Holly C. Groom

Primary Care Screening for and Treatment of Depression in Pregnant and Postpartum Women: Evidence Report and Systematic Review for the US Preventive Services Task Force

IMPORTANCE Depression is a source of substantial burden for individuals and their families, including women during the pregnant and postpartum period. OBJECTIVE To systematically review the benefits and harms of depression screening and treatment, and accuracy of selected screening instruments, for pregnant and postpartum women. Evidence for depression screening in adults in general is available in the full report. DATA SOURCES MEDLINE, PubMed, PsycINFO, and the Cochrane Collaboration Registry of Controlled Trials through January 20, 2015; references; and government websites. STUDY SELECTION English-language trials of benefits and harms of depression screening, depression treatment in pregnant and postpartum women with screen-detected depression, and diagnostic accuracy studies of depression screening instruments in pregnant and postpartum women. DATA EXTRACTION AND SYNTHESIS Two investigators independently reviewed abstracts and full-text articles and extracted data from fair- and good-quality studies. Random-effects meta-analysis was used to estimate the benefit of cognitive behavioral therapy (CBT) in pregnant and postpartum women. MAIN OUTCOMES AND MEASURES Depression remission, prevalence, symptoms, and related measures of depression recovery or response; sensitivity and specificity of selected screening measures to detect depression; and serious adverse effects of antidepressant treatment. RESULTS Among pregnant and postpartum women 18 years and older, 6 trials (n = 11,869) showed 18% to 59% relative reductions with screening programs, or 2.1% to 9.1% absolute reductions, in the risk of depression at follow-up (3-5 months) after participation in programs involving depression screening, with or without additional treatment components, compared with usual care. Based on 23 studies (n = 5398), a cutoff of 13 on the English-language Edinburgh Postnatal Depression Scale demonstrated sensitivity ranging from 0.67 (95% CI, 0.18-0.96) to 1.00 (95% CI, 0.67-1.00) and specificity consistently 0.87 or higher. Data were sparse for Patient Health Questionnaire instruments. Pooled results for the benefit of CBT for pregnant and postpartum women with screen-detected depression showed an increase in the likelihood of remission (pooled relative risk, 1.34 [95% CI, 1.19-1.50]; No. of studies [K] = 10, I2 = 7.9%) compared with usual care, with absolute increases ranging from 6.2% to 34.6%. Observational evidence showed that second-generation antidepressant use during pregnancy may be associated with small increases in the risks of potentially serious harms. CONCLUSIONS AND RELEVANCE Direct and indirect evidence suggested that screening pregnant and postpartum women for depression may reduce depressive symptoms in women with depression and reduce the prevalence of depression in a given population. Evidence for pregnant women was sparser but was consistent with the evidence for postpartum women regarding the benefits of screening, the benefits of treatment, and screening instrument accuracy.

Behavioral Counseling to Promote a Healthy Lifestyle in Persons With Cardiovascular Risk Factors: A Systematic Review for the U.S. Preventive Services Task Force

Decreases in cardiovascular mortality rates in recent decades have been attributed, in part, to improvements in modifiable risk factors (1). A substantial portion of the U.S. population has at least one modifiable risk factor for cardiovascular disease (CVD) (such as hypertension, dyslipidemia, impaired fasting glucose, the metabolic syndrome, and cigarette smoking) (27). Despite convincing evidence that healthy diet and physical activity are associated with important health outcomes, including reduction in cardiovascular events and mortality rates (817), U.S. adults are not meeting recommendations for healthy diet and physical activity (1820). Likewise, nutrition and exercise counseling practices in primary care remain suboptimal, even for persons at high risk for CVD (2124). In 2012, the U.S. Preventive Services Task Force (USPSTF) recommended that clinicians consider selectively providing or referring adults without preexisting CVD or risk factors for intensive behavioral counseling interventions (C recommendation) (25). The USPSTF subsequently recommended that clinicians screen all adults for obesity and offer or refer obese patients to intensive, multicomponent behavioral interventions (B recommendation) (26). This systematic review was designed to complement the existing reviews that supported the 2012 USPSTF recommendations and to support the USPSTF in updating its 2002 and 2003 recommendations on healthy diet and physical activity counseling in persons with known cardiovascular risk factors (27, 28). To conduct this review, we developed an analytic framework with 4 key questions (Supplement 1) that included the effect of dietary or physical activity counseling on patient health outcomes (question 1), intermediate cardiovascular diseaserelated outcomes (question 2), behavioral outcomes (question 3), and the harms of counseling (question 4). Supplement 1. Analytic Framework Methods Detailed methods, including search strategies; detailed inclusion criteria; and excluded studies are publically available in our full evidence report (29). Data Sources and Searches We searched MEDLINE, PubMed, PsycINFO, the Database of Abstracts of Reviews of Effects, and the Cochrane Central Register of Controlled Trials from January 2001 to October 2013. We supplemented our searches with suggestions from experts and reference lists from other relevant systematic reviews. Study Selection Two investigators independently reviewed 7218 abstracts and 553 full-text articles against a priorispecified inclusion criteria (Supplement 2). We included studies in adults who had at least 1 cardiovascular risk factor, including hypertension, dyslipidemia, impaired fasting glucose or glucose tolerance, the metabolic syndrome, and cigarette smoking. We excluded studies limited to persons with known diabetes (considered a CVD risk equivalent), coronary artery disease, cerebrovascular disease, peripheral artery disease, or severe chronic kidney disease. We also excluded populations at increased risk for CVD (such as those who are obese, physically inactive, and prehypertensive) but without other CVD risk factors because these bodies of evidence were considered in previous reviews (30, 31) and USPSTF recommendations (25, 26). We included behaviorally based counseling interventions to promote a healthy diet or physical activity, delivered alone or as part of a multicomponent intervention. We excluded interventions that provided controlled diets or supervised exercise, as opposed to interventions aimed at evaluating whether counseling could change behavior. Supplement 2. Literature Flow Diagram We limited studies of efficacy or effectiveness to fair- or good-quality randomized, controlled trials or controlled clinical trials that had at least 6 months of follow-up, were done in developed countries, and published their results in 1990 or later. Included trials had to have a control group (such as usual care, a minimal intervention, or attention control). We examined health outcomes (such as morbidity or mortality related to CVD), intermediate health outcomes (such as physiologic measures of blood pressure, lipid and glucose, and weight; diabetes incidence; medication use; and composite CVD risk scores), and behavioral outcomes (such as self-reported dietary intake and physical activity or objectively measured markers of behavior change [such as VO2max or urinary sodium]). We also included observational studies that reported serious harms (that is, adverse events resulting in unexpected or unwanted medical attention). Data Extraction and Quality Assessment One reviewer extracted population characteristics, study design elements, intervention and control characteristics, and study results into standardized evidence tables. A second reviewer checked the data for accuracy. Articles that met our inclusion criteria were critically appraised by 2 reviewers independently using the USPSTF and National Institute for Health and Care Excellence criteria (32, 33). We rated articles as good-, fair-, or poor-quality. Good-quality studies generally met all criteria, whereas fair-quality studies did not meet all criteria but had no known important limitation that could invalidate its results. Poor-quality studies had important limitations that were considered fatal flaws (for example, more than 40% attrition with or without differential attrition between intervention groups; lack of randomization with biased assignment of participants to intervention groups, often with differences in baseline characteristics or no reporting of baseline characteristics; per protocol analyses only; and description of methods that did not allow adequate assessment of quality). These studies were excluded from this review. Data Synthesis and Analysis Because of the clinical heterogeneity across this body of evidence, we stratified our analyses according to the type of intervention (that is, a focus on dietary counseling alone, physical activity alone, or combined diet and physical activity counseling) and according to how study populations were targeted or defined (that is, dyslipidemia, hypertension, impaired fasting glucose or glucose tolerance, or mixed risk factors). We did random-effects meta-analyses for 5 or more studies using the DerSimonianLaird method to estimate the effect size of counseling on intermediate health outcomes (that is, systolic and diastolic blood pressure; total, high-density lipoprotein, and low-density lipoprotein cholesterol; triglycerides; fasting blood glucose; diabetes incidence; and weight or body mass index) (34). We did qualitative synthesis for health outcomes, behavioral outcomes, and harms. Outcome analyses were also stratified by length of follow-up after randomization (short term was less than 12 months, intermediate term was 12 to 24 months, and long term was greater than 24 months). We used stratified analyses, visual inspection of forest plots arranged by effect size, and/or meta-regressions to examine the effect of a priorispecified primary sources of heterogeneity on effect size: study population, intervention type, overall intervention intensity (low was less than 30 minutes of total contact, medium was 30 to 360 minutes, and high was more than 360 minutes), number of intervention contacts, duration of intervention, length of follow-up, overall study quality, year of publication, country setting, type of control group, and population risk (including average age; percentage of persons who smoke or have hypertension, dyslipidemia, or diabetes; average systolic blood pressure; average low-density lipoprotein cholesterol level; average body mass index; and use of medications). We assessed the presence of statistical heterogeneity among the studies using standard chi-square tests, and the magnitude of heterogeneity was estimated using the I 2 statistic (35). In instances of 10 or more studies, we formally assessed for publication bias and whether the distribution of the effect sizes was symmetrical with respect to the precision measure by using funnel plots and the Egger linear regression method (36, 37). We did all analyses using Stata, version 11.2. Role of the Funding Source Agency for Healthcare Research and Quality staff oversaw the project and assisted in external review of the companion draft evidence synthesis. Liaisons for the USPSTF helped to resolve issues about the scope of the review but were not involved in the conduct of the review. Results Description of Included Trials Seventy-four fair- or good-quality healthy lifestyle counseling trials in persons with cardiovascular risk factors met our inclusion criteria (Supplements 3 and 4). Forty-nine trials evaluated combined lifestyle counseling interventions, 18 diet-only interventions, and 10 physical activityonly interventions. Of the interventions evaluated, only 2 were low-intensity, 48 were medium-intensity, and 37 were high-intensity. Medium-intensity interventions had a median of 5 contacts (interquartile range [IQR], 3 to 8 contacts) and a median duration of 9 months (IQR, 4 to 11 months). High-intensity interventions had a median of 16 contacts (IQR, 9 to 31 contacts) and a median duration of 12 months (IQR, 8 to 18 months). Counseling interventions included didactic education as well as individualized care plans, problem-solving skills, and audit and feedback. Many trials included weight loss or weight goals for participants who were overweight. Some counseling interventions included cointerventions (such as smoking cessation counseling when applicable, protocols for medication adjustment, and provision of free or low-cost exercise options). Interventions were delivered by dietitians, nutritionists, physiotherapists, exercise professionals or consultants, or trained interventionists (such as health educators, psychologists, nurses, or case managers). Supplement 3. Trial Results in Health Outcomes (Key Question 1) Supplement 4. Included Studies and Outcomes, by Intervention

Influenza Vaccination During Pregnancy

INTRODUCTION Pregnant women are at risk for influenza-related complications and have been recommended for vaccination by the Advisory Committee on Immunization Practices (ACIP) since 1990. Annual rates of influenza coverage of pregnant women have been consistently low. The Vaccine Safety Datalink was used to assess influenza vaccine coverage over 10 consecutive years (2002-2012); assess patterns related to changes in ACIP recommendations; identify predictors of vaccination; and compare the results with those published by national U.S. surveys. METHODS Retrospective cohort study of 721,898 pregnancies conducted in 2014. Coverage rates were assessed for all pregnancies and for live births only. Multivariate regression analysis identified predictors associated with vaccination. RESULTS Coverage increased from 8.8% to 50.9% in 2002-2012. Seasonal coverage rates increased slowly following the 2004 ACIP influenza vaccine recommendation (to remove the first trimester restriction), but spiked significantly during the 2009 H1N1 influenza pandemic. Significant predictors of vaccination during pregnancy included older age; vaccination in a previous season; high-risk conditions in addition to pregnancy; pregnancy during either the 2004-2005 or 2009-2010 seasons; entering the influenza season after the first trimester of pregnancy; and a pregnancy with longer overlap with the influenza season (p<0.001 for each). CONCLUSIONS Influenza vaccination coverage among pregnant women increased between the 2002-2003 and 2011-2012 seasons, although it was still below the developmental Healthy People 2020 goal of 80%. The 2004 ACIP language change positively impacted first-trimester vaccination uptake. Vaccine Safety Datalink data estimates were consistent with U.S. estimates.

White Paper on studying the safety of the childhood immunization schedule in the Vaccine Safety Datalink.

While the large majority of parents in the U.S. vaccinate their children according to the recommended immunization schedule, some parents have refused or delayed vaccinating, often citing safety concerns. In response to public concern, the U.S. Institute of Medicine (IOM) evaluated existing research regarding the safety of the recommended immunization schedule. The IOM concluded that although available evidence strongly supported the safety of the currently recommended schedule as a whole, additional observational research was warranted to compare health outcomes between fully vaccinated children and those on a delayed or alternative schedule. In addition, the IOM identified the Vaccine Safety Datalink (VSD) as an important resource for conducting this research. Guided by the IOM findings, the Centers for Disease Control and Prevention (CDC) commissioned a White Paper to assess how the VSD could be used to study the safety of the childhood immunization schedule. Guided by subject matter expert engagement, the resulting White Paper outlines a 4 stage approach for identifying exposure groups of undervaccinated children, presents a list of health outcomes of highest priority to examine in this context, and describes various study designs and statistical methods that could be used to analyze the safety of the schedule. While it appears feasible to study the safety of the recommended immunization schedule in settings such as the VSD, these studies will be inherently complex, and as with all observational studies, will need to carefully address issues of confounding and bias. In light of these considerations, decisions about conducting studies of the safety of the schedule will also need to assess epidemiological evidence of potential adverse events that could be related to the schedule, the biological plausibility of an association between an adverse event and the schedule, and public concern about the safety of the schedule.

Assessing misclassification of vaccination status: Implications for studies of the safety of the childhood immunization schedule

BACKGROUND To address public concern about the safety of the childhood immunization schedule, the Institute of Medicine recommended observational studies comparing adverse health outcomes of fully vaccinated children to children under-vaccinated due to parental choice. Misclassification of vaccination status could bias such studies. OBJECTIVE To assess risk of misclassification of vaccination status within the Vaccine Safety Datalink (VSD). DESIGN/METHODS A retrospective cohort study was conducted in three phases. In phase 1, electronic health record (EHR) data were used to identify patterns of under-vaccination during the first 24months of life potentially due to parental choice. In phase 2, a random sample of records of under-vaccinated children was manually reviewed. In phase 3, a separate sample of parents were surveyed to assess whether EHR data accurately reflected their childs vaccination status. Phases 1 and 2 were conducted at 6 VSD sites, phase 3 at 1 site. RESULTS The study cohort included 361,901 children born 2004 through 2012. By 24months of age, 198,249 (54.8%) were fully vaccinated with no delays, 84,698 (23.4%) experienced delays but were fully vaccinated by 24months of age, 4865 (1.3%) received no vaccines, 3789 (1.0%) delayed starting vaccination until ≥4months of age, 4781 (1.3%) had consistent vaccine-limiting (≤2 vaccines per visit), and the remaining 65,519 (18.1%) were missing vaccine series or doses. When a diagnosis code for vaccine refusal was present in EHR data, encounter notes confirmed vaccine refusal as the reason for under-vaccination for nearly 100% of sampled records. Parent surveys confirmed these findings. Parents of under-vaccinated children were more likely to report visiting an alternative medical provider than parents of fully vaccinated children. CONCLUSIONS Specific groups of children, under-vaccinated due to parental choice, can be identified with relatively low likelihood of misclassification of vaccination status using EHR-based vaccine data and diagnosis codes.

Association Between Estimated Cumulative Vaccine Antigen Exposure Through the First 23 Months of Life and Non–Vaccine-Targeted Infections From 24 Through 47 Months of Age

Importance Some parents are concerned that multiple vaccines in early childhood could weaken their child’s immune system. Biological data suggest that increased vaccine antigen exposure could increase the risk for infections not targeted by vaccines. Objective To examine estimated cumulative vaccine antigen exposure through the first 23 months of life in children with and without non–vaccine-targeted infections from 24 through 47 months of age. Design, Setting, and Participants A nested case-control study was conducted in 6 US health care organizations participating in the Vaccine Safety Datalink. Cases were identified by International Classification of Diseases codes for infectious diseases in the emergency department and inpatient medical settings and then validated by medical record review. Cases of non–vaccine-targeted infection were matched to controls by age, sex, health care organization site, and chronic disease status. Participants were children ages 24 through 47 months, born between January 1, 2003, and September 31, 2013, followed up until December 31, 2015. Exposures Cumulative vaccine antigen exposure, estimated by summing the number of antigens in each vaccine dose received from birth through age 23 months. Main Outcomes and Measures Non–vaccine-targeted infections, including upper and lower respiratory infections and gastrointestinal infections, from 24 through 47 months of age, and the association between these infections and estimated cumulative vaccine exposure from birth through 23 months. Conditional logistic regression was used to estimate matched odds ratios representing the odds of non–vaccine-targeted infections for every 30-unit increase in estimated cumulative number of antigens received. Results Among the 944 patients (193 cases and 751 controls), the mean (SD) age was 32.5 (6.3) months, 422 (45%) were female, and 61 (7%) had a complex chronic condition. Through the first 23 months, the estimated mean (SD) cumulative vaccine antigen exposure was 240.6 (48.3) for cases and 242.9 (51.1) for controls. The between-group difference for estimated cumulative antigen exposure was −2.3 (95% CI, −10.1 to 5.4; P = .55). Among children with vs without non–vaccine-targeted infections from 24 through 47 months of age, the matched odds ratio for estimated cumulative antigen exposure through age 23 months was not significant (matched odds ratio, 0.94; 95% CI, 0.84 to 1.07). Conclusions and Relevance Among children from 24 through 47 months of age with emergency department and inpatient visits for infectious diseases not targeted by vaccines, compared with children without such visits, there was no significant difference in estimated cumulative vaccine antigen exposure through the first 23 months of life.

Implementing a Multipartner Hpv Vaccination Assessment and Feedback Intervention in an Integrated Health System.

Context: Human papillomavirus (HPV) vaccine initiation rates are persistently lower than rates for other adolescent-recommended vaccines. Assessment and feedback interventions are a recommended strategy for improving vaccination rates. Objective: To provide a guide for implementing a multipartner intervention to increase HPV vaccine initiation rates. Setting: Nine primary care facilities within the Kaiser Permanente Northwest (KPNW) health care system. Intervention: In 2015-2016, we implemented a system-wide assessment and feedback intervention to promote HPV vaccination. In partnership with the Centers for Disease Control and Prevention, the Oregon Immunization Program, and KPNWs leadership, we developed an education session combining information on HPV infection, parental communication strategies, and facility-specific coverage data. Results: Twelve months postintervention, HPV dose 1 vaccination coverage increased from 71% to 72% among females and from 65% to 68% among males. Conclusions: A collaborative approach was critical to engaging leadership and enlisting support from providers and to developing appropriate materials for clinical audiences. Information provided here can be used as a guide for conducting assessment and feedback interventions focused on HPV vaccination initiation.

Human Papillomavirus Vaccine Coverage and Prevalence of Missed Opportunities for Vaccination in an Integrated Healthcare System

BACKGROUND Human papillomavirus (HPV) vaccination has been recommended in the United States for female and male adolescents since 2006 and 2011, respectively. Coverage rates are lower than those for other adolescent vaccines. The objective of this study was to evaluate an assessment and feedback intervention designed to increase HPV vaccination coverage and quantify missed opportunities for HPV vaccine initiation at preventive care visits. METHODS We examined changes in HPV vaccination coverage and missed opportunities within the adolescent (11-17 years) population at 9 Oregon-based Kaiser Permanente Northwest outpatient clinics after an assessment and feedback intervention. Quarterly coverage rates were calculated for the adolescent populations at the clinics, according to age group (11-12 and 13-17 years), sex, and department (Pediatrics and Family Medicine). Comparison coverage assessments were calculated at 3 nonintervention (control) clinics. Missed opportunities for HPV vaccine initiation, defined as preventive care visits in which a patient eligible for HPV dose 1 remained unvaccinated, were examined according to sex and age group. RESULTS An average of 29,021 adolescents were included in coverage assessments. Before the intervention, 1-dose and 3-dose quarterly coverage rates were increasing at intervention as well as at control clinics in both age groups. Postimplementation quarterly trends in 1-dose or 3-dose coverage did not differ significantly between intervention and control clinics for either age group. One-dose coverage rates among adolescents with Pediatrics providers were significantly higher than those with Family Medicine providers (56% vs 41% for 11- to 12-year-old and 82% vs 69% for 13- to 17-year-old girls; 55% vs 40% for 11- to 12-year-old and 78% vs 62% for 13- to 17-year-old boys). CONCLUSIONS No significant differences in HPV vaccine coverage were identified at intervention clinics. However, coverage rates were increasing before the start of the intervention and might have been influenced by ongoing health system best practices. HPV vaccine coverage rates varied significantly according to department, which could allow for targeted improvement opportunities.

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

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.

A model for rapid, active surveillance for medically-attended acute gastroenteritis within an integrated health care delivery system

Background This study presents a novel methodology for estimating all-age, population-based incidence rates of norovirus and other pathogens that contribute to acute gastroenteritis in the United States using an integrated healthcare delivery system as a surveillance platform. Methods All cases of medically attended acute gastroenteritis within the delivery system were identified from April 1, 2014 through September 30, 2016. A sample of these eligible patients were selected to participate in two phone-based surveys and to self-collect a stool sample for laboratory testing. To ascertain household transmission patterns, information on household members with acute gastroenteritis was gathered from participants, and symptomatic household members were contacted to participate in a survey and provide stool sample as well. Results 54% of individuals who met enrollment criteria agreed to participate, and 76% of those individuals returned a stool sample. Among household members, 85% of eligible individuals agreed to participate, and 68% of those returned a stool sample. Participant demographics were similar to those of the eligible population, although minority racial/ethnic groups were somewhat underrepresented in the final sample. Conclusions This study demonstrates the feasibility of conducting acute infectious disease research within an integrated health care delivery system. The surveillance, sampling, recruitment, and data collection methods described here are broadly applicable to conduct baseline and epidemiological assessments, as well as for other research requiring representative samples of stool specimens.