Colorado Multiple Institutional Review Board Research Articles

Does engagement matter? The impact of patient and community engagement on implementation of cardiovascular health materials in primary care settings

BackgroundEngaging patients and community members in healthcare implementation, research and evaluation has become more popular over the past two decades. Despite the growing interest in patient engagement, there is scant evidence of its impact and importance. Boot Camp Translation (BCT) is one evidence-based method of engaging communities in research. The purpose of this report is to describe the uptake by primary care practices of cardiovascular disease prevention materials produced through four different local community engagement efforts using BCT.MethodsEvidenceNOW Southwest (ENSW) was a randomized trial to increase cardiovascular disease (CVD) prevention in primary care practices. Because of its study design, Four BCTs were conducted, and the materials created were made available to participating practices in the “enhanced” study arm. As a result, ENSW offered one of the first opportunities to explore the impact of the BCT method by describing the uptake by primary care practices of health messages and materials created locally using the BCT process. Analysis compared uptake of locally translated BCT products vs. all other products among practices based on geography, type of practice, and local BCT.ResultsWithin the enhanced arm of the study that included BCT, 69 urban and 13 rural practices participated with 9 being federally qualified community health centers, 14 hospital owned and 59 clinician owned. Sixty-three practices had 5 or fewer clinicians. Two hundred and ten separate orders for materials were placed by 43 of the 82 practices. While practices ordered a wide variety of BCT products, they were more likely to order materials developed by their local BCT.ConclusionsIn this study, patients and community members generated common and unique messages and materials for cardiovascular disease prevention relevant to their regional and community culture. Primary care practices preferred the materials created in their region. The greater uptake of locally created materials over non-local materials supports the use of patient engagement methods such as BCT to increase the implementation and delivery of guideline-based care. Yes, patient and community engagement matters.Trial registration and IRBTrial registration was prospectively registered on July 31, 2015 at ClinicalTrials.gov (NCT02515578, protocol identifier 15–0403). The project was approved by the Colorado Multiple Institutional Review Board and the University of New Mexico Human Research Protections Office.

Examining Coping Skills, Anxiety, and Depression Dynamics Amidst the COVID-19 Pandemic

This cross-sectional study, conducted amid the COVID-19 pandemic, delves into the intricate connections between coping strategies and levels of anxiety and depression, presenting vital implications for medical, clinical, and broader societal contexts. As crises like the pandemic highlight the importance of adaptive coping, this investigation underscores the imperative to comprehend and address maladaptive coping strategies. The study utilized a diverse sample of 386 participants during the pandemic's peak, employing online platforms for recruitment and ensuring broad demographic representation. Data were collected through self-report measures, including the Patient Health Questionnaire-4 (PHQ-4) for depression and anxiety symptoms and the Brief Coping Orientation to Problems Experienced (COPE) inventory to assess coping skills across various domains. The coping skills assessment measured strategies such as Self-Distraction, Active Coping, Denial, Substance Use, Emotional and Instrumental Support, Behavioral Disengagement, Venting, Positive Reframing, Planning, Humor, Acceptance, Religion, and Self-Blame. The Colorado Multiple Institutional Review Board prioritized and approved ethical considerations, and participants provided informed consent. Data analysis involved rigorous cleaning, recoding, and quantitative analysis using SPSS. Descriptive statistics, regression analyses, and correlation analyses were employed to uncover nuanced relationships between coping strategies and mental health outcomes, contributing to understanding the phenomena under investigation within the context of the pandemic. The findings highlight the pivotal role of individualized approaches and the potential of humor as an essential coping mechanism, emphasizing the need for tailored interventions during crises.

Experiences of dignity: Age at onset of serious illness matters.

Preserving persons' dignity is integral to nursing. More research is needed to explore how a diversity of patients, particularly those that experience illness from a young age, experience dignity. Describe the characteristics of dignity for persons living with serious illness. Using a secondary data set of twenty audio-recorded interviews, a thematic content analysis was conducted to identify characteristics of dignity. The research team employed van Gennip et al.'s, 2013 "Model of Dignity in Illness" (1) to create a codebook, which the authors utilized to independently code twenty narrative interview transcripts. Twenty persons living with serious illness of heart failure and/or dialysis-dependent renal failure who were admitted in an acute care hospital. This study was approved on August 26, 2019, by the Colorado Multiple Institutional Review Board (COMIRB) IRB Protocol #19-1874. Early-onset participants expressed markedly different dignity concerns than late-onset participants. In the individual domain, early-onset participants felt that their illness was "normal"; they did not experience the "healthy person to patient" transition described by older onset participants. In the relational domain, early-onset participants expressed that their relationships had already integrated their illness while late-onset participants felt that their illness harmed many of their relationships. In the societal domain, early-onset participants described dignity concerns related to how society impacted their ability to financially support themselves during their illness. Differences in the dignity experience of early-onset and late-onset participants are informed by Erikson's "Model of Development" and by Aranda and Jones feminist critique of dignity in healthcare. Persons with early-onset illness experience dignity differently. Awareness of the importance of work and financial independence to the experience of dignity for seriously ill patients may enhance persons' dignity experience.

Firearm Owners' Preferences for Locking Devices: Results of a National Survey.

Firearm Owners' Preferences for Locking Devices: Results of a National Survey.

Investigating transmission of SARS-CoV-2 using novel face mask sampling: a protocol for an observational prospective study of index cases and their contacts in a congregate setting

IntroductionThis study aims to measure how transmission of SARS-CoV-2 occurs in communities and to identify conditions that lend to increased transmission focusing on congregate situations. We will measure SARS-CoV-2 in...

Comparing Prescribing Practices of Statin Therapy in Atherosclerotic Cardiovascular Disease Patients with Varying Levels of Chronic Kidney Disease

Lead Author's Financial Disclosures Nothing to disclose. Study Funding None. Background/Synopsis Evidence supporting high-intensity statin therapy in patients with atherosclerotic cardiovascular disease (ASCVD) and advanced chronic kidney disease (CKD), not on dialysis, is not robust. Cardiovascular risk reduction from statin therapy within this population is predominantly derived from post-hoc subgroup analysis of larger trials. This subset of ASCVD patients is often at higher risk for medication-related adverse effects, secondary to reduced renal clearance, polypharmacy, and high prevalence of co-morbidities. This increased risk may result in provider hesitation and under prescribing of high-intensity statin therapy among ASCVD patients. Of the available high-intensity statins atorvastatin does not require renal dose adjustments although rosuvastatin does. On a population level, prescribing of statins among patients with ASCVD and CKD has improved in recent years but remains sub-optimal. Results from this study can provide insight into whether providers are following guideline recommendations and package labeled dosing when prescribing statin therapy in a real-world setting. Objective/Purpose This study aims to evaluate real-world prescribing patterns of statin-therapy among ASCVD patients with non-dialysis dependent Stage 4-5 CKD and Stage 3a and 3b CKD. Methods This study is a retrospective, cross-sectional observational study and has been reviewed by the Colorado Multiple Institutional Review Board as exempt. Patients with a diagnosis of clinical ASCVD, non-dialysis dependent CKD stage 3a-5, and prescribed a statin between 1/1/2020-9/30/2021 were identified. The primary outcome will be prescribing ahigh-intensityy statin among patients with eGFR <30 mL/min compared to patients with eGFR 30-<60 mL/min. Secondary outcomes will include differences in mean LDL-C between the two groups and proportion of patients on FDA approved dosing of rosuvastatin. A chi-square test will be used for qualitative data and a student t-test for quantitative data. Results A total of 6000 patients have been identified and will be evaluated for inclusion into this study. Results are currently in progress. Conclusions Will be presented. Nothing to disclose.

Understanding the Shades of Gray in Diagnosis-An Online Course in Bayesian Reasoning.

Foundational skills in Bayesian reasoning may aid clinical decision-making, decrease overreliance on single diagnostic tests, and improve patient care. However, clinicians are often unskilled in applying Bayes' rule at the bedside, such as using likelihood ratios to calculate posttest probabilities.1While published literature measures clinicians' abilities to update conditional probabilities based on dichotomous test results, many diagnostic tests used in clinical practice are not dichotomous.1 One of the gaps in clinical decision-making revolves around the interpretation of continuous tests such as D-dimer, troponin, and procalcitonin. Although often dichotomized as “normal” and “abnormal” for simplicity, the test's degree of abnormality may have a profound effect on how the result changes the disease probability. Explicit instruction in understanding the “shades of gray” in diagnostic test interpretation is lacking.Clinicians who are deficient in knowledge of Bayesian reasoning are often involved in trainee education. Faculty development initiatives to improve Bayesian reasoning would presumably have positive downstream effects on learners. Educational efforts may be limited by faculty time, availability, and lack of local experts in Bayesian reasoning. Furthermore, the recent COVID-19 pandemic has presented additional challenges to designing and delivering in-person educational curricula.We developed an online, self-paced, asynchronous, case-based curriculum in Bayesian reasoning. The course uses a flipped classroom approach and revolves around 10 core clinical cases. Each case represents a realistic patient scenario. The learner reads each scenario and answers a series of questions assessing a range of skills involved in Bayesian reasoning. The learner is asked to incorporate various findings in the estimation of disease probability, updating disease probability based on new information and integrating this information to guide subsequent management decisions. Each case is followed by video explanations that guide learners through the fundamentals of Bayesian reasoning. The course gradually builds from simple test characteristics, such as sensitivity and specificity, to understanding multilevel likelihood ratios, receiver operating characteristic curves, and action thresholds when making decisions under uncertainty. Course completion is estimated to take 6 to 8 hours. All course materials were created by the study authors.The course was piloted to faculty volunteers beginning June 2021 for the Division of Hospital Medicine faculty at the University of Colorado. Informed consent was obtained. Each participant took 15-question pre- and posttests to evaluate the baseline and gained knowledge. Participants also self-assessed their prior knowledge, ranked the importance of Bayesian reasoning in their clinical care, and noted their satisfaction with the course on a 4-point Likert scale that excluded neutral responses. The Colorado Multiple Institutional Review Board granted the study an exempt status.As of October 2021, 18 out of 20 invited faculty members started the course, and 12 (67%) completed it. Overall, 11 of 12 (92%) faculty members rated their prior knowledge in Bayesian reasoning as “somewhat” or “very weak.” Most (10 of 12) participants rated the importance of Bayesian reasoning in clinical care as “very important,” and the rest rated it as “somewhat important.” All participants (100%) reported feeling “very satisfied” with the course and indicated that it is “very likely” they would recommend the course to a colleague. The pretest assessment demonstrated serious deficiencies in all tested domains, and the posttest assessment showed marked improvement in all of them (Figure). This online course is now integrated into the internal medicine residency curriculum, and all trainees completed the course by February 2022. Further dissemination is planned to medical schools, residency training programs, and faculty outside of our institution.

ASPMN Position Paper Update: RNs Caring for Patients Receiving Analgesia by Catheter – Ascertaining Standard of Practice

PURPOSE: This cross-sectional study by survey was designed to ascertain if there is a standard of care for registered nurses (RNs) caring for analgesia by catheter technique. This was important to do since a review of literature and statements from state Boards of Nursing did not identify a standard of care of patients receiving medication by catheters. The American Society for Pain Management Nursing (ASPMN) position paper on this subject was authored in 2007 and revision is needed. This study was found to be Exempt by the Colorado Multiple Institutional Review Board (COMIRB) Methods: The Task Force reviewing and updating the ASPMN “Registered Nurse Management and Monitoring of Analgesia by Catheter Techniques: Position Paper” developed an COMIRB approved convenience sample survey that was disseminated via the ASPMN ListServe and E-Newsletter.

Prospective multisite cohort study of patient-reported outcomes in adults with new-onset seizures.

ObjectiveNew‐onset seizures affect up to 10% of people over their lifetime, however, their health economic impact has not been well‐studied. This prospective multicenter study will collect patient‐reported outcome measures (PROMs) from adults with new‐onset seizures seen in six Seizure Clinics across Melbourne, Australia and The University of Colorado, USA.MethodsApproximately 450 eligible patients will be enrolled in the study at or following their initial attendance to Seizure Clinics at the study hospitals. Inclusion criteria for the study group are those with new‐onset acute symptomatic seizures, new‐onset unprovoked seizures, and new‐onset epilepsy. Inclusion criteria for the three comparator groups are those with noncardiac syncope, those with psychogenic nonepileptic seizures, as well as published PROMs data from the Australian general population. Exclusion criteria are those aged less than 18 years, those with a preexisting epilepsy diagnosis, and those with intellectual disabilities or other impairments which would preclude them from comprehending and completing the questionnaires. Patients will complete eight online questionnaires regarding the effect that their seizures (or seizure mimics) have had on various aspects of their life. These questionnaires will be readministered at 6 and 12 months. Patients with new‐diagnosis epilepsy will also be asked to share the reasons why they have accepted or declined antiseizure medications.AnalysisPrimary outcome measures will be quality of life, work productivity, informal care needs, and mood, at baseline compared to 6 and 12 months later for those with new‐onset seizures and comparing these outcomes to those in the three comparator groups. Secondary outcomes include mapping of QoLIE‐31 to the EQ‐5D‐5L in epilepsy, modelling indirect costs of new‐onset seizures, and exploring why patients may or may not wish to take antiseizure medications.SignificanceThese data will form an evidence‐base for future studies that examine the effectiveness of various healthcare interventions for new‐onset seizure patients.Ethics and disseminationThis study is approved by the Alfred Health Human Research Ethics Committee (SERP: 52 538, Alfred HREC: 307/19), the Austin Health Human Research Ethics Committee (HREC/59148/Austin‐2019), and the Colorado Multiple Institutional Review Board (COMIRB) (COMIRB #20‐3028).ANZCTR trial registration numberACTRN12621000908831.

Abstract 13114: Effectiveness of a Novel Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest: A Pilot Study of the “Tool to EMPOwer Surrogate Decision Makers” (TEMPO)

Introduction: Surrogate decision makers (SDMs) represent critical stakeholders in decision making for comatose survivors of cardiac arrest, yet these individuals are often unprepared for decision making and unfamiliar with the complexity of post-cardiac arrest care. To that end, we created a decision aid for SDMs intended to inform and support evidence-based decision making for comatose survivors of cardiac arrest. Methods: We conducted a pilot trial to measure real world effectiveness of the Tool to EMPOwer (TEMPO) Surrogate Decision Makers, by measuring knowledge and acceptability. Individuals were enrolled who self-identified as the SDM for a comatose survivor of OHCA admitted to an academic tertiary care hospital. Participants completed a pre-intervention survey prior to the provision of TEMPO, and a post-intervention survey approximately 24 hours after exposure to the intervention. Pre-survey questions included SDM demographics and an 8-question knowledge survey. Post-intervention surveys included the same knowledge questions, the Ottawa Acceptability of Decision Aid tool, and questions to measure if SDMs shared TEMPO with others. This study was approved by the Colorado Multiple Institutional Review Board and registered at Clinicaltrials.gov (NCT03908346). Results: Twenty SDMs were enrolled between 9/1/2020 and 6/7/2021. One subject did not complete the post-intervention survey therefore 19 subject responses were analyzed for the purpose of this report. Participants were 85.0% Female, 47.4 +/- 14.8 years, and 45.0% were the spouse of the patient. In the 8-question knowledge survey, results improved from 57.2% correct to 90.8% correct after exposure to TEMPO (p&lt;0.001). Using the Ottawa Acceptability Tool, 89.5% of participants stated TEMPO was useful in decision-making and 94.7% reported that TEMPO made their decision “easier”. Most (79.0%) participants reported they shared the DA with another family/friend in-person, while some (52.6%) reported they shared content with another person by telephone. Conclusion: Initial pilot data on the efficacy of the Tool to EMPOwer Surrogate Decision Makers of comatose survivors of cardiac arrest shows significant promise in improving knowledge and supporting decision-making.

Letter: A Novel Neurosurgery Virtual Interest Group for Disadvantaged Medical Students: Lessons Learned for the Postpandemic Era

Letter: A Novel Neurosurgery Virtual Interest Group for Disadvantaged Medical Students: Lessons Learned for the Postpandemic Era

A Study Protocol for an Open-Label Feasibility Treatment Trial of Visual Snow Syndrome With Transcranial Magnetic Stimulation.

Background: Visual Snow (VS) syndrome is believed to be due to aberrant central visual processing. Positron Emission Tomography (PET) brain imaging and visual evoked potential studies provide evidence for excessive neuronal activity in the medial temporal lobe, specifically the lingual gyrus, and suggest the VS syndrome is a hyperexcitability syndrome. These data provide the basis for consideration of repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for the VS syndrome.Objective: To publish the study protocol for a pilot study underway at the University of Colorado School of Medicine to investigate the use of rTMS intervention to improve symptoms and visual dysfunction associated with VS. The study aims to determine the adverse events and drop-out rate, evaluate performance of outcome measures, including a novel VS symptom scale, and describe changes in outcomes associated with treatment.Methods and Design: Up to 10 participants meeting criteria for VS syndrome, age 19–65 years, will undergo an open-label intervention consisting of 10 rTMS sessions, occurring 5 days a week over a 2-week period. Participants will complete pre-treatment and post-treatment assessments that include: the Colorado Visual Snow Scale (CVSS), the National Eye Institute Visual Functional Questionnaire—25 (VFQ-25), the General Anxiety Disorder—7 scale (GAD-7), and three psychophysical visual processing tasks.Discussion: Knowledge gained from this pilot study will inform future study planning and provide valuable lessons for future investigation of rTMS for the VS syndrome. An overview of study proceedings thus far demonstrates recruitment challenges associated with the COVID-19 pandemic, and additional challenges that are unique to the VS syndrome and to treatment schedules associated with TMS.Registration: This study has been approved by the Colorado Multiple Institutional Review Board. ClinicalTrials.gov Identifier: NCT04925232.

146. A novel vertebral numbering system for identifying congenital anomalies of the spine using full spine radiographs with the EOS imaging system

<h3>BACKGROUND CONTEXT</h3> The numbering of vertebral transitional anatomy can be challenging and controversial. Disagreement exists on how to best report anomalous vertebra and which imaging modality (CT, MRI, X-ray, etc) is most consistent. For these reasons, there is often a discrepancy in the numbering of transitional levels between radiologists and surgeons. Moreover, correlating levels identified intraoperatively by fluoroscopy with inconsistently numbered vertebrae on preoperative MRI or CT is arduous. Errors in numbering can have devastating implications for patients. A simple and accurate vertebral numbering system that can be applied to routine imaging is needed. <h3>PURPOSE</h3> The purpose of this study was to describe a novel and more simplified vertebral numbering system that can be used amongst surgeons and radiologists. <h3>STUDY DESIGN/SETTING</h3> A retrospective imaging study analyzing full-length spine X-rays was performed with the approval of a Colorado Multiple Institutional Review Board (COMIRB protocol:17-1920). <h3>PATIENT SAMPLE</h3> A total of 5,422 images were obtained that included all adult patients who presented to the Spine Center at the University of Colorado and obtained full-spine X-rays using the EOS imaging system between January 31st of 2018 and March 31st of 2020. Images from the same patient at multiple time points were excluded and 3,250 unique patient images were included in our study. After the initial period of data collection, 103 images were excluded from the final analysis due to poor image quality or missing image files. <h3>OUTCOME MEASURES</h3> Total presacral mobile segments were identified and counted using 24 as the number found in conventional spinal anatomy. The total number of ribs were counted for each patient including hypoplastic ribs, and the level of the first-ribbed vertebrae and last-ribbed vertebrae were recorded. <h3>METHODS</h3> Image analysis was conducted by five experienced researchers. The results were reviewed and verified by the senior authors. Any disagreements were reviewed and resolved by two board-certified musculoskeletal radiologists. Final results were evaluated and a novel vertebral numbering system with the lowest probability of error was agreed upon. <h3>RESULTS</h3> In our study cohort, 91.1% (2,868/3,147) demonstrated the conventional 24 presacral mobile segments, whereas 3.3% (104) had 23 presacral mobile segments, 5.5% (174) had 25, and 0.03% (1) had 26. Transitional anatomy, as defined by a number of presacral segments other than 24, was noted in 8.8% (279) of the total number of patients. Within this same group, the majority (94.6%; 2,976) had 12 ribs (including hypoplastic ribs), 4.5% (143) had 11 ribs, and 0.88% (28) had 13 ribs. Just 3.5% (112) had incomplete or hypoplastic ribs. Furthermore, 1.8% (56) of patients had both transitional anatomy and an abnormal number of ribs, with the pattern of transitional anatomy and 11 ribs being the most common combination identified. Considering the first nonribbed vertebrae as the first lumbar vertebrae yielded the lowest probability of a numbering error. <h3>CONCLUSIONS</h3> We are proposing a novel vertebral numbering system that yields the lowest probability of error in reporting anomalous anatomy which can be applied to routine cervical, thoracic, and lumbar radiographs. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Risk Factors for Hospitalization in People With HIV and COVID-19.

Risk Factors for Hospitalization in People With HIV and COVID-19.

What the head and neck? A study of integrated gross anatomy with embryology and its effect on learning and retention

Mastery in anatomical sciences is critical for medical professionals for competent practice and patient safety. However, widespread curricular changes focused on integration of subjects and clinical content resulted in minimal contact hours for anatomical sciences and increasing reliance on adjunct online resources. The COVID-19 pandemic further highlighted the need for quality online teaching materials. Despite the central role online resources play in anatomical sciences, most remain subject-specific with minimal integration of other disciplines; thus, the educational effect of integrated online resources is unclear. To that end, two versions of a head and neck gross anatomy tutorial were created; although the gross anatomy content was identical, the experimental tutorial also integrated embryology of the head and neck. In a Colorado Multiple Institutional Review Board (COMIRB) exempt #20-2175 randomized single blind study, the first (DS1) and the second year (DS2) dental students enrolled in a gross anatomy course were recruited. The DS1s had never been exposed to the content of the tutorial while the DS2s had learned the content in the prior year. All participants completed a pre-test. Then the participants were randomly assigned to access either the control or the experimental tutorial before completing a post-test and a survey. DS1s also completed a retention test one week after completing the post-test. Seventy-one DS1s, and 71 DS2s completed the study. Both cohorts scored statistically higher in the post-test compared to the pre-test (Tukey HSD, all p's < 0.001). The post-test performance increase for DS2s was significantly higher than for DS1s (main cohort effect: F(1,2) = 4.88, p < 0.05, partial h2 = 0.06, Tukey HSD, p < 0.05). A two-way repeated-measures ANOVA revealed a significantly higher retention test score compared to the pre-test scores for DS1 (Tukey HSD: p < 0.01). Thematic analytics of the survey comments were mostly positive and similar across the experimental conditions. Notably, the experimental group indicated a positive perception of integrated embryology content attributed to providing context for gross anatomy. These findings suggest that a digital tutorial on head and neck anatomy leads to significant learning and short-term retention, regardless of integrated embryology content presentation, but based on thematic analysis students perceive the integrated content to be contextually valuable. The post-test increase difference between DS1 andDS2 indicate that the digital tutorials yield better outcomes as a review resource as opposed to an introductory resource.

Parental Vaccine Hesitancy and Vaccination Disparities in a Safety-Net System

Poor and minority children still lag behind wealthier, white children in vaccination coverage.1,2 Structural, logistic, cultural, and attitudinal barriers contribute to vaccination disparities.3,4 Vaccine hesitancy (VH) is an important attitudinal barrier and a growing challenge.5 We measured VH and its association with child average days undervaccinated (ADU) in English- and Spanish-speaking parents of children aged 2 years in 3 safety-net clinics, describing associations by language, race, and ethnicity.We surveyed English- and Spanish-speaking parents bringing children aged 2 years to 3 pediatric clinics for well or sick care from August 2019 through February 2020. Parents were eligible if (1) English or Spanish was their first language, (2) their child turned 2 years in the last 12 months, and (3) the child had 1 previous well visit in the last 18 months. We excluded parents of children with medical contraindications to vaccination. A bilingual research assistant recruited dyads in waiting rooms; parents completed the survey on an iPad and received $5. The Colorado Multiple Institutional Review Board approved this study.We measured parental VH with the Parent Attitudes about Childhood Vaccines (PACV) tool because of its previous validation studies,6–8 brevity and simplicity, and rigorous Spanish translation.9 We transformed responses into scaled (0–100) and dichotomized (<50 = not hesitant and ≥50 = hesitant) scores, as described in previous validation work.7 We collected parent demographics and extracted child vaccination data from electronic medical records. Our independent variable of interest was parental VH. Our outcome variable was child ADU at age 2 years (ie, 730 days), which calculates the difference between when vaccine doses are given and when they are due and ranges from 0 (immunized on time) to 638 (unvaccinated).10 We compared parents by VH status on independent variables and performed multivariable linear regression analyses to assess parental VH with child ADU associations. For a 2-sided α of .05, power of 0.80, population ADU mean of 36 ± 89,10 VH effect size of 55 ADU,8,9 and parental VH prevalence of 10%,8,9 we estimated needing 259 parents (24 hesitant and 235 not hesitant). Analyses were conducted by using R (R Foundation for Statistical Computing, Vienna, Austria).Of 293 parents approached, 263 (90%) participated. Two surveys were incomplete, and 6 parents responded twice. In Table 1, we describe our final sample of 255 predominantly Hispanic, English-speaking dyads, stratified by parental VH status. Thirty-three (13%) parents were hesitant; 4 (4%) Spanish-speaking parents were hesitant versus 29 (19%) English-speaking parents (P < .01). PACV item responses also differed by language (Supplemental Table 3). Among all children, the mean ADU at age 2 was 66 days (SD 151). In adjusted analyses, children of English-speaking VH parents had a 114-day greater ADU compared with children of English-speaking non-VH parents (P = .02). Parental VH did not associate with changes in child ADU for Spanish-speaking dyads (P = .61). Children of Black parents (referent to non-Hispanic white) were significantly undervaccinated, independent of parental VH (Table 2).In a safety-net system sample, we found VH in 1 in 8 parents of children aged 2 years, with differential impacts by language, race, and ethnicity. In previous studies, researchers described VH in wealthier, privately insured clinics; in our study, we found VH in clinics serving minority, publicly insured, and Spanish-speaking children, with a prevalence (13%) similar to that previously reported (8%–25%).8,9,11 Nearly 1 in 4 Black parents had VH, and Black children aged 2 years were additionally undervaccinated, independent of parental VH. Parental VH should be explored as an important vaccination barrier along with others identified for Black toddlers, such as public insurance, access, distrust of health care, and missed opportunities.12–15 Parental VH was not associated with ADU changes among Spanish-speaking families, perhaps because of respeto, the cultural value by which Spanish-speaking parents may deferentially subjugate their concerns to clinical expertise.16 This finding bolsters existing work showing how language and culture impact pediatric care.17As a single-site retrospective study of parents of children aged 2 years, our conclusions should be explored in other systems and with other age and language groups. Furthermore, trust between staff and patients may have caused a social desirability bias to participate, and we were unable to recruit dyads who failed to present for care. Still, our work highlights the need to explore VH by language and culture and pursue implementation studies to adapt evidence-based interventions for families in safety-net systems.We acknowledge Jason Glanz, PhD, and the Kaiser Permanente Institute for Health Research for providing us with the algorithm for ADU and instructing us in its use.

Northern Colorado SARS-CoV-2 Biorepository (NoCo-COBIO): A Multi-Matrix, Longitudinal Biobank of COVID-19 Patient Specimens

Background: SARS-CoV-2 has swept across the globe and caused over 1.5 million deaths worldwide. Successful prevention and treatment of COVID-19 is dependent on in-depth knowledge of viral behavior across the spectrum of patient phenotypes and physiologic responses. Biobanking provides a valuable resource of easily-accessed, quality-controlled samples for researchers to study current and future pandemics.Methods: Patients with a history of a positive SARS-CoV-2 nasopharyngeal PCR are recruited to enroll in the Northern Colorado SARS-CoV-2 Biorepository (NoCo-COBIO). Participants are enrolled in the acute phase of their disease or from the community during convalescence. Blood, saliva, nasopharyngeal, and stool specimens, as well as extensive clinical and demographic data, are collected at the time of enrollment. This biobanking effort has a longitudinal patient follow-up of four time points, with standardized multi-matrix sample and data collections over a 6-month period. One-year follow up will be performed to assess mortality data and sequelae.Findings: To date, we have enrolled and collected samples from 60 acute and 40 convalescent participants. Twenty (33%) of the acute participants have had one or more follow-up visits, and 90% of participants enrolled during convalescence have completed 2 or more visits.Interpretation: We have successfully created a multi-faceted biobank of specimens from individuals with COVID-19 to advance human SARS-CoV-2 research.Trial Registration: ClinicalTrials.gov (NCT05603677).Funding Statement: The biorepository was initiated by and supported with funding and translational research infrastructure in the CSU ERHS department (Elizabeth P. Ryan) and with the University of Colorado Health Northern Colorado Trauma Research Department (Julie Dunn).Declaration of Interests: The authors disclose no conflict of interest related to the manuscript.Ethics Approval Statement: This biorepository was approved by CSU’s Research Integrity and Compliance Review Office Institutional Review Board (protocol ID 20-10063H), as well as UCH Institutional Review Board (Colorado Multiple Institutional Review Board 20-6043).

The Effects of Coronavirus Disease 2019 on Pediatric Anesthesiologists: A Survey of the Members of the Society for Pediatric Anesthesia.

The coronavirus disease 2019 (COVID-19) pandemic has affected the personal and professional lives of all health care workers. Anesthesiologists frequently perform virus-aerosolizing procedures (eg, intubation and extubation) that place them at increased risk of infection. We sought to determine how the initial COVID-19 outbreak affected members of the Society for Pediatric Anesthesia (SPA) on both personal and professional levels. Specifically, we examined the potential effects of gender and age on personal stress, burnout, sleep deprivation, anxiety, depression, assessed job satisfaction, and explored financial impact. After receiving approval from the SPA Committees for Research and Quality and Safety and the Colorado Multiple Institutional Review Board, we e-mailed a questionnaire to all 3245 SPA members. The survey included 22 questions related to well-being and 13 questions related to effects of COVID-19 on current and future practice, finances, retirement planning, academic time and productivity, and clinical and home responsibilities. To address low initial response rates and quantify nonresponse bias, we sent a shortened follow-up survey to a randomly selected subsample (n = 100) of SPA members who did not respond to the initial survey. Response differences between the 2 cohorts were determined. A total of 561 (17%) members responded to the initial questionnaire. Because of COVID-19, 21.7% of respondents said they would change their clinical responsibilities, and 10.6% would decrease their professional working time. Women were more likely than men to anticipate a future COVID-19-related job change (odds ratio [OR] = 1.92, 95% confidence interval [CI], 1.12-2.63; P = .011), perhaps because of increased home responsibilities (OR = 2.63, 95% CI, 1.74-4.00; P < .001). Additionally, 14.2% of respondents planned to retire early, and 11.9% planned to retire later. Women and non-White respondents had higher likelihoods of burnout on univariate analysis (OR = 1.75, 95% CI, 1.06-2.94, P = .026 and OR = 1.82, 95% CI, 1.08-3.04, P = .017, respectively), and 25.1% of all respondents felt socially isolated. In addition, both changes in retirement planning and future occupational planning were strongly associated with total job satisfaction scores (both P < .001). The COVID-19 pandemic has affected the personal and professional lives of pediatric anesthesiologists, albeit not equally, as women and non-Whites have been disproportionately impacted. The pandemic has significantly affected personal finances, home responsibilities, and retirement planning; reduced clinical and academic practice time and responsibilities; and increased feelings of social isolation, stress, burnout, and depression/anxiety.

Engaging practices and communities in the development of interventions to promote HPV vaccine uptake: a protocol for implementing Boot Camp Translation in the private practice setting

IntroductionThe Healthy People 2020 report states a goal of 80% uptake of recommended vaccines among adolescents, including the human papillomavirus (HPV) vaccine. However, the rate of uptake of the HPV...

Motivational Interviewing for Maternal Immunisation (MI4MI) study: a protocol for an implementation study of a clinician vaccine communication intervention for prenatal care settings

IntroductionVaccination against influenza and pertussis in pregnancy offers a ‘two-for-one’ opportunity to protect mother and child. Pregnant patients have increased risk of severe disease from influenza and newborns have increased...