Validation of an algorithm to prioritize patients for comprehensive medication management in primary care settings.

BACKGROUND: Comprehensive medication management (CMM) programs optimize the effectiveness and safety of patients' medication regimens, but CMM may be underutilized. Whether healthcare claims data can identify patients appropriate for CMM is not well-studied. AIM: Determine the face validity of a claims-based algorithm to prioritize patients who likely need CMM. METHOD: We used claims data to construct patient-level markers of "regimen complexity" and "high-risk for adverse effects," which were combined to define four categories of claims-based CMM-need (very likely, likely, unlikely, very unlikely) among 180 patient records. Three clinicians independently reviewed each record to assess CMM need. We assessed concordance between the claims-based and clinician-review CMM need by calculating percent agreement as well as kappa statistic. RESULTS: Most records identified as 'very likely' (90%) by claims-based markers were identified by clinician-reviewers as needing CMM. Few records within the 'very unlikely' group (5%) were identified by clinician-reviewers as needing CMM. Interrater agreement between CMM-based algorithm and clinician review was moderate in strength (kappa = 0.6, p < 0.001). CONCLUSION: Claims-based pharmacy measures may offer a valid approach to prioritize patients into CMM-need groups. Further testing of this algorithm is needed prior to implementation in clinic settings.

Supratherapeutic INR During Treatment With Nirmatrelvir/Ritonavir and Warfarin and Acute Illness With COVID-19: A Case Report.

Background: Several studies have examined INR fluctuations using pharmacokinetic (PK) models or post-hoc INR values after completing nirmatrelvir/ritonavir, but further study of the effects of the drug interaction with warfarin during treatment is necessary. Case Summary: Nirmatrelvir/ritonavir is largely utilized in the outpatient setting so data regarding INR trends in hospitalized patients on warfarin is limited. However, many who receive nirmatrelvir/ritonavir outpatient experience difficulty with presenting to clinic for INR checks due to feeling acutely ill along with isolation precautions. We present the case of a patient receiving warfarin and utilizing home INR testing for monitoring. After diagnosis of coronavirus disease of 2019 (COVID-19), she was started on nirmatrelvir/ritonavir on day five after testing positive. Most recent INR prior to the start of therapy was 2.7 and had been stable on the same dose for months prior to infection. On day two of nirmatrelvir/ritonavir, her INR rose to 4.0 on home point of care INR testing. Despite reducing her dose of warfarin by 15%, her INR remained supratherapeutic the day after completing nirmatrelvir/ritonavir (4.0) and for several checks after. One month after completion of therapy, her INR returned to therapeutic levels. Practice Implications: While PK models and case series have hypothesized both potential increases or decreases in INR with the nirmatrelvir/ritonavir and warfarin interaction, COVID-19 infection itself can cause several pharmacodynamic changes which can increase INR, including decreased appetite and, in severe cases, organ dysfunction. This case provides real-world insight into the drug interaction between nirmatrelvir/ritonavir and the drug-disease state interaction between warfarin and COVID-19.

Personalised recommendations for hospitalised patients with Acute Kidney Injury using a Kidney Action Team (KAT-AKI): protocol and early data of a randomised controlled trial.

INTRODUCTION: Although studies have examined the utility of clinical decision support tools in improving acute kidney injury (AKI) outcomes, no study has evaluated the effect of real-time, personalised AKI recommendations. This study aims to assess the impact of individualised AKI-specific recommendations delivered by trained clinicians and pharmacists immediately after AKI detection in hospitalised patients. METHODS AND ANALYSIS: KAT-AKI is a multicentre randomised investigator-blinded trial being conducted across eight hospitals at two major US hospital systems planning to enrol 4000 patients over 3 years (between 1 November 2021 and 1 November 2024). A real-time electronic AKI alert system informs a dedicated team composed of a physician and pharmacist who independently review the chart in real time, screen for eligibility and provide combined recommendations across the following domains: diagnostics, volume, potassium, acid-base and medications. Recommendations are delivered to the primary team in the alert arm or logged for future analysis in the usual care arm. The planned primary outcome is a composite of AKI progression, dialysis and mortality within 14 days from randomisation. A key secondary outcome is the percentage of recommendations implemented by the primary team within 24 hours from randomisation. The study has enrolled 500 individuals over 8.5 months. Two-thirds were on a medical floor at the time of the alert and 17.8% were in an intensive care unit. Virtually all participants were recommended for at least one diagnostic intervention. More than half (51.6%) had recommendations to discontinue or dose-adjust a medication. The median time from AKI alert to randomisation was 28 (IQR 15.8-51.5) min. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of each study site (Yale University and Johns Hopkins institutional review board (IRB) and a central IRB (BRANY, Biomedical Research Alliance of New York). We are committed to open dissemination of the data through clinicaltrials.gov and sharing of data on an open repository as well as publication in a peer-reviewed journal on completion. TRIAL REGISTRATION NUMBER: NCT04040296.

Perceptions and Experiences With Evidence-based Treatments Among People Who Use Opioids.

OBJECTIVES: Even where treatment is available, people who use drugs (PWUD) may not seek help. Few published studies examine beliefs, experiences, and perceptions of evidence-based treatment among PWUD who are not actively engaged in care. This study aimed to explore the experiences of PWUD in considering or accessing treatment and gauge receptiveness to low-threshold treatment models. METHODS: A purposeful sample of participants actively using opioids and with previous interest in or experience with treatment was recruited from a harm reduction program in Chicago. Semistructured interviews were conducted to explore key phenomena while allowing for unanticipated themes. The instrument included questions about historical drug use, treatment experience, and perceptions of how to improve treatment access and services. Private interviews were audio recorded, transcribed, and double coded by 2 analysts. Queries of coded data were analyzed using issue-focused analysis to identify themes. RESULTS: The sample (N = 40) approximated groups at highest risk of fatal overdose in Chicago, with more than 80% between the ages of 45 to 64 years, 65% African American, and 62% male identified. The majority had prior treatment experience, although all resumed use after completing or leaving treatment. The most prevalent barriers to treatment included structural barriers related to social determinants, lack of readiness for abstinence, burdensome intake procedures, and regulatory/programmatic requirements. Most participants expressed interest in low-threshold treatment. CONCLUSIONS: Existing treatment barriers may be addressed by shifting to lower-threshold intake processes and/or outreach-based delivery of opioid agonist treatment. Engaging PWUD in efforts to create lower-threshold treatment programs is necessary to ensure that needs are met.

The impact of COVID-19 on adolescent wellness in Chicago.

PURPOSE: This study aimed to understand the impact of the initial COVID-19 pandemic remote schooling period on self-reported wellness among adolescents in Chicago. METHODS: Students (n = 55) completed a 22-item wellness questionnaire before (February 2020) and shortly after the onset of the COVID-19 outbreak (April 2020). Precomparisons/postcomparisons (overall and by survey item) were evaluated using two-sided paired t-tests with an alpha level of 0.05. Descriptive statistics were used to evaluate mean scores overall by demographic variables. RESULTS: Significant differences were found in the following areas: Balance (Pre: 7.3, During: 6.4, p = 0.02), Education (Pre: 8.4, During 7.7, p = 0.03) and Friends (Pre:8.0, During: 6.3, p = 0.001). Overall wellness scores varied by demographic variables, though not significantly. CONCLUSIONS: Results suggest the onset of the pandemic impacted students' ability to effectively learn, as well as to maintain balance in their lives and social relationships. Comprehensive support is needed in these areas to promote adolescent wellness.

Examining the efficacy of vibrotactile displays for monitoring patient vital signs: Six laboratory studies of change detection and state identification.

Healthcare workers often monitor patients while moving between different locations and tasks, and away from conventional monitoring displays. Vibrotactile displays can provide patient information in vibrotactile patterns that are felt regardless of the worker's location. We examined how effectively participants could identify changes in vibrotactile representations of patient heart rate (HR) and oxygen saturation (SpO2). In Experiment 1, participants identified changes in HR and SpO2 with greater than 90% accuracy while using vibrotactile displays configured in either an integrated or a separated format. In Experiment 2, incidental auditory and visual cues were removed and performance was still greater than 90% for the integrated display. In Experiments 3 and 4, ongoing tasks with low or high task load were introduced; high load worsened participants' response accuracy and speed at identifying vital signs. In Experiments 5 and 6, alternative designs were tested, including a design with a seemingly more natural mapping of HR to vibrotactile stimulation. However, no design supported more accurate performance than the integrated display. Results are interpreted with respect to multiple resource theory, and constraints on conforming to design guidelines are noted. Vibrotactile displays appear to be viable and therefore potentially suitable for use in healthcare and other contexts. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Disparities in access to fertility care: who's in and who's out.

OBJECTIVE: To study the racial and socioeconomic characteristics of women seeking fertility care in a state with mandated insurance coverage for fertility testing and treatment. DESIGN: Cross-sectional, self-administered survey. SETTING: Academic fertility center in Illinois. PATIENTS: Of 5,000 consecutive fertility care patients, 1,460 completed the survey and were included in the study sample. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Details about demographic characteristics and health care access on the basis of patient race/ethnicity and socioeconomic status. RESULTS: The mean age of participants was 36.1 years; 75.5% were White, 10.2% Asian, 7.3% Black, 5.7% Latinx, and 1.3% Other. Most women had a bachelor's (35.5%) or master's degree (40.5%) and an annual household income of >$100,000 (81.5%). Black and Hispanic women traveled twice as far (median 10 miles) as White and Asian women (median 5 miles for both) for treatment. Black women (14.7%) were more likely to report that their race was a barrier to getting fertility treatment compared with White (0.0%), Hispanic (5.1%), and Asian (5.4%) women. Black and Hispanic women were approximately twice as likely to report income level (26.5% and 20.3%, respectively) and weight (7.8% and 8.9%, respectively) as barriers compared with White and Asian respondents. CONCLUSIONS: Significant racial and socioeconomic disparities exist among fertility patients accessing care. Beyond providing all Americans with health insurance that covers fertility treatment, further research in the general population is needed to understand the complex social, cultural, racial, and economic factors that prohibit many individuals from accessing needed fertility care.

Characterizing Biphasic Food-Related Allergic Reactions Through a US Food Allergy Patient Registry.

BACKGROUND: Understanding about patient-reported biphasic food-related allergic reactions is currently sparse. OBJECTIVE: To characterize patient-reported biphasic food-related allergic reactions among a national food allergy registry. METHODS: We used two patient registry surveys established by Food Allergy Research and Education. Variables were described with proportions and 95% confidence intervals (CIs); unadjusted results were stratified by respondent type. Multivariable logistic regression evaluated the adjusted odds of reporting a biphasic reaction. RESULTS: The incidence of reported biphasic reactions was 16.4% (95% CI, 15.3-17.7). A total of 12.8% of parent or guardian respondents (95% CI, 12.5-14.3) and 21.8% of self-respondents (95% CI, 19.7-23.8) indicated a biphasic reaction during their most recent food-allergic reaction. Among respondents with a mild initial reaction, 7.4% reported a biphasic reaction, compared with 30% with a very severe initial reaction. When the initial reaction was mild, 69.6% of parent or guardian respondents (95% CI, 47.2-85.4) and 52.0% of self-respondents (95% CI, 38.0-35.7) with a biphasic reaction reported a mild secondary reaction. When the initial reaction was very severe, 36.3% of parent or guardian respondents (95% CI, 26.4-47.5) and 42.9% of self-respondents (95% CI, 31.1-55.5) with a biphasic reaction reported a very severe secondary reaction. Female sex, Black race, reaction age 5-12 and 26-66 years, initial moderate, severe, or very severe reaction, and one or more annual reactions were associated with increased odds of a biphasic reaction. CONCLUSIONS: This study characterizes the incidence of patient-reported biphasic reactions and provides valuable information on the probable severity of a biphasic food-related allergic reaction. Further research is necessary to understand the epidemiology of food-related biphasic reactions.

Characterization of polycystic ovary syndrome among Flo app users around the world.

BACKGROUND: Polycystic ovary syndrome (PCOS) is a complex and multi-faceted endocrine disorder that affects 5-20% of women. Literature is limited regarding potentially differing PCOS phenotypes among women around the world. OBJECTIVE: To use Flo app technology to understand the multifaceted characteristics of PCOS across several countries and identify contributing risk factors to the development of this condition. STUDY DESIGN: Flo is a widely used female health and wellbeing app with period tracking functionality that provides a globally representative and medically unbiased perspective on PCOS symptomatology. A chatbot dialog on PCOS was subsequently administered on the Flo application (app) to users from 142 countries (with at least 100 respondents) who have the app running in English during September-October 2019. RESULTS: For analyses, we selected the five countries with the greatest number of respondents: US (n = 243,238), UK (n = 68,325), India (n = 40,092), Philippines (n = 35,131), and Australia (n = 29,926). Bloating was the most frequently reported symptom among PCOS-positive women and appeared to be the main predictor of PCOS in our model (odds ratio 3·76 [95% CI 3·60-3·94]; p < 0·0001). Additional top predictors of PCOS are high blood cholesterol and glucose levels. As BMI increased, the percentage of women who reported a physician-confirmed PCOS diagnosis also increased. However, women in India did not follow this trend. CONCLUSION: Our findings are based on the largest known PCOS dataset and indicate that symptoms are more complex than previously understood. The most frequently reported symptoms (bloating, facial hirsutism, irregular cycles, hyperpigmentation, and baldness) are broader than those included in the Rotterdam criteria. Future work should reevaluate and refine the criteria utilized in PCOS diagnosis.

Emotional stress and reproduction: what do fertility patients believe?

PURPOSE: To better understand the beliefs about a causal role of emotional stress maintained by women seeking fertility care. METHODS: A cross-sectional, self-administered survey was distributed to fertility care patients at an academic fertility center in Illinois. Of 5000 consecutive patients, 1460 completed the survey and were included in the study sample. RESULTS: Members of our sample (N = 1460) were between 20 and 58 years (mean = 36.2, SD = 4.4). Most respondents were White (72.2%), were in a heterosexual relationship (86.8%), and felt that their physician understood their cultural background (79.4%). Of the sample, 28.9% believed emotional stress could cause infertility, 69.0% believed emotional stress could reduce success with fertility treatment, and 31.3% believed that emotional stress could cause a miscarriage, with evidence of significant racial differences. Less than a quarter (23.8%) of the sample believed emotional stress had no impact on fertility. Lower household income and educational attainment were associated with a greater belief in emotional stress as a causative factor in reproduction with regard to infertility, fertility treatment, and miscarriage. CONCLUSION: The majority of women seeking fertility care believe emotional stress could reduce the success of fertility treatment. Furthermore, beliefs about emotional stress and reproduction significantly differ based on race/ethnicity, income, and education. Particular attention should be paid to specific groups of women who may more likely not be aware of the lack of a proven biological relationship between emotional stress and reproduction.

Infertility in the Midwest: perceptions and attitudes of current treatment.

BACKGROUND: Although infertility affects an estimated 6.1 million individuals in the United States, only half of those individuals seek fertility treatment and the majority of those patients are White and of high socioeconomic status. Research has shown that insurance mandates are not enough to ensure equal access. Many workplaces, schools, and medical education programs have made efforts in recent years to improve the cultural humility of providers in efforts to engage more racially and economically underrepresented groups in medical care. However, these efforts have not been assessed on a population of patients receiving fertility care, an experience that is uniquely shaped by individual social, cultural, and economic factors. OBJECTIVE: This study aimed to better understand the racial, cultural, economic, and religious factors that impact patient experiences obtaining fertility care. STUDY DESIGN: A cross-sectional self-administered survey was administered at an academic fertility center in Chicago, Illinois. Of 5000 consecutive fertility care patients, 1460 completed the survey and were included in the study sample. No interventions were used. Descriptive univariate frequencies and percentages were calculated to summarize sociodemographic and other relevant patient characteristics (eg, race or ethnicity, age, household income, religious affiliation, insurance coverage). Rates of endorsing perceived physician cultural competency were compared among demographic subgroups using Pearson chi-squared tests with 2-sided P<.05 indicative of statistical significance. To identify the key determinants of patient-reported worry regarding 9 different fertility treatment outcomes and related concerns, a series of multiple logistic regression models were fit to examine factors associated with patient report of being "very worried" or "extremely worried." RESULTS: Members of our sample (N=1460) were between 20 and 58 years of age (meanadjusted, 36.2; standard deviation, 4.4). Among Black participants, 42.3% reported that their physician does not understand their cultural background compared with 16.5% of White participants (P<.0001). Participants who identified as Latinx were significantly more likely than White participants to report being very/extremely worried about side effects of treatment, a miscarriage, ectopic pregnancies, and birth defects (P<.05, P=.02, P=.002, P=.001, respectively). Individuals who identify as Hindu were nearly 4 times more likely to report being very/extremely worried about experiencing an ectopic pregnancy than nonreligious participants (P<.0002). Respondents most strongly identified the biology or physiology of the couple (meanadjusted, 21.6; confidence interval, 20.4-22.7) and timing or age (meanadjusted, 27.8; confidence interval, 26.5-29.1) as being associated with fertility. Overall, respondents most strongly disagreed that the ability to bear children rests upon God's will (meanadjusted, 65.4; confidence interval, 63.7-67.1), which differed most significantly by race (P<.0001) and religion (P<.0001). CONCLUSION: Of the patient characteristics investigated, racial and ethnic subgroups showed the greatest degree of variation in regard to worries and concerns surrounding the experience of fertility treatment. Our findings emphasize a need for improved cultural humility on behalf of physicians, in addition to affordable psychological support for all patients seeking fertility care.

Understanding Food-Related Allergic Reactions Through a US National Patient Registry.

BACKGROUND: Although previous studies have focused on unintentional food-related allergic reactions, few have explored the motivation of intentional exposure to a known food allergen, independent of oral food challenges and/or oral immunotherapy. Still, data on the frequency and context of food-related allergic reactions remain sparse. OBJECTIVE: To identify the frequency and context of food-related allergic reactions among children and adults. METHODS: We analyzed surveys from the Patient Registry established by Food Allergy Research and Education. Multivariable logistic regression evaluated characteristics associated with having frequent food-related allergic reactions as well as intentional food-related allergic reactions. RESULTS: Over one-third of 4075 (37.7%) respondents reported having more than 1 food-related allergic reaction per year, and 12.8% reported having 1 reaction per year. Of the 3054 respondents who completed the most recent reaction survey, 9.9% of food allergen exposures were classified as intentional, 82.1% as unintentional, and 4.8% as medically related. Among children with intentional exposures, the most common reason was that the child had never had a serious reaction (50.0%), and among adults, it was the decision to take the risk anyway (47.8%). Cross-contamination was the most commonly cited reason for unintentional exposure (children: 24.1%; adults: 32.2%). CONCLUSION: Among patients in a national food allergy registry, reports of food-related allergic reactions were common, and a non-negligible number of intentional reactions were reported. Our findings indicate the need for research on reactions in and out of the emergency department as well as intentional risk-taking behavior.

Food allergy-related bullying and associated peer dynamics among Black and White children in the FORWARD study.

BACKGROUND: The experiences of Black children with food allergy (FA) are not well characterized, particularly with respect to bullying victimization and other psychosocial outcomes. OBJECTIVE: To evaluate bullying experiences of Black and White children with FA, including associations with peer relationships, anxiety, and school policies. METHODS: Surveys were administered to parents of 252 children with physician-diagnosed FA enrolled in the multisite FORWARD cohort. The surveys assessed demographics, atopic disease, bullying victimization, and school FA management practices and policies. Descriptive statistics of bullying by race were compared by χ2 tests. Multiple logistic regression analyses adjusting for race, age, parental education, household income, child sex, and multi-FA compared adjusted probabilities of bullying victimization by school policies. RESULTS: Nearly 20% of school-aged children were bullied for FA with no substantial racial differences overall, though for children ages 11 years and up, White children reported higher rates of bullying. However, Black children experienced non-FA-related bullying twice as frequently as White children (38.6% vs 17.7%; P = .002). Most of the caregivers (85.7%) who intervened in their child's bullying reported that it was helpful. Among parents, 17.3% reported that they were teased or bullied owing to their child's FA. More than half of the respondents (54.8%) reported that some allergens are banned from their child's school, most typically peanut. In schools banning peanuts, FA-related bullying was less frequently reported by all students who have food allergy. CONCLUSION: Bullying owing to FA is common, and caregivers, medical professionals, and school administrators can help reduce bullying by screening for bullying and supporting and educating school policies.