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"Raviotta, Jonathan M."
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Using the 4 pillars™ practice transformation program to increase adult influenza vaccination and reduce missed opportunities in a randomized cluster trial
2016
Background
An evidence-based, step-by-step guide, the 4 Pillars™ Practice Transformation Program, was the foundation of an intervention to increase adult immunizations in primary care and was tested in a randomized controlled cluster trial. The purpose of this study is to report changes in influenza immunization rates and on factors related to receipt of influenza vaccine.
Methods
Twenty five primary care practices were recruited in 2013, stratified by city (Houston, Pittsburgh), location (rural, urban, suburban) and type (family medicine, internal medicine), and randomized to the intervention (
n
= 13) or control (
n
= 12) in Year 1 (2013-14). A follow-up intervention occurred in Year 2 (2014-15). Demographic and vaccination data were derived from de-identified electronic medical record extractions.
Results
A cohort of 70,549 adults seen in their respective practices (
n
= 24 with 1 drop out) at least once each year was followed. Baseline mean age was 55.1 years, 35 % were men, 21 % were non-white and 35 % were Hispanic. After one year, both intervention and control arms significantly (
P
< 0.001) increased influenza vaccination, with average increases of 2.7 to 6.5 percentage points. In regression analyses, likelihood of influenza vaccination was significantly higher in sites with lower percentages of patients with missed opportunities (
P
< 0.001) and, after adjusting for missed opportunities, the intervention further improved vaccination rates in Houston (lower baseline rates) but not Pittsburgh (higher baseline rates). In the follow-up intervention, the likelihood of vaccination increased for both intervention sites and those that reduced missed opportunities (
P
< 0.005).
Conclusions
Reducing missed opportunities across the practice increases likelihood of influenza vaccination of adults. The 4 Pillars™ Practice Transformation Program provides strategies for reducing missed opportunities to vaccinate adults.
Trial registration
This study was registered as a clinical trial on 03/20/2013 at ClinicalTrials.gov, Clinical Trial Registry Number:
NCT01868334
, with a date of enrollment of the first participant to the trial of April 1, 2013.
Journal Article
Influenza Vaccine Effectiveness in the United States During 2012-2013: Variable Protection by Age and Virus Type
2015
Background. During the 2012-2013 influenza season, there was cocirculation of influenza A(H3N2) and 2 influenza lineage viruses in the United States. Methods. Patients with acute cough illness for ≤7 days were prospectively enrolled and had swab samples obtained at outpatient clinics in 5 states. Influenza vaccination dates were confirmed by medical records. The vaccine effectiveness (VE) was estimated as [100% × (1 - adjusted odds ratio)] for vaccination in cases versus test-negative controls. Results. Influenza was detected in 2307 of 6452 patients (36%); 1292 (56%) had influenza A(H3N2), 582 (25%) had influenza B/Yamagata, and 303 (13%) had influenza B/Victoria. VE was 49% (95% confidence interval [CI], 43%-55%) overall, 39% (95% CI, 29%-47%) against influenza A(H3N2), 66% (95% CI, 58%-73%) against influenza B/Yamagata (vaccine lineage), and 51% (95% CI, 36%-63%) against influenza B/Victoria. VE against influenza A(H3N2) was highest among persons aged 50-64 years (52%; 95% CI, 33%-65%) and persons aged 6 months-8 years (51%; 95% CI, 32%-64%) and lowest among persons aged ≥65 years (11%; 95% CI, -41% to 43%). In younger age groups, there was evidence of residual protection from receipt of the 2011-2012 vaccine 1 year earlier. Conclusions. The 2012-2013 vaccines were moderately effective in most age groups. Cross-lineage protection and residual effects from prior vaccination were observed and warrant further investigation.
Journal Article
Cost-effectiveness of recombinant influenza vaccine compared with standard dose influenza vaccine in adults 18–64 years of age
2024
•ACIP prefers enhanced vaccines such as recombinant influenza vaccine (RIV4) and could consider RIV4 for all adults.•This model from the societal perspective suggests that RIV4 is cost-effective compared with SD-IIV4 in adults 18–64 years old.•This model comparing RIV4 and SD-IIV4 in adults 18–64 years is sensitive to vaccine efficacy, vaccine cost and other factors.•Use of RIV4 in 18–64-year-olds would result in fewer influenza cases, outpatient visits, hospitalizations and deaths.
The Advisory Committee on Immunization Practices (ACIP) uses the Evidence to Recommendations Framework that includes cost-effectiveness analyses (CEA) for determining vaccine recommendations. ACIP’s preference for protecting adults ≥ 65 years is enhanced vaccines, including recombinant influenza vaccine (RIV4), adjuvanted or high dose influenza vaccine. Less is known about the CEA of enhanced vaccines for younger adults.
We used decision analysis modeling from a societal perspective to determine the cost-effectiveness, measured in quality adjusted life years (QALYs), of RIV4 compared with standard dose quadrivalent influenza vaccine (SD-IIV4) in adults 18–64 years old. Model inputs included 2018–2020 vaccine effectiveness (VE) estimates based on medical record data from a large local health system, 2019–2020 national vaccination and influenza epidemic parameters, with costs and population distributions fitted to the season.
Among adults ages 18–64 years, RIV4 cost $94,186/QALY gained, compared to SD-IIV4. Among those 50–64 years old, RIV4 was relatively more cost-effective ($61,329/QALY gained). Cost-effectiveness estimates for 18–64-year-olds were sensitive to the absolute difference in VE between SD-IIV4 and RIV4, among other parameters. Use of RIV4 in 18–64-year-olds would result in fewer cases (669,984), outpatient visits (261,293), hospitalizations (20,046) and deaths (1,018) annually. The majority (59 %; 597 of 1018) of the decreases in deaths occurred in the 50–64-year-olds.
While RIV4 was effective and cost-effective relative to SD-IIV4 for both 50–64-year-old and 18–64-year-old adults, cost-effectiveness was sensitive to small changes in parameters among 18–64-year-olds. Because substantial public health benefits occur with enhanced vaccines, health systems and policy makers may opt for preferential product use in select age/risk groups (e.g., 50–64 year olds) to maximize their cost-benefit ratios.
Journal Article
Vaccine effectiveness of recombinant and standard dose influenza vaccines against influenza related hospitalization using a retrospective test-negative design
2023
Relative effectiveness of various vaccine formulations provide important input for vaccine policy decisions and provider purchasing decisions. We used electronic databases to conduct a test-negative case control study to determine relative vaccine effectiveness (rVE) of recombinant influenza vaccine (RIV4) compared with standard dose vaccines (SD-IIV4) against influenza hospitalization.
Adults 18–64 and ≥65 years of age hospitalized in a large U.S. health system (19 hospitals) in 2018–2019 and 2019–2020 who were clinically tested for influenza using reverse transcription polymerase chain reaction (RT-PCR) assays were included. The hospital system electronic medical record (EMR) and the state immunization registry were used to confirm influenza vaccination. Propensity scores with inverse probability weighting were used to adjust for potential confounders and determine rVE.
Of the 14,590 individuals included in the primary analysis, 3,338 were vaccinated with RIV4 and 976 were vaccinated with SD-IIV4, with the balance of 10,276 being unvaccinated. Most participants were white (80 %), most (70 %) had a high-risk condition, just over half were female (54 %) and age 65 years or older (53 %). Overall RIV4 rVE was significant when adjusted for propensity scores with inverse probability weights (rVE = 31; 95 % CI = 11 %, 46 %). Among younger adults (18–64 years-old), overall rVE of RIV4 was significant (rVE = 29; 95 % CI = 4 %, 47 %).
Over all adults, both RIV4 and SD-IIV4 were effective against influenza hospitalization, with RIV4 providing better protection compared with SD-IIV4 overall, for females, younger adults, and those with no high-risk conditions.
Journal Article
Using Facebook™ to Recruit College-Age Men for a Human Papillomavirus Vaccine Trial
by
Raviotta, Jonathan M.
,
Huang, Hsin-Hui
,
Lin, Chyongchiou Jeng
in
Adolescent
,
Adult
,
Health Promotion - organization & administration
2016
College-age men were recruited using Facebook™ advertisements (ads), as well as traditional recruitment methods, for a randomized controlled trial to compare immunological responses to human papillomavirus vaccine administered in two dosing schedules. This study compares enrollees who were recruited through traditional recruitment methods versus social networking sites (SNSs), including Facebook. Potential participants were recruited using flyers posted on and off campus(es), and distributed at health fairs, classes, sporting, and other campus events; e-mails to students and student organizations; and print advertisements in student newspapers and on city buses. Facebook ads were displayed to users with specific age, geographic, and interest characteristics; ads were monitored daily to make adjustments to improve response. A total of 220 males, aged 18 to 25 years enrolled between October 2010 and May 2011. The majority of participants (51%) reported print advertisements as the method by which they first heard about the study, followed by personal contact (29%) and Facebook or other SNSs (20%). The likelihood of a SNS being the source by which the participant first heard about the study compared with traditional methods was increased if the participant reported (a) being homosexual or bisexual or (b) posting daily updates on SNSs. Facebook and other SNSs are a viable recruitment strategy for reaching potential clinical trial participants among groups who typically use social media to stay connected with their friends and hard-to-reach groups such as young men who self-identify as homosexual or bisexual.
Journal Article
Agreement among sources of adult influenza vaccination in the age of immunization information systems
by
Raviotta, Jonathan M.
,
Balasubramani, G.K.
,
Nowalk, Mary Patricia
in
Adult influenza vaccination
,
Adults
,
Age groups
2021
Many vaccination studies rely on self-reported vaccination status, with its inherent biases. Accuracy of influenza vaccination self-report has been evaluated periodically, typically using the medical record as the gold standard. The burgeoning of electronic medical records (EMRs) and immunization information systems (IISs) and the rise of adult vaccine administration in community pharmacies suggest the need for a reevaluation of self-reported vaccination status.
Vaccination data from self-report, the state IIS, the health system EMR and other sources were compared for participants in outpatient and inpatient influenza vaccine effectiveness studies for four seasons (2016–2017 to 2019–2020). Agreement among the sources was calculated along with sensitivity and specificity. Tests for trend assessed changes in completeness of the Pennsylvania - Statewide IIS (PA-SIIS) data over time.
With self-report as the gold standard, agreement with the local EMR, PA-SIIS, and all sources was 62%, 77% and 85%, respectively. Sensitivity of the EMR was 42% (95% CI = 41, 43) and specificity was 91% (90, 92). With PA-SIIS-as the gold standard, agreement with the local EMR and all sources was 77% and 78%, respectively. Sensitivity of all sources combined was 96% (95, 97) and specificity was (63% (62, 64). Capture of influenza vaccinations in the IIS has not consistently improved over time, with a significant increase among children (P = 0.001), no change among working-age adults and a decrease among older adults (P = 0.004). However, PA-SIIS provided the largest percentage of verified vaccines (69.3%) compared with EMR (43.3%) and other sources (12.4%).
Both self-report and PA-SIIS are good estimates of actual vaccine uptake. When high accuracy data are required, such as for vaccine effectiveness studies, triangulation using multiple sources should be conducted.
Journal Article
Improving adolescent HPV vaccination in a randomized controlled cluster trial using the 4 Pillars™ practice Transformation Program
by
Moehling, Krissy K.
,
Raviotta, Jonathan M.
,
Lin, Chyongchiou J.
in
Adolescent
,
Adolescents
,
Allergy and Immunology
2017
Uptake of meningococcal vaccine (MCV) and tetanus, diphtheria and pertussis (Tdap) vaccine among adolescents has approached Healthy People 2020 goals, but human papillomavirus (HPV) vaccination has not. This study evaluated an intervention using the 4 Pillars™ Practice Transformation Program to increase HPV, MCV and Tdap uptake among adolescents in primary care practices.
Practices with at least 50 patients 11–17years old with estimated vaccination rates less than national goals, were assigned to intervention (n=11) and control (n=11) groups in a randomized controlled cluster trial; 9 intervention and 11 control sites completed the study. The baseline and active study periods were 7/1/2013–6/30/2014 and 7/1/2014–3/31/2015, respectively. Vaccination and demographic data for patients who had a visit in both study periods were derived from de-identified EMR extractions. Primary outcomes were vaccination rates and percentage point (PP) changes. Data were analyzed in 2015–16.
Among the cohort of 10,861 adolescent patients, 38% were 11–13years old; 50% were female; 18% were non-white; and 64% were commercially insured. Average baseline HPV initiation rates were 52.5% for intervention and 61.8% for control groups. After 9months, the intervention sites increased HPV initiation 10.2PP compared with 7.3PP in control sites (P<0.001); HPV series completion rates did not differ between groups. Implementation of >10 strategies to improve rates significantly increased the likelihood of HPV series initiation (OR=2.06, 95% CI=1.43, 2.96).
Using >10 strategies from the 4 Pillars™ Practice Transformation Program is effective for increasing HPV series initiation among adolescents.
Clinical trial registry number: NCT02165722.
Journal Article
Estimating the Impact of Low Influenza Activity in 2020 on Population Immunity and Future Influenza Seasons in the United States
2022
Abstract
Background
Influenza activity in the 2020–2021 season was remarkably low, likely due to implementation of public health preventive measures such as social distancing, mask wearing, and school closure. With waning immunity, the impact of low influenza activity in the 2020–2021 season on the following season is unknown.
Methods
We built a multistrain compartmental model that captures immunity over multiple influenza seasons in the United States. Compared with the counterfactual case, where influenza activity remained at the normal level in 2020–2021, we estimated the change in the number of hospitalizations when the transmission rate was decreased by 20% in 2020–2021. We varied the level of vaccine uptake and effectiveness in 2021–2022. We measured the change in population immunity over time by varying the number of seasons with lowered influenza activity.
Results
With the lowered influenza activity in 2020–2021, the model estimated 102 000 (95% CI, 57 000–152 000) additional hospitalizations in 2021–2022, without changes in vaccine uptake and effectiveness. The estimated changes in hospitalizations varied depending on the level of vaccine uptake and effectiveness in the following year. Achieving a 50% increase in vaccine coverage was necessary to avert the expected increase in hospitalization in the next influenza season. If the low influenza activity were to continue over several seasons, population immunity would remain low during those seasons, with 48% of the population susceptible to influenza infection.
Conclusions
Our study projected a large compensatory influenza season in 2021–2022 due to a light season in 2020–2021. However, higher influenza vaccine uptake would reduce this projected increase in influenza.
Journal Article
Does cost-effectiveness of influenza vaccine choice vary across the U.S.? An agent-based modeling study
by
Raviotta, Jonathan M.
,
Nowalk, Mary Patricia
,
Shim, Eunha
in
Adults
,
Age composition
,
Agent-based modeling
2017
•Agent based modeling (ABM) enhances risk estimates for decision analyses.•ABM provided epidemiological data for comparing influenza vaccine choice options.•Vaccine choice was tested in 5 U.S. counties with different population structures.•Vaccine choices were standard vaccine and age appropriate needle-sparing options.•In all counties, offering a choice to both adults and children was cost-effective.
In a prior agent-based modeling study, offering a choice of influenza vaccine type was shown to be cost-effective when the simulated population represented the large, Washington DC metropolitan area. This study calculated the public health impact and cost-effectiveness of the same four strategies: No Choice, Pediatric Choice, Adult Choice, or Choice for Both Age Groups in five United States (U.S.) counties selected to represent extremes in population age distribution.
The choice offered was either inactivated influenza vaccine delivered intramuscularly with a needle (IIV-IM) or an age-appropriate needle-sparing vaccine, specifically, the nasal spray (LAIV) or intradermal (IIV-ID) delivery system. Using agent-based modeling, individuals were simulated as they interacted with others, and influenza was tracked as it spread through each population. Influenza vaccination coverage derived from Centers for Disease Control and Prevention (CDC) data, was increased by 6.5% (range 3.25%–11.25%) to reflect the effects of vaccine choice.
Assuming moderate influenza infectivity, the number of averted cases was highest for the Choice for Both Age Groups in all five counties despite differing demographic profiles. In a cost-effectiveness analysis, Choice for Both Age Groups was the dominant strategy. Sensitivity analyses varying influenza infectivity, costs, and degrees of vaccine coverage increase due to choice, supported the base case findings.
Offering a choice to receive a needle-sparing influenza vaccine has the potential to significantly reduce influenza disease burden and to be cost saving. Consistent findings across diverse populations confirmed these findings.
Journal Article
Cost-effectiveness and public health impact of alternative influenza vaccination strategies in high-risk adults
by
Raviotta, Jonathan M.
,
Nowalk, Mary Patricia
,
Wateska, Angela
in
Adults
,
Antibodies, Viral - immunology
,
Baby boomers
2017
•Use of HD-IIV3 or RIV may increase vaccine effectiveness in high-risk adults.•Use of HD-IIV3 and RIV for middle-aged, high-risk patients may increase public health benefits.•Clinical trials of these vaccines in the adult, high-risk population may be warranted.
High-dose trivalent inactivated influenza vaccine (HD-IIV3) or recombinant trivalent influenza vaccine (RIV) may increase influenza vaccine effectiveness (VE) in adults with conditions that place them at high risk for influenza complications. This analysis models the public health impact and cost-effectiveness (CE) of these vaccines for 50–64year-olds.
Markov model CE analysis compared 5 strategies in 50–64year-olds: no vaccination; only standard-dose IIV3 offered (SD-IIV3 only), only quadrivalent influenza vaccine offered (SD-IIV4 only); high-risk patients receiving HD-IIV3, others receiving SD-IIV3 (HD-IIV3 & SD-IIV3); and high-risk patients receiving HD-IIV3, others receiving SD-IIV4 (HD-IIV3 & SD-IIV4). In a secondary analysis, RIV replaced HD-IIV3. Parameters were obtained from U.S. databases, the medical literature and extrapolations from VE estimates. Effectiveness was measured as 3%/year discounted quality adjusted life year (QALY) losses avoided.
The least expensive strategy was SD-IIV3 only, with total costs of $99.84/person. The SD-IIV4 only strategy cost an additional $0.91/person, or $37,700/QALY gained. The HD-IIV3 & SD-IIV4 strategy cost $1.06 more than SD-IIV4 only, or $71,500/QALY gained. No vaccination and HD-IIV3 & SD-IIV3 strategies were dominated. Results were sensitive to influenza incidence, vaccine cost, standard-dose VE in the entire population and high-dose VE in high-risk patients. The CE of RIV for high-risk patients was dependent on as yet unknown parameter values.
Based on available data, using high-dose influenza vaccine or RIV in middle-aged, high-risk patients may be an economically favorable vaccination strategy with public health benefits. Clinical trials of these vaccines in this population may be warranted.
Journal Article