Early Estimate of Nirsevimab Effectiveness for Prevention of Respiratory Syncytial Virus-Associated Hospitalization Among Infants Entering Their First Respiratory Syncytial Virus Season - New Vaccine Surveillance Network, October 2023-February 2024.

Respiratory syncytial virus (RSV) is the leading cause of hospitalization among infants in the United States. In August 2023, CDC's Advisory Committee on Immunization Practices recommended nirsevimab, a long-acting monoclonal antibody, for infants aged <8 months to protect against RSV-associated lower respiratory tract infection during their first RSV season and for children aged 8-19 months at increased risk for severe RSV disease. In phase 3 clinical trials, nirsevimab efficacy against RSV-associated lower respiratory tract infection with hospitalization was 81% (95% CI = 62%-90%) through 150 days after receipt; post-introduction effectiveness has not been assessed in the United States. In this analysis, the New Vaccine Surveillance Network evaluated nirsevimab effectiveness against RSV-associated hospitalization among infants in their first RSV season during October 1, 2023-February 29, 2024. Among 699 infants hospitalized with acute respiratory illness, 59 (8%) received nirsevimab ≥7 days before symptom onset. Nirsevimab effectiveness was 90% (95% CI = 75%-96%) against RSV-associated hospitalization with a median time from receipt to symptom onset of 45 days (IQR = 19-76 days). The number of infants who received nirsevimab was too low to stratify by duration from receipt; however, nirsevimab effectiveness is expected to decrease with increasing time after receipt because of antibody decay. Although nirsevimab uptake and the interval from receipt of nirsevimab were limited in this analysis, this early estimate supports the current nirsevimab recommendation for the prevention of severe RSV disease in infants. Infants should be protected by maternal RSV vaccination or infant receipt of nirsevimab.

Evaluation of behavioral economic strategies to raise influenza vaccination rates across a health system: Results from a randomized clinical trial.

Influenza vaccination rates are low. Working with a large US health system, we evaluated three health system-wide interventions using the electronic health record's patient portal to improve influenza vaccination rates. We performed a two-arm RCT with a nested factorial design within the treatment arm, randomizing patients to usual-care control (no portal interventions) or to one or more portal interventions. We included all patients within this health system during the 2020-2021 influenza vaccination season, which overlapped with the COVID-19 pandemic. Through the patient portal, we simultaneously tested: pre-commitment messages (sent September 2020, asking patients to commit to a vaccination); monthly portal reminders (October - December 2020), direct appointment scheduling (patients could self-schedule influenza vaccination at multiple sites); and pre-appointment reminder messages (sent before scheduled primary care appointments, reminding patients about influenza vaccination). The main outcome measure was receipt of influenza vaccine (10/01/2020-03/31/2021). We randomized 213,773 patients (196,070 adults ≥18 years, 17,703 children). Influenza vaccination rates overall were low (39.0%). Vaccination rates for study arms did not differ: Control (38.9%), pre-commitment vs no pre-commitment (39.2%/38.9%), direct appointment scheduling yes/no (39.1%/39.1%), pre-appointment reminders yes/no (39.1%/39.1%); p > 0.017 for all comparisons (p value cut-off adjusted for multiple comparisons). After adjusting for age, gender, insurance, race, ethnicity, and prior influenza vaccination, none of the interventions increased vaccination rates. We conclude that patient portal interventions to remind patients to receive influenza vaccine during the COVID-19 pandemic did not raise influenza immunization rates. More intensive or tailored interventions are needed beyond portal innovations to increase influenza vaccination.

Effect of Personalized Messages Sent by a Health System's Patient Portal on Influenza Vaccination Rates: a Randomized Clinical Trial.

BACKGROUND: Adult influenza vaccination rates are low. Tailored patient reminders might raise rates. OBJECTIVE: Evaluate impact of a health system's patient portal reminders: (1) tailored to patient characteristics and (2) incorporating behavioral science strategies, on influenza vaccination rates among adults. DESIGN: Pragmatic 6-arm randomized trial across a health system during the 2019-2020 influenza vaccination season. The setting was one large health system-53 adult primary care practices. PARTICIPANTS: All adult patients who used the patient portal within 12 months, stratified by the following: young adults (18-64 years, without diabetes), older adults (≥65 years, without diabetes), and those with diabetes (≥18 years). INTERVENTIONS: Patients were randomized within strata to either (1) pre-commitment reminder alone (1 message, mid-October), (2) pre-commitment + loss frame messages, (3) pre-commitment + gain frame messages, (4) loss frame messages alone, (5) gain frame messages alone, or (6) standard of care control. Patients in the pre-commitment group were sent a message in mid-October, asking if they planned on getting an influenza vaccination. Patients in loss or gain frame groups were sent up to 3 portal reminders (late October, November, and December, if no documented influenza vaccination in the EHR) about importance and safety of influenza vaccine. MAIN MEASURES: Receipt of 1 influenza vaccine from 10/01/2019 to 03/31/2020. KEY RESULTS: 196,486 patients (145,166 young adults, 29,795 older adults, 21,525 adults with diabetes) were randomized. Influenza vaccination rates were as follows: for young adults 36.8%, for older adults 55.6%, and for diabetics 60.6%. On unadjusted and adjusted (for age, gender, insurance, race, ethnicity, and prior influenza vaccine history) analyses, influenza vaccination rates were not statistically different for any study group versus control. CONCLUSIONS: Patient reminders sent by a health system's patient portal that were tailored to patient demographics (young adults, older adults, diabetes) and that incorporated two behavioral economic messaging strategies (pre-commitment and loss/gain framing) were not effective in raising influenza vaccination rates. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (NCT04110314).

Perspectives on Maternal Vaccination from Obstetrical Clinicians: A Qualitative Multi-site Study.

OBJECTIVES: Despite the seriousness of influenza and pertussis, availability of safe and effective vaccines against them, and long-standing maternal vaccination recommendations, US maternal influenza and Tdap vaccination rates have been low. To increase vaccination rates in obstetric offices, it is important to understand clinician perspectives and office processes. We conducted in-depth interviews with nurses and providers on these topics. METHODS: Interviewees worked in obstetric offices in one-of-four participating health systems in NY and CA. We audio-recorded and transcribed 20-30-min interviews. We used predetermined categories to code interviews with Dedoose, then iteratively refined codes and identified themes. RESULTS: We conducted 20 interviews between 4/2020 and 9/2020: 13 providers (physician or nurse midwife) (5 NY, 8 CA); 7 office nurses (6 NY, 1 CA). In almost all offices, patient refusal of influenza vaccine was considered the major vaccination barrier; Tdap was often deferred by patients until post-delivery. Nurse-only visits for either vaccine were rare. Vaccination outside the office was uncommon; few offices systematically documented vaccines given elsewhere in a retrievable manner. Participants emphasized patient education as key to prenatal care, but the number of topics left little time for immunizations. Few interviewees could identify an office "immunization champion," knew their office vaccination rates, or had participated in vaccination quality improvement. Several interviewees indicated that they or another provider were good at persuading hesitant patients, but their method had not been shared with other clinicians. CONCLUSIONS FOR PRACTICE: Multiple practical barriers and maternal vaccine hesitancy limit maternal vaccination. Quality improvement strategies are needed.

Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages.

OBJECTIVE: To evaluate the effect of different modalities of centralized reminder/recall (autodialer, text, mailed reminders) on increasing childhood influenza vaccination. STUDY DESIGN: Two simultaneous randomized clinical trials conducted from October 2017 to April 1, 2018, in New York State and Colorado. There were 61 931 children in New York (136 practices) and 23 845 children in Colorado (42 practices) who were randomized to different centralized reminder/recall modalities-4 arms in New York (autodialer, text, mailed, and no reminder control) and 3 arms in Colorado (autodialer, mailed, and no reminder control). The message content was similar across modalities. Up to 3 reminders were sent for intervention arms. The main outcome measure was receipt of ≥1 influenza vaccine. RESULTS: In New York, compared with the control arm (26.6%), postintervention influenza vaccination rates in the autodialer arm (28.0%) were 1.4 percentage points higher (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10), but the rates for text (27.6%) and mail (26.8%) arms were not different from controls. In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively. Compared with the control arm, the incremental cost per additional vaccine delivered was $20 (New York) and $16 (Colorado) for autodialer messages. CONCLUSIONS: Centralized reminder/recall for childhood influenza vaccine was most effective via autodialer, less effective via mail, and not effective via text messages. The impact of each modality was modest. Compared with no reminders, the incremental cost per additional vaccine delivered was also modest for autodialer messages. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03294473 and NCT03246100.

A quality improvement collaborative to increase human papillomavirus vaccination rates in local health department clinics.

Human papillomavirus (HPV) vaccination rates are well below the Healthy People 2020 goal of 80%. Vaccinating in settings other than primary care, such as local health departments (LHDs), may help achieve higher HPV immunization rates. We tested the effect of a quality improvement (QI) collaborative to reduce missed opportunities (MOs) for HPV vaccine in LHDs. Between 2016 and 2019, we conducted four consecutive cohorts of a virtual QI collaborative at 24 LHDs across multiple states. Participants were trained on topics including how to provide an effective recommendation for HPV vaccine, strategies to reduce MOs, and motivational interviewing. Throughout the 6-month project implementation, LHDs tested strategies to reduce MOs through Plan-Do-Study-Act cycles, performed chart reviews to identify and characterize MOs, and received feedback reports to assess progress on MOs. HPV vaccination rates were assessed pre- and post-intervention. LHDs reduced MOs for HPV vaccine in all four cohorts with aggregated data showing a 25.3 percentage point reduction in MOs. Modified Poisson regression analysis found a 44% reduction in the relative risk of missing the opportunity for an HPV vaccine at a visit (RR = 0.56, 0.46-0.68, p < .001). This project shows that strategies effective in reducing MO for HPV vaccine in primary care settings are also effective in LHD settings. Training LHD staff on these strategies may help the U.S. approach national goals for HPV vaccine coverage.

Cost effectiveness of school-located influenza vaccination programs for elementary and secondary school children.

BACKGROUND: Studies have noted variations in the cost-effectiveness of school-located influenza vaccination (SLIV), but little is known about how SLIV's cost-effectiveness may vary by targeted age group (e.g., elementary or secondary school students), or vaccine consent process (paper-based or web-based). Further, SLIV's cost-effectiveness may be impacted by its spillover effect on practice-based vaccination; prior studies have not addressed this issue. METHODS: We performed a cost-effectiveness analysis on two SLIV programs in upstate New York in 2015-2016: (a) elementary school SLIV using a stepped wedge design with schools as clusters (24 suburban and 18 urban schools) and (b) secondary school SLIV using a cluster randomized trial (16 suburban and 4 urban schools). The cost-per-additionally-vaccinated child (i.e., incremental cost-effectiveness ratio (ICER)) was estimated by dividing the incremental SLIV intervention cost by the incremental effectiveness (i.e., the additional number of vaccinated students in intervention schools compared to control schools). We performed deterministic analyses, one-way sensitivity analyses, and probabilistic analyses. RESULTS: The overall effectiveness measure (proportion of children vaccinated) was 5.7 and 5.5 percentage points higher, respectively, in intervention elementary (52.8%) and secondary schools (48.2%) than grade-matched control schools. SLIV programs vaccinated a small proportion of children in intervention elementary (5.2%) and secondary schools (2.5%). In elementary and secondary schools, the ICER excluding vaccine purchase was $85.71 and $86.51 per-additionally-vaccinated-child, respectively. When additionally accounting for observed spillover impact on practice-based vaccination, the ICER decreased to $80.53 in elementary schools -- decreasing substantially in secondary schools. (to $53.40). These estimates were higher than the published practice-based vaccination cost (median = $25.50, mean = $45.48). Also, these estimates were higher than our 2009-2011 urban SLIV program mean costs ($65) due to additional costs for use of a new web-based consent system ($12.97 per-additionally-vaccinated-child) and higher project coordination costs in 2015-2016. One-way sensitivity analyses showed that ICER estimates were most sensitive to the SLIV effectiveness. CONCLUSIONS: SLIV raises vaccination rates and may increase practice-based vaccination in primary care practices. While these SLIV programs are effective, to be as cost-effective as practice-based vaccination our SLIV programs would need to vaccinate more students and/or lower the costs for consent systems and project coordination. TRIAL REGISTRATION: ClinicalTrials.gov NCT02227186 (August 25, 2014), updated NCT03137667 (May 2, 2017).

Text vs Patient Portal Messaging to Improve Influenza Vaccination Coverage: A Health System-Wide Randomized Clinical Trial.

Importance: Increasing influenza vaccination rates is a public health priority. One method recommended by the US Centers for Disease Control and Prevention and others is for health systems to send reminders nudging patients to be vaccinated. Objective: To evaluate and compare the effect of electronic health record (EHR)-based patient portal reminders vs text message reminders on influenza vaccination rates across a health system. Design, Setting, and Participants: This 3-arm randomized clinical trial was conducted from September 7, 2022, to April 30, 2023, among primary care patients within the University of California, Los Angeles (UCLA) health system. Interventions: Arm 1 received standard of care. The health system sent monthly reminder messages to patients due for an influenza vaccine by portal (arm 2) or text (arm 3). Arm 2 had a 2 × 2 nested design, with fixed vs responsive monthly reminders and preappointment vs no preappointment reminders. Arm 3 had 1 × 2 design, with preappointment vs no preappointment reminders. Preappointment reminders for eligible patients were sent 24 and 48 hours before scheduled primary care visits. Fixed reminders (in October, November, and December) involved identical messages via portal or text. Responsive portal reminders involved a September message asking patients about their plans for vaccination, with a follow-up reminder if the response was affirmative but the patient was not yet vaccinated. Main Outcomes and Measures: The primary outcome was influenza vaccination by April 30, 2023, obtained from the UCLA EHR, including vaccination from pharmacies and other sources. Results: A total of 262 085 patients (mean [SD] age, 45.1 [20.7] years; 237 404 [90.6%] adults; 24 681 [9.4%] children; 149 349 [57.0%] women) in 79 primary care practices were included (87 257 in arm 1, 87 478 in arm 2, and 87 350 in arm 3). At the entire primary care population level, none of the interventions improved influenza vaccination rates. All groups had rates of approximately 47%. There was no statistical or clinically significant improvement following portal vs text, preappointment reminders vs no preappointment reminders (portal and text reminders combined), or responsive vs fixed monthly portal reminders. Conclusions and Relevance: At the population level, neither portal nor text reminders for influenza vaccination were effective. Given that vaccine hesitancy may be a major reason for the lack of impact of portal or text reminders, more intensive interventions by health systems are needed to raise influenza vaccination coverage levels. Trial Registration: ClinicalTrials.gov Identifier: NCT05525494.

Respiratory Syncytial Virus-Associated Hospitalizations in Children <5 Years: 2016-2022.

BACKGROUND: The coronavirus disease 2019 pandemic disrupted respiratory syncytial virus (RSV) seasonality resulting in early, atypical RSV seasons in 2021 and 2022, with an intense 2022 peak overwhelming many pediatric healthcare facilities. METHODS: We conducted prospective surveillance for acute respiratory illness during 2016-2022 at 7 pediatric hospitals. We interviewed parents, reviewed medical records, and tested respiratory specimens for RSV and other respiratory viruses. We estimated annual RSV-associated hospitalization rates in children aged <5 years and compared hospitalization rates and characteristics of RSV-positive hospitalized children over 4 prepandemic seasons (2016-2020) to those hospitalized in 2021 or 2022. RESULTS: There was no difference in median age or age distribution between prepandemic and 2021 seasons. Median age of children hospitalized with RSV was higher in 2022 (9.6 months vs 6.0 months, P < .001). RSV-associated hospitalization rates were higher in 2021 and 2022 than the prepandemic average across age groups. Comparing 2021 to 2022, RSV-associated hospitalization rates were similar among children <2 years of age; however, children aged 24 to 59 months had significantly higher rates of RSV-associated hospitalization in 2022 (rate ratio 1.68 [95% confidence interval 1.37-2.00]). More RSV-positive hospitalized children received supplemental oxygen and there were more respiratory virus codetections in 2022 than in prepandemic seasons (P < .001 and P = .003, respectively), but there was no difference in the proportion hypoxemic, mechanically ventilated, or admitted to intensive care. CONCLUSIONS: The atypical 2021 and 2022 RSV seasons resulted in higher hospitalization rates with similar disease severity to prepandemic seasons.

Performance Feedback for Human Papillomavirus Vaccination: A Randomized Trial From the American Academy of Pediatrics Pediatric Research in Office Settings Research Network.

OBJECTIVE: To test the hypothesis that a feedback-based intervention would reduce human papillomavirus (HPV) vaccine missed opportunities. METHODS: In a longitudinal cluster randomized controlled trial of 48 pediatric primary care practices, we allocated half the practices to receive a sequential, multicomponent intervention phased over consecutive periods. In a prior trial (period 1), communication skills training reduced missed opportunities for the initial HPV vaccine dose at well visits but not at acute/chronic visits. The current trial (period 2) evaluated the added value of performance feedback to clinicians after communication training. Performance feedback consisted of an introductory training module, weekly electronic "Quick Tips," and 3 individualized performance feedback reports to clinicians. We fit logistic regression models for the primary outcome of HPV vaccination missed opportunities using generalized estimating equations with independence working correlation, accounting for clustering at the practice level. RESULTS: Performance feedback resulted in a 3.4 (95% confidence interval [CI]: -6.8, 0.0) percentage point greater reduction in missed HPV vaccine opportunities for the intervention versus control group during acute/chronic visits for subsequent HPV vaccinations (dose 2 or 3). However, during well visits for HPV vaccination dose #1, intervention practices increased missed opportunities (worsened) by 4.2 (95% CI: 1.0, 7.4) percentage points more than control practices, reducing the prior period 1 improvements and blunting the overall effect of performance feedback. We did not observe differences for the other visit/dose categories. CONCLUSIONS: Performance feedback improved HPV vaccination for one subset of visits (acute/chronic, subsequent HPV vaccinations due), but not for well visits.

Missed Opportunities for Adolescent Immunizations at Well-Care Visits During the COVID-19 Pandemic.

PURPOSE: The Coronavirus Disease 2019 pandemic disrupted healthcare, but the impact on vaccination missed opportunities (MOs, vaccine-eligible visits without vaccination) is unknown. We evaluated pandemic-related trends in MOs at adolescent well-care visits for three vaccines: human papillomavirus; quadrivalent meningococcal conjugate; and tetanus, diphtheria, and acellular pertussis (Tdap). METHODS: We analyzed electronic health record data from 24 pediatric primary care practices in 13 states from 1/1/2018 to 12/31/2021. Segmented logistic regression estimated risk differences for MOs during the pandemic relative to prepandemic trends. RESULTS: Among 106,605 well-care visits, we observed decreases in MOs prepandemic followed by an increase in MOs during the pandemic for all three vaccines. Relative to prepandemic, MOs increased for human papillomavirus (+15.9%, 95% confidence interval [CI]: 11.7%, 20.1%), meningococcal conjugate (+9.4%, 95% CI: 5.2%, 13.7%), and tetanus, diphtheria, and acellular pertussis (Tdap) (+ 8.2%, 95% CI: 4.3%, 12.1%). DISCUSSION: Increases in vaccine MOs during the pandemic equaled or exceeded pre-pandemic decreases. Reducing MOs in adolescent well-care could raise vaccine coverage.

Clinician Prompts for Human Papillomavirus Vaccination: A Cluster Randomized Trial.

OBJECTIVE: We assessed the impact of an online intervention using clinician prompts for human papillomavirus (HPV) vaccination with a cluster randomized controlled trial. METHODS: The randomized trial occurred July 2021-January 2022 in 48 primary care pediatric practices (24 intervention, 24 control) across the US. We trained clinicians via two online learning modules, plus weekly ''quick tips'' delivered via text or email. The training taught practices to implement a staff prompt to the clinician (e.g., printed reminders placed on the keyboard) plus electronic health record (EHR) prompts (if not already done) at well and acute/chronic visits for initial and subsequent HPV vaccination. We assessed missed opportunities for HPV vaccination using logistic regression models accounting for clustering by practice on an intent to treat basis. Surveys assessed facilitators and barriers to using prompts. RESULTS: During the 6-month intervention, missed opportunities for HPV vaccination increased (worsened) in both intervention and control groups. However, at well child care visits, missed opportunities for the initial HPV vaccine increased by 4.5 (95% CI: -9.0%, -0.1%) percentage points less in intervention versus control practices. Change in missed opportunities for subsequent doses at well child care and non-well child care visits did not differ between trial groups. An end-of trial survey found understaffing as a common challenge. CONCLUSIONS: Clinician prompts reduced missed opportunities for HPV vaccination at well child care visits. Understaffing related to the COVID-19 pandemic may have led to worsening missed opportunities for both groups and likely impeded practices in fully implementing changes.

Behavioral and Social Drivers of COVID-19 Vaccination in the United States, August-November 2021.

INTRODUCTION: COVID-19 vaccines are safe, effective, and widely available, but many adults in the U.S. have not been vaccinated for COVID-19. This study examined the associations between behavioral and social drivers of vaccination with COVID-19 vaccine uptake in the U.S. adults and their prevalence by region. METHODS: A nationally representative sample of U.S. adults participated in a cross-sectional telephone survey in August-November 2021; the analysis was conducted in January 2022. Survey questions assessed self-reported COVID-19 vaccine initiation, demographics, and behavioral and social drivers of vaccination. RESULTS: Among the 255,763 respondents, 76% received their first dose of COVID-19 vaccine. Vaccine uptake was higher among respondents aged ≥75 years (94%), females (78%), and Asian non-Hispanic people (94%). The drivers of vaccination most strongly associated with uptake included higher anticipated regret from nonvaccination, risk perception, and confidence in vaccine safety and importance, followed by work- or school-related vaccination requirements, social norms, and provider recommendation (all p<0.05). The direction of association with uptake varied by reported level of difficulty in accessing vaccines. The prevalence of all of these behavioral and social drivers of vaccination was highest in the Northeast region and lowest in the Midwest and South. CONCLUSIONS: This nationally representative survey found that COVID-19 vaccine uptake was most strongly associated with greater anticipated regret, risk perception, and confidence in vaccine safety and importance, followed by vaccination requirements and social norms. Interventions that leverage these social and behavioral drivers of vaccination have the potential to increase COVID-19 vaccine uptake and could be considered for other vaccine introductions.

Obstetric Provider Attitudes and Office Practices for Maternal Influenza and Tdap Vaccination.

Background: Although maternal vaccination with influenza and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines improve health outcomes for pregnant individuals and infants, maternal vaccination rates are low. This study assessed obstetric providers' attitudes and practices related to influenza and Tdap vaccination in four large health systems in New York (NY) and California (CA). Methods: We conducted a cross-sectional survey of all obstetric providers within four health systems (two in NY, two in CA) to evaluate provider attitudes and office systems used for Tdap and influenza vaccination. The survey assessed perceptions of influenza and Tdap vaccination based on the Health Belief Model, and assessed office systems (reminders, prompts, standing orders, and patient education) and communication with pregnant patients related to influenza and Tdap vaccines. Results: We had 112 responses (52% response rate) for analyses. Respondents strongly supported vaccination during pregnancy but viewed influenza disease as less of a concern for newborns than for pregnant individuals (40% vs. 67% considered influenza disease to be very significant, p < 0.001). Only 84% agreed that giving influenza vaccine in the first trimester is very safe. Patient vaccine refusal was the most commonly named barrier for both influenza and Tdap vaccination. Providers frequently used office system prompts, but did not frequently use standing orders, patient educational materials, vaccine champions, and feedback on vaccination rates. Conclusions: While most providers consider influenza and Tdap vaccination important during pregnancy, there is room for improvement in focusing on the importance of maternal vaccination to the health of the infant, and increasing the use of office systems to improve vaccination during pregnancy.

A multi-center, qualitative assessment of pediatrician and maternal perspectives on rotavirus vaccines and the detection of Porcine circovirus.

BACKGROUND: In 2010, researchers using novel laboratory techniques found that US-licensed rotavirus vaccines contain DNA or DNA fragments from Porcine circovirus (PCV), a virus common among pigs but not believed to cause illness in humans. We sought to understand pediatricians' and mothers' perspectives on this finding. METHODS: We conducted three iterations of focus groups for pediatricians and non-vaccine hesitant mothers in Seattle, WA, Cincinnati, OH, and Rochester, NY. Focus groups explored perceptions of rotavirus disease, rotavirus vaccination, and attitudes about the detection of PCV material in rotavirus vaccines. RESULTS: Pediatricians understood firsthand the success of rotavirus vaccines in preventing severe acute gastroenteritis among infants and young children. They measured this benefit against the theoretical risk of DNA material from PCV in rotavirus vaccines, determining overall that the PCV finding was of no clinical significance. Particularly influential was the realization that the large, randomized clinical trials that found both vaccines to be highly effective and safe were conducted with DNA material from PCV already in the vaccines.Most mothers supported the ideal of full disclosure regarding vaccination risks and benefits. However, with a scientific topic of this complexity, simplified information regarding PCV material in rotavirus vaccines seemed frightening and suspicious, and detailed information was frequently overwhelming. Mothers often remarked that if they did not understand a medical or technical topic regarding their child's health, they relied on their pediatrician's guidance.Many mothers and pediatricians were also concerned that persons who abstain from pork consumption for religious or personal reasons may have unsubstantiated fears of the PCV finding. CONCLUSIONS: Pediatricians considered the detection of DNA material from PCV in rotavirus vaccines a "non-issue" and reported little hesitation in continuing to recommend the vaccines. Mothers desired transparency, but ultimately trusted their pediatrician's recommendation. Both vaccines are currently approved for their intended use, and no risk of human PCV illness has been reported. Communicating this topic to pediatricians and mothers requires sensitivity to a broad range of technical understanding and personal concerns.

A validated modification of the vaccine hesitancy scale for childhood, influenza and HPV vaccines.

INTRODUCTION: Vaccine hesitancy contributes to outbreaks of preventable disease worldwide. The Vaccine Hesitancy Scale (VHS), developed by the international WHO SAGE Working Group, has been validated previously for measuring hesitancy towards childhood vaccines; some psychometric properties were suboptimal. METHODS: We collected data using large, nationally-representative samples of parents in the U.S. We adapted the VHS items, and additional hesitancy items, to assess hesitancy towards influenza and HPV vaccines in addition to routine childhood vaccines. We then used exploratory and confirmatory factor analysis to identify latent constructs and create modified scales for childhood (VHS-child), influenza (VHS-flu) and HPV (VHS-HPV) vaccines with improved psychometric properties. Finally, we compared hesitancy scores on the VHS-child, VHS-flu, and VHS-HPV, to self-reported receipt of each vaccine category, and compared subscale scores to assess whether drivers of hesitancy differed by vaccine category. RESULTS: 2052 parents of children <18 years old completed the VHS-child and VHS-flu while 2020 parents of adolescents completed the VHS-HPV. A two-factor structure of 'risks' and a 'lack of confidence' was found for each vaccine category. Slight modifications to the VHS improved psychometric properties. Hesitancy was strongly associated with vaccine receipt: e.g., 76% of parents not hesitant towards influenza vaccine had vaccinated their child the past season, versus 9% of hesitant parents (p < 0.0001). Subscale scores also differed significantly between vaccines: lack of confidence was greater towards influenza (Median (IQR): 2.0 (1.2, 3.3)) and HPV (2.0 (1.3, 3.0)) vaccines than childhood (1.2 (1.0, 1.8), p < 0.0001 for both) vaccines; perceived risks of HPV vaccines (2.7 (1.7, 3.7)) were greater than for childhood vaccines (2.0 (1.3, 3.0), p < 0.0001). CONCLUSIONS: Our modified VHS scales perform well psychometrically and allow for consistent measurement of the extent and reasons for hesitancy between vaccine categories. We suggest that future work use these scales to examine hesitancy towards other vaccines and to monitor hesitancy over time.

Patient Portal Reminders for Pediatric Influenza Vaccinations: A Randomized Clinical Trial.

OBJECTIVES: In a large health system, we evaluated the effectiveness of electronic health record patient portal reminders in increasing pediatric influenza vaccination rates. METHODS: We conducted an intention-to-treat randomized clinical trial of 22 046 children from 6 months to <18 years of age in 53 primary care practices. Patients (or parent and/or proxies) who were active portal users were randomly assigned to receive reminder messages framed as gains or losses or no messages. They were separately randomly assigned to receive a precommitment message before the influenza season. The primary outcome was receipt of ≥1 seasonal influenza vaccinations. Additionally, children 6 months to <3 years of age due for a second influenza vaccine were randomly assigned to receive a reminder or no reminder for the second vaccination. RESULTS: First-dose influenza vaccination rates were 56.9% in the control group, 58.0% in the loss-frame reminders group (P = .07), and 58.0% in the gain-frame group (P = .47). Rates were 58.3% in the precommitment group versus 57.0% in the control group (P = .11). Adjusted risk ratios for first vaccination were 1.02 (95% confidence interval [CI]: 1.00-1.04) for loss-frame reminders, 1.01 (95% CI: 0.98-1.05) for gain-frame reminders, and 1.02 (95% CI: 1.00-1.04) for precommitment messages versus controls. Second-dose vaccination rates were 44.1% in the control group and 55.0% in the reminder group, with an adjusted risk ratio of 1.25 (95% CI: 1.07-1.45). CONCLUSIONS: Patient portal reminders for influenza vaccines in children, whether framed as gains or losses, did not increase first-dose influenza vaccination rates but were highly effective for the second dose of the vaccine.

Centralized Reminder/Recall for Human Papillomavirus Vaccination: Findings From Two States-A Randomized Clinical Trial.

PURPOSE: Centralized reminder/recall (C-R/R) using Immunization Information Systems has been effective in increasing childhood immunization rates. Previously, C-R/R using autodialer for human papillomavirus (HPV) vaccine did not raise rates. We assessed C-R/R for HPV vaccine using other modalities and focused on younger adolescents. METHODS: We conducted a three-arm pragmatic RCT in randomly sampled primary care practices in Colorado (n = 88) and New York (n = 136), proportionate to where adolescents received care. We randomized, within practices, adolescents aged 11-14 years who had not completed the HPV vaccination series to receive C-R/R using different modalities (Colorado: autodialer, mail, or control; New York: autodialer, text, or control). Up to two reminders were sent in intervention arms for each dose needed between 2/2017 and 12/2018. RESULTS: In Colorado, no significant differences were found for series initiation (31.3% control, 31.1% autodial, 31.8% mail), with slight improvement for series completion in the autodialer arm (29.7% control, 31.1% autodialer, p = .04) but not the mail arm (30.9%, p = .06). No significant differences were found in New York for series initiation (24.1% for all arms) or completion (17.1% control, 16.9% autodial, 17.9% text). Adjusted analyses showed higher completion rates for the autodialer arm in Colorado but not for other arms. In Colorado, C-R/R reduced time to series completion by around 2 months. Cost per adolescent was $1.81 for mail; under $.40 for all other modalities. CONCLUSIONS: C-R/R has less benefit for raising HPV vaccination rates than other studies have noted for childhood immunizations, although it may quicken series completion at little cost.

Effect of Training Pediatric Clinicians in Human Papillomavirus Communication Strategies on Human Papillomavirus Vaccination Rates: A Cluster Randomized Clinical Trial.

Importance: Missed opportunities for human papillomavirus (HPV) vaccination during pediatric health care visits are common. Objectives: To evaluate the effect of online communication training for clinicians on missed opportunities for HPV vaccination rates overall and at well-child care (WCC) visits and visits for acute or chronic illness (hereafter referred to as acute or chronic visits) and on adolescent HPV vaccination rates. Design, Setting, and Participants: From December 26, 2018, to July 30, 2019, a longitudinal cluster randomized clinical trial allocated practices to communication training vs standard of care in staggered 6-month periods. A total of 48 primary care pediatric practices in 19 states were recruited from the American Academy of Pediatrics Pediatric Research in Office Settings network. Participants were clinicians in intervention practices. Outcomes were evaluated for all 11- to 17-year-old adolescents attending 24 intervention practices (188 clinicians) and 24 control practices (177 clinicians). Analyses were as randomized and performed on an intent-to-treat basis, accounting for clustering by practice. Interventions: Three sequential online educational modules were developed to help participating clinicians communicate with parents about the HPV vaccine. Weekly text messages were sent to participating clinicians to reinforce learning. Statisticians were blinded to group assignment. Main Outcomes and Measures: Main outcomes were missed opportunities for HPV vaccination overall and for HPV vaccine initiation and subsequent doses at WCC and acute or chronic visits (visit-level outcome). Secondary outcomes were HPV vaccination rates (person-level outcome). Outcomes were compared during the intervention vs baseline. Results: Altogether, 122 of 188 clinicians in intervention practices participated; of these, 120, 119, and 116 clinicians completed training modules 1, 2, and 3, respectively. During the intervention period, 29 206 adolescents (14 664 girls [50.2%]; mean [SD] age, 14.2 [2.0] years) made 15 888 WCC and 28 123 acute or chronic visits to intervention practices; 33 914 adolescents (17 069 girls [50.3%]; mean [SD] age, 14.2 [2.0] years) made 17 910 WCC and 35 281 acute or chronic visits to control practices. Intervention practices reduced missed opportunities overall by 2.4 percentage points (-2.4%; 95% CI, -3.5% to -1.2%) more than controls. Intervention practices reduced missed opportunities for vaccine initiation during WCC visits by 6.8 percentage points (-6.8%; 95% CI, -9.7% to -3.9%) more than controls. The intervention had no effect on missed opportunities for subsequent doses of the HPV vaccine or at acute or chronic visits. Adolescents in intervention practices had a 3.4-percentage point (95% CI, 0.6%-6.2%) greater improvement in HPV vaccine initiation compared with adolescents in control practices. Conclusions and Relevance: This scalable, online communication training increased HPV vaccination, particularly HPV vaccine initiation at WCC visits. Results support dissemination of this intervention. Trial Registration: ClinicalTrials.gov Identifier: NCT03599557.

Identifying Strategies to Reduce Missed Opportunities for HPV Vaccination in Primary Care: A Qualitative Study of Positive Deviants.

The objectives of this study were to assess the contextual factors, practice strategies, and sustainability of interventions implemented during a national quality improvement (QI) project to raise human papillomavirus (HPV) vaccination rates. We conducted semistructured interviews with positive deviant practices that successfully reduced missed opportunities by ≥20% for HPV vaccination in the prior year. We assessed leadership support, motivators, interventions used, and sustainability. Key themes related to QI teams included strong leadership support, multidisciplinary teams, having a practice champion, and a collaborative environment. Themes related to the interventions included using a presumptive bundled recommendation for all appropriate vaccines at age 11, previsit planning, and reminders for preventive visits, which were sustainable for most practices 1-year postintervention. Both internal practice-level factors (multidisciplinary teams, collaboration, and previsit planning) and organizational factors (institutional support and health system-level reminders for preventive visits) were key to a successful QI intervention to improve HPV vaccination.