Michelle Henninger

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.

Effectiveness of Seasonal Trivalent Influenza Vaccine for Preventing Influenza Virus Illness Among Pregnant Women: A Population-Based Case-Control Study During the 2010–2011 and 2011–2012 Influenza Seasons

BACKGROUND Although vaccination with trivalent inactivated influenza vaccine (TIV) is recommended for all pregnant women, no vaccine effectiveness (VE) studies of TIV in pregnant women have assessed laboratory-confirmed influenza outcomes. METHODS We conducted a case-control study over 2 influenza seasons (2010-2011 and 2011-2012) among Kaiser Permanente health plan members in 2 metropolitan areas in California and Oregon. We compared the proportion vaccinated among 100 influenza cases (confirmed by reverse transcription polymerase chain reaction) with the proportions vaccinated among 192 controls with acute respiratory illness (ARI) who tested negative for influenza and 200 controls without ARI (matched by season, site, and trimester). RESULTS Among influenza cases, 42% were vaccinated during the study season compared to 58% and 63% vaccinated among influenza-negative controls and matched ARI-negative controls, respectively. The adjusted VE of the current season vaccine against influenza A and B was 44% (95% confidence interval [CI], 5%-67%) using the influenza-negative controls and 53% (95% CI, 24%-72%) using the ARI-negative controls. Receipt of the prior seasons vaccine, however, had an effect similar to receipt of the current seasons vaccine. As such, vaccination in either or both seasons had statistically similar adjusted VE using influenza-negative controls (VE point estimates range = 51%-76%) and ARI-negative controls (48%-76%). CONCLUSIONS Influenza vaccination reduced the risk of ARI associated with laboratory-confirmed influenza among pregnant women by about one-half, similar to VE observed among all adults during these seasons.

Predictors of seasonal influenza vaccination during pregnancy.

OBJECTIVE: Although pregnant women are a high-priority group for influenza vaccination, vaccination rates in this population remain below recommended levels. This prospective cohort study followed a group of pregnant women during the 2010–2011 influenza season to determine possible predictors of vaccination. METHODS: Participants were 552 pregnant women who had not already received the influenza vaccine at the time of enrollment. Women completed a survey assessing knowledge, attitudes, and beliefs about vaccination (based on the Health Belief Model) by telephone and were then followed to determine vaccination status by the end of the 2010–2011 influenza season. RESULTS: Forty-six percent (n=252) of the women were vaccinated, and 54% (n=300) remained unvaccinated after enrollment in the study. Few baseline characteristics, with the exception of study site, month of enrollment, and maternal ethnicity, were predictive of vaccination status. Even after adjusting for significant baseline characteristics, we found that at least one item from each domain of the Health Beliefs Model was predictive of subsequent vaccination. Specifically, women who perceived they were susceptible to influenza, that they were at risk of getting seriously ill from influenza, that they would regret not getting vaccinated, and who trusted recommended guidelines about influenza vaccination during pregnancy were more likely to get vaccinated. Women who were concerned about vaccine side effects were less likely to get vaccinated. CONCLUSION: Trust in recommendations, perceived susceptibility to and seriousness of influenza, perceived regret about not getting vaccinated, and vaccine safety concerns predict vaccination in pregnant women. LEVEL OF EVIDENCE: II

Identifying pregnancy episodes, outcomes, and mother-infant pairs in the Vaccine Safety Datalink

BACKGROUND The need for research on the safety of vaccination during pregnancy is widely recognized. Large, population-based data systems like the Vaccine Safety Datalink (VSD) may be useful for this research, but identifying pregnancies using electronic medical record (EMR) and claims data can be challenging. METHODS We modified an existing data processing algorithm to identify pregnancies within seven of the ten VSD sites. We validated the algorithm by calculating the agreement in pregnancy outcome type, end date, and gestational age between the algorithm and manual medical record review. At each participating site, we randomly sampled 15 episodes within four outcome type strata (live births, spontaneous abortions, elective abortions, and other pregnancy outcomes) for a total of 60 episodes per site. We also developed and validated methods to link mothers to their infants in the electronic data. RESULTS We identified 595,929 pregnancy episodes ending in 2002 through 2006 among women 12 through 55 years of age. Of these pregnancies, 75% ended in live births, 12% in spontaneous abortions, and 9% in elective abortions. We were able to confirm a pregnancy within 28 days of the algorithm-estimated pregnancy start date for 99% of live births, 93% of spontaneous abortions, 92% of elective abortions, and 90% of other outcomes sampled. The agreement between the algorithm-identified and the abstractor-identified outcome date ranged from 70% (elective abortion) to 96% (live birth) depending on outcome type. When gestational age was available in the EMR, agreement ranged from 82% (other) to 98% (live birth) depending on outcome type. We confirmed 100% of the 350 sampled mother-infant linkages with manual medical record review. CONCLUSIONS The VSD algorithm accurately identifies pregnancy episodes and mother-infant pairs across participating sites. Additional manual record review may be needed to improve the precision of the pregnancy date estimates depending on specific study needs. These algorithms will allow us to conduct large, population-based studies of the safety of vaccination during pregnancy.

Safety of influenza vaccination during pregnancy: A review of subsequent maternal obstetric events and findings from two recent cohort studies

Pregnant women and their infants are vulnerable to severe disease and secondary complications from influenza infection. For this reason, annual influenza vaccination is recommended for all pregnant women in the United States. Women frequently cite concerns about vaccine safety as a barrier to vaccination. This review describes the safety of inactivated influenza vaccination during pregnancy with a focus on maternal obstetric events, including hypertensive disorders, gestational diabetes, and chorioamnionitis. Included in the review are new findings from two studies which examined the safety of seasonal inactivated influenza vaccination during pregnancy. The first study enrolled 641 pregnant women during the 2010-2011 season and prospectively followed them until delivery or pregnancy termination. The second study enrolled 1616 pregnant women during the 2010-2011 influenza season, and followed the women and their infants for six months after delivery. No associations between inactivated influenza vaccination and gestational diabetes, gestational hypertension, preeclampsia/eclampsia, or chorioamnionitis were observed in either cohort. When considered as a whole, these studies should further reassure women and clinicians that influenza vaccination during pregnancy is safe for mothers.

Primary Care Interventions to Support Breastfeeding: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance Although 80% of infants in the United States start breastfeeding, only 22% are exclusively breastfed up to around 6 months as recommended by a number of professional organizations. Objective To systematically review the evidence on the benefits and harms of breastfeeding interventions to support the US Preventive Services Task Force in updating its 2008 recommendation. Data Sources MEDLINE, PubMed, Cumulative Index for Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, and PsycINFO for studies published in the English language between January 1, 2008, and September 25, 2015. Studies included in the previous review were re-evaluated for inclusion. Surveillance for new evidence in targeted publications was conducted through January 26, 2016. Study Selection Review of randomized clinical trials and before-and-after studies with concurrent controls conducted in a developed country that evaluated a primary care-relevant breastfeeding intervention among mothers of full- or near-term infants. Of 211 full-text articles reviewed, 52 studies met inclusion criteria. Thirty-one studies were newly identified, and 21 studies were carried forward from the previous review. Data Extraction and Synthesis Independent critical appraisal of all provisionally included studies. Data were independently abstracted by one reviewer and confirmed by another. Main Outcomes and Measures Child and maternal health outcomes, rates and duration of breastfeeding, and harms related to interventions as prespecified before data collection. Results Fifty-two studies (n = 66 757) in 57 publications were included. Six trials (n = 2219) reported inconsistent effects of the interventions on infant health outcomes; no studies reported maternal health outcomes. Pooled estimates based on random-effects meta-analyses using the DerSimonian and Laird method indicated beneficial associations between individual-level breastfeeding interventions and any breastfeeding for less than 3 months (risk ratio [RR], 1.07 [95% CI, 1.03-1.11]; 26 studies [n = 11 588]), at 3 to less than 6 months (RR, 1.11 [95% CI, 1.04-1.18]; 23 studies [n = 8942]), and for exclusive breastfeeding for less than 3 months (RR, 1.21 [95% CI, 1.11-1.33]; 22 studies [n = 8246]), 3 to less than 6 months (RR, 1.20 [95% CI, 1.05-1.38]; 18 studies [n = 7027]), and at 6 months (RR, 1.16 [95% CI, 1.02-1.32]; 17 studies [n = 7690]). Absolute differences in the rates of any breastfeeding ranged from 14.1% in favor of the control group to 18.4% in favor of the intervention group. There was no significant association between interventions and breastfeeding initiation (RR, 1.00 [95% CI, 0.99-1.02]; 14 studies [n = 9428]). There was limited mixed evidence of an association between system-level interventions and rates of breastfeeding from well-controlled studies as well as for harms related to breastfeeding interventions, including maternal anxiety scores, decreased confidence, and concerns about confidentiality. Conclusions and Relevance The updated evidence confirms that breastfeeding support interventions are associated with an increase in the rates of any and exclusive breastfeeding. There are limited well-controlled studies examining the effectiveness of system-level policies and practices on rates of breastfeeding or child health and none for maternal health.

Reported adverse events in young women following quadrivalent human papillomavirus vaccination.

PURPOSE To assess and describe young womens experiences with their first dose of quadrivalent human papillomavirus vaccine (HPV4) (Gardasil®) in a large managed care organization. METHODS We collected survey and electronic medical record (EMR) data for 899 young women aged 11-26 receiving their first HPV4 injection from February through September 2008. Survey items included questions about adverse events, interactions with healthcare providers, and knowledge and attitudes toward HPV disease and HPV4. RESULTS Six hundred ninety-six (78%) participants reported pain at the injection site. Other common reactions included injection site bruising or discoloration (n=155, 17%) or swelling (n=127, 14%) and presyncope or syncope (n=134, 15%). Overall, preteens and teens were more likely than adult participants to report vaccine adverse events. Most respondents, particularly in the adult age group, reported that their healthcare provider reviewed important information about HPV infection and about the risks and benefits of receiving the vaccine. Knowledge and attitudes about HPV and HPV4 also varied by age, with older women generally exhibiting more accurate knowledge about HPV and perceived susceptibility to cervical cancer. CONCLUSIONS There were significant age differences in young womens experiences with their first HPV4 injection. These findings highlight the importance of age-appropriate education and provider communications about HPV disease and vaccination.

Trends in influenza vaccine coverage in pregnant women, 2008 to 2012.

CONTEXT Pregnant women are at increased risk of severe influenza-related complications and hospitalizations and are a priority group for influenza vaccination. OBJECTIVE To examine coverage of seasonal and pandemic influenza A (H1N1) vaccines in pregnant women in a managed care setting, from 2008 to 2012. DESIGN Retrospective cohort study of 10,145 pregnant women. MAIN OUTCOME MEASURES H1N1 and seasonal influenza vaccination rates. RESULTS Seasonal influenza vaccine coverage increased from 38% to 63% between the 2008-2009 and 2010-2011 seasons, and then dropped to 61% in 2011-2012. Vaccine coverage was higher in women considered at high risk of influenza complications, increasing from 43% in 2008-2009 to 71% in 2010-2011, before decreasing to 69% in 2011-2012. H1N1 vaccine coverage was greater than seasonal influenza coverage in 2009-2010 in the overall pregnant population (61% vs 53%) and in the high-risk group (64% vs 59%). We observed statistically significant differences in vaccination rates by trimester, gravidity, maternal age, and race/ethnicity. CONCLUSIONS Vaccination rates increased significantly from 2008 to 2011, then dropped slightly in 2011-2012. Continued efforts are needed to ensure adequate vaccination coverage in this high-risk population.

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.

The Association Between Influenza Vaccination and Other Preventative Health Behaviors in a Cohort of Pregnant Women

Objectives. Although pregnant women are a high-priority group for seasonal influenza vaccination, vaccination rates in this population remain below target levels. Previous studies have identified sociodemographic predictors of vaccine choice, but relationships between preconception heath behaviors and seasonal influenza vaccination are poorly understood. This prospective cohort study followed pregnant women during the 2010-2011 influenza season to determine if certain health behaviors were associated with vaccination status. Method. Participants were pregnant women receiving prenatal care from Kaiser Permanente Northwest and Kaiser Permanente Northern California. Women were surveyed about preconception smoking, alcohol consumption, and vitamin/supplement use. Vaccination data were obtained from health plan databases and state immunization records. Results. Data from 1,204 women were included in this analysis. Most participants (1,204; 66.4%) received a seasonal influenza vaccine during the study period. Women vaccinated prior to pregnancy were more likely to use a supplement containing folic acid (80%) or vitamin D (30%) compared with women who were vaccinated during pregnancy (72% and 15%, respectively) or unvaccinated women (62% and 12%, respectively, p < .001). Women vaccinated prior to or during pregnancy were more likely (75%) to have never smoked compared with women who were not vaccinated (70%, p = .005). There were no significant differences in alcohol use or household cigarette smoke exposure by vaccination group. Conclusions. Women who engaged in specific preconception health behaviors were more likely to receive seasonal influenza vaccination. Failure to participate in these health behaviors could alert health care practitioners to patients’ increased risk of remaining unvaccinated during pregnancy.