Four different study designs to evaluate vaccine safety were equally validated with contrasting limitations

OBJECTIVE: We conducted a simulation study to empirically compare four study designs [cohort, case-control, risk-interval, self-controlled case series (SCCS)] used to assess vaccine safety. STUDY DESIGN AND METHODS: Using Vaccine Safety Datalink data (a Centers for Disease Control and Prevention-funded project), we simulated 250 case sets of an acute illness within a cohort of vaccinated and unvaccinated children. We constructed the other three study designs from the cohort at three different incident rate ratios (IRRs, 2.00, 3.00, and 4.00), 15 levels of decreasing disease incidence, and two confounding levels (20%, 40%) for both fixed and seasonal confounding. Each of the design-specific study samples was analyzed with a regression model. The design-specific beta; estimates were compared. RESULTS: The beta; estimates of the case-control, risk-interval, and SCCS designs were within 5% of the true risk parameters or cohort estimates. However, the case-control\u27s estimates were less precise, less powerful, and biased by fixed confounding. The estimates of SCCS and risk-interval designs were biased by unadjusted seasonal confounding. CONCLUSIONS: All the methods were valid designs, with contrasting strengths and weaknesses. In particular, the SCCS method proved to be an efficient and valid alternative to the cohort method

Development and implementation of a prescription opioid registry across diverse health systems

Objective: Develop and implement a prescription opioid registry in 10 diverse health systems across the US and describe trends in prescribed opioids between 2012 and 2018. Materials and Methods: Using electronic health record and claims data, we identified patients who had an outpatient fill for any prescription opioid, and/or an opioid use disorder diagnosis, between January 1, 2012 and December 31, 2018. The registry contains distributed files of prescription opioids, benzodiazepines and other select medications, opioid antagonists, clinical diagnoses, procedures, health services utilization, and health plan membership. Rates of outpatient opioid fills over the study period, standardized to health system demographic distributions, are described by age, gender, and race/ethnicity among members without cancer. Results: The registry includes 6 249 710 patients and over 40 million outpatient opioid fills. For the combined registry population, opioid fills declined from a high of 0.718 per member-year in 2013 to 0.478 in 2018, and morphine milligram equivalents (MMEs) per fill declined from 985 MMEs per fill in 2012 to 758 MMEs in 2018. MMEs per member declined from 692 MMEs per member in 2012 to 362 MMEs per member in 2018. Conclusion: This study established a population-based opioid registry across 10 diverse health systems that can be used to address questions related to opioid use. Initial analyses showed large reductions in overall opioid use per member among the combined health systems. The registry will be used in future studies to answer a broad range of other critical public health issues relating to prescription opioid use

Mortality risk after COVID-19 vaccination: A self-controlled case series study

Background Although previous studies found no-increased mortality risk after COVID-19 vaccination, residual confounding bias might have impacted the findings. Using a modified self-controlled case series (SCCS) design, we assessed the risk of non-COVID-19 mortality, all-cause mortality, and four cardiac-related death outcomes after primary series COVID-19 vaccination. Methods We analyzed all deaths between December 14, 2020, and August 11, 2021, among individuals from eight Vaccine Safety Datalink sites. Demographic characteristics of deaths in recipients of COVID-19 vaccines and unvaccinated individuals were reported. We conducted SCCS analyses by vaccine type and death outcomes and reported relative incidences (RI). The observation period for death spanned from the dates of emergency use authorization to the end of the study period (August 11, 2021) without censoring the observation period upon death. We pre-specified a primary risk interval of 28-day and a secondary risk interval of 14-day after each vaccination dose. Adjusting for seasonality in mortality analyses is crucial because death rates vary over time. Deaths among unvaccinated individuals were included in SCCS analyses to account for seasonality by incorporating calendar month in the models. Results For Pfizer-BioNTech (BNT162b2), RIs of non-COVID-19 mortality, all-cause mortality, and four cardiac-related death outcomes were below 1 and 95 % confidence intervals (CIs) excluded 1 across both doses and both risk intervals. For Moderna (mRNA-1273), RI point estimates of all outcomes were below 1, although the 95 % CIs of two RI estimates included 1: cardiac-related (RI = 0.78, 95 % CI, 0.58-1.04) and non-COVID-19 cardiac-related mortality (RI = 0.80, 95 % CI, 0.60-1.08) 14 days after the second dose in individuals without pre-existing cancer and heart disease. For Janssen (Ad26.COV2.S), RIs of four cardiac-related death outcomes ranged from 0.94 to 0.98 for the 14-day risk interval, and 0.68 to 0.72 for the 28-day risk interval and 95 % CIs included 1. Conclusion Using a modified SCCS design and adjusting for temporal trends, no-increased risk was found for non-COVID-19 mortality, all-cause mortality, and four cardiac-related death outcomes among recipients of the three COVID-19 vaccines used in the US

Addressing Parental Vaccine Concerns: Engagement, Balance, and Timing.

The recent United States measles epidemic has sparked another contentious national discussion about childhood vaccination. A growing number of parents are expressing concerns about the safety of vaccines, often fueled by misinformation from the internet, books, and other nonmedical sources. Many of these concerned parents are choosing to refuse or delay childhood vaccines, placing their children and surrounding communities at risk for serious diseases that are nearly 100% preventable with vaccination. Between 10% and 15% of parents are asking physicians to space out the timing of vaccines, which often poses an ethical dilemma for physicians. This trend reflects a tension between personal liberty and public health, as parents fight to control the decisions that affect the health of their children and public health officials strive to maintain high immunization rates to prevent outbreaks of vaccine-preventable diseases. Interventions to address this emerging public health issue are needed. We describe a framework by which web-based interventions can be used to help parents make evidence-based decisions about childhood vaccinations

Social Media Vaccine Websites: A Comparative Analysis of Public and Moderated Websites

The internet is an important source of vaccine information for parents. We evaluated and compared the interactive content on an expert moderated vaccine social media (VSM) website developed for parents of children 24 months of age or younger and enrolled in a health care system to a random sample of interactions extracted from publicly available parenting and vaccine-focused blogs and discussion forums. The study observation period was September 2013 through July 2016. Three hundred sixty-seven eligible websites were located using search terms related to vaccines. Seventy-nine samples of interactions about vaccines on public blogs and discussion boards and 61 interactions from the expert moderated VSM website were coded for tone, vaccine stance, and accuracy of information. If information was inaccurate, it was coded as corrected, partially corrected or uncorrected. Using chi-square or Fisher’s exact tests, we compared coded interactions from the VSM website with coded interactions from the sample of publicly available websites. We then identified representative quotes to illustrate the quantitative results. Tone, vaccine stance, and accuracy of information were significantly different (all p \u3c .05). Publicly available vaccine websites tended to be more contentious and have a negative stance toward vaccines. These websites also had inaccurate and uncorrected information. In contrast, the expert moderated website had a more civil tone, minimal posting of inaccurate information, with very little participant-to-participant interaction. An expert moderated, interactive vaccine website appears to provide a platform for parents to gather accurate vaccine information, express their vaccine concerns and ask questions of vaccine experts

Click for updates Substance Abuse A Review of Opioid Overdose Prevention and Naloxone Prescribing: Implications for Translating Community Programming Into Clinical Practice A Review of Opioid Overdose Prevention and Naloxone Prescribing: Implications for

ABSTRACT. Background: As physicians have increased opioid prescribing, overdose deaths from pharmaceutical opioids have substantially increased in the United States. Naloxone hydrochloride (naloxone), an opioid antagonist, is the standard of care for treatment of opioid induced respiratory depression. Since 1996, community-based programs have offered overdose prevention education and distributed naloxone for bystander administration to people who use opioids, particularly heroin. There is growing interest in translating overdose education and naloxone distribution (OEND) into conventional medical settings for patients who are prescribed pharmaceutical opioids. For this review, we summarized and classified existing publications on overdose education and naloxone distribution to identify evidence of effectiveness and opportunities for translation into conventional medical settings. Methods: For this review, we searched English language PubMed for articles on naloxone based on primary data collection from humans, including feasibility studies, program evaluations, surveys, qualitative studies, and studies comparing the effectiveness of different routes of naloxone administration. We also included cost-effectiveness studies. Results: We identified 41 articles that represented 5 categories: evaluations of OEND programs, effects of OEND programs on experiences and attitudes of participants, willingness of medical providers to prescribe naloxone, comparisons of different routes of naloxone administration, and the cost-effectiveness of naloxone. Conclusions: Existing research suggests that people who are at risk for overdose and other bystanders are willing and able to be trained to prevent overdoses and administer naloxone. Counseling patients about the risks of opioid overdose and prescribing naloxone is an emerging clinical practice that may reduce fatalities from overdose while enhancing the safe prescribing of opioids

Rates and risk factors associated with hospitalization for pneumonia with ICU admission among adults

Abstract Background Pneumonia poses a significant burden to the U.S. health-care system. However, there are few data focusing on severe pneumonia, particularly cases of pneumonia associated with specialized care in intensive care units (ICU). Methods We used administrative and electronic medical record data from six integrated health care systems to estimate rates of pneumonia hospitalizations with ICU admissions among adults during 2006 through 2010. Pneumonia hospitalization was defined as either a primary discharge diagnosis of pneumonia or a primary discharge diagnosis of sepsis or respiratory failure with a secondary diagnosis of pneumonia in administrative data. ICU admissions were collected from internal electronic medical records from each system. Comorbidities were identified by ICD-9-CM codes coded during the current pneumonia hospitalization, as well as during medical visits that occurred during the year prior to the date of admission. Results We identified 119,537 adult hospitalizations meeting our definition for pneumonia. Approximately 19% of adult pneumonia hospitalizations had an ICU admission. The rate of pneumonia hospitalizations requiring ICU admission during the study period was 76 per 100,000 population/year; rates increased for each age-group with the highest rates among adults aged ≥85 years. Having a co-morbidity approximately doubled the risk of ICU admission in all age-groups. Conclusions Our study indicates a significant burden of pneumonia hospitalizations with an ICU admission among adults in our cohort during 2006 through 2010, especially older age-groups and persons with underlying medical conditions. These findings reinforce current strategies aimed to prevent pneumonia among adults