, 43.5% non-Hispanic White individuals, and 4 years of follow-up (median follow-up of 11 [interquartile range, 5-20] calendar quarters), the LA plus SA group was associated with increased all-cause mortality compared with the LA group (hazard ratio, 1.27; 95% CI, 1.05-1.49) and a decreased risk of acute myocardial infarction (hazard ratio, 0.89; 95% CI, 0.81-0.97). Treatment with long-acting plus short-acting insulin was not associated with increased risks of congestive heart failure, stroke, or cardiovascular mortality.

Conclusions And Relevance: Findings of this retrospective cohort study suggested an increased risk of all-cause mortality and a decreased risk of acute myocardial infarction for the LA plus SA group compared with the LA group. Given the lack of an increase in major cardiovascular events or cardiovascular mortality, the increased all-cause mortality with long-acting plus short-acting insulin may be explained by noncardiovascular events or unmeasured confounding.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.26605DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8463942PMC
September 2021

Point: Uncertainty about estimating the risks of COVID-19 during pregnancy.

Paediatr Perinat Epidemiol 2021 Jul 13. Epub 2021 Jul 13.

HealthPartners Institute, Minneapolis, MN, USA.

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http://dx.doi.org/10.1111/ppe.12773DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8447357PMC
July 2021

Vaccine Safety Datalink infrastructure enhancements for evaluating the safety of maternal vaccination.

Ther Adv Drug Saf 2021 14;12:20420986211021233. Epub 2021 Jun 14.

HealthPartners Institute, Minneapolis, MN, USA.

Background: Identifying pregnancy episodes and accurately estimating their beginning and end dates are imperative for observational maternal vaccine safety studies using electronic health record (EHR) data.

Methods: We modified the Vaccine Safety Datalink (VSD) Pregnancy Episode Algorithm (PEA) to include both the International Classification of Disease, ninth revision (ICD-9 system) and ICD-10 diagnosis codes, incorporated additional gestational age data, and validated this enhanced algorithm with manual medical record review. We also developed the new Dynamic Pregnancy Algorithm (DPA) to identify pregnancy episodes in real time.

Results: Around 75% of the pregnancy episodes identified by the enhanced VSD PEA were live births, 12% were spontaneous abortions (SABs), 10% were induced abortions (IABs), and 0.4% were stillbirths (SBs). Gestational age was identified for 99% of live births, 89% of SBs, 69% of SABs, and 42% of IABs. Agreement between the PEA-assigned and abstractor-identified pregnancy outcome and outcome date was 100% for live births, but was lower for pregnancy losses. When gestational age was available in the medical record, the agreement was higher for live births (97%), but lower for pregnancy losses (75%). The DPA demonstrated strong concordance with the PEA and identified pregnancy episodes ⩾6 months prior to the outcome date for 89% of live births.

Conclusion: The enhanced VSD PEA is a useful tool for identifying pregnancy episodes in EHR databases. The DPA improves the timeliness of pregnancy identification and can be used for near real-time maternal vaccine safety studies.

Plain Language Summary: It is important to monitor of the safety of vaccines after they have been approved and licensed by the Food and Drug Administration, especially among women vaccinated during pregnancy. The Vaccine Safety Datalink (VSD) monitors vaccine safety through observational studies within large databases of electronic medical records. Since 2012, VSD researchers have used an algorithm called the Pregnancy Episode Algorithm (PEA) to identify the medical records of women who have been pregnant. Researchers then use these medical records to study whether receiving a particular vaccine is linked to any negative outcomes for the woman or her child. The goal of this study was to update and enhance the PEA to include the full set of medical record diagnostic codes [both from the older International Classification of Disease, ninth revision (ICD-9 system) and the newer ICD-10 system] and to incorporate additional sources of data about gestational age. To ensure the validity of the PEA following these enhancements, we manually reviewed medical records and compared the results with the algorithm. We also developed a new algorithm, the Dynamic Pregnancy Algorithm (DPA), to identify women earlier in pregnancy, allowing us to conduct more timely vaccine safety assessments. The new version of the PEA identified 2,485,410 pregnancies in the VSD database. The enhanced algorithm more precisely estimated the beginning of pregnancies, especially those that did not result in live births, due to the new sources of gestational age data. Our new algorithm, the DPA, was successful at identifying pregnancies earlier in gestation than the PEA. The enhanced PEA and the new DPA will allow us to better evaluate the safety of current and future vaccinations administered during or around the time of pregnancy.
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http://dx.doi.org/10.1177/20420986211021233DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8207278PMC
June 2021

Association of Inadvertent 9-Valent Human Papillomavirus Vaccine in Pregnancy With Spontaneous Abortion and Adverse Birth Outcomes.

JAMA Netw Open 2021 04 1;4(4):e214340. Epub 2021 Apr 1.

Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale University School of Medicine, New Haven, Connecticut.

Importance: The 9-valent human papillomavirus (9vHPV) vaccine is recommended for individuals through age 26 years and may be administered to women up to age 45 years. Data on 9vHPV vaccine exposures during pregnancy are limited.

Objective: To evaluate the associations between 9vHPV vaccine exposures during pregnancy or peripregnancy and selected pregnancy and birth outcomes (spontaneous abortion [SAB], preterm birth, small-for-gestational age [SGA] birth, and major structural birth defect).

Design, Setting, And Participants: This cohort study analyzed data from 7 participating health systems in the Vaccine Safety Datalink. The cohort comprised pregnancies among girls and women aged 12 to 28 years that ended between October 26, 2015, and November 15, 2018. Singleton pregnancies that ended in a live birth, stillbirth, or SAB were included.

Exposures: Vaccine exposure windows were distal (9vHPV or 4vHPV vaccine administered from 22 to 16 weeks before last menstrual period [LMP]), peripregnancy (9vHPV vaccine administered from 42 days before LMP until LMP), and during pregnancy (9vHPV vaccine administered from LMP to 19 completed weeks' gestation). Primary comparisons were (1) girls and women with 9vHPV vaccine exposures during pregnancy vs those with 4vHPV or 9vHPV distal vaccine exposures, (2) girls and women with vaccine exposures peripregnancy vs those with 4vHPV or 9vHPV distal vaccine exposures, and (3) girls and women with 9vHPV vaccine exposures during pregnancy or peripregnancy vs those with 4vHPV or 9vHPV distal vaccine exposure.

Main Outcomes And Measures: Spontaneous abortions were confirmed based on medical record review and adjudication. Preterm and SGA births were identified from electronic health record and birth data. Major structural birth defects were based on diagnostic codes using a validated algorithm. Inverse probability weighting was used to balance the covariates. Time-dependent covariate Cox proportional hazards regression models and Poisson regression were used to estimate the associations between 9vHPV vaccine exposures and pregnancy and birth outcomes.

Results: The final cohort included 1493 pregnancies among girls and women with a mean (SD) maternal age of 23.9 (2.9) years. Of these pregnancies, 445 (29.8%) had exposures to the 9vHPV vaccine during pregnancy, 496 (33.2%) had exposures to the 9vHPV vaccine peripregnancy, and 552 (37.0%) had 4vHPV or 9vHPV distal vaccine exposures. The 9vHPV vaccine administered during pregnancy was not associated with increased risk for SAB (hazard ratio, 1.12; 95% CI, 0.66-1.93) compared with distal vaccine exposures. Findings were similar for 9vHPV vaccine exposures peripregnancy (relative risk [RR], 0.72; 95% CI, 0.42-1.24). Among live births (n = 1409), 9vHPV vaccine exposures during pregnancy were not associated with increased risks for preterm birth (RR, 0.73; 95% CI, 0.44-1.20) or SGA birth (RR, 1.31; 95% CI, 0.78-2.20). Results were similar regarding the association between 9vHPV vaccine exposures peripregnancy and preterm birth (RR, 0.72; 95% CI, 0.45-1.17) and SGA birth (RR, 1.10; 95% CI, 0.65-1.88). Birth defects were rare in all exposure groups, occurring in about 1% of live births with available infant data.

Conclusions And Relevance: This study found that 9vHPV vaccine exposures during or around the time of pregnancy were uncommon and not associated with SABs or selected adverse birth outcomes. These findings can inform counseling for inadvertent 9vHPV vaccine exposures.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.4340DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8022219PMC
April 2021

Effect of Clinical Decision Support on Diagnostic Imaging for Pediatric Appendicitis: A Cluster Randomized Trial.

JAMA Netw Open 2021 02 1;4(2):e2036344. Epub 2021 Feb 1.

Division of Research, HealthPartners Institute, Minneapolis, Minnesota.

Importance: Appendicitis is the most common pediatric surgical emergency. Efforts to improve efficiency and quality of care have increased reliance on computed tomography (CT) and ultrasonography (US) in children with suspected appendicitis.

Objective: To evaluate the effectiveness of an electronic health record-linked clinical decision support intervention, AppyCDS, on diagnostic imaging, health care costs, and safety outcomes for patients with suspected appendicitis.

Design, Setting, And Participants: In this parallel, cluster randomized trial, 17 community-based general emergency departments (EDs) in California, Minnesota, and Wisconsin were randomized to the AppyCDS intervention group or usual care (UC) group. Patients were aged 5 to 20 years, presenting for an ED visit with right-sided or diffuse abdominal pain lasting 5 days or less. We excluded pregnant patients, those with a prior appendectomy, those with selected comorbidities, and those with traumatic injuries. The trial was conducted from October 2016 to July 2019.

Interventions: AppyCDS prompted data entry at the point of care to estimate appendicitis risk using the pediatric appendicitis risk calculator (pARC). Based on pARC estimates, AppyCDS recommended next steps in care.

Main Outcomes And Measures: Primary outcomes were CT, US, or any imaging (CT or US) during the index ED visit. Safety outcomes were perforations, negative appendectomies, and missed appendicitis. Costs were a secondary outcome. Ratio of ratios (RORs) for primary and safety outcomes and differences by group in cost were used to evaluate effectiveness of the clinical decision support tool.

Results: We enrolled 3161 patients at intervention EDs and 2779 patients at UC EDs. The mean age of patients was 11.9 (4.6) years and 2614 (44.0%) were boys or young men. RORs for CT (0.94; 95% CI, 0.75-1.19), US (0.98; 95% CI, 0.84-1.14), and any imaging (0.96; 95% CI, 0.86-1.07) did not differ by study group. In an exploratory analysis conducted in 1 health system, AppyCDS was associated with a reduction in any imaging (ROR, 0.82; 95% CI, 0.73- 0.93) for patients with pARC score of 15% or less and a reduction in CT (ROR, 0.58; 95% CI, 0.45-0.74) for patients with a pARC score of 16% to 50%. Perforations, negative appendectomies, and cases of missed appendicitis by study phase did not differ significantly by study group. Costs did not differ overall by study group.

Conclusions And Relevance: In this study, AppyCDS was not associated with overall reductions in diagnostic imaging; exploratory analysis revealed more appropriate use of imaging in patients with a low pARC score.

Trial Registration: ClinicalTrials.gov Identifier: NCT02633735.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.36344DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7873779PMC
February 2021

Developing algorithms for identifying major structural birth defects using automated electronic health data.

Pharmacoepidemiol Drug Saf 2021 02 3;30(2):266-274. Epub 2020 Dec 3.

University of Iowa, Iowa City, Iowa, USA.

Purpose: Given the 2015 transition to International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnostic coding, updates to our previously published algorithms for major structural birth defects (BDs) were necessary. Aims of this study were to update, validate, and refine algorithms for identifying selected BDs, and then to use these algorithms to describe BD prevalence in the vaccine safety datalink (VSD) population.

Methods: We converted our ICD-9-CM list of selected BDs to ICD-10-CM using available crosswalks with manual review of codes. We identified, chart reviewed, and adjudicated a sample of infants in the VSD with ≥2 ICD-10-CM diagnoses for one of seven common BDs. Positive predictive values (PPVs) were calculated; for BDs with suboptimal PPV, algorithms were refined. Final automated algorithms were applied to a cohort of live births delivered 10/1/2015-9/30/2017 at eight VSD sites to estimate BD prevalence. This research was approved by the HealthPartners Institutional Review Board, by all participating VSD sites, and by the CDC, with a waiver of informed consent.

Results: Of 573 infants with ≥2 diagnoses for a targeted BD, on adjudication, we classified 399 (69.6%) as probable cases, 31 (5.4%) as possible cases and 143 (25.0%) as not having the targeted BD. PPVs for the final BD algorithms ranged from 0.76 (hypospadias) to 1.0 (gastroschisis). Among 212 857 births over 2 years following transition to ICD-10-CM coding, prevalence for the full list of selected defects in the VSD was 1.8%.

Conclusions: Algorithms can identify infants with selected BDs using automated healthcare data with reasonable accuracy. Our updated algorithms can be used in observational studies of maternal vaccine safety and may be adapted for use in other surveillance systems.
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http://dx.doi.org/10.1002/pds.5177DOI Listing
February 2021

Evaluating the Association of Stillbirths After Maternal Vaccination in the Vaccine Safety Datalink.

Obstet Gynecol 2020 12;136(6):1086-1094

Centers for Disease Control and Prevention, Atlanta, Georgia; the HealthPartners Institute, Minneapolis, Minnesota; Yale University, New Haven, Connecticut; the Marshfield Clinic Research Institute, Marshfield, Wisconsin; Kaiser Permanente Southern California, Pasadena, California; Kaiser Permanente Colorado, Denver, Colorado; Kaiser Permanente Northwest, Portland, Oregon; Kaiser Permanente Northern California, Oakland, California; and Kaiser Permanente Washington, Seattle, Washington.

Objective: To evaluate whether the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended influenza and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccinations in pregnancy are associated with increased risk of stillbirth.

Methods: We performed a case-control study in the Vaccine Safety Datalink that was matched 1:4 on site, month, and year of last menstrual period, comparing the odds of vaccination in pregnancies that ended in stillbirth (defined as fetal loss at or after 20 weeks of gestation) compared with those that ended in live birth from January 1, 2012, to September 30, 2015. We included patients with singleton pregnancies that ended in stillbirth or live birth who had at least one prenatal care visit, pregnancy dating information, and continuous health plan enrollment for the duration of pregnancy. Medical records for all stillbirths were reviewed. We were statistically powered to detect an odds ratio (OR) of 1.37 when evaluating the association between influenza or Tdap vaccination and stillbirth. We also examined stillbirth rates in pregnant patients aged 14-49 years in the Vaccine Safety Datalink between 2007 and 2015.

Results: In our matched analysis of 795 confirmed stillbirths in the case group and 3,180 live births in the control group, there was no significant association between influenza vaccination during pregnancy and stillbirth (343/795 [43.1%] stillbirths in the case group vs 1,407/3,180 [44.3%] live births in the control group, OR 0.94, adjusted OR 0.95, 95% CI 0.79-1.14, P=.54) and no significant association between Tdap vaccination during pregnancy and stillbirth (184/795 [23.1%] stillbirths in the case group vs 746/3,180 [23.5%] live births in the control group, OR 0.97, aOR 0.96, 95% CI 0.76-1.28, P=.91). From 2007 to 2015, the stillbirth rate in the Vaccine Safety Datalink was 5.2 per 1,000 live births and stillbirths.

Conclusion: No association was found between vaccination during pregnancy and the odds of stillbirth. These findings support the safety of ACIP recommendations for vaccination during pregnancy.
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http://dx.doi.org/10.1097/AOG.0000000000004166DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8108006PMC
December 2020

The effects of financial incentives on diabetes prevention program attendance and weight loss among low-income patients: the We Can Prevent Diabetes cluster-randomized controlled trial.

BMC Public Health 2020 Oct 21;20(1):1587. Epub 2020 Oct 21.

HealthPartners Institute, Bloomington, MN, USA.

Background: Penetration and participation of real life implementation of lifestyle change programs to prevent type 2 diabetes has been challenging. This is particularly so among low income individuals in the United States. The purpose of this study is to examine the effectiveness of financial incentives on attendance and weight loss among Medicaid beneficiaries participating in the 12-month Diabetes Prevention Program (DPP).

Methods: This is a cluster-randomized controlled trial with two financial incentive study arms and an attention control study arm. Medicaid beneficiaries with prediabetes from 13 primary care clinics were randomly assigned to individually earned incentives (IND; 33 groups; n = 309), a hybrid of individual- and group-earned incentives (GRP; 30 groups; n = 259), and an attention control (AC; 30 groups; n = 279). Up to $520 in incentives could be earned for attaining attendance and weight loss goals over 12 months. Outcomes are percent weight loss from baseline, achieving 5% weight loss from baseline, and attending 75% of core and 75% of maintenance DPP sessions. Linear mixed models were used to examine weight change and attendance rates over the 16 weeks and 12 months.

Results: The percent weight change at 16 weeks for the IND, GRP, and AC participants were similar, at - 2.6, - 3.1%, and - 3.4%, respectively. However, participants achieving 5% weight loss in the IND, GRP, and AC groups was 21.5, 24.0% (GRP vs AC, P < 0.05), and 15.2%. Attendance at 75% of the DPP core sessions was significantly higher among IND (60.8%, P < 0.001) and GRP (64.0%, P < 0.001) participants than among AC (38.6%) participants. Despite substantial attrition over time, attendance at 75% of the DPP maintenance sessions was also significantly higher among IND (23.0%, P < 0.001) and GRP (26.1%, P < 0.001) participants than among AC (11.0%) participants.

Conclusions: Financial incentives can improve the proportion of Medicaid beneficiaries attending the 12-month DPP and achieving at least 5% weight loss.

Trial Registration: ClinicalTrials.gov NCT02422420 ; retrospectively registered April 21, 2015.
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http://dx.doi.org/10.1186/s12889-020-09683-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7580006PMC
October 2020

An Analysis of Changes in Emergency Department Visits After a State Declaration During the Time of COVID-19.

Ann Emerg Med 2020 11 11;76(5):595-601. Epub 2020 Jun 11.

Department of Emergency Medicine, Regions Hospital, St. Paul, MN.

Study Objective: In the initial period of the coronavirus disease 2019 (COVID-19) pandemic, there has been a substantial decrease in the number of patients seeking care in the emergency department. A first step in estimating the impact of these changes is to characterize the patients, visits, and diagnoses for whom care is being delayed or deferred.

Methods: We conducted an observational study, examining demographics, visit characteristics, and diagnoses for all ED patient visits to an urban level 1 trauma center before and after a state emergency declaration and comparing them with a similar period in 2019. We estimated percent change on the basis of the ratios of before and after periods with respect to 2019 and the decline per week using Poisson regression. Finally, we evaluated whether each factor modified the change in overall ED visits.

Results: After the state declaration, there was a 49.3% decline in ED visits overall, 35.2% (95% confidence interval -38.4 to -31.9) as compared with 2019. Disproportionate declines were seen in visits by pediatric and older patients, women, and Medicare recipients, as well as for presentations of syncope, cerebrovascular accidents, urolithiasis, and abdominal and back pain. Significant proportional increases were seen in ED visits for upper respiratory infections, shortness of breath, and chest pain.

Conclusion: There have been significant changes in patterns of care seeking during the COVID-19 pandemic. Declines in ED visits, especially for certain demographic groups and disease processes, should prompt efforts to understand these phenomena, encourage appropriate care seeking, and monitor for the morbidity and mortality that may result from delayed or deferred care.
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http://dx.doi.org/10.1016/j.annemergmed.2020.06.019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7287464PMC
November 2020

Characteristics and Price Increases Among Sole-Source, Off-Patent Drugs in the United States, 2008 to 2018.

JAMA Netw Open 2020 08 3;3(8):e2013595. Epub 2020 Aug 3.

HealthPartners Institute, Minneapolis, Minnesota.

Importance: Some sole-source, off-patent drugs in the United States have undergone substantial price hikes in recent years. Despite increased attention by lawmakers, there are limited data to guide policy.

Objectives: To describe key attributes of sole-source, off-patent, off-exclusivity drugs; to characterize the prevalence of price increases; and to identify attributes associated with price increases.

Design, Setting, And Participants: In this cross-sectional study, 300 sole-source, off-patent, off-exclusivity drug products met inclusion criteria and were selected for analysis from January 1, 2008, to December 31, 2018. Attributes were identified from multiple sources, and yearly wholesale acquisition cost prices were determined from First Databank.

Main Outcomes And Measures: The association of drug attributes with the following 2 price change thresholds was measured after adjusting for inflation: 25% or more price increase in a calendar year (wholesale acquisition cost) and 50% or more price increase in a calendar year. The rate of annual price increase over time was also measured.

Results: Of the 300 drug products and 2242 observations analyzed, the overall inflation-adjusted mean increase in drug prices was 8.8% (95% CI, 7.8%-9.8%) per year. Ninety-five drugs (31.7%) increased by 25% or more during any calendar year, and 66 drugs (22.0%) increased by 50% or more during any calendar year. An initial price of less than $2 per unit (adjusted odds ratio [aOR], 2.36; 95% CI, 1.69-3.29), antineoplastic and immunomodulatory class (aOR, 2.72; 95% CI, 1.31-5.65), dermatologic class (aOR, 2.95; 95% CI, 1.80-4.84), oral route (aOR, 2.01; 95% CI, 1.45-2.79), and US Food and Drug Administration (FDA) approval before 1990 (aOR, 1.52; 95% CI, 1.14-2.03) were attributes of drugs that were more likely to be associated with a 25% or more price increase in a calendar year after adjusting for by initial price. Similarly, an initial price of less than $2 per unit (aOR, 2.68; 95% CI, 1.76-4.09), antineoplastic and immunomodulatory class (aOR, 3.07; 95% CI, 1.54-6.12), oral route of administration (aOR, 1.70; 95% CI, 1.11-2.60), and FDA approval before 1990 (aOR, 2.02; 95% CI, 1.40-2.94) were attributes of drugs that were more likely to be associated with a 50% or more price increase in a calendar year after adjusting for by initial price. Price increases of 25% or more were most common in 2014, and price increases of 50% or more were most common in 2013.

Conclusions And Relevance: Price increases among sole-source, off-patent drugs are common, and policy interest in this practice is warranted. These findings should inform state drug pricing legislation.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.13595DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7431990PMC
August 2020

Oral Corticosteroids and Risk of Preterm Birth in the California Medicaid Program.

J Allergy Clin Immunol Pract 2021 01 11;9(1):375-384.e5. Epub 2020 Aug 11.

Department of Pediatrics, University of California, San Diego, Calif; Department of Family Medicine and Public Health, University of California, San Diego, Calif.

Background: There is limited information regarding the impact of dose and gestational timing of oral corticosteroid (OCS) use on preterm birth (PTB), especially among women with asthma.

Objectives: To evaluate OCS dose and timing on PTB for asthma and, as a comparison, systemic lupus erythematosus (SLE).

Methods: We used health care data from California Medicaid enrollees linked to birth certificates (2007-2013), identifying women with asthma (n = 22,084) and SLE (n = 1174). We estimated risk ratios (RR) for OCS cumulative dose trajectories and other disease-related medications before gestational day 140 and hazard ratios (HR) for time-varying exposures after day 139.

Results: For asthma, PTB risk was 14.0% for no OCS exposure and 14.3%, 16.8%, 20.5%, and 32.7% in low, medium, medium-high, and high cumulative dose trajectory groups, respectively, during the first 139 days. The high-dose group remained associated with PTB after adjustment (adjusted RR [aRR]: 1.46; 95% confidence interval [CI]: 1.00, 2.15). OCS dose after day 139 was not clearly associated with PTB, nor were controller medications. For SLE, PTB risk for no OCS exposure was 24.9%, and it was 39.1% in low- and 61.2% in high-dose trajectory groups. aRR were 1.80 (95% CI: 1.34, 2.40) for high and 1.24 (95% CI: 0.97, 1.58) for low groups. Only prednisone equivalent dose >20 mg/day after day 139 was associated with increased PTB (adjusted HR: 2.54; 95% CI: 1.60, 4.03).

Conclusions: For asthma, higher OCS doses early in pregnancy, but not later, were associated with increased PTB. For SLE, higher doses early and later in pregnancy were associated with PTB.
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http://dx.doi.org/10.1016/j.jaip.2020.07.047DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7805577PMC
January 2021

Diagnostic Performance of Emergency Physician Gestalt for Predicting Acute Appendicitis in Patients Age 5 to 20 Years.

Acad Emerg Med 2020 09 2;27(9):821-831. Epub 2020 Apr 2.

Division of Research, Kaiser Permanente, Oakland, CA.

Objectives: Pediatric appendicitis remains a challenging diagnosis in the emergency department (ED). Available risk prediction algorithms may contribute to excessive ED imaging studies. Incorporation of physician gestalt assessment could help refine predictive tools and improve diagnostic imaging decisions.

Methods: This study was a subanalysis of a parent study that prospectively enrolled patients ages 5 to 20.9 years with a chief complaint of abdominal pain presenting to 11 community EDs within an integrated delivery system between October 1, 2016, and September 30, 2018. Prior to diagnostic imaging, attending emergency physicians enrolled patients with ≤5 days of right-sided or diffuse abdominal pain using a Web-based application embedded in the electronic health record. Predicted risk (gestalt) of acute appendicitis was prospectively entered using a sliding scale from 1% to 100%. As a planned secondary analysis, we assessed the performance of gestalt via c-statistics of receiver operating characteristic (ROC) curves; tested associations between gestalt performance and patient, physician, and facility characteristics; and examined clinical characteristics affecting gestalt estimates.

Results: Of 3,426 patients, 334 (9.8%) had confirmed appendicitis. Physician gestalt had excellent ROC curve characteristics (c-statistic = 0.83, 95% confidence interval = 0.81 to 0.85), performing particularly well in the low-risk strata (appendicitis rate = 1.1% in gestalt 1%-10% range, negative predictive value of 98.9% for appendicitis diagnosis). Physicians with ≥5 years since medical school graduation demonstrated improved gestalt performance over those with less experience (p = 0.007). All clinical characteristics tested, except pain <24 hours, were significantly associated with physician gestalt value (p < 0.05).

Conclusion: Physician gestalt for acute appendicitis diagnosis performed well, especially in low-risk patients and when employed by experienced physicians.
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http://dx.doi.org/10.1111/acem.13931DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8310728PMC
September 2020

Comparison of Mortality and Major Cardiovascular Events Among Adults With Type 2 Diabetes Using Human vs Analogue Insulins.

JAMA Netw Open 2020 01 3;3(1):e1918554. Epub 2020 Jan 3.

HealthPartners Institute, Minneapolis, Minnesota.

Importance: The comparative cardiovascular safety of analogue and human insulins in adults with type 2 diabetes who initiate insulin therapy in usual care settings has not been carefully evaluated using machine learning and other rigorous analytic methods.

Objective: To examine the association of analogue vs human insulin use with mortality and major cardiovascular events.

Design, Setting, And Participants: This retrospective cohort study included 127 600 adults aged 21 to 89 years with type 2 diabetes at 4 health care delivery systems who initiated insulin therapy from January 1, 2000, through December 31, 2013. Machine learning and rigorous inference methods with time-varying exposures were used to evaluate associations of continuous exposure to analogue vs human insulins with mortality and major cardiovascular events. Data were analyzed from September 1, 2017, through June 30, 2018.

Exposures: On the index date (first insulin dispensing), participants were classified as using analogue insulin with or without human insulin or human insulin only.

Main Outcomes And Measures: Overall mortality, mortality due to cardiovascular disease (CVD), myocardial infarction (MI), stroke or cerebrovascular accident (CVA), and hospitalization for congestive heart failure (CHF) were evaluated. Marginal structural modeling (MSM) with inverse probability weighting was used to compare event-free survival in separate per-protocol analyses. Adjusted and unadjusted hazard ratios and cumulative risk differences were based on logistic MSM parameterizations for counterfactual hazards. Propensity scores were estimated using a data-adaptive approach (machine learning) based on 3 nested covariate adjustment sets. Sensitivity analyses were conducted to address potential residual confounding from unmeasured differences in risk factors across delivery systems.

Results: The 127 600 participants (mean [SD] age, 59.4 [12.6] years; 68 588 men [53.8%]; mean [SD] body mass index, 32.3 [7.1]) had a median follow-up of 4 quarters (interquartile range, 3-9 quarters) and experienced 5464 deaths overall (4.3%), 1729 MIs (1.4%), 1301 CVAs (1.0%), and 3082 CHF hospitalizations (2.4%). There were no differences in adjusted hazard ratios for continuous analogue vs human insulin exposure during 10 quarters for overall mortality (1.15; 95% CI, 0.97-1.34), CVD mortality (1.26; 95% CI, 0.86-1.66), MI (1.11; 95% CI, 0.77-1.45), CVA (1.30; 95% CI, 0.81-1.78), or CHF hospitalization (0.93; 95% CI, 0.75-1.11).

Conclusions And Relevance: Insulin-naive adults with type 2 diabetes who initiate and continue treatment with human vs analogue insulins had similar observed rates of major cardiovascular events, CVD mortality, and overall mortality.
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http://dx.doi.org/10.1001/jamanetworkopen.2019.18554DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6991251PMC
January 2020

Birth and early developmental screening outcomes associated with cannabis exposure during pregnancy.

J Perinatol 2020 03 7;40(3):473-480. Epub 2020 Jan 7.

Department of Epidemiology, University of Iowa, Iowa City, IA, USA.

Objective: To compare birth and early developmental screening outcomes for infants with and without in utero cannabis exposures.

Study Design: Observational cohort of women receiving prenatal care within a large health system, live birth between October 1, 2015 and December 1, 2017, and at least one infant visit. Cannabis exposure was through routine urine toxicology screen. Preterm birth, small for gestational age (SGA) birth, birth defects, and early developmental screening outcomes were assessed from birth and electronic health record data.

Results: Of 3435 women, 283 (8.2%) had a positive urine toxicology screen. In utero cannabis exposure was associated with SGA birth, adjusted rate ratio (aRR) 1.69 (95% confidence interval [CI]: 1.22-2.34). Abnormal 12-month developmental screens occurred in 9.1% of infants with in utero cannabis exposure vs. 3.6% of those with negative maternal screens, aRR 1.90 (95% CI: 0.92-3.91). Additional birth outcomes were not associated with in utero cannabis exposure.

Conclusions: Exposure to cannabis during pregnancy may adversely impact fetal growth.
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http://dx.doi.org/10.1038/s41372-019-0576-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7047636PMC
March 2020

Oral corticosteroid use during pregnancy and risk of preterm birth.

Rheumatology (Oxford) 2020 06;59(6):1262-1271

Department of Pediatrics, University of California, CA, USA.

Objective: To evaluate the associations between oral corticosteroid (OCS) dose early and late in pregnancy and preterm birth (PTB) among women with RA.

Methods: Pregnant women in the MotherToBaby Pregnancy Studies (2003-2014) with RA (n = 528) were included in the primary analysis. Information was collected by phone interview and from medical records. We estimated risk ratios (RR) for OCS dose trajectories and other disease-related medications before gestational day 140 and hazard ratios (HR) for time-varying exposures after gestational day 139.

Results: PTB risk was 15.5% overall. Compared with no OCS, PTB risk was increased in high (adjusted (a)RR: 4.77 (95% CI: 2.76, 8.26)) and medium (aRR: 1.81 (95% CI: 1.10, 2.97)) cumulative OCS dose trajectories during the first 139 gestational days. The low cumulative trajectory group was associated with an increased risk of PTB that was not statistically significant (aRR: 1.38 (95% CI: 0.79, 2.38)), and DMARDs were not associated with PTB (biologic DMARDs aHR: 1.08 (95% CI: 0.70, 1.66); non-biologic DMARDs aHR: 0.87 (95% CI: 0.55, 1.38)). OCS exposure to ⩾10 mg of prednisone equivalent daily dose after gestational day 139 vs none was associated with increased PTB rate (aHR: 2.45 (95% CI: 1.32, 4.56)), whereas <10 mg was associated with a modestly increased rate of PTB that was not statistically significant (aHR: 1.18 (95% CI: 0.60, 2.30)).

Conclusion: Higher OCS doses vs no OCS use, both earlier and later in pregnancy, were associated with an increase in PTB among women with RA.
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http://dx.doi.org/10.1093/rheumatology/kez405DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7244781PMC
June 2020

Uptake and safety of hepatitis A vaccination during pregnancy: A Vaccine Safety Datalink study.

Vaccine 2019 10 20;37(44):6648-6655. Epub 2019 Sep 20.

Center for Health Research, Kaiser Permanente Northwest, Portland, OR, United States.

Introduction: Infection with hepatitis A virus (HAV) during pregnancy, although uncommon, is associated with gestational complications and pre-term labor. Hepatitis A vaccine (HepA) is recommended for anyone at increased risk for contracting hepatitis A, including women at risk who are also pregnant. Limited data are available on the safety of maternal HepA vaccination.

Objectives: Assess the frequency of maternal HepA receipt and evaluate the potential association between maternal vaccination and pre-specified maternal and infant safety outcomes.

Methods: A retrospective cohort of pregnancies in the Vaccine Safety Datalink (VSD) resulting in live births from 2004 through 2015 was included. Pregnancies with HepA exposure were compared to those with other vaccine exposures, and to those with no vaccine exposures. Risk factors for contracting hepatitis A were identified up to one-year prior to or during the pregnancy using ICD-9 codes. Maternal and fetal adverse events were evaluated according to maternal HepA exposure status. Adjusted odds ratio (OR) were used to describe the association.

Results: Among 666,233 pregnancies in the study period, HepA was administered at a rate of 1.7 per 1000 (n = 1140), most commonly within the first six weeks of pregnancy. Less than 3% of those exposed to HepA during pregnancy had an ICD-confirmed risk factor. There were no significant associations between HepA exposure during pregnancy and gestational hypertension, gestational diabetes, pre-eclampsia/eclampsia, cesarean delivery, pre-term delivery, and low birthweight. There was a statistically significant association between HepA exposure during pregnancy and small-for-gestational age (SGA) infants (aOR 1.32, [95% CI 1.09, 1.60], p = 0.004).

Conclusions: The rate of maternal HepA vaccination was low and rarely due to documented risk factors for vaccination. HepA vaccination during pregnancy was not associated with an increased risk for a range of adverse events examined among pregnancies resulting in live births, but an identified association between maternal HepA and SGA infant outcomes, while likely due to unmeasured confounding, warrants further exploration.
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http://dx.doi.org/10.1016/j.vaccine.2019.09.043DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8082525PMC
October 2019

Validation of the Pediatric Appendicitis Risk Calculator (pARC) in a Community Emergency Department Setting.

Ann Emerg Med 2019 10 19;74(4):471-480. Epub 2019 Jun 19.

Permanente Medical Group, Oakland, CA; Kaiser Permanente, Division of Research, Oakland, CA; Kaiser Permanente, San Rafael Medical Center, San Rafael, CA.

Study Objective: The pediatric Appendicitis Risk Calculator (pARC) is a validated clinical tool for assessing a child's probability of appendicitis. Our objective was to assess the performance of the pARC in community emergency departments (EDs) and to compare its performance with that of the Pediatric Appendicitis Score (PAS).

Methods: We conducted a prospective validation study from October 1, 2016, to April 30, 2018, in 11 community EDs serving general populations. Patients aged 5 to 20.9 years and with a chief complaint of abdominal pain and less than or equal to 5 days of right-sided or diffuse abdominal pain were eligible for study enrollment. Our primary outcome was the presence or absence of appendicitis within 7 days of the index visit. We reported performance characteristics and secondary outcomes by pARC risk strata and compared the receiver operator characteristic (ROC) curves of the PAS and pARC.

Results: We enrolled 2,089 patients with a mean age of 12.4 years, 46% of whom were male patients. Appendicitis was confirmed in 353 patients (16.9%), of whom 55 (15.6%) had perforated appendixes. Fifty-four percent of patients had very low (<5%) or low (5% to 14%) predicted risk, 43% had intermediate risk (15% to 84%), and 4% had high risk (≥85%). In the very-low- and low-risk groups, 1.4% and 3.0% of patients had appendicitis, respectively. The area under the ROC curve was 0.89 (95% confidence interval 0.87 to 0.92) for the pARC compared with 0.80 (95% confidence interval 0.77 to 0.82) for the PAS.

Conclusion: The pARC accurately assessed appendicitis risk for children aged 5 years and older in community EDs and the pARC outperformed the PAS.
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http://dx.doi.org/10.1016/j.annemergmed.2019.04.023DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8364751PMC
October 2019

Safety of guidelines recommending live attenuated influenza vaccine for routine use in children and adolescents with asthma.

Vaccine 2019 07 10;37(30):4055-4060. Epub 2019 Jun 10.

HealthPartners Institute, Minneapolis, MN, United States.

Objective: Evaluate whether a guideline recommending Live Attenuated Influenza Vaccine (LAIV) for children 2 years and older with asthma increased risks for lower respiratory events (LREs), within 21 or 42 days of vaccination, as compared to standard guidelines to administer Inactivated Influenza Vaccine (IIV) in children with asthma.

Methods: This was a pre/post guideline retrospective cohort study of children ages 2-17 years with asthma and receiving one or more influenza vaccines in two large medical groups from 2007 to 2016. Both groups recommended IIV in the pre-period; in 2010, one group implemented a guideline recommending LAIV for all children, including those with asthma. Main outcomes were medically attended LREs within 21 and 42 days after influenza immunization. Analysis used a generalized estimating equation regression to estimate the ratio of rate ratios (RORs) comparing pre/post events between LAIV guideline and control group.

Results: The cohort included 7851 influenza vaccinations in 4771 children with asthma. Among patients in the LAIV guideline group, the proportion receiving LAIV increased from 23% to 68% post-guideline implementation, versus an increase from 7 to 11% in the control group. Age and baseline asthma severity adjusted ROR showed no increase in LREs, primarily asthma exacerbations, following implementation of the LAIV guideline: overall aROR (95% Confidence Interval): 0.74 (0.43-1.29) for LRE within 21 days of vaccination, 0.77 (0.53-1.14) for LRE within 42 days of vaccination. For the subset of children ages 2-4 years aROR: 0.92 (0.34-2.53) for LRE within 21 days of vaccination and 0.94 (0.49-1.82) for LRE within 42 days of vaccination; for children 5-18 years aROR (95% CI): 0.58 (0.26-1.30) for LRE within 21 days of vaccination and 0.67 (0.37-1.23) for LRE within 42 days.

Conclusion: In a large cohort of children with asthma, a guideline recommending LAIV rather than IIV did not increase LREs following vaccination.
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http://dx.doi.org/10.1016/j.vaccine.2019.05.081DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6786490PMC
July 2019

Development of a Clinical Decision Support System for Pediatric Abdominal Pain in Emergency Department Settings Across Two Health Systems Within the HCSRN.

EGEMS (Wash DC) 2019 Apr 12;7(1):15. Epub 2019 Apr 12.

Children's MN, Department of Pediatric Emergency Medicine, Minneapolis, Minnesota, US.

Background: Appendicitis is a common surgical emergency in children, yet diagnosis can be challenging. An electronic health record (EHR) based, clinical decision support (CDS) system called Appy CDS was designed to help guide management of pediatric patients with acute abdominal pain within the Health Care Systems Research Network (HCSRN).

Objectives: To describe the development and implementation of a clinical decision support tool (Appy CDS) built independently but synergistically at two large HCSRN affiliated health systems using well-established platforms, and to assess the tool's Triage component, aiming to identify pediatric patients at increased risk for appendicitis.

Results: Despite differences by site in design and implementation, such as the use of alerts, incorporating gestalt, and other workflow variations across sites, using simple screening questions and automated exclusions, both systems were able to identify a population with similar appendicitis rates (11.8 percent and 10.6 percent), where use of the full Appy CDS would be indicated.

Discussion: These 2 HCSRN sites designed Appy CDS to capture a population at risk for appendicitis and deliver CDS to that population while remaining locally relevant and adhering to organizational preferences. Despite different approaches to point-of-care CDS, the sites have identified similar cohorts with nearly identical background rates of appendicitis.

Next Steps: The full Appy CDS tool, providing personalized risk assessment and tailored recommendations, is undergoing evaluation as part of a pragmatic cluster randomized trial aiming to reduce reliance on advanced diagnostic imaging. The novel approaches to CDS we present could serve as the basis for future ED interventions.
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http://dx.doi.org/10.5334/egems.282DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6460497PMC
April 2019

Uptake and safety of Hepatitis B vaccination during pregnancy: A Vaccine Safety Datalink study.

Vaccine 2018 10 5;36(41):6111-6116. Epub 2018 Sep 5.

Center for Health Research, Kaiser Permanente Northwest, Portland, OR, United States.

Introduction: Hepatitis B virus (HBV) infection acquired during pregnancy can pose a risk to the infant at birth that can lead to significant and lifelong morbidity. Hepatitis B vaccine (HepB) is recommended for anyone at increased risk for contracting HBV infection, including pregnant women. Limited data are available on the safety of HepB administration during pregnancy.

Objectives: To assess the frequency of maternal HepB receipt among pregnant women and evaluate the potential association between maternal vaccination and pre-specified maternal and infant safety outcomes.

Methods: We examined a retrospective cohort of pregnancies in the Vaccine Safety Datalink (VSD) resulting in live birth outcomes from 2004 through 2015. Eligible pregnancies in women aged 12-55 years who were continuously enrolled from 6 months pre-pregnancy to 6 weeks postpartum in VSD integrated health systems were included. We compared pregnancies with HepB exposure to those with other vaccine exposures, and to those with no vaccine exposures. High-risk conditions for contracting HBV infection were identified up to one-year prior to or during the pregnancy using ICD-9 codes. Maternal and fetal adverse events were also evaluated according to maternal HepB exposure status.

Results: Among over 650,000 pregnancies in the study period, HepB was administered at a rate of 2.1 per 1000 pregnancies (n = 1399), commonly within the first 5 weeks of pregnancy. Less than 3% of the HepB-exposed group had a high-risk ICD-9 code indicating need for HepB; this was similar to the rate among HepB unvaccinated groups. There were no significant associations between HepB exposure during pregnancy and gestational hypertension, gestational diabetes, pre-eclampsia/eclampsia, cesarean delivery, pre-term delivery, low birthweight or small for gestational age infants.

Conclusions: Most women who received maternal HepB did not have high-risk indications for vaccination. No increased risk for the adverse events that were examined were observed among women who received maternal HepB or their offspring.
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http://dx.doi.org/10.1016/j.vaccine.2018.08.074DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6325631PMC
October 2018

Risk of Spontaneous Abortion After Inadvertent Human Papillomavirus Vaccination in Pregnancy.

Obstet Gynecol 2018 07;132(1):35-44

HealthPartners Institute, Minneapolis, Minnesota; the Department of Obstetrics, Gynecology, & Reproductive Sciences, Yale University School of Medicine, New Haven, Connecticut; the Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon; the Vaccine Study Center, Kaiser Permanente Northern California, Oakland, and the Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California; the Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado; Marshfield Clinic Research Institute, Marshfield, Wisconsin; Kaiser Permanente Washington Health Research Institute, Seattle, Washington; Harvard Pilgrim Health Care Institute, Boston, Massachusetts; and the Centers for Disease Control and Prevention, Atlanta, Georgia.

Objective: To evaluate the risk of spontaneous abortion after quadrivalent human papillomavirus (4vHPV) vaccination before and during pregnancy across seven integrated health systems within the Vaccine Safety Datalink.

Methods: Within a retrospective observational cohort, we compared risks for spontaneous abortion after 4vHPV in three exposure windows: distal (16-22 weeks before the last menstrual period [LMP]), peripregnancy (within 6 weeks before the LMP), and during pregnancy (LMP through 19 weeks of gestation). Women 12-27 years of age with a pregnancy between 2008 and 2014, with continuous insurance enrollment 8 months before and through pregnancy end, and with a live birth, stillbirth, or spontaneous abortion were included. Pregnancies were identified through validated algorithms. Spontaneous abortions and stillbirths were verified by chart review with spontaneous abortions adjudicated by clinical experts. We excluded multiple gestations, spontaneous abortions before 6 weeks of gestation, and women using medications increasing risk of spontaneous abortion. Spontaneous abortion risk after 4vHPV during pregnancy was compared with distal vaccination using time-dependent covariate Cox models. Spontaneous abortion risk for peripregnancy compared with distal vaccination was evaluated with standard Cox models.

Results: We identified 2,800 pregnancies with 4vHPV exposure in specified risk windows: 919 (33%) distal, 986 (35%) peripregnancy, and 895 (32%) during pregnancy. Mean age was 22.4 years in distal and peripregnancy groups compared with 21.4 years among women vaccinated during pregnancy. Among women with distal 4vHPV exposure, 96 (10.4%) experienced a spontaneous abortion. For peripregnancy and during pregnancy exposures, spontaneous abortions occurred in 110 (11.2%) and 77 (8.6%), respectively. The risk of spontaneous abortion was not increased among women who received 4vHPV during pregnancy (adjusted hazard ratio 1.10, 95% CI 0.81-1.51) or peripregnancy 1.07 (0.81-1.41).

Conclusion: Inadvertent 4vHPV exposure during or peripregnancy was not significantly associated with an increased risk of spontaneous abortion.
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http://dx.doi.org/10.1097/AOG.0000000000002694DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6019196PMC
July 2018

Cost-Effectiveness of a Community-Based Diabetes Prevention Program with Participation Incentives for Medicaid Beneficiaries.

Health Serv Res 2018 12 16;53(6):4704-4724. Epub 2018 May 16.

HealthPartners Institute, Bloomington, MN.

Objective: To examine the cost-effectiveness of a community-based Diabetes Prevention Program (DPP) for Medicaid beneficiaries from the perspective of the health care sector.

Data Sources/study Setting: A total of 847 Medicaid enrollees at high risk for type 2 diabetes participating in a community-based DPP.

Study Design: Pre- and post clinical outcome and cost data were used as inputs into a validated diabetes simulation model. The model was used to evaluate quality-adjusted life years (QALYs) and health care costs over a 40-year time horizon from the perspective of the health care sector.

Data Collection/extraction Methods: Clinical outcome and cost data were derived from a study examining the effect of financial incentives on weight loss.

Principal Findings: Study participants lost an average of 4.2 lb (p < .001) and increased high-density lipoprotein cholesterol by 1.75 mg/dl (p = .002). Intervention costs, which included financial incentives for participation and weight loss, were $915 per participant. The incremental cost-effectiveness ratio was estimated to be $14,011 per QALY but was sensitive to the time horizon studied.

Conclusions: Widespread adoption of community-based DPP has the potential to reduce diabetes and cardiovascular-related morbidity and mortality for low-income persons at high risk for diabetes and may be a cost-effective investment for Medicaid programs.
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http://dx.doi.org/10.1111/1475-6773.12973DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6232439PMC
December 2018

Development and Validation of a Novel Pediatric Appendicitis Risk Calculator (pARC).

Pediatrics 2018 04 13;141(4). Epub 2018 Mar 13.

Division of Research, HealthPartners Institute, Bloomington, Minnesota.

Objectives: We sought to develop and validate a clinical calculator that can be used to quantify risk for appendicitis on a continuous scale for patients with acute abdominal pain.

Methods: The pediatric appendicitis risk calculator (pARC) was developed and validated through secondary analyses of 3 distinct cohorts. The derivation sample included visits to 9 pediatric emergency departments between March 2009 and April 2010. The validation sample included visits to a single pediatric emergency department from 2003 to 2004 and 2013 to 2015. Variables evaluated were as follows: age, sex, temperature, nausea and/or vomiting, pain duration, pain location, pain with walking, pain migration, guarding, white blood cell count, and absolute neutrophil count. We used stepwise regression to develop and select the best model. Test performance of the pARC was compared with the Pediatric Appendicitis Score (PAS).

Results: The derivation sample included 2423 children, 40% of whom had appendicitis. The validation sample included 1426 children, 35% of whom had appendicitis. The final pARC model included the following variables: sex, age, duration of pain, guarding, pain migration, maximal tenderness in the right-lower quadrant, and absolute neutrophil count. In the validation sample, the pARC exhibited near perfect calibration and a high degree of discrimination (area under the curve: 0.85; 95% confidence interval: 0.83 to 0.87) and outperformed the PAS (area under the curve: 0.77; 95% confidence interval: 0.75 to 0.80). By using the pARC, almost half of patients in the validation cohort could be accurately classified as at <15% risk or ≥85% risk for appendicitis, whereas only 23% would be identified as having a comparable PAS of <3 or >8.

Conclusions: In our validation cohort of patients with acute abdominal pain, the pARC accurately quantified risk for appendicitis.
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http://dx.doi.org/10.1542/peds.2017-2699DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5869337PMC
April 2018

Infant Hospitalizations and Mortality After Maternal Vaccination.

Pediatrics 2018 03 20;141(3). Epub 2018 Feb 20.

Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.

Background: The Advisory Committee on Immunization Practices currently recommends pregnant women receive influenza and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines. There are limited studies of the long-term safety in infants for vaccines administered during pregnancy. We evaluate whether maternal receipt of influenza and Tdap vaccines increases the risk of infant hospitalization or death in the first 6 months of life.

Methods: We included singleton, live birth pregnancies in the Vaccine Safety Datalink between 2004 and 2014. Outcomes were infant hospitalizations and mortality in the first 6 months of life. We performed a case-control study matching case patients and controls 1:1 and used conditional logistic regression to estimate odds ratios for maternal exposure to influenza and/or Tdap vaccines in pregnancy.

Results: There were 413 034 live births in our population. Of these, 25 222 infants had hospitalizations and 157 infants died in the first 6 months of life. We found no association between infant hospitalization and maternal influenza (adjusted odds ratio: 1.00; 95% confidence interval [CI]: 0.96-1.04) or Tdap (adjusted odds ratio: 0.94; 95% CI: 0.88-1.01) vaccinations. We found no association between infant mortality and maternal influenza (adjusted odds ratio: 0.96; 95% CI: 0.54-1.69) or Tdap (adjusted odds ratio: 0.44; 95% CI: 0.17-1.13) vaccinations.

Conclusions: We found no association between vaccination during pregnancy and risk of infant hospitalization or death in the first 6 months of life. These findings support the safety of current recommendations for influenza and Tdap vaccination during pregnancy.
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http://dx.doi.org/10.1542/peds.2017-3310DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6586222PMC
March 2018

Performance of the Net Reclassification Improvement for Nonnested Models and a Novel Percentile-Based Alternative.

Am J Epidemiol 2018 06;187(6):1327-1335

HealthPartners Institute, Minneapolis, Minnesota.

The net reclassification improvement (NRI) is a widely used metric used to assess the relative ability of 2 risk models to distinguish between low- and high-risk individuals. However, the validity and usefulness of the NRI have been questioned. Criticism of the NRI focuses on its use comparing nested risk models, whereas in practice it is often used to compare nonnested risk models derived from distinct data sources. In this study, we evaluated the performance of the NRI in a nonnested context by using it to compare competing cardiovascular risk-prediction models. We explored the NRI's sensitivity to variations in risk categories and to the calibration of the compared models. We found that the NRI was very sensitive to changes in the definition of risk categories, especially when at least 1 model was miscalibrated. To address these shortcomings, we describe a novel alternative to the usual NRI that uses percentiles of risk instead of cutoffs based on absolute risk. This percentile-based NRI demonstrates the relative ability of 2 models to rank patient risk. It displays more stable behavior, and we recommend its use when there are no established risk categories or when models are miscalibrated.
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http://dx.doi.org/10.1093/aje/kwx374DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5982725PMC
June 2018

Reducing diabetes distress and improving self-management with mindfulness.

Soc Work Health Care 2018 01 24;57(1):48-65. Epub 2017 Oct 24.

c HealthPartners Institute , Minneapolis , MN , USA.

Stress associated with diabetes makes managing diabetes harder. We investigated whether mindfulness-based stress reduction (MBSR) could reduce diabetes distress and improve management. We recruited 38 participants to complete an MBSR program. Surveys and lab values were completed at baseline and post-intervention. Participants showed significant improvement in diabetes-related distress (Cohen's d -.71, p < .002), psychosocial self-efficacy (Cohen's d .80, p < .001), and glucose control (Cohen's d -.79, p < .001). Significant improvements in depression, anxiety, stress, coping, self-compassion, and social support were also found. These results suggest that MBSR may offer an effective method for helping people better self-manage their diabetes and improve mental health.
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http://dx.doi.org/10.1080/00981389.2017.1388898DOI Listing
January 2018
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