Measurement and improvement as a model to strengthen immunization information systems and overcome data gaps.

BACKGROUND: IIS are important tools in the public health system and exist to improve and protect the nation's health from vaccine-preventable diseases. A network of 62 independent state, territorial, and jurisdictional immunization information systems (IIS) are operated within the United States. These systems are relied upon to implement an increasingly complex vaccination schedule, consolidate and create comprehensive immunization records, as well as monitor vaccine safety, efficacy, and support vaccine delivery. Despite their importance and necessity, the number of varying systems, coupled with jurisdictional policy and resource limitations, presents challenges with standardization, interoperability, data exchange, and the capture of complete immunization records. In partnership with the Centers for Disease Control (CDC) and IIS partners, the American Immunization Registry Association (AIRA) instituted its Measurement and Improvement (M&I) Initiative in 2015 as an innovative effort to evaluate and increase alignment of IIS with national functional standards. Lessons and strategies can be adapted for broader implementation as global systems develop methods to better achieve 2030 Sustainable Development Goal (SDG) targets, particularly related to global population health and infrastructure. METHODS: AIRA works closely with its partners to propose, vet, and refine processes and measures that can be compared across IIS, resulting in a uniform, standardized approach for measurement. The M&I Initiative is conducted as a third-party, independent evaluation through AIRA connecting with IIS pre-production systems to test the IIS response to test messages and measures across multiple content areas prioritized by the IIS community. The process includes three stages: 1) Testing and Discovery, 2) Assessment, and 3) Validation. Content areas currently evaluated include clinical decision support, interoperability transport, HL7 submission/acknowledgement, HL7 message query/response, and data quality. Testing is performed using the AIRA-developed Aggregate Analysis Reporting Tool (AART), an electronic testing tool and user interface specifically designed to compile and visualize results from the measures and tests. RESULTS: The M&I Initiative is voluntary with 86 percent (50/58) of the IIS programs targeted for measurement participating as of Spring 2020. To date, AIRA has actively measured standards alignment and published data on Validation in the first three content areas of Transport, Submission/Acknowledgement, and Query/Response. Thirty-one individual IIS have been validated in at least two of these three content areas. The number of IIS meeting one primary Transport measure has increased from 19 to 39 in three years, an increase of 105 percent. The number of IIS who were able to process the submission of a correctly formatted full immunization record for a patient jumped from 17 to 34, a 200 percent increase from baseline. Similarly, the number of IIS sending standards-conformant HL7 Acknowledgment messages has increased fourteen-fold since measurement began in 2017. The number of IIS who were able to process and respond to a query requesting a patient's evaluated immunization record and forecast increased from nine to 42, a 367 percent increase from baseline. Within the first two quarters of assessment, the percentage of IIS meeting the CDS measures aimed at supporting IIS alignment with ACIP recommendations increased 15 percent from baseline. CONCLUSION: The M&I initiative has helped to reduce variability across IIS and strengthen immunization data in IIS that is more complete, accurate, and can be utilized with confidence. The successes and experience offer an innovative model that could be adapted to standardize measures of success and data-sharing capabilities across global borders, particularly of value in achieving SDGs aimed at ensuring healthy lives and promoting well-being for all ages through strengthened immunization systems.

The potential for centralized reminder/recall to increase immunization rates: A national survey of immunization information systems (IIS) managers.

Little is known about Immunization Information System (IIS) attitudes and experiences using Centralized IIS-based Reminder/Recall (CI-R/R), an effective approach to increasing immunization rates. To describe among IIS managers as it relates to CI-R/R: 1) past experiences and future plans conducting it; 2) attitudes and barriers, 3) IIS capabilities and polices that influence, and 4) factors that differentiate IIS who have and have not conducted CI-R/R. Electronic Surveys were sent to all IIS managers in July 2018 using a member listserve. Fifty-seven of 62 IIS programs contacted (92%) responded. The majority (61%) had ever conducted CI-R/R; 34% reported they were "very likely" to conduct CI-R/R within 6 months. The majority (64%) were in favor of CI-R/R. Barriers included lack of staff (78%), competing demands (76%), and cost (63%). Thirty percent reported receiving a ≥75% of immunization data via real-time electronic interfaces (HL7). Overall, 49% and 24% of jurisdictions had mandatory immunization reporting from private and public health entities for childhood and adult immunizations, respectively. Differences between IIS that ever and never performed CI-R/R, respectively, included: mandatory reporting from private and public entities for children (65% v 27%, p = 0.006), having a legal mandate for CI-R/R (50% v 19%, p = 0.02), less likely to prefer practice-based R/R to CI-R/R (68% v. 91%, p = 0.04), and not reporting having too many competing demands (29% v 67%, p = 0.007). Most IIS have conducted CI-R/R and have positive attitudes towards it. Given it effectiveness and low cost, efforts to sustain it should be considered.

Keen on teen vaccines: improvement of adolescent vaccine coverage in rural North Carolina.

PURPOSE: To improve adolescent immunization coverage in a rural North Carolina county. METHODS: Adolescent immunization coverage rates in an intervention and four comparison counties were compared over 1 year. We introduced practice-based interventions in seven practices centering on immunization registry-driven recall of adolescents for immunizations with postcard reminders (Phase 1), and 6 months later employed nontargeted school-generated telephone reminders to parents of adolescents (Phase 2). RESULTS: Improvements in the intervention county among 11- to 12-year-olds occurred for first-dose human papillomavirus vaccine in both boys (overall change, 14.2%-32.1%) and girls (27.4%-43.4%) and the meningococcal vaccine (34.6%-49.4%). Improvements among adolescents 13-18 years were limited to human papillomavirus vaccine completion in boys (1.6%-4.2%). Improvements were greater during Phase 1 than Phase 2 and among younger adolescents. Coverage improvements in the comparison counties were smaller than those observed in the intervention county. CONCLUSIONS: A resource-light two-phase intervention led to modest improvements in immunization coverage, most notably in the largest adolescent practice in the county, and suggested potential for further gains, particularly among younger adolescents.

Increasing provision of adolescent vaccines in primary care: a randomized controlled trial.

OBJECTIVES: To assess the effectiveness of in-person and webinar-delivered AFIX (Assessment, Feedback, Incentives, and eXchange) consultations for increasing adolescent vaccine coverage. METHODS: We randomly assigned 91 primary care clinics in North Carolina, serving 107 443 adolescents, to receive no consultation or an in-person or webinar AFIX consultation. We delivered in-person consultations in April through May 2011 and webinar consultations in May through August 2011. The state's immunization registry provided vaccine coverage data for younger patients (ages 11-12 years) and older patients (ages 13-18 years) for 3 adolescent vaccines: tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap); meningococcal; and human papillomavirus (HPV) vaccines (≥1 dose, females only). RESULTS: At the 5-month follow-up, AFIX consultations increased vaccine coverage among younger adolescents. Patients in the in-person arm experienced coverage changes that exceeded those in the control arm for Tdap (3.4% [95% confidence interval (CI): 2.2 to 4.6]), meningococcal (4.7% [95% CI: 2.3 to 7.2], and HPV (1.5% [95% CI: 0.3 to 2.7]) vaccines. Patients in the webinar versus control arm also experienced larger changes for these vaccines. AFIX did little to improve coverage among older adolescents. At 1 year, the 3 arms showed similar coverage changes. The effectiveness of in-person and webinar consultations was not statistically different at either time point (all, P >.05). CONCLUSIONS: Webinar AFIX consultations were as effective as in-person consultations in achieving short-term increases in vaccine coverage for younger adolescents. AFIX consultations for adolescents need improvement to have a stronger and more durable impact, especially for HPV vaccine.

Improving quality of health care using the North Carolina Immunization Registry.

The North Carolina Immunization Registry (NCIR) is a secure, Web-based clinical tool that serves as an official record of immunization status. This commentary provides an overview of the NCIR and describes how providers, communities, and public health agencies use its data to improve quality of care.

Comparing in-person and webinar delivery of an immunization quality improvement program: a process evaluation of the adolescent AFIX trial.

BACKGROUND: Immunization quality improvement programs are often limited by the cost and inconvenience associated with delivering face-to-face consultations to primary care providers. To investigate a more efficient mode of intervention delivery, we conducted a process evaluation that compared in-person consultations to those delivered via interactive webinar. METHODS: The Centers for Disease Control and Prevention's Assessment, Feedback, Incentives, and eXchange (AFIX) Program is an immunization quality improvement program implemented in all 50 states. In 2011, we randomly assigned 61 high-volume primary care clinics in North Carolina to receive an in-person or webinar AFIX consultation focused on adolescent immunization. We used surveys of participating vaccine providers and expense tracking logs to evaluate delivery modes on participation, satisfaction, and cost. Clinics served 71,874 patients, ages 11 to 18. RESULTS: Clinics that received in-person and webinar consultations reported similar levels of participation on key programmatic activities with one exception: more webinar clinics reported improving documentation of previously administered, 'historical' vaccine doses. Both in-person and webinar clinics showed sustained improvement in confidence to use reminder/recall systems (both p < 0.05). Participants rated delivery modes equally highly on satisfaction measures such as convenience (mean = 4.6 of 5.0). Delivery cost per clinic was $152 for in-person consultations versus $100 for webinar consultations. CONCLUSIONS: In-person and webinar delivery modes were both well received, but webinar AFIX consultations cost substantially less. Interactive webinar delivery shows promise for considerably extending the reach of immunization quality improvement programs. TRIAL REGISTRATION: Clinicaltrials.gov, NCT01544764.

Organizational correlates of adolescent immunization: findings of a state-wide study of primary care clinics in North Carolina.

OBJECTIVE: To analyze organizational correlates of immunization coverage among adolescents served by high-volume primary care providers in North Carolina. METHODS: We randomly selected 91 clinics with at least 200 active records for patients ages 11-18 in the North Carolina Immunization Registry. For the 105,121 adolescents served by these clinics, we obtained immunization status for 6 vaccines, including human papillomavirus (HPV) vaccine (females only); meningococcal conjugate; and tetanus, diphtheria, and pertussis booster (Tdap). RESULTS: Clinics specializing in pediatrics had higher coverage for meningococcal vaccine (OR=1.79, 95% CI: 1.25-2.55), Tdap vaccine (OR=1.22, 95% CI: 1.00-1.50), and childhood vaccines. However, pediatric clinics had lower coverage for HPV vaccine initiation (OR=0.70, 95% CI: 0.52-0.94). Other correlates, which varied by vaccine, included policies related to vaccine documentation and the age at which clinics recommended vaccines. CONCLUSION: Overall, adolescents were more likely to receive vaccines, except HPV vaccine, if they attended a pediatric clinic with supportive clinical policies.

Experimental validation of phase using Nomarski microscopy with an extended Fried algorithm.

Reconstruction of an image (or shape or wavefront) from measurements of the derivatives of the image in two orthogonal directions is a common problem. We demonstrate how a particular reconstructor, commonly referred to as the Fried algorithm, can be used with megapixel derivative images to recover the original image. Large datasets are handled by breaking the derivative images into smaller tiles, applying the Fried algorithm and stitching the tiles back together. The performance of the algorithm is demonstrated using differential interference contrast microscopy on a known test object.

Increasing adolescent immunization by webinar: a brief provider intervention at federally qualified health centers.

OBJECTIVE: To evaluate a brief intervention to increase provision of adolescent vaccines at health centers that reach the medically underserved. METHOD: In April 2010, clinical coordinators from 17 federally qualified health centers (serving 7827 patients ages 12-17) participated in a competition to increase uptake of recommended adolescent vaccines: tetanus, diphtheria, and pertussis booster; meningococcal conjugate; and human papillomavirus. Vaccination coordinators attended a webinar that reviewed provider-based changes recommended by the CDC's Assessment, Feedback, Incentives, and eXchanges (AFIX) program and received weekly follow-up emails. Data on vaccine uptake came from the North Carolina Immunization Registry. RESULTS: Uptake of targeted adolescent vaccines increased during the one-month intervention period by about 1-2% (all p<.05). These small but reliable increases were greater than those observed for non-targeted vaccines (measles, mumps, and rubella; hepatitis B; and varicella). CONCLUSION: This AFIX webinar led to small increases in provision of targeted adolescent vaccines over a one-month period. Similar, sustainable programs at healthcare facilities, including federally qualified health centers that function as safety net providers for medically underserved populations could help reach populations with great need.

Preparation of dissolvable albumin stents for vascular anastomosis with a 1.9 µm laser and in vitro mechanical strength assessments.

INTRODUCTION: We present a clinically relevant method for producing and sterilizing dissolvable albumin stents to provide intraluminal support during vascular anastomosis, and a method for photothermally soldering vessels using a 1.9 µm diode laser with a 200-µm spot size, albumin solder, and water as the chromophore. Our aim in this study was to assess the mechanical integrity of soldered vessels, and to determine if gamma-irradiation affected the solubility of the stents. MATERIALS AND METHODS: The axial tensile strength and burst pressure of 3.75 ± 0.3 mm inner-diameter vessels soldered with varied swath width (1-7 mm), laser power (430-610 mW), solder concentration (22-46%w/w), and solder layering (1-3 layers) was tested in vitro. Stent dissolution was monitored by weight in blood, and with UV absorbance measurements in phosphate buffered saline (PBS). Solubility was measured for stents sterilized by 25 kGy gamma-irradiation, and stents with varied diameter and wall thickness. RESULTS: Optimized soldering parameters yielded tensile strengths of 4.4 ± 1.2 N and burst pressures of 400 ± 90 mm Hg with stay sutures. Differences in stent solubility in blood and PBS were not statistically significant (p = 0.99). Sterilization by 25 kGy gamma-irradiation did not cause significant changes (p > 0.6) in stent solubility, which was primarily volume-dependent. Under simulated intravascular flow conditions, 3 mm stents dissolved completely with 2.7 ± 0.7 ml/mg. CONCLUSIONS: The results show that fast-dissolving stents can be produced reliably using the extrusion technique, and sterilized by gamma-irradiation. Without stay sutures, soldered vessels exhibited low tensile strength, but burst pressures comparable to sutured vessels. It was concluded that stay sutures would be necessary in vivo due to degradation of the tensile strength of soldered vessels with exposure to moisture.

Light-guided lumpectomy: first clinical experience.

Despite numerous advances, lumpectomy remains a challenging procedure. We report on the early use of light-guided lumpectomy. Eight patients with non-palpable breast cancer undergoing lumpectomy for biopsy-proven and radiographically identifiable cancer were enrolled in the study. An optical wire was designed that incorporated a standard hook-wire with an optical fiber. The optical wire was placed in the same manner as a standard hook-wire. During light-guided lumpectomy, an eye-safe laser illuminated the optical wire and created a sphere of light surrounding the cancer. The light was visible at the beginning of each surgery and facilitated approaching the cancer without using the wire. Dissection around the sphere of light kept the wire tip within the surgical specimen. Three of eight initial surgical specimens had focally positive margins. Additional cavity shaves were performed during five lumpectomies and resulted in negative margins in seven of eight patients. Light-guided lumpectomy is a minor change to breast conserving surgery that can be easily incorporated into clinical practice. Further investigation into the clinical benefit of light-guided lumpectomy is warranted.

Quantitative Carré differential interference contrast microscopy to assess phase and amplitude.

We present a method of using an unmodified differential interference contrast microscope to acquire quantitative information on scatter and absorption of thin tissue samples. A simple calibration process is discussed that uses a standard optical wedge. Subsequently, we present a phase-stepping procedure for acquiring phase gradient information exclusive of absorption effects. The procedure results in two-dimensional maps of the local angular (polar and azimuthal) ray deviation. We demonstrate the calibration process, discuss details of the phase-stepping algorithm, and present representative results for a porcine skin sample.

Light-guided lumpectomy: device and case report.

We describe the development, design, fabrication, and testing of an optical wire to assist in the surgical removal of small lesions during breast-conserving surgery. We modify a standard localization wire by adding a 200-µm optical fiber alongside it; the resulting optical wire fit through an 18 gauge needle for insertion in the breast. The optical wire is anchored in the lesion by a radiologist under ultrasonic and mammographic guidance. At surgery, the tip is illuminated with an eye-safe, red, HeNe laser, and the resulting glowball of light in the breast tissue surrounds the lesion. The surgeon readily visualizes the glowball in the operating room. This glowball provides sufficient feedback to the surgeon that it is used (1) to find the lesion and (2) as a guide during resection. Light-guided lumpectomy is a simple enhancement to traditional wire localization that could improve the current standard of care for surgical treatment of small, nonpalpable breast lesions.