Evaluation of non-continuous temperature monitoring practices for vaccine storage units: A Monte Carlo simulation study.

Objectives: Evaluate different non-continuous temperature monitoring practices for detection of out-of-range temperatures (above or below the recommended temperature range of 2-8°C for refrigeration units), which are called excursions, within vaccine storage units. Methods: Simulations based on temperature data collected by 243 digital data loggers operated in vaccine storage units at health care providers who participated in a CDC-sponsored continuous temperature monitoring pilot project, from 2012 to 2015. In the primary analysis, we evaluate: (1) twice-daily current temperature readings without minimum and maximum readings (min/max), (2) twice-daily current temperature readings with once-daily min/max, and (3) twice-daily current temperature readings with twice-daily min/max. Results: Recording current temperature twice-daily without min/max resulted in the detection of 4.8-6.4% of the total number of temperature excursions. When min/max readings were introduced, the percentage of detected temperature excursions increased to 27.8-96.6% with once-daily min/max and to 34.8-96.7% with twice-daily min/max. Conclusions: Including min/max readings improves the ability of a temperature monitoring practice to detect temperature excursions. No combination of the non-continuous temperature monitoring practices were able to consistently detect all simulated temperature excursions.

Evaluation of temperature stability among different types and grades of vaccine storage units: Data from continuous temperature monitoring devices.

OBJECTIVE: To evaluate the ability of different types of vaccine storage units to maintain appropriate temperatures for the storage of vaccines and to characterize deviations from recommended temperatures. DATA SOURCES: Continuous temperature monitoring devices, or digital data loggers, from vaccine providers who participated in a continuous temperature monitoring pilot project. STUDY DESIGN: We computed descriptive statistics on the percentage of runtime with an out-of-range temperature, or excursion, for different storage unit types (freezers and refrigerators) and for different storage unit grades (household-grade combination, household-grade stand alone, and purpose-built or pharmaceutical grade). We developed frequency histograms for the percentage of storage unit runtime outside of the normal range. We plotted the duration and temperature extrema for identified excursions. Analyses were stratified by storage unit type and grade. RESULTS: Household-grade combination units underperformed relative to household-grade stand-alone and purpose-built units. Among refrigerators, household-grade combination units operated in the normal temperature range an average of 98.9% of their observed runtime, which was lower than 99.4% (p value = 0.038) for household-grade stand-alone and 99.9% (p value < 0.001) for purpose-built units. Among freezers, household-grade combination units operated in the normal temperature range an average of 95.0% of their observed runtime, which was lower than 99.3% (p value < 0.001) for household-grade stand-alone units and 99.7% (p value < 0.001) for purpose-built units. CONCLUSION: These findings, in particular the underperformance of household-grade combination units relative to household-grade stand-alone and purpose-built units, support current CDC recommendations to avoid the use of household-grade combination storage units when possible.

How should immunization rates be measured in the office setting? A study from PROS and NMA PedsNet.

The aim of the study was to compare the validity and reliability of 2 sampling methods for measuring immunization rates to a reference standard in a national sample of pediatric office practices. The consecutive method involved patients seen consecutively in the office for any reason; the random record was a random selection of medical records; and the reference standard active method, data of a randomly selected subgroup of children in the random record survey were supplemented with information from a telephone interview. The consecutive method of assessing immunization rates results in rates that are, on average, higher and closer to the reference standard, but also more variable. The random record method rates are lower and further from the study reference standard compared with the consecutive method, but more precise. The consecutive method for measuring practice immunization rates could be a useful quality improvement tool as practices seek to improve immunization delivery and quality of care. It is inexpensive, simple, and easy to implement.

Using registry data to evaluate the 2004 pneumococcal conjugate vaccine shortage.

BACKGROUND: The most recent pneumococcal conjugate vaccine (PCV7) shortage occurred between December 2003 and September 2004. To ensure vaccination of the highest-risk children, the Centers for Disease Control and Prevention recommended that providers delay administration of the third and fourth doses of vaccine to healthy children. We used Michigan Child Immunization Registry (MCIR) data collected from September 1, 2001 to November 30, 2004 to evaluate changes in PCV7 coverage. METHODS: Vaccination and demographic data from MCIR were reviewed for 420,733 children born between September 2001 and August 2004. Main outcome measures were the proportion of children who received the third dose of PCV7 by 7 months of age and the fourth dose of PCV7 by 16 months of age. Vaccine coverage for measles, mumps, and rubella vaccine (MMR) and diphtheria, tetanus, and acellular pertussis vaccine (DTaP) was used for comparison, as these vaccines were abundant during this time period and their administration schedule is the same as the third and fourth doses of PCV7, respectively. Data analysis was conducted in spring 2005. RESULTS: Coverage for the third dose of DTaP and the first dose of MMR remained steady, while PCV7 coverage for the third dose dropped from 29% to 11%, and the fourth dose dropped from 27% to 22% in the month following the recommendations to defer doses. Coverage returned close to pre-shortage levels shortly after the recommendations to resume the normal schedule. PCV7 coverage trends were similar for children seen in the private or public sector. CONCLUSIONS: Registry data can be useful for evaluating vaccination coverage trends during a shortage. Our findings suggest that providers were compliant with recommendations to alter vaccine administration during the shortage.

Provider adoption of pneumococcal conjugate vaccine and the impact of vaccine shortages.

OBJECTIVES: To 1) determine the factors associated with provider acceptance of pneumococcal conjugate vaccine and 2) describe how providers prioritize pneumococcal conjugate vaccine during shortages. DESIGN/METHODS: During April-November 2002, we conducted a mailed survey of rural and urban Colorado practitioners who provided routine pediatric immunizations. Three groups were surveyed: 1) all immunization providers (n = 51) in 2 geographically large rural areas, identified through a regional immunization registry; 2) all providers (n = 61) from private pediatric practices in metropolitan Denver that were actively participating in the same registry; and 3) all family physicians (n = 244) from the same urban areas as the pediatric practices. RESULTS: Response rate was 60%. Provider adoption of pneumococcal conjugate vaccine was strong: 66% of urban family physicians, 84% of rural providers, and 98% of urban pediatric providers always recommended pneumococcal conjugate vaccine to healthy children < or = 23 months old when vaccine supplies were adequate. In multivariate analysis, vaccine nonadopters were significantly more likely than adopters to report financial barriers to vaccination (odds ratio [OR] 3.17, 95% confidence interval [CI] 1.58, 6.35) and concerns about vaccine safety (OR 3.37, 95% CI 1.37, 8.26). Eighty-nine percent of respondents had encountered pneumococcal conjugate vaccine shortages. During shortages, children <5 years old with a chronic medical condition were considered the highest priority for vaccination. CONCLUSIONS: While provider acceptance of pneumococcal conjugate vaccine appears high, concerns about vaccine safety, cost, and availability exist, and these concerns will need to be addressed to maximize prevention of invasive pneumococcal disease in children.

Do laws bring children in child care centers up to date for immunizations?

BACKGROUND: Pennsylvania state law requires licensed child care centers (CCCs) to document that each enrolled child is up to date (UTD) for routine immunizations within 60 days of enrollment. This study evaluates the law's impact on immunization coverage among children aged

Physician compliance with pneumococcal conjugate vaccine shortage recommendations in 2004.

OBJECTIVE: To assess pattern of pneumococcal conjugate vaccine (PCV) administration during periods of vaccine shortage and changing recommendations. METHODS: During 2004 PCV shortages, the Advisory Committee for Immunization Practices recommended delay of doses 3 and 4 (PCV3 and PCV4) to healthy children. A managed care health plan evaluated PCV doses administered to all enrolled children at ages 3, 5, 7, and 16 months in 2004; ICD9 codes were used to identify high-risk children. RESULTS: Immunization coverage for the first two PCV doses remained relatively stable throughout 2004 for both high-risk and healthy children. PCV3 coverage for healthy children dropped significantly from 63 percent preshortage (February 2004) to a low of 7 percent (June 2004), then rose to preshortage levels of 2 months after recommendations were made to resume PCV3 administration. Coverage of high-risk children followed a similar pattern as that for healthy children. PCV4 coverage showed similar declines and increases following shortage-related recommendations as PCV3. Most children whose PCV3 dose may have been delayed during the shortage did receive PCV3 after the shortage. CONCLUSIONS: Providers demonstrated rapid change in PCV administration in response to shortage-related recommendations. Little coverage difference was seen between healthy and high-risk children, possibly due to inadequate ability to determine which children truly are at high risk identified on the basis of ICD9 codes.

A status report from 1996-2004: are more effective immunization interventions being used in the women, infants, and children (WIC) program?

BACKGROUND: The Special Supplemental Nutrition Program for Women, Infants and Children (WIC) enrolls almost 50% of the US birth cohort and these children have significantly lower immunization coverage rates than their counterparts not eligible for WIC. In 1994, the Centers for Disease Control and Prevention (CDC) and USDA began a national initiative to increase immunization coverage in low-income children by incorporating immunization-promoting activities into WIC visits (WIC/Immunization linkages). Since 1998, CDC has monitored the WIC/Immunization linkages assessment and referral (with and without the more aggressive strategy of monthly voucher pick-up, client outreach and tracking and parental incentives) and three other immunization supporting activities (computerized systems to assess immunization status, collocation of WIC and immunization services, coordination of WIC and immunization services). METHODS: Through an annual survey of state Immunization and WIC programs, a trend analysis was conducted for years 1998 through 2004 to determine changes in the use and frequency of WIC/Immunization linkage activities. RESULTS: During the 7-year study period, the use of assessment and referral increased from 71% to 94%, monthly voucher pick-up from 24% to 35%, and coordination of WIC and immunization services from 61% to 78% (p<0.0001 for all comparisons) in WIC sites nationwide. The frequency of assessment and referral (at each visit [four or more times/ year] versus certification visits [two times/year]) was reported to decrease during the study period (p<0.0001). Outreach and tracking and collocation of services did not change significantly while the use of parental incentives decreased (p<0.0001). The availability of computers and their use immunization assessment increased during the period. From 2002-2004, the number of states reporting that they base assessment and referral on a single vaccine (diphtheria-tetanus-acellular pertussis) instead of counting multiple vaccines increased from 5 to 10. CONCLUSIONS: Immunization promoting activities, especially those known to be most effective in improving coverage such as monthly voucher pickup, are increasing in WIC. Focusing on effective interventions including supporting activities such as computerized assessment will be essential in meeting Healthy People 2010 infant and childhood immunization coverage goals. In addition, the use of WIC resources can be minimized by encouraging evaluation of diphtheria-tetanus-acellular pertussis coverage as a marker for up to date status, instead of counting all vaccine doses.

Identification and recall of children with chronic medical conditions for influenza vaccination.

OBJECTIVES: Despite long-standing recommendations to provide annual influenza vaccination to children with chronic medical conditions, immunization rates are <10% in most primary care settings. Many obstacles impede implementation of these recommendations, including the challenge of identifying targeted children and the need to immunize yearly in a short time interval. The objective of this study was to assess the accuracy of billing data for identifying children who have high-risk conditions (HRCs) and need influenza vaccination and 2) to evaluate the efficacy of reminder/recall for children with HRCs. METHODS: The study was conducted in 4 private pediatric practices in metropolitan Denver, Colorado, that share a computerized billing system and also participate in an immunization registry. For all children aged 6 to 72 months, registry records were linked with the billing database. Patients with >or=1 encounters for an HRC in the previous 24 months were selected, with HRCs identified from International Classification of Diseases, Ninth Revision, Clinical Modification diagnostic codes. Using medical records as the "gold standard," we reviewed 327 randomly selected records to determine the sensitivity, specificity, and accuracy of billing data for identifying HRCs. For children with an HRC, we then conducted a randomized, controlled trial of reminder/recall for influenza vaccination. The primary outcome of the recall trial was receipt of influenza vaccine. RESULTS: Billing data had a sensitivity of 72% (95% confidence interval [CI]: 48%-95%), specificity of 95% (95% CI: 90%-100%), and overall accuracy of 90% (95% CI: 84%-96%) in determining which children had an HRC. Of the 17,273 patients aged 6 to 72 months, 2007 had >or=1 HRCs (12% overall; range: 9%-14% per practice). Asthma/reactive airways disease accounted for 87% of all HRCs. Reminder/recall significantly increased influenza immunization in children with HRCs, with a vaccination rate of 42% in those recalled, compared with 25% in control subjects. Recalled subjects were more likely to have an office visit (68% vs 60%) and less likely to have a missed opportunity to immunize (28% vs 37%) compared with control subjects. CONCLUSIONS: Diagnosis-based billing data accurately identified children who had HRCs and needed annual influenza vaccination, and registry-driven reminder/recall significantly increased influenza immunization in targeted children.

Comparison of e-mail, fax, and postal surveys of pediatricians.

OBJECTIVES: To compare 3 communication modes (postal, fax, and e-mail) in a rotavirus vaccine physician survey. METHODS: We used 3 communication modes to distribute a survey to physicians listed in the membership directory of the Georgia Chapter of the American Academy of Pediatrics. The directory listed 1391 members; however, 404 were deemed ineligible on the basis of their listing as a specialist, retiree, resident in training, or government public health employee. Of the 987 members expected to administer vaccines, 150 were selected randomly to receive the postal survey (postal group). Of the remaining listings, 488 (58%) of 837 listed a fax number; 150 members were selected randomly and faxed a survey (fax group). Of the remaining members, 266 (39%) of 687 had e-mail addresses listed; 150 members were selected randomly for the e-mail survey (e-mail group). A follow-up survey was sent by the same mode at 2 weeks. A final survey was sent via another mode (mixed mode) at 1 month: by fax to e-mail and postal nonresponders and by post to fax nonresponders and those without fax. RESULTS: Eligible respondents in the 3 survey groups were similar in their practice setting and location. Although the e-mail group had fewer median years (8 years) since medical school graduation than the fax group (19 years) and postal group (17 years), a similar percentage of responders in all groups had computers (>85%) and Internet access (> or =70%) at work. However, only 39% of members listed an e-mail address in the directory. In the 2 weeks after the first mailing, 39 surveys were completed via postal mail, 50 via fax, and 16 via e-mail. In the 2 weeks after the second contact (sent at 2 weeks), 20 surveys were completed via postal mail, 15 via fax, and 17 via e-mail. The response rate after the first 2 mailings was 41% (59 of 143) for postal, 47% (65 of 137) for fax, and 26% (33 of 125) for e-mail surveys. The third and final survey (sent 1 month after the first mailing) was sent by a different (ie, mixed) mode and elicited an additional 73 responses: 19 responses (15 postal, 4 fax) from the postal group, 19 responses (18 postal, 1 fax) from the fax group, and 35 responses (15 postal, 13 fax, 7 e-mail) from the e-mail group. Twenty-three percent (9 of 40) of the e-mail and 18% (15 of 83) of the fax surveys completed were returned on the same or subsequent day they were sent, compared with none of the postal surveys. There were significant differences among the 3 groups for invalid addresses/numbers (4% postal, 8% fax, and 16% e-mail) listed in the directory. Using mixed modes as the third contact, the overall response rate increased from 39% before mixed mode to a final of 53%. On the basis of the 3 initial groups, responses to 1 of 12 rotavirus questions differed significantly. CONCLUSIONS: Future use of e-mail surveys in selected circumstances is promising, because the majority of providers have Internet access and acknowledged interest in participating in e-mail surveys. E-mail surveys could be especially useful if rapid response time is necessary. There were fewer incomplete questions by participants who completed the e-mail survey compared with postal or fax participants. Updating membership e-mail addresses and routinely using e-mail as a communication tool should improve the ability to use e-mail surveys. There may need to be ongoing evaluations that critically evaluate providers' responses to e-mail surveys compared with other survey modes before e-mail surveys can become a standard survey tool. In the meantime, mixed-mode surveys may be an option.

A survey of pediatricians on the reintroduction of a rotavirus vaccine.

OBJECTIVE: Rhesus-based rotavirus tetravalent vaccine (RRV-TV; RotaShield) was withdrawn voluntarily from the market in October 1999, and recommendations for use were suspended. Rotavirus infection continues to be a significant health problem affecting children worldwide. The objective of this study was to investigate whether pediatricians would either reconsider using RRV-TV or consider other, newer, and presumably safer rotavirus vaccines if they were recommended routinely and to determine factors that influence their opinion. METHODS: A questionnaire was sent to a random sample of 250 members of the Wisconsin Chapter of the American Academy of Pediatrics (AAP) and to 437 randomly selected members of the Georgia Chapter of the AAP. Nonresponders received reminder questionnaires. RESULTS: Of the 687 pediatricians surveyed, 384 (56%) responded. Responses from 319 eligible immunization providers were included in the final analysis. Although only 15% of respondents reported that they would give RRV-TV if it were available today, 94% reported that they would use a new rotavirus vaccine if proved to be safer than RRV-TV and if recommended by the AAP and Advisory Committee on Immunization Practices for routine use among infants. Barriers to reintroducing a rotavirus vaccine were fear of adverse reactions among 95% of pediatricians, followed by potential high vaccine cost (63%) and amount of time required to educate parents (57%). CONCLUSIONS: Pediatricians reported that they would use a rotavirus vaccine if it was safer than RRV-TV and routinely recommended by the AAP and the Advisory Committee on Immunization Practices.