Risk for Reinfection After SARS-CoV-2: A Living, Rapid Review for American College of Physicians Practice Points on the Role of the Antibody Response in Conferring Immunity Following SARS-CoV-2 Infection.

BACKGROUND: The strength and duration of immunity from infection with SARS-CoV-2 are important for public health planning and clinical practice. PURPOSE: To synthesize evidence on protection against reinfection after SARS-CoV-2 infection. DATA SOURCES: MEDLINE (Ovid), the World Health Organization global literature database, ClinicalTrials.gov, COVID19reviews.org, and reference lists. STUDY SELECTION: Longitudinal studies that compared the risk for reinfection after SARS-CoV-2 infection versus infection risk in individuals with no prior infection. DATA EXTRACTION: Two investigators sequentially extracted study data and rated quality. DATA SYNTHESIS: Across 18 eligible studies, reinfection risk ranged from 0% to 2.2%. In persons with recent SARS-CoV-2 infection compared with unvaccinated, previously uninfected individuals, 80% to 98% of symptomatic infections with wild-type or Alpha variants were prevented (high strength of evidence). In the meta-analysis, previous infection reduced risk for reinfection by 87% (95% CI, 84% to 90%), equaling 4.3 fewer infections per 100 persons in both the general population (risk difference, -0.043 [CI, -0.071 to -0.015]) and health care workers (risk difference, -0.043 [CI, -0.069 to -0.016]), and 26.6 fewer infections per 100 persons in care facilities (risk difference, -0.266 [CI, -0.449 to -0.083]). Protection remained above 80% for at least 7 months, but no study followed patients after the emergence of the Delta or Omicron variant. Results for the elderly were conflicting. LIMITATION: Methods to ascertain and diagnose infections varied. CONCLUSION: Before the emergence of the Delta and Omicron variants, persons with recent infection had strong protection against symptomatic reinfections for 7 months compared with unvaccinated, previously uninfected individuals. Protection in immunocompromised persons, racial and ethnic subgroups, and asymptomatic index case patients is unclear. The durability of protection in the setting of the Delta and Omicron variants is unknown. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality. (PROSPERO: CRD42020207098).

Frequency of newborn bathing in the first 9 weeks of life and related factors: An observational study in a community-based sample from Meta-LARC.

PURPOSE: Environmental factors such as bathing may play a role in atopic dermatitis (AD) development. This analysis utilized data from the Community Assessment of Skin Care, Allergies, and Eczema (CASCADE) Trial (NCT03409367), a randomized controlled trial of emollient therapy for AD prevention in the general population, to estimate bathing frequency and associated factors within the first 9 weeks of life. METHODS: Data were collected from 909 parent/newborn dyads recruited from 25 pediatric and family medicine clinics from the Meta-network Learning and Research Center (Meta-LARC) practice-based research network (PBRN) consortium in Oregon, North Carolina, Colorado, and Wisconsin for the CASCADE trial. Ordinal logistic regression was used to conduct a cross-sectional analysis of the association between bathing frequency (measured in baths per week) and demographic, medical, and lifestyle information about the infant, their family, and their household. Variables were selected using a backwards-stepwise method and estimates from the reduced model are reported in the text. RESULTS: Moisturizer use (OR = 2.03, 95% CI: 1.54-2.68), Hispanic or Latino ethnicity (OR = 1.97, 95% CI: 1.42-2.72), a parental education level lower than a 4-year college degree (OR = 2.48, 95% CI: 1.70-3.62), living in North Carolina or Wisconsin (compared to Oregon; OR = 2.12 and 1.47, 95% CI: 1.53-2.93 and 1.04-2.08, respectively), and increasing child age (in days; OR = 1.02, 95% CI: 1.01-1.02) were significantly associated with more frequent bathing, while pet ownership (OR = 0.67, 95% CI: 0.52-0.87) was significantly associated with less frequent bathing. CONCLUSIONS: We found significant ethnic, geographic, and socioeconomic variation in bathing frequency before 9 weeks of age that may be of relevance to AD prevention studies.

The Transforming Outcomes for Patients Through Medical Home Evaluation and reDesign (TOPMED) Cluster Randomized Controlled Trial: Cost and Utilization Results.

BACKGROUND: Primary Care Medical Home (PCMH) redesign efforts are intended to enhance primary care's ability to improve population health and well-being. PCMH transformation that is focused on "high-value elements" (HVEs) for cost and utilization may improve effectiveness. OBJECTIVES: The objective of this study was to determine if a focus on achieving HVEs extracted from successful primary care transformation models would reduce cost and utilization as compared with a focus on achieving PCMH quality improvement goals. RESEARCH DESIGN: A stratified, cluster randomized controlled trial with 2 arms. All practices received equal financial incentives, health information technology support, and in-person practice facilitation. Analyses consisted of multivariable modeling, adjusting for the cluster, with difference-in-difference results. SUBJECTS: Eight primary care clinics that were engaged in PCMH reform. MEASURES: We examined: (1) total claims payments; (2) emergency department (ED) visits; and (3) hospitalizations among patients during baseline and intervention years. RESULTS: In total, 16,099 patients met the inclusion criteria. Intervention clinics had significantly lower baseline ED visits (P=0.02) and claims paid (P=0.01). Difference-in-difference showed a decrease in ED visits greater in control than intervention (ED per 1000 patients: +56; 95% confidence interval: +96, +15) with a trend towards decreased hospitalizations in intervention (-15; 95% confidence interval: -52, +21). Costs were not different. In modeling monthly outcome means, the generalized linear mixed model showed significant differences for hospitalizations during the intervention year (P=0.03). DISCUSSION: The trial had a trend of decreasing hospitalizations, increased ED visits, and no change in costs in the HVE versus quality improvement arms.

Source matters: a survey of cost variation for fecal immunochemical tests in primary care.

BACKGROUND: Colorectal cancer (CRC) screening can improve health outcomes, but screening rates remain low across the US. Mailed fecal immunochemical tests (FIT) are an effective way to increase CRC screening rates, but is still underutilized. In particular, cost of FIT has not been explored in relation to practice characteristics, FIT selection, and screening outreach approaches. METHODS: We administered a cross-sectional survey drawing from prior validated measures to 252 primary care practices to assess characteristics and context that could affect the implementation of direct mail fecal testing programs, including the cost, source of test, and types of FIT used. We analyzed the range of costs for the tests, and identified practice and test procurement factors. We examined the distributions of practice characteristics for FIT use and costs answers using the non-parametric Wilcoxon rank-sum test. We used Pearson's chi-squared test of association and interpreted a low p-value (e.g. < 0.05) as evidence of association between a given practice characteristic and knowing the cost of FIT or fecal occult blood test (FOBT). RESULTS: Among the 84 viable practice survey responses, more than 10 different types of FIT/FOBTs were in use; 76% of practices used one of the five most common FIT types. Only 40 practices (48%) provided information on FIT costs. Thirteen (32%) of these practices received the tests for free while 27 (68%) paid for their tests; median reported cost of a FIT was $3.04, with a range from $0.83 to $6.41 per test. Costs were not statistically significantly different by FIT type. However, practices who received FITs from manufacturer's vendors were more likely to know the cost (p = 0.0002) and, if known, report a higher cost (p = 0.0002). CONCLUSIONS: Our findings indicate that most practices without lab or health system supplied FITs are spending more to procure tests. Cost of FIT may impact the willingness of practices to distribute FITs through population outreach strategies, such as mailed FIT. Differences in the ability to obtain FIT tests in a cost-effective manner could have consequences for implementation of outreach programs that address colorectal cancer screening disparities in primary care practices.

Distance to Care, Rural Dwelling Status, and Patterns of Care Utilization in Adult Congenital Heart Disease.

Many patients with adult congenital heart disease (ACHD) do not receive guideline-directed care. While distance to an ACHD center has been identified as a potential barrier to care, the impact of distance on care location is not well understood. The Oregon All Payer All Claims database was queried to identify subjects 18-65 years who had a health encounter from 2010 to 2015 with an International Classification of Diseases-9 code consistent with ACHD. Residence area was classified using metropolitan statistical areas and driving distance was queried from Google Maps. Utilization rates and percentages were calculated and odds ratios were estimated using negative binomial and logistic regression. Of 10,199 identified individuals, 52.4% lived < 1 h from the ACHD center, 37.5% 1-4 h, and 10.1% > 4 h. Increased distance from the ACHD center was associated with a lower rate of ACHD-specific follow-up [< 1 h: 13.0% vs. > 4 h: 5.0%, adjusted OR 0.32 (0.22, 0.48)], but with more inpatient, emergency room, and outpatient visits overall. Those who more lived more than 4 h from the ACHD center had less inpatient visits at urban hospitals (55.5% vs. 93.9% in those < 1 h) and the ACHD center (6.2% vs. 18.2%) and more inpatient admissions at rural or critical access hospitals (25.5% vs. 1.9%). Distance from the ACHD center was associated with a decreased probability of ACHD follow-up but higher health service use overall. Further work is needed to identify strategies to improve access to specialized ACHD care for all individuals with ACHD.

Primary care practices' ability to predict future risk of expenditures and hospitalization using risk stratification and segmentation.

BACKGROUND: Patients with complex health care needs may suffer adverse outcomes from fragmented and delayed care, reducing well-being and increasing health care costs. Health reform efforts, especially those in primary care, attempt to mitigate risk of adverse outcomes by better targeting resources to those most in need. However, predicting who is susceptible to adverse outcomes, such as unplanned hospitalizations, ED visits, or other potentially avoidable expenditures, can be difficult, and providing intensive levels of resources to all patients is neither wanted nor efficient. Our objective was to understand if primary care teams can predict patient risk better than standard risk scores. METHODS: Six primary care practices risk stratified their entire patient population over a 2-year period, and worked to mitigate risk for those at high risk through care management and coordination. Individual patient risk scores created by the practices were collected and compared to a common risk score (Hierarchical Condition Categories) in their ability to predict future expenditures, ED visits, and hospitalizations. Accuracy of predictions, sensitivity, positive predictive values (PPV), and c-statistics were calculated for each risk scoring type. Analyses were stratified by whether the practice used intuition alone, an algorithm alone, or adjudicated an algorithmic risk score. RESULTS: In all, 40,342 patients were risk stratified. Practice scores had 38.6% agreement with HCC scores on identification of high-risk patients. For the 3,381 patients with reliable outcomes data, accuracy was high (0.71-0.88) but sensitivity and PPV were low (0.16-0.40). Practice-created scores had 0.02-0.14 lower sensitivity, specificity and PPV compared to HCC in prediction of outcomes. Practices using adjudication had, on average, .16 higher sensitivity. CONCLUSIONS: Practices using simple risk stratification techniques had slightly worse accuracy in predicting common outcomes than HCC, but adjudication improved prediction.

Binaural Pitch Fusion in Children With Normal Hearing, Hearing Aids, and Cochlear Implants.

OBJECTIVES: Binaural pitch fusion is the perceptual integration of stimuli that evoke different pitches between the ears into a single auditory image. Adults who use hearing aids (HAs) or cochlear implants (CIs) often experience abnormally broad binaural pitch fusion, such that sounds differing in pitch by as much as 3 to 4 octaves are fused across ears, leading to spectral averaging and speech perception interference. The main goal of this study was to measure binaural pitch fusion in children with different hearing device combinations and compare results across groups and with adults. A second goal was to examine the relationship of binaural pitch fusion to interaural pitch differences or pitch match range, a measure of sequential pitch discriminability. DESIGN: Binaural pitch fusion was measured in children between the ages of 6.1 and 11.1 years with bilateral HAs (n = 9), bimodal CI (n = 10), bilateral CIs (n = 17), as well as normal-hearing (NH) children (n = 21). Depending on device combination, stimuli were pure tones or electric pulse trains delivered to individual electrodes. Fusion ranges were measured using simultaneous, dichotic presentation of reference and comparison stimuli in opposite ears, and varying the comparison stimulus to find the range that fused with the reference stimulus. Interaural pitch match functions were measured using sequential presentation of reference and comparison stimuli, and varying the comparison stimulus to find the pitch match center and range. RESULTS: Children with bilateral HAs had significantly broader binaural pitch fusion than children with NH, bimodal CI, or bilateral CIs. Children with NH and bilateral HAs, but not children with bimodal or bilateral CIs, had significantly broader fusion than adults with the same hearing status and device configuration. In children with bilateral CIs, fusion range was correlated with several variables that were also correlated with each other: pure-tone average in the second implanted ear before CI, and duration of prior bilateral HA, bimodal CI, or bilateral CI experience. No relationship was observed between fusion range and pitch match differences or range. CONCLUSIONS: The findings suggest that binaural pitch fusion is still developing in this age range and depends on hearing device combination but not on interaural pitch differences or discriminability.

The Role of Caregiver-Reported Risks in Predicting Adverse Pediatric Outcomes.

OBJECTIVE: Certain social risk factors (e.g., housing instability, food insecurity) have been shown to directly and indirectly influence pediatric health outcomes; however, there is limited understanding of which social factors are most salient for children admitted to the hospital. This study examines how caregiver-reported social and medical characteristics of children experiencing an inpatient admission are associated with the presence of future health complications. METHODS: Caregivers of children experiencing an inpatient admission (N = 249) completed a predischarge questionnaire designed to capture medical and social risk factors across systems (e.g., patient, caregiver, family, community, healthcare environment). Electronic health record (EHR) data were reviewed for child demographic data, chronic disease status, and subsequent emergency department visits or readmissions (i.e., acute events) 90 days postindex hospitalization. Associations between risk factors and event presence were estimated using odds ratios (ORs) and confidence intervals (CI), both unadjusted and adjusted OR (aOR) for chronic disease and age. RESULTS: Thirty-three percent (N = 82) of children experienced at least one event. After accounting for child age and chronic disease status, caregiver perceptions of child's health being generally "poor" or "not good" prior to discharge (aOR = 4.7, 95% CI = 2.3, 9.7), having high care coordination needs (aOR = 3.2, 95% CI = 1.6, 6.1), and experiencing difficulty accessing care coordination (aOR = 2.5, 95% CI = 1.4, 4.7) were significantly associated with return events. CONCLUSIONS: Caregiver report of risks may provide valuable information above and beyond EHR records to both determine risk of future health problems and inform intervention development.

Use of Telehealth Videoconferencing in Pediatric Type 1 Diabetes in Oregon.

INTRODUCTION: We reviewed the impact of telehealth videoconferencing clinics on outcomes of care in pediatric patients with type 1 diabetes in rural Oregon. METHODS: We performed a chart review as well as the review of patient satisfaction questionnaires from 27 patients seen in the first year of the program. RESULTS: The number of yearly visits to diabetes clinic increased from average 1.5 to 2.7, which was statistically significant (p < 0.0001). Glycemic control remained stable, and there was no difference in the amount of emergency department visits or hospitalizations related to diabetes. Patients expressed high satisfaction with the service and majority considered it equal to in-person visits. CONCLUSION: We conclude that telehealth videoconferencing visits have the potential to improve care in pediatric diabetes patients, particularly the patients living in areas distant from subspecialty centers.

Milk Options Observation (MOO): A Mixed-Methods Study of Chocolate Milk Removal on Beverage Consumption and Student/Staff Behaviors in a Rural Elementary School.

Providing flavored milk in school lunches is controversial, with conflicting evidence on its impact on nutritional intake versus added sugar consumption and excess weight gain. Nonindustry-sponsored studies using individual-level analyses are needed. Therefore, we conducted this mixed-methods study of flavored milk removal at a rural primary school between May and June 2012. We measured beverage selection/consumption pre- and post-chocolate milk removal and collected observation field notes. We used linear and logistic mixed models to assess beverage waste and identified themes in staff and student reactions. Our analysis of data from 315 unique students and 1,820 beverages choices indicated that average added sugar intake decreased by 2.8 g postremoval, while average reductions in calcium and protein consumption were negligible (12.2 mg and 0.3 g, respectively). Five thematic findings emerged, including concerns expressed by adult staff about student rebellion following removal, which did not come to fruition. Removing flavored milk from school-provided lunches may lower students' daily added sugar consumption without considerably decreasing calcium and protein intake and may promote healthy weight.

Factors Influencing Internal Medicine Resident Choice of Infectious Diseases or Other Specialties: A National Cross-sectional Study.

BACKGROUND: Only 49% of infectious diseases (ID) fellowship programs were filled in 2015 through the national match, but little is known about internal medicine (IM) resident perceptions of ID and factors related to IM resident career choice. METHODS: We conducted 25 interviews and disseminated a Web-based survey to graduating IM residents in the United States utilizing a 2-stage sampling strategy. Participants were categorized into 3 groups based on interest in ID: (1) applied/intended to apply to ID; (2) interested in ID but did not apply; (3) never interested in ID. We conducted all analysis using poststratification adjustment weights with survey data analysis procedures. RESULTS: Of the 590 participants, 42 (7%) selected category 1, 188 (32%) category 2, and 360 (61%) category 3. Most (65%) developed an interest in their ultimate career before residency. Of those interested in ID, >52% rated their ID medical school curriculum as very good and influential on their interest in ID. Ninety-one percent of category 2 participants felt mentorship was influential on career choice, although 43% identified an ID mentor. Category 2 chose salary as the most dissuading factor and the most likely intervention to increase ID interest. CONCLUSIONS: In this nationally representative sample of graduating IM residents, most develop an interest in their ultimate career before residency. Factors influencing this decision reside in both medical school and residency, which is consistent with career decision-making constructs. By identifying career determining factors and understanding how they fit into medical training frameworks, we can develop targeted initiatives to reinvigorate interest in ID.

Effect of a Pragmatic, Cluster-randomized Controlled Trial on Patient Experience With Care: The Transforming Outcomes for Patients Through Medical Home Evaluation and reDesign (TOPMED) Study.

BACKGROUND: Health reform programs like the patient-centered medical home are intended to improve the triple aim. Previous studies on patient-centered medical homes have shown mixed effects, but high value elements (HVEs) are expected to improve the triple aim. OBJECTIVE: The aim of this study is to understand whether focusing on HVEs would improve patient experience with care. METHODS: Eight clinics were cluster-randomized in a year-long trial. Both arms received practice facilitation, IT-based reporting, and financial incentives. Intervention practices were encouraged to choose HVEs for quality improvement goals. To assess patient experience, 1597 Consumer Assessment of Healthcare Providers and Systems surveys were sent pretrial and posttrial to a stratified random sample of patients. Difference-in-difference multivariate analysis was used to compare patient responses from intervention and control practices, adjusting for confounders. RESULTS: The response rate was 43% (n=686). Nonrespondent analysis showed no difference between arms, although differences were seen by risk status and age. The overall difference in difference was 2.8%, favoring the intervention. The intervention performed better in 9 of 11 composites. The intervention performed significantly better in follow-up on test results (P=0.091) and patients' rating of the provider (P=0.091), whereas the control performed better in access to care (P=0.093). Both arms also had decreases, including 4 of 11 composites for the intervention, and 8 of 11 for the control. DISCUSSION: Practices that targeted HVEs showed significantly more improvement in patient experience of care. However, contemporaneous trends may have affected results, leading to declines in patient experience in both arms.

Axillary Lymph Node Dissection Is a Risk Factor for Major Complications After Immediate Breast Reconstruction.

BACKGROUND: Complications after immediate breast reconstruction pose a significant challenge to the reconstructive surgeon. Known risk factors include smoking, obesity, age, and adjuvant oncologic therapies. Less is known about the association between axillary lymph node dissection (ALND) and the development of postoperative complications. METHODS: We conducted a retrospective study of all patients who underwent immediate breast reconstruction after mastectomy at our institution over a 10-year period. Our outcome was an occurrence of a major complication within 90 days postoperatively. For each patient, we recorded data on demographics, smoking status, pertinent medical history, reconstruction type, adjuvant chemotherapy and radiation, tumor pathology, and whether an ALND was performed. Odds ratios (OR) were calculated to estimate the risk of a complication if an ALND was performed. RESULTS: One hundred eighty-four women, with 270 surgically treated breasts, were identified as having mastectomy with immediate reconstruction between 2002 and 2012. Mean age was 49.4 years (range, 25-84 years). There were 71 mastectomies with ALND performed, with 22 complications, and 199 mastectomies without ALND, with 20 complications (31% complication rate vs 10%, respectively; OR, 3.84; P < 0.001). When adjusted for reconstruction type, smoking history, obesity, age, presence of invasive disease, chemotherapy, and radiation therapy, the OR for complications was 3.49 (P < 0.01). The most common complication was infection in both groups. CONCLUSIONS: Mastectomy with ALND is associated with a 3-fold increase in risk of major complications in women undergoing immediate breast reconstruction, even after adjustment for known risk factors and confounders. Further studies are warranted to elucidate how ALND leads to these complications and what measures can reduce their occurrence.

Racial and ethnic differences in clinical outcome trajectories for care managed patients.

BACKGROUND: Care management has demonstrated improvements in quality of care for patients with complex care needs. The extent to which these interventions benefit race/ethnic minority populations is unclear. OBJECTIVES: To characterize race/ethnic differences in the longitudinal control of clinical outcomes for patients with complex care needs enrolled in Care Management Plus, a health information technology-enabled care coordination intervention. RESEARCH DESIGN: Multilevel models of repeated observations from clinical encounters before and after program enrollment for 6 Oregon and California primary care clinics. SUBJECTS: A total of 18,675 clinic patients were examined. We estimated multilevel models for 1481 and 5320 care-managed individuals with repeated hemoglobin A1c and blood pressure measurements, respectively. MEASURES: Primary outcomes were changes over time for 2 clinical markers of health status for complex care patients: (1) hemoglobin A1c for patients with diabetes; and (2) mid-blood pressure (BP) (average systolic and diastolic blood pressure). RESULTS: We found significant reductions in A1c for patients with previously uncontrolled A1c (preperiod slope, b=1.03 [0.83, 1.24]; postperiod slope, b=-0.63 [-0.91, -0.35]). For mid-BP we found increasing unconditional preperiod trajectories (b=3.52 [2.39, 4.64]) and decreasing postperiod trajectories (b=-5.21 [-5.70, -4.72]). We also found the trajectories of A1c and mid-BP were not statistically different for black, Latino, and white patients. CONCLUSIONS: These analyses demonstrate some promising results for intermediate clinical outcomes for underrepresented patients with complex chronic care needs. It remains to be seen whether these health care system delivery redesigns yield long-term benefits for patients, such as improvements in function and quality of life.

Modeling risk of hypoglycemia during and following physical activity in people with type 1 diabetes using explainable mixed-effects machine learning.

BACKGROUND: Physical activity (PA) can cause increased hypoglycemia (glucose <70 mg/dL) risk in people with type 1 diabetes (T1D). We modeled the probability of hypoglycemia during and up to 24 h following PA and identified key factors associated with hypoglycemia risk. METHODS: We leveraged a free-living dataset from Tidepool comprised of glucose measurements, insulin doses, and PA data from 50 individuals with T1D (6448 sessions) for training and validating machine learning models. We also used data from the T1Dexi pilot study that contains glucose management and PA data from 20 individuals with T1D (139 session) for assessing the accuracy of the best performing model on an independent test dataset. We used mixed-effects logistic regression (MELR) and mixed-effects random forest (MERF) to model hypoglycemia risk around PA. We identified risk factors associated with hypoglycemia using odds ratio and partial dependence analysis for the MELR and MERF models, respectively. Prediction accuracy was measured using the area under the receiver operating characteristic curve (AUROC). RESULTS: The analysis identified risk factors significantly associated with hypoglycemia during and following PA in both MELR and MERF models including glucose and body exposure to insulin at the start of PA, low blood glucose index 24 h prior to PA, and PA intensity and timing. Both models showed overall hypoglycemia risk peaking 1 h after PA and again 5-10 h after PA, which is consistent with the hypoglycemia risk pattern observed in the training dataset. Time following PA impacted hypoglycemia risk differently across different PA types. Accuracy of hypoglycemia prediction using the fixed effects of the MERF model was highest when predicting hypoglycemia during the first hour following the start of PA (AUROCVALIDATION = 0.83 and AUROCTESTING = 0.86) and decreased when predicting hypoglycemia in the 24 h after PA (AUROCVALIDATION = 0.66 and AUROCTESTING = 0.68). CONCLUSION: Hypoglycemia risk after the start of PA can be modeled using mixed-effects machine learning to identify key risk factors that may be used within decision support and insulin delivery systems. We published the population-level MERF model online for others to use.

Outcomes of Fracture Surgery in Patients With Escalating Hemoglobin A1C in the Setting of Unmanaged Diabetes.

OBJECTIVE: To determine whether there is a threshold of elevated hemoglobin A1C (HbA1c) above which the complication risk is so high that fracture fixation should be avoided. DESIGN: Retrospective cohort study. SETTING: Academic Level I trauma center. PATIENTS/PARTICIPANTS: A cohort of 187 patients with HbA1c values >7 and operatively treated extremity fractures. INTERVENTION: Surgical fixation of extremity fractures. MAIN OUTCOME MEASUREMENTS: Rate of major orthopaedic complication (loss of reduction, nonunion, infection, and need for salvage procedure). RESULTS: 34.8% demonstrated HbA1c > 9% and 12.3% with HbA1c > 11. Major complications occurred in 31.4%; HbA1c values were not predictive. We found no evidence of a clinically or statistically significant relationship between HbA1c and risk of major complication. The odds ratio for a one-point increase in HbA1c was 1.006 ( P = 0.9439), and the area under the receiver operating characteristic curve, which reflects the average probability that someone with a major complication will have a higher HbA1c than someone without, was 0.51 (95% confidence interval 0.42-0.61), equivalent to random chance. CONCLUSION: Diabetic patients with fracture demonstrated an extremely high overall rate of complications, with 30.5% experiencing a major complication. However, patients with extreme diabetic neglect did not have higher complication rates after extremity fracture fixation when compared with patients with controlled and uncontrolled diabetes. There was no correlation between rate of complication and level of HbA1c. In addition, there was no difference in complication rate between upper and lower extremity fractures or between fractures treated with open or percutaneous fixation. This suggests that fracture treatment decision-making should not be altered for patients with poor diabetic control, and that surgery is not contraindicated in patients with an extremely high HbA1c. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Substance Use Disorders Are Prevalent in Adults With Congenital Heart Disease and Are Associated With Increased Healthcare Use.

Adults with congenital heart disease (CHD) represent a heterogeneous group with significant long-term health risks. Previous studies have demonstrated a high prevalence of psychiatric disorders among adults with CHD; however, little is known about the frequency of co-morbid substance use disorders (SUDs) in patients with CHD. The Oregon All Payer All Claims (APAC) database for the years 2014 to 2017 was queried for adults aged 18 to 65 years with International Classification of Diseases, Ninth or Tenth Revision codes consistent with CHD. Alcohol and substance use were identified by International Classification of Diseases codes for use or dependence and classified in mutually exclusive categories of none, alcohol only, and other drugs (with or without alcohol). Descriptive statistics were used to characterize prevalence and chi-square tests were used to test for associations between variables. A total of 12,366 adults with CHD were identified. The prevalence of substance use was 15.7%. The prevalence of isolated alcohol use was 3.9%. A total of 19% of patients used tobacco. Insurance type, presence of a concurrent mental health diagnosis, and age were associated with substance use, whereas CHD complexity was not. Cardiovascular co-morbidities were more common in patients with reported substance use. Inpatient and emergency care use were higher in those with SUD. In conclusion, this study of substance and alcohol use among adults with CHD demonstrates high rates of co-morbid SUD, particularly among patients with mental health disorders and Medicaid insurance, associated with increased healthcare utilization. We identify a population in need of targeted interventions to improve long-term health.

Improving colorectal cancer screening in rural primary care: Preliminary effectiveness and implementation of a collaborative mailed fecal immunochemical test pilot.

BACKGROUND: Mailed fecal immunochemical test (FIT) outreach can improve colorectal cancer (CRC) screening rates. We piloted a collaborative mailed FIT program with health plans and rural clinics to evaluate preliminary effectiveness and refine implementation strategies. METHODS: We conducted a single-arm study using a convergent, parallel mixed-methods design to evaluate the implementation of a collaborative mailed FIT program. Enrollees were identified using health plan claims and confirmed via clinic scrub. The intervention included a vendor-delivered automated phone call (auto-call) prompt, FIT mailing, and reminder auto-call; clinics were encouraged to make live reminder calls. Practice facilitation was the primary implementation strategy. At 12 months post mailing, we assessed the rates of: (1) mailed FIT return and (2) completion of any CRC screening. We took fieldnotes and conducted postintervention key informant interviews to assess implementation outcomes (eg, feasibility, acceptability, and adaptations). RESULTS: One hundred and sixty-nine Medicaid or Medicare enrollees were mailed a FIT. Over the 12-month intervention, 62 participants (37%) completed screening of which 21% completed the mailed FIT (most were returned within 3 months), and 15% screened by other methods (FITs distributed in-clinic, colonoscopy). Enrollee demographics and the reminder call may encourage mailed FIT completion. Program feasibility and acceptability was high and supported by perceived positive benefit, alignment with existing workflows, adequate staffing, and practice facilitation. CONCLUSION: Collaborative health plan-clinic mailed FIT programs are feasible and acceptable for implementation in rural clinics and support CRC screening completion. Studies that pragmatically test collaborative approaches to mailed FIT and patient navigation follow-up after abnormal FIT and support broad scale-up in rural settings are needed.

Integrating metabolic expenditure information from wearable fitness sensors into an AI-augmented automated insulin delivery system: a randomised clinical trial.

BACKGROUND: Exercise can rapidly drop glucose in people with type 1 diabetes. Ubiquitous wearable fitness sensors are not integrated into automated insulin delivery (AID) systems. We hypothesised that an AID can automate insulin adjustments using real-time wearable fitness data to reduce hypoglycaemia during exercise and free-living conditions compared with an AID not automating use of fitness data. METHODS: Our study population comprised of individuals (aged 21-50 years) with type 1 diabetes from from the Harold Schnitzer Diabetes Health Center clinic at Oregon Health and Science University, OR, USA, who were enrolled into a 76 h single-centre, two-arm randomised (4-block randomisation), non-blinded crossover study to use (1) an AID that detects exercise, prompts the user, and shuts off insulin during exercise using an exercise-aware adaptive proportional derivative (exAPD) algorithm or (2) an AID that automates insulin adjustments using fitness data in real-time through an exercise-aware model predictive control (exMPC) algorithm. Both algorithms ran on iPancreas comprising commercial glucose sensors, insulin pumps, and smartwatches. Participants executed 1 week run-in on usual therapy followed by exAPD or exMPC for one 12 h primary in-clinic session involving meals, exercise, and activities of daily living, and 2 free-living out-patient days. Primary outcome was time below range (<3·9 mmol/L) during the primary in-clinic session. Secondary outcome measures included mean glucose and time in range (3·9-10 mmol/L). This trial is registered with ClinicalTrials.gov, NCT04771403. FINDINGS: Between April 13, 2021, and Oct 3, 2022, 27 participants (18 females) were enrolled into the study. There was no significant difference between exMPC (n=24) versus exAPD (n=22) in time below range (mean [SD] 1·3% [2·9] vs 2·5% [7·0]) or time in range (63·2% [23·9] vs 59·4% [23·1]) during the primary in-clinic session. In the 2 h period after start of in-clinic exercise, exMPC had significantly lower mean glucose (7·3 [1·6] vs 8·0 [1·7] mmol/L, p=0·023) and comparable time below range (1·4% [4·2] vs 4·9% [14·4]). Across the 76 h study, both algorithms achieved clinical time in range targets (71·2% [16] and 75·5% [11]) and time below range (1·0% [1·2] and 1·3% [2·2]), significantly lower than run-in period (2·4% [2·4], p=0·0004 vs exMPC; p=0·012 vs exAPD). No adverse events occurred. INTERPRETATION: AIDs can integrate exercise data from smartwatches to inform insulin dosing and limit hypoglycaemia while improving glucose outcomes. Future AID systems that integrate exercise metrics from wearable fitness sensors may help people living with type 1 diabetes exercise safely by limiting hypoglycaemia. FUNDING: JDRF Foundation and the Leona M and Harry B Helmsley Charitable Trust, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases.

Gait and balance in apolipoprotein Ɛ4 allele carriers in older adults and Parkinson's disease.

Background: Gait and balance impairments are among the most troublesome and heterogeneous in Parkinson's disease (PD). This heterogeneity may, in part, reflect genetic variation. The apolipoprotein E (APOE) gene has three major allelic variants (ε2, ε3 and ε4). Previous work has demonstrated that older adult (OA) APOE ε4 carriers demonstrate gait deficits. This study compared gait and balance measures between APOE ε4 carriers and non-carriers in both OA and PD. Methods: 334 people with PD (81 APOE ε4 carriers and 253 non-carriers) and 144 OA (41 carriers and 103 non-carriers) were recruited. Gait and balance were assessed using body-worn inertial sensors. Two-way analyses of covariance (ANCOVA) compared gait and balance characteristics between APOE ε4 carriers and non-carriers in people with PD and OA, controlling for age, gender, and testing site. Results: Gait and balance were worse in people with PD compared to OA. However, there were no differences between APOE ε4 carriers and non-carriers in either the OA or PD group. In addition, there were no significant group (OA/PD) by APOE ε4 status (carrier/non-carrier) interaction effects for any measures of gait or balance. Conclusions: Although we found expected impairments in gait and balance in PD compared to OA, gait and balance characteristics did not differ between APOE ε4 carriers and non-carriers in either group. While APOE status did not impact gait and balance in this cross-sectional study, future work is needed to determine whether progression of gait and balance deficits is faster in PD APOE Ɛ4 carriers.