Real-world evidence in lung and hematologic oncology health technology appraisals: a review of six assessment agencies.

Aim: To assess the use and acceptability of real-world evidence (RWE) in lung and hematologic cancer appraisals. Materials & methods: A review of appraisals published by National Institute for Health and Care Excellence (NICE) in the UK was conducted. A total of 20 case studies employing RWE were identified and compared across five additional health technology assessment agencies: Scottish Medicines Consortium (SMC) (Scotland), CADTH (Canada), INESSS (Quebec), HAS (France) and IQWiG (Germany). Results: Of 80 RWE references from 20 case studies from NICE, 67 were identified in the respective CADTH submissions, 46 in IQWiG, 37 in INESSS, 37 in HAS, and 33 in SMC. NICE had the highest RWE acceptance rate (90%), followed by HAS (88%), SMC (82%), INESSS (73%), IQWiG (68%) and CADTH (67%). Conclusion: RWE was generally accepted by respective committees, allowing improved access to innovative treatments.

Use of real-world evidence for assessing the value of cancer treatments Health technology assessment (HTA) is a process used to decide whether a drug works well enough to be worth paying for. Most drugs have data showing how well they work from special studies called clinical trials. Sometimes a manufacturer also has evidence of a drug or disease that is not from a clinical trial but from the real world. This review discusses how real-world evidence (RWE) is being used for HTAs of new lung and blood cancer therapies. We reviewed twenty HTA submissions for new therapies. All twenty were submitted to these agencies: National Institute for HealthCare and Excellence (NICE; UK), Scottish Medicines Consortium (SMC; Scotland), Canadian Agency for Drugs and Technologies in Health (CADTH; Canada), National Institute of Excellence in Health and Social Services (INESSS; Quebec), French National Authority for Health (HAS; France) and Institute for Quality and Efficiency in HealthCare (IQWiG; Germany). RWE was often used to describe the type of patient that needs the new therapy. RWE was also used to show the cost of the treatment and how well the treatment worked in relation to its cost. It was also used to show how well the new therapy works compared with other treatments. Most of the RWE was accepted by the agencies. High-quality RWE in relevant patients helped support access to new treatments.

Birth by caesarean section and school performance in Swedish adolescents- a population-based study.

BACKGROUND: Our objective was to assess the impact of obstetric mode of delivery, and in particular birth by Caesarean section (CS), on school performance in adolescents using a large, population-based cohort. METHODS: We extracted data from the Swedish Medical Birth Register and National School Register. We included all live singleton births in Sweden from 1982-1995 (n = 1,489,925). School grades were reported on a scale from 0 to 320, scores less than 160 (i.e. "pass") were considered to be "poor school performance." Mode of delivery was categorised as: unassisted vaginal delivery (VD), assisted VD, elective CS and emergency CS. We measured the association between mode of delivery and "poor school performance" using logistic regression. We then used quantile regression to assess the association between mode of delivery and school performance across the distribution of scores. We adjusted for maternal age, parity, small and large for gestational age, gestational age, maternal country of birth, maternal depression, non-affective disorder or bipolar disorder, parental income at time of birth, and parental social welfare at time of birth. We also conducted sensitivity analyses to investigate the association further. RESULTS: With logistic regression analysis, the adjusted odds ratio (aOR) of assisted VD and poor school performance, compared to unassisted VD, was 1.06 (95% CI: 1.03-1.08). For elective CS it was 1.06 (95% CI:1.03-1.09) and for emergency CS it was 1.12 (95% CI: 1.09-1.15). With quantile regression, assisted VD showed little difference in scores, when compared to unassisted VD, at any point across the distribution. Elective CS was associated with a 1-3 point decrease in scores, and emergency CS was associated with a 2-5 point decrease in scores. CONCLUSION: A slight association was found between birth by CS and school performance. However, the effect was quite small and given the complex nature of the relationship, should be interpreted with caution.

Research review: Birth by caesarean section and development of autism spectrum disorder and attention-deficit/hyperactivity disorder: a systematic review and meta-analysis.

BACKGROUND: Given the growing prevalence of birth by Caesarean section (CS) worldwide, it is important to understand any long-term effects CS delivery may have on a child's development. We assessed the impact of mode of delivery on autism spectrum disorders (ASD) and attention-deficit/hyperactivity disorder (ADHD). METHODS: We conducted a systematic review of the literature in PubMed, Embase, CINAHL, PsycINFO and Web of Science up to 28 February 2014. No publication date, language, location or age restrictions were employed. RESULTS: Thirteen studies reported an adjusted estimate for CS-ASD, producing a pooled odds ratio (OR) of 1.23 (95% CI: 1.07, 1.40). Two studies reported an adjusted estimate for CS-ADHD, producing a pooled OR of 1.07 (95% CI: 0.86, 1.33). CONCLUSIONS: Delivery by CS is associated with a modest increased odds of ASD, and possibly ADHD, when compared to vaginal delivery. Although the effect may be due to residual confounding, the current and accelerating rate of CS implies that even a small increase in the odds of disorders, such as ASD or ADHD, may have a large impact on the society as a whole. This warrants further investigation.

Health disparities in human papillomavirus vaccine coverage: trends analysis from the National Immunization Survey-Teen, 2008-2011.

Adolescent uptake of human papillomavirus (HPV) vaccine remains low. We evaluated HPV vaccine uptake patterns over 2008-2011 by race/ethnicity, poverty status, and the combination of race/ethnicity and poverty status, utilizing National Immunization Survey-Teen data. Minority and below-poverty adolescents consistently had higher series initiation than white and above-poverty adolescents.

A national survey of immunization programs regarding immunization information systems data sharing and use.

OBJECTIVE: To determine and characterize practices regarding data sharing and usage (particularly for research) in immunization information systems (IISs), as well as barriers to using such data for research. DESIGN: We surveyed immunization program managers (IPMs) associated with all 64 Centers for Disease Control and Prevention grantee immunization programs (IPs) between July and September 2012. RESULTS: More than 95% of IPMs (61/64) responded. The top 2 barriers reported by IPMs to using IIS data for research were insufficient time and too few employees, irrespective of whether or not the jurisdiction reported using data for research purposes. Those IPMs who agreed with the statement "Research is part of the mission of an immunization program" were more likely to report using data for research (P = .045). Among those who responded, the most common kind of IIS research conducted involved determinants of vaccination coverage (n = 24/26; 92%). A greater percentage of IPMs in jurisdictions that reported using IIS data for research reported having data-sharing agreements in place. Those IPs that have used IIS data for research were more likely to report online IIS provider enrollment, integration with insurance company records, and integration with hospital records. Alternatively, IPs that did not report using IIS data for research were more likely to have IISs with modules addressing topics such as adverse event reporting, smallpox, and first-responder vaccination. CONCLUSION: Staff size and time were the 2 most cited barriers to conducting research with IIS data. Therefore, focus should also be placed on providing IPs with the resources needed to conduct such research.

Concept mapping applied to the intersection between older adults' outdoor walking and the built and social environments.

OBJECTIVE: For older adults, the ability to navigate walking routes in the outdoor environment allows them to remain active and socially engaged, facilitating community participation and independence. In order to enhance outdoor walking, it is important to understand the interaction of older adults within their local environments and the influence of broader stakeholder priorities that impact these environments. Thus, we aimed to synthesize perspectives from stakeholders to identify elements of the built and social environments that influence older adults' ability to walk outdoors. METHOD: We applied a concept mapping approach with the input of diverse stakeholders (N=75) from British Columbia, Canada in 2012. RESULTS: A seven-cluster map best represented areas that influence older adults' outdoor walking. Priority areas identified included sidewalks, crosswalks, and neighborhood features. CONCLUSION: Individual perceptions and elements of the built and social environments intersect to influence walking behaviors, although targeted studies that address this area are needed.

Real-world ALK Testing Trends in Patients With Advanced Non-Small-Cell Lung Cancer in the United States.

INTRODUCTION: Patients with non-small-cell lung cancer (NSCLC) whose tumors harbor anaplastic lymphoma kinase (ALK) rearrangements can be treated with ALK tyrosine kinase inhibitors. We assessed real-world ALK biomarker testing and treatment patterns of patients with NSCLC in the United States. PATIENTS AND METHODS: Data were extracted from the Flatiron Health electronic health record-derived deidentified database for patients aged ≥18 years with stage IIIB or IV NSCLC and ≥2 clinic visits between January 2011 and December 2019. RESULTS: Among 60,025 eligible patients, tumors from 36,691 (61.1%) patients were tested for ALK rearrangements, and 1042 (2.8%) tested positive (ALK+). From 2011 to 2019, ALK testing rates increased from 33.1% to 73.0%; testing via fluorescence in situ hybridization declined from 68.3% to 32.1% while next-generation sequencing increased from <1% to 52.2%. Although tissue samples were more commonly used than blood (85.1% vs. 13.5% of tests), blood sample testing increased from 0.1% in 2011 to 28.2% in 2019. Median (interquartile range) time from diagnosis of advanced NSCLC to first ALK+ test result was 23 (13-43) days, including laboratory processing time of 9 (6-14) days. For the 24.7% of patients with an ALK+ test result who began treatment before receiving the positive result, chemotherapy was initiated most often overall until 2018 when immuno-oncology agents became most common. CONCLUSION: Although ALK testing in NSCLC increased over time, testing rates among eligible patients did not reach 100% during the study period. Treatment decisions for some patients with NSCLC may have been made without important, guideline-recommended biomarker data.

Non-small cell lung cancer with EGFR exon 20 insertion mutation: a systematic literature review and meta-analysis of patient outcomes.

INTRODUCTION: EGFR exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC) is rare, has a poor prognosis, and outcomes are not fully established. We describe and evaluate outcomes from real-world and clinical evidence in these patients. METHODS: A systematic literature review (SLR) identified interventional and real-world evidence (RWE) studies reporting clinical outcomes for EGFR exon 20 insertion mutation-positive NSCLC. Meta-analyses were conducted by line of therapy to synthesize pooled survival and response outcomes across RWE. Published evidence from interventional studies was summarized individually. RESULTS: The SLR identified 23 RWE and 19 original interventional studies. In the meta-analysis of RWE, pooled response and survival outcomes were low for first-line EGFR-tyrosine kinase inhibitors (TKIs) and immuno-oncology (IO) agents. First-line chemotherapy resulted in a pooled ORR 25.7%, pooled PFS 5.6 months, and pooled OS 18.3 months. Pooled outcomes were further reduced in second or later lines (≥2 L): pooled ORR was 5.0%, 3.3%, and 13.9%; pooled PFS was 2.1 months, 2.3 months, and 4.4 months; and pooled OS was 14.1 months, 8.8 months, and 17.1 months (not a pooled result) for EGFR-TKIs, IO agents, and chemotherapy, respectively. Interventional studies reported outcomes for TKIs (mobocertinib, poziotinib, osimertinib, afatinib, CLN-081, DZD9008), a monoclonal antibody (amivantamab), and a heat shock protein 90 inhibitor (luminespib). While there is limited RWE for the recently approved agents mobocertinib and amivantamab, which specifically target exon 20 insertion mutations, interventional evidence supports their potential as effective treatment options. CONCLUSIONS: Conventional treatments used in patients with EGFR exon 20 insertion mutation-positive NSCLC have limited efficacy, though chemotherapy appeared to be associated with better response and survival outcomes than non-exon 20 targeting EGFR-TKIs and IO agents. This supports the need to identify EGFR exon 20 insertion mutations as the availability of new targeted treatments may offer additional therapeutic options to these patients.

The Effect of Hypertensive Disorders of Pregnancy on the Risk of ADHD in the Offspring.

OBJECTIVE: Evidence suggests that perinatal factors may contribute to the development of ADHD. Our objective was to examine the association between hypertensive disorders of pregnancy (HDP) and ADHD, and behavioral difficulties among 7-year-old children. METHOD: The study cohort consisted of 13,192 children (weighted = 13,500) who participated in the Millennium Cohort Study (MCS) at age 7. HDP (raised blood pressure, preeclampsia, eclampsia, and toxemia) were reported by mothers 9 months postdelivery. ADHD was reported by parents at age 7 years. Weighted logistic regression models were used to assess the association. RESULTS: In all, 1,069 (7.9%) women reported HDP and 166 (1.2%) children had an ADHD diagnosis. There was a significant association between HDP and ADHD (adjusted odds ratio [OR] = 1.78, 95% confidence interval [CI] = [1.03, 3.07]). CONCLUSION: These findings suggest that HDP is associated with an increased risk of ADHD. It is important to confirm this in larger cohorts and to understand the biological basis of this association.

Exposure to Hypertensive Disorders of Pregnancy Increases the Risk of Autism Spectrum Disorder in Affected Offspring.

There is growing awareness that prenatal adversity may increase the risk of autism spectrum disorder (ASD). Here, we examined the association between hypertensive disorders of pregnancy (HDP) and ASD risk at 7 years of age using the Millennium Cohort Study (MCS), a representative cohort of 13,192 children born in the UK from 2000 to 2001. We also sought to examine cytokine expression in the serum of women with pre-eclampsia, which is the most common HDP, and whether exposure of foetal neurons to this serum could change patterns of neuronal growth. HDP were reported by mothers 9 months post-delivery. ASD was parent reported at age seven, based on a doctor or health care professional's diagnosis. Weighted logistic regression was used for data analysis, adjusting for several potential confounders including maternal alcohol consumption, education, depression, age, and poverty status. Sensitivity analyses were performed excluding pre-term births, small for gestational age (SGA), and pre-pregnancy hypertension and depression. There was a significant association between HDP and a twofold increased risk of ASD (AOR = 2.10 [95% CI 1.20-3.70]). Excluding preterm births, SGA births, and offspring of women who had pre-pregnancy hypertension or over the age of 40 did not change the results materially. At the cellular level, exposure of foetal cortical neurons to 3% serum isolated from women with an established HDP increased neuronal growth and branching in vitro. These findings indicate that HDP exposure may increase the risk of ASD in the offspring.

A systematic review of the psychobiological burden of informal caregiving for patients with dementia: Focus on cognitive and biological markers of chronic stress.

As the physiological impact of chronic stress is difficult to study in humans, naturalistic stressors are invaluable sources of information in this area. This review systematically evaluates the research literature examining biomarkers of chronic stress, including neurocognition, in informal dementia caregivers. We identified 151 papers for inclusion in the final review, including papers examining differences between caregivers and controls as well as interventions aimed at counteracting the biological burden of chronic caregiving stress. Results indicate that cortisol was increased in caregivers in a majority of studies examining this biomarker. There was mixed evidence for differences in epinephrine, norepinephrine and other cardiovascular markers. There was a high level of heterogeneity in immune system measures. Caregivers performed more poorly on attention and executive functioning tests. There was mixed evidence for memory performance. Interventions to reduce stress improved cognition but had mixed effects on cortisol. Risk of bias was generally low to moderate. Given the rising need for family caregivers worldwide, the implications of these findings can no longer be neglected.

Obstetric mode of delivery and attention-deficit/hyperactivity disorder: a sibling-matched study.

BACKGROUND: It has been suggested that birth by caesarean section (CS) may affect psychological development through changes in microbiota or stress response. We assessed the impact of mode of delivery, specifically CS, on the development of attention-deficit/hyperactivity disorder (ADHD), using a large, population-based cohort. METHODS: The study cohort consisted of all singleton live births in Sweden from 1990 to 2008 using data from Swedish national registers. Mode of delivery included: unassisted vaginal delivery(VD), assisted VD, elective CS or emergency CS. ADHD was determined using International Classification of Diseases version 10 (F90 or F98.8), or prescription for ADHD medication. We used Cox regression to assess the association between birth by CS and ADHD in the total study population, adjusting for perinatal and sociodemographic factors, then stratified Cox regression analysis on maternal identification number to assess the association among siblings. RESULTS: Our cohort consisted of 1 722 548 children, and among these 47 778 cases of ADHD. The hazard ratio (HR) of the association between elective CS, compared with unassisted VD, and ADHD was 1.15 [95% confidence interval (CI): 1.11-1.20] in the cohort, and 1.05 (95% CI: 0.93-1.18) in the stratified analysis. The HR of the association between emergency CS and ADHD was 1.16 (95% CI: 1.12-1.20])in the cohort and 1.13 (95% CI: 1.01-1.26) in the stratified analysis. CONCLUSION: Birth by CS is associated with a small increased risk of ADHD. However among siblings the association only remained for emergency CS. If this were a causal effect by CS, the association would be expected to persist for both types of CS, suggesting the observed association is due to confounding.

Birth by Caesarean Section and the Risk of Adult Psychosis: A Population-Based Cohort Study.

Despite the biological plausibility of an association between obstetric mode of delivery and psychosis in later life, studies to date have been inconclusive. We assessed the association between mode of delivery and later onset of psychosis in the offspring. A population-based cohort including data from the Swedish National Registers was used. All singleton live births between 1982 and 1995 were identified (n= 1,345,210) and followed-up to diagnosis at age 16 or later. Mode of delivery was categorized as: unassisted vaginal delivery (VD), assisted VD, elective Caesarean section (CS) (before onset of labor), and emergency CS (after onset of labor). Outcomes included any psychosis; nonaffective psychoses (including schizophrenia only) and affective psychoses (including bipolar disorder only and depression with psychosis only). Cox regression analysis was used reporting partially and fully adjusted hazard ratios (HR) with 95% confidence intervals (CI). Sibling-matched Cox regression was performed to adjust for familial confounding factors. In the fully adjusted analyses, elective CS was significantly associated with any psychosis (HR 1.13, 95% CI 1.03, 1.24). Similar findings were found for nonaffective psychoses (HR 1.13, 95% CI 0.99, 1.29) and affective psychoses (HR 1.17, 95% CI 1.05, 1.31) (χ(2)for heterogeneityP= .69). In the sibling-matched Cox regression, this association disappeared (HR 1.03, 95% CI 0.78, 1.37). No association was found between assisted VD or emergency CS and psychosis. This study found that elective CS is associated with an increase in offspring psychosis. However, the association did not persist in the sibling-matched analysis, implying the association is likely due to familial confounding by unmeasured factors such as genetics or environment.

Obstetrical Mode of Delivery and Childhood Behavior and Psychological Development in a British Cohort.

The association between mode of delivery [specifically birth by Cesarean section (CS)] and induction of labor (IOL) psychological development at age 7 was assessed [including autism spectrum disorders (ASD), attention-deficit/hyperactivity disorder (ADHD) and behavioral difficulties]. The Millennium cohort study, a nationally representative UK cohort of children (including 13,141 children), was used. There was no association between planned CS and ASD [aOR 0.58; (95 % CI 0.19-1.79)] or ADHD [aOR 0.54; (95 % CI 0.18-1.64)] analyses. Induced vaginal delivery was significantly associated with behavioral difficulties in unadjusted [OR 1.26; (95 % CI 1.03-1.54)], but not adjusted analysis [OR 1.15; (95 % CI 0.82-1.60)]. There was no association between mode of delivery and ASD or ADHD in this cohort. Further research is needed to understand the relationship between mode of delivery and IOL and psychological development.

Association Between Obstetric Mode of Delivery and Autism Spectrum Disorder: A Population-Based Sibling Design Study.

IMPORTANCE: Because the rates of cesarean section (CS) are increasing worldwide, it is becoming increasingly important to understand the long-term effects that mode of delivery may have on child development. OBJECTIVE: To investigate the association between obstetric mode of delivery and autism spectrum disorder (ASD). DESIGN, SETTING, AND PARTICIPANTS: Perinatal factors and ASD diagnoses based on the International Classification of Diseases, Ninth Revision (ICD-9),and the International Statistical Classification of Diseases, 10th Revision (ICD-10),were identified from the Swedish Medical Birth Register and the Swedish National Patient Register. We conducted stratified Cox proportional hazards regression analysis to examine the effect of mode of delivery on ASD. We then used conditional logistic regression to perform a sibling design study, which consisted of sibling pairs discordant on ASD status. Analyses were adjusted for year of birth (ie, partially adjusted) and then fully adjusted for various perinatal and sociodemographic factors. The population-based cohort study consisted of all singleton live births in Sweden from January 1, 1982, through December 31, 2010. Children were followed up until first diagnosis of ASD, death, migration, or December 31, 2011 (end of study period), whichever came first. The full cohort consisted of 2,697,315 children and 28,290 cases of ASD. Sibling control analysis consisted of 13,411 sibling pairs. EXPOSURES: Obstetric mode of delivery defined as unassisted vaginal delivery (VD), assisted VD, elective CS, and emergency CS (defined by before or after onset of labor). MAIN OUTCOMES AND MEASURES: The ASD status as defined using codes from the ICD-9 (code 299) and ICD-10 (code F84). RESULTS: In adjusted Cox proportional hazards regression analysis, elective CS (hazard ratio, 1.21; 95% CI, 1.15-1.27) and emergency CS (hazard ratio, 1.15; 95% CI, 1.10-1.20) were associated with ASD when compared with unassisted VD. In the sibling control analysis, elective CS was not associated with ASD in partially (odds ratio [OR], 0.97; 95% CI, 0.85-1.11) or fully adjusted (OR, 0.89; 95% CI, 0.76-1.04) models. Emergency CS was significantly associated with ASD in partially adjusted analysis (OR, 1.20; 95% CI, 1.06-1.36), but this effect disappeared in the fully adjusted model (OR, 0.97; 95% CI, 0.85-1.11). CONCLUSIONS AND RELEVANCE: This study confirms previous findings that children born by CS are approximately 20% more likely to be diagnosed as having ASD. However, the association did not persist when using sibling controls, implying that this association is due to familial confounding by genetic and/or environmental factors.

Challenges and changes: immunization program managers share perspectives in a 2012 national survey about the US immunization system since the H1N1 pandemic response.

In mid-2012 we conducted survey of immunization program managers (IPMs) for the purpose of describing relationships between immunization programs and emergency preparedness programs, IPM's perceptions of challenges encountered and changes made or planned in programmatic budgeting, vaccine allocation and pandemic plans as a result of the H1N1 vaccination campaign. Over 95% of IPMs responded (61/64) to the survey. IPMs reported that a primary budget-related challenge faced during H1N1 included staff-related restrictions that limited the ability to hire extra help or pay regular staff overtime resulting in overworked regular staff. Other budget-related challenges related to operational budget shortfalls and vaccine procurement delays. IPMs described overcoming these challenges by increasing staff where possible, using executive order or other high-level support by officials to access emergency funds and make policy changes, as well as expedite hiring and spending processes according to their pandemic influenza plan or by direction from leadership. Changes planned for response to future pandemic vaccine allocation strategies were to "tailor the strategy to the event" taking into account disease virulence, vaccine production rates and public demand, having flexible vaccine allocation strategies, clarifying priority groups for vaccine receipt to providers and the public, and having targeted clinics such as through pharmacies or schools. Changes already made to pandemic plans were improving strategies for internal and external communication, improving vaccine allocation efficiency, and planning for specific scenarios. To prepare for future pandemics, programs should ensure well-defined roles, collaborating during non-emergency situations, sustaining continuity in preparedness funding, and improved technologies.

Vaccine providers' perspectives on impact, challenges, and response during the California 2010 pertussis outbreak.

INTRODUCTION: California has experienced its worst outbreak of pertussis in 50 y. In preparing for such outbreaks of pertussis, vaccine providers in the state play a key role in educating patients about the public health implications of vaccination, explaining the benefits to immunization, and facilitating patients' receipt of recommended immunizations. METHODS: We conducted a survey of 800 California vaccine providers to investigate provider level response to recent pertussis outbreaks and regulation by provider type and geography. RESULTS: Sixty-nine percent (533/777) of vaccine providers within the state of California responded to the survey. Fifty-three percent (278/527) of vaccine providers indicated that it was part of standard care at their practice or pharmacy location to ask adult patients about pertussis vaccine (Table 1) and this varied across practice types (P<0.0001). Fifty-seven percent of providers (270/476) indicated that the information they received from the state about pertussis during the 2010 California pertussis outbreak was very useful or useful, while 52% of providers indicated this information was neutral, not useful, not at all useful. Vaccine administration, patient groups seen, and challenges varied by provider type however meaningful differences among subpopulations to which the vaccine was administered were found between provider types (P<0.001, Table 2). CONCLUSION: The 2010 pertussis outbreak in California challenged vaccine providers in a way that changed the preparation, promotion, and planning for future outbreaks and emergency situations. Adaptability to the new state law and increased awareness of pertussis in the physician community were important in the number of patients receiving the vaccine. Also, forming partnerships with schools and health agencies were important in facilitating and promoting wide spread vaccination.

Legal considerations surrounding mandatory influenza vaccination for healthcare workers in the United States.

Recent years have brought increased focus on the desirability of vaccinating more healthcare workers against influenza. The concern that novel 2009 H1N1 influenza A would spark a particularly severe influenza season in 2009-2010 spurred several institutions and one state to institute mandatory vaccination policies for healthcare workers, and several new mandates have been introduced since then. Some healthcare workers, however, have voiced objections in the media and in legal proceedings. This paper reviews the characteristics of influenza and how it is transmitted in the healthcare setting; surveys possible constitutional, administrative, and common law arguments against mandates; assesses the viability of those arguments; and identifies potential new legal strategies to support influenza vaccine mandates. It is intended to assist those involved in the regulation and administration of public and private healthcare institutions who may be considering approaches to mandates but have concerns about legal challenges.

Evaluation of the frequency of immunization information system use for public health research.

Immunization information systems (IIS) have been useful for consolidating immunization data and increasing coverage, and have the potential to be a valuable resource for immunization research, but the extent which IIS data are used for research purposes has not been evaluated. We reviewed studies conducted using data from federally supported state and city immunization program IIS, and categorized research type based on study objectives to evaluate patterns in the types of research conducted. Research papers using IIS data published between 1999 and July 3, 2012 were identified by searching the CDC IIS publication database and PubMed. These searches produced 304 and 884 papers, respectively, 44 of which were eligible to be included in this evaluation. The most common research category was evaluation of factors associated with vaccine coverage and vaccine coverage estimates (n = 20). This study shows that IIS may not be used to their full potential with regards to research. Further research is needed to determine barriers to using IIS data for research purposes.