US Academic Medical Centers Research Articles

592-P: Living with Type 1 Diabetes (T1DM) as an Older Adult: A Qualitative Study Examining Experiences and Attitudes about Continuous Glucose Monitoring (CGM)

There is a growing population of adults over the age of 65 years with T1DM, but their lived experiences have not been well-characterized, especially in the context of evolving advances in self-management technology. We conducted focus groups with adults 65+ yrs with T1DM to characterize their perspectives surrounding T1DM and its management, focusing on CGM experiences. Participants were recruited from a US academic medical center and encouraged to bring a caregiver. Focus groups were stratified by CGM use, facilitated by standardized questions, audiotaped and transcribed. A team-based, inductive coding approach using ATLAS.ti identified themes. There were 33 adults (mean age 73.3±4.3 years [range 66-85]; 55% women, 82% non-Hispanic white, 12% non-CGM users, 83% pump users, 12% caregivers) . Five CGM-related themes were identified from all participants, including adoption challenges and complex clinical and psychosocial effects (Table) . Caregiver participants emphasized increased security with CGM use. Patient participants expressed a prevalent “survivor” mentality and a desire for increased peer support and strategies to minimize intrusiveness of T1DM management. Findings reinforce that older adults’ experiences with T1DM and CGM necessitate individualized psychosocial and tactical support for management and adoption of new technology. Disclosure A.Kahkoska: None. L.A.Young: Research Support; Bayer AG, Boehringer Ingelheim International GmbH, Dexcom, Inc., Eli Lilly and Company, Novo Nordisk, vTv Therapeutics. K.Hassmiller lich: None. A.Cristello: None. C.Smith: None. S.R.Thomas: None. J.Batsis: None. E.J.Mayer-davis: None. M.R.Kosorok: n/a. R.E.Pratley: Other Relationship; Bayer AG, Corcept Therapeutics, Dexcom, Inc., Hanmi Pharm. Co., Ltd., Merck & Co., Inc., Metavention, Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. R.S.Weinstock: Research Support; Boehringer Ingelheim International GmbH, Dexcom, Inc., Diasome, Eli Lilly and Company, Insulet Corporation, Kowa Pharmaceuticals America, Inc., Medtronic, Novo Nordisk, Tandem Diabetes Care, Inc., Tolerion, Inc. Funding ARK is supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant KL2TR002490. The project was supported by UL1TR002489 from the Clinical and Translational Science Award program of the Division of Research Resources, National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

Self-Perceived Barriers and Facilitators to Dietary Approaches to Stop Hypertension Diet Adherence Among Black Americans With Chronic Kidney Disease: A Qualitative Study

The Dietary Approaches to Stop Hypertension (DASH) eating plan improves hypertension in Black individuals and is associated with favorable chronic kidney disease (CKD) outcomes. Yet, adherence to DASH is low among US adults in general, particularly among Black Americans. We assessed perceptions about DASH, its cultural compatibility, and barriers and facilitators to DASH adherence in Black adults with CKD. We conducted focus groups and semistructured individual interviews involving 22 Black men and women with CKD Stages 3-4 from outpatient clinics at a US academic medical center. Transcripts of audio-recorded interviews were analyzed using thematic analysis. Among participants (2 focus groups [N=8 and 5] and 9 individual interviews), 13 (59%) had CKD Stage 3, 13 (59%) were female, the median age was 61years, and 19 (90%) had hypertension. After receiving information about DASH, participants perceived it as culturally compatible based on 3 emergent themes: (1) Black individuals already eat DASH-recommended foods ("Blacks eat pretty much like this"), (2) traditional recipes (e.g., southern or soul food) can be modified into healthy versions ("you can come up with decent substitutes to make it just as good"), and ( 3) diet is not uniform among Black individuals ("I can't say that I eat traditional"). Perceived barriers to DASH adherence included unfamiliarity with serving sizes, poor cooking skills, unsupportive household members, and high cost of healthy food. Eleven (52%) reported after paying monthly bills that they "rarely" or "never" had leftover money to purchase healthy food. Perceived facilitators included having local access to healthy food, living alone or with supportive household members, and having willpower and internal/external motivation for change. Black adults with CKD viewed DASH as a healthy, culturally compatible diet. Recognizing that diet in Black adults is not uniform, interventions should emphasize person-centered, rather than stereotypically culture-centered, approaches to DASH adherence.

Assessing electrodiagnostic skills among residents and fellows: Relationships between workplace-based assessments using the Electromyography Direct Observation Tool and other measures of trainee performance.

Graduate medical education programs must ensure residents and fellows acquire skills needed for independent practice. Workplace-based observational assessments are informative but can be time- and resource-intensive. In this study we sought to gather "relations-to-other-variables" validity evidence for scores generated by the Electromyography Direct Observation Tool (EMG-DOT) to inform its use as a measure of electrodiagnostic skill acquisition. Scores on multiple assessments were compiled by trainees during Clinical Neurophysiology and Electromyography rotations at a large US academic medical center. Relationships between workplace-based EMG-DOT scores (n=298) and scores on a prerequisite simulated patient exercise, patient experience surveys (n=199), end-of-rotation evaluations (n=301), and an American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) self-assessment examination were assessed using Pearson correlations. Among 23 trainees, EMG-DOT scores assigned by physician raters correlated positively with end-of-rotation evaluations (r=0.63, P=.001), but EMG-DOT scores assigned by technician raters did not (r=0.10, P=.663). When physician and technician ratings were combined, higher EMG-DOT scores correlated with better patient experience survey scores (r=0.42, P=.047), but not with simulated patient or AANEM self-assessment examination scores. End-of-rotation evaluations can provide valid assessments of trainee performance when completed by individuals with ample opportunities to directly observe trainees. Inclusion of observational assessments by technicians and patients provides a more comprehensive view of trainee performance. Workplace- and classroom-based assessments provide complementary information about trainee performance, reflecting underlying differences in types of skills measured.

Safety, Tolerability, and Immunogenicity of the ACI-24 Vaccine in Adults With Down Syndrome

Individuals with Down syndrome (DS) are at high risk of developing Alzheimer disease due to an increased dose of the amyloid precursor protein gene, APP, which leads to increased levels of full-length APP and its products, including amyloid-β (Aβ). The liposome-based antiamyloid ACI-24 vaccine is intended to treat neurological disorders caused by misfolded Aβ pathological protein. However, the safety, tolerability, and immunogenicity of the ACI-24 vaccine among adults with DS have not been fully examined. To assess the safety and tolerability of the ACI-24 vaccine among adults with DS as well as its ability to induce immunogenicity measured by anti-Aβ immunoglobulin G titers. This multicenter double-blind placebo-controlled dose-escalation phase 1b randomized clinical trial was conducted at 3 US academic medical centers with affiliated Down syndrome clinics between March 30, 2016, and June 29, 2020. A total of 20 adults with DS were screened; of those, 16 adults were eligible to participate. Eligibility criteria included men or women aged 25 to 45 years with cytogenetic diagnosis of either trisomy 21 or complete unbalanced translocation of chromosome 21. Between April 27, 2016, and July 2, 2018, participants were randomized 3:1 into 2 dose-level cohorts (8 participants per cohort, with 6 participants receiving the ACI-24 vaccine and 2 receiving placebo) in a 96-week study. Participants received 48 weeks of treatment followed by an additional 48 weeks of safety follow-up. Participants were randomized to receive 7 subcutaneous injections of ACI-24, 300 μg or 1000 μg, or placebo. Primary outcomes were measures of safety and tolerability as well as antibody titers. Among 16 enrolled participants, the mean (SD) age was 32.6 (4.4) years; 9 participants were women, and 7 were men. All participants were White, and 1 participant had Hispanic or Latino ethnicity. Treatment adherence was 100%. There were no cases of meningoencephalitis, death, or other serious adverse events (AEs) and no withdrawals as a result of AEs. Most treatment-emergent AEs were of mild intensity (110 of 132 events [83.3%]) and unrelated or unlikely to be related to the ACI-24 vaccine (113 of 132 events [85.6%]). No amyloid-related imaging abnormalities with edema or cerebral microhemorrhage and no evidence of central nervous system inflammation were observed on magnetic resonance imaging scans. Increases in anti-Aβ immunoglobulin G titers were observed in 4 of 12 participants (33.3%) receiving ACI-24 (2 receiving 300 μg and 2 receiving 1000 μg) compared with 0 participants receiving placebo. In addition, a greater increase was observed in plasma Aβ1-40 and Aβ1-42 levels among individuals receiving ACI-24. In this study, the ACI-24 vaccine was safe and well tolerated in adults with DS. Evidence of immunogenicity along with pharmacodynamic and target engagement were observed, and anti-Aβ antibody titers were not associated with any adverse findings. These results support progression to clinical trials using an optimized formulation of the ACI-24 vaccine among individuals with DS. ClinicalTrials.gov Identifier: NCT02738450.

How can healthcare organizations improve cost-of-care conversations? A qualitative exploration of clinicians’ perspectives

ObjectivesClinicians increasingly believe they should discuss costs with their patients. We aimed to learn what strategies clinicians, clinic leaders, and health systems can use to facilitate vital cost-of-care conversations. MethodsWe conducted focus groups and semi-structured interviews with outpatient clinicians at two US academic medical centers. Clinicians recalled previous cost conversations and described strategies that they, their clinic, or their health system could use to facilitate cost conversations. Independent coders recorded, transcribed, and coded focus groups and interviews. ResultsTwenty-six clinicians participated between December 2019 and July 2020: general internists (23%), neurologists (27%), oncologists (15%), and rheumatologists (35%). Clinicians proposed the following strategies: teach clinicians to initiate cost conversations; systematically collect financial distress information; partner with patients to identify costs; provide accurate insurance coverage and/or out-of-pocket cost information via the electronic health record; develop local lists of lowest-cost pharmacies, laboratories, and subspecialists; hire financial counselors; and reduce indirect costs (e.g., parking). ConclusionsDespite considerable barriers to discussing, identifying, and reducing patient costs, clinicians described a variety of strategies for improving cost communication in the clinic. Practice implicationsHealth systems and clinic leadership can and should implement these strategies to improve the financial health of the patients they serve.

Cohort profile for the Loma Linda University Health BREATHE programme: a model to study continuously incentivised employee smoking cessation

PurposeThe purpose of the Loma Linda University Health (LLUH) BREATHE cohort is to test the efficacy of a novel method of continuously incentivising participation in workplace smoking cessation on participation,...

Mechanism of action of a 0.075 mg norgestrel progestogen-only pill 2. Effect on cervical mucus and theoretical risk of conception

ObjectiveTo evaluate the cervical mucus effects of a norgestrel 0.075 mg progestin-only contraceptive pill over a 28-day cycle. Study DesignWe recruited persons ages 18 to 35 with normal cycles at 2 US academic medical centers. Participants took norgestrel 0.075 mg daily for 28 days at the same time (within a 3 hour window) daily, recorded through a text-message based e-diary. We extracted cervical mucus using a standardized aspiration technique on the day of pill initiation and then at least every 3 to 4 days over the cycle. We monitored subjects for follicular activity with transvaginal ultrasound examination and blood sampling for ovarian hormones and gonadotropins at each visit. We assessed cervical mucus scoring using a 4-category/12-point modified Insler scale (score ≥9 [favoring fertility], 5–8 [intermediate], and ≤4 [unfavorable to fertility]). We stratified cervical mucus scores by serum estradiol levels and ovulatory status based on a modified Hoogland score. ResultsExcluding enrollment, we collected and evaluated 413 mucus samples from 51 participants. Participants had a median mucus score of 0 (Interquartile Range 0, 2); most had scores ≤4 (samples = 385, 93%) and none had a score ≥9 favoring fertility. Seventeen (33%) participants ovulated, of which 14 (82%) had unfavorable mucus scores (≤4) at the time of ovulation and 3 (18%) had intermediate scores (5-8). ConclusionsNorgestrel 0.075 mg daily prevents mucus changes that favor fertility, even during ovulatory cycles. ImplicationsDaily administration of norgestrel 0.075 mg over an initial 28-day cycle did not result in fertile cervical mucus. Although approximately one-third of users ovulated in this first cycle of pill use, contraceptive efficacy may be maintained by mucus effects.

Disparities in COVID-19 vaccine uptake among health care workers

BackgroundCOVID-19 vaccine uptake by healthcare workers (HCWs) is critical to protect HCWs, the patients they care for, and the healthcare infrastructure. Our study aims to examine the actual COVID-19 vaccination rate among HCWs and identify risk factors associated with vaccine nonacceptance. Study Design and MethodsA retrospective analysis of COVID-19 vaccinations for HCWs at a large multi-site US academic medical center from 12/18/2020 through 05/04/2021. Comparisons between groups were performed using unpaired student t-test for continuous variables and the chi-square test for categorical variables. A logistic regression analysis was used to assess the associations between vaccine uptake and risk factor(s). ResultsOf the 65,270 HCWs included in our analysis, the overall vaccination rate was 78.6%. Male gender, older age, White and Asian race, and direct patient care were associated with higher vaccination rates (P <.0001). Significant differences were observed between different job categories. Physicians and advanced practice staff, and healthcare professionals were more likely to be vaccinated than nurses and support staff. ConclusionsOur data demonstrated higher initial vaccination rates among HCWs than the general population national average during the study period. We observed significant disparities among different high-risk HCWs groups, especially among different job categories, black HCWs and younger HCWs despite their high risk of contracting the infection. Interventions to address lower vaccination rate and vaccine hesitancy should be built with these disparities and differences in mind to create more targeted interventions.

Predictive Accuracy of a Perioperative Laboratory Test–Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery

Effective treatment of acute kidney injury (AKI) is predicated on timely diagnosis; however, the lag in the increase in serum creatinine levels after kidney injury may delay therapy initiation. To determine the derivation and validation of predictive models for AKI after cardiac surgery. Multivariable prediction models were derived based on a retrospective observational cohort of adult patients undergoing cardiac surgery between January 2000 and December 2019 from a US academic medical center (n = 58 526) and subsequently validated on an external cohort from 3 US community hospitals (n = 4734). The date of final follow-up was January 15, 2020. Perioperative change in serum creatinine and postoperative blood urea nitrogen, serum sodium, potassium, bicarbonate, and albumin from the first metabolic panel after cardiac surgery. Area under the receiver-operating characteristic curve (AUC) and calibration measures for moderate to severe AKI, per Kidney Disease: Improving Global Outcomes (KDIGO), and AKI requiring dialysis prediction models within 72 hours and 14 days following surgery. In a derivation cohort of 58 526 patients (median [IQR] age, 66 [56-74] years; 39 173 [67%] men; 51 503 [91%] White participants), the rates of moderate to severe AKI and AKIrequiring dialysis were 2674 (4.6%) and 868 (1.48%) within 72 hours and 3156 (5.4%) and 1018 (1.74%) within 14 days after surgery. The median (IQR) interval to first metabolic panel from conclusion of the surgical procedure was 10 (7-12) hours. In the derivation cohort, the metabolic panel-based models had excellent predictive discrimination for moderate to severe AKI within 72 hours (AUC, 0.876 [95% CI, 0.869-0.883]) and 14 days (AUC, 0.854 [95% CI, 0.850-0.861]) after the surgical procedure and for AKI requiring dialysis within 72 hours (AUC, 0.916 [95% CI, 0.907-0.926]) and 14 days (AUC, 0.900 [95% CI, 0.889-0.909]) after the surgical procedure. In the validation cohort of 4734 patients (median [IQR] age, 67 (60-74) years; 3361 [71%] men; 3977 [87%] White participants), the models for moderate to severe AKI after the surgical procedure showed AUCs of 0.860 (95% CI, 0.838-0.882) within 72 hours and 0.842 (95% CI, 0.820-0.865) within 14 days and the models for AKI requiring dialysis and 14 days had an AUC of 0.879 (95% CI, 0.840-0.918) within 72 hours and 0.873 (95% CI, 0.836-0.910) within 14 days after the surgical procedure. Calibration assessed by Spiegelhalter z test showed P >.05 indicating adequate calibration for both validation and derivation models. Among patients undergoing cardiac surgery, a prediction model based on perioperative basic metabolic panel laboratory values demonstrated good predictive accuracy for moderate to severe acute kidney injury within 72 hours and 14 days after the surgical procedure. Further research is needed to determine whether use of the risk prediction tool improves clinical outcomes.

Retrospective comparison of parent-reported genetics knowledge, empowerment, and familial uptake of cardiac screening between parents who received genetic counseling by a certified genetic counselor and those who did not: A single US academic medical center study.

Bicuspid aortic valve (BAV) is the most common congenital heart defect, which can cause severe cardiac complications. BAVs cluster in families and demonstrate high heritability. Cardiac screening for first-degree relatives of individuals with a BAV is recommended. This retrospective two-group study evaluated the impact of cardiovascular genetic counseling provided by a board-certified genetic counselor on parent-reported outcomes by comparing parental responses of those who received genetic counseling by a genetic counselor (GC group) for family history of BAV to those who did not (non-GC group). A retrospective chart review from May 2016 to June 2019 identified 133 pediatric patients with an isolated BAV. Parents of eligible probands were invited to complete an online survey assessing genetics knowledge, empowerment (Genomics Outcome Scale), and familial uptake of cardiac screening. Surveys were completed by 38/97 (39%) parents in the non-GC group and 20/36 (56%) parents in the GC group. The median genetics knowledge score was not significantly different between the two groups (GC group: 8, range 3-11 out of a maximum possible of 12; non-GC group: 7, range 2-11; p=.08). The mean empowerment score was not significantly different between the two groups (GC group: mean 24.6, SD 2.2; non-GC group: mean 23.2, SD 3.5; p=.06). The uptake of cardiac screening was significantly higher in the GC group with 39/59 (66%) total first-degree relatives reported as having been screened compared with 36/91 (40%) in the non-GC group (p=.002). Parent-reported outcomes in our study suggest that receiving genetic counseling by a board-certified genetic counselor significantly increased familial uptake of cardiac screening for first-degree relatives of pediatric patients with a BAV. Studies with larger sample sizes are needed to confirm the findings of this study; however, a referral to a genetic counselor should be considered for patients with a BAV.

National Network of Depression Centers' Recommendations on Harmonizing Clinical Documentation of Electroconvulsive Therapy.

Electroconvulsive therapy (ECT) is a highly therapeutic and cost-effective treatment for severe and/or treatment-resistant major depression. However, because of the varied clinical practices, there is a great deal of heterogeneity in how ECT is delivered and documented. This represents both an opportunity to study how differences in implementation influence clinical outcomes and a challenge for carrying out coordinated quality improvement and research efforts across multiple ECT centers. The National Network of Depression Centers, a consortium of 26+ US academic medical centers of excellence providing care for patients with mood disorders, formed a task group with the goals of promoting best clinical practices for the delivery of ECT and to facilitate large-scale, multisite quality improvement and research to advance more effective and safe use of this treatment modality. The National Network of Depression Centers Task Group on ECT set out to define best practices for harmonizing the clinical documentation of ECT across treatment centers to promote clinical interoperability and facilitate a nationwide collaboration that would enable multisite quality improvement and longitudinal research in real-world settings. This article reports on the work of this effort. It focuses on the use of ECT for major depressive disorder, which accounts for the majority of ECT referrals in most countries. However, most of the recommendations on clinical documentation proposed herein will be applicable to the use of ECT for any of its indications.

Nursing Infection Control Practice Adherence, Related Barriers, and Methods of Intervention.

This study aims to evaluate the level of infection control (IC) practice adherence and related barriers among nursing staff at a US academic medical center. Furthermore, it surveys staff to identify interventions to improve adherence with IC practices. Infectious disease emergencies have exposed healthcare workers to increased infection risk. This study aims to explore IC practice adherence in the tertiary hospital setting and further investigate the personal protective equipment (PPE) champion role as a method to boost adherence. This descriptive quality improvement study includes 2 parts: 1) A PPE champion role was piloted to support healthcare worker adherence to IC practices; and 2) a survey was disseminated to nursing staff to identify the perceptions of their own and coworkers' adherence to IC practices as well as suggestions for improvement. Twenty-six percent of PPE champion observations found nursing staff nonadherent with IC practices and policies. Barriers included knowledge deficit (38%), lack of motivation (38%), time constraints (21%), and lack of supplies (3%). Two hundred sixty-four RNs and nurse technicians responded to the IC survey. Nursing staff rated their IC adherence higher than observed by their peers. Perceived barriers to adherence included the lack of supplies (53%), knowledge of proper technique (41%), time constraints (35%), and motivation (5%). Staff recommended using PPE champions (52%) and mandating supervised practice of essential skills (48%) to increase adherence. Nursing staff reported barriers related to their knowledge of proper technique and suggested interventions including supervised practice of critical skills. It seems that the PPE champion role is a popular method to boost IC practice adherence that can be implemented during pandemic and nonpandemic environments at minimal cost.

Faculty Physician and Trainee Experiences with Micro- and Macroaggressions: a Qualitative Study.

Micro- and macroaggressions are often stereotype threats that can have detrimental effects on the recipients. Survey data shows that these aggressions are happening. However, there are few qualitative studies on trainees and faculty physicians' experiences with such aggressions and their impact. Explore how micro- and macroaggressions impact physician trainees and faculty. Virtual, one-on-one, semi-structured interviews were conducted between February and September 2021, among 14 physicians and trainees (medical students, residents, fellows, and faculty) at a tertiary, urban, US academic medical center and its associated hospitals. Participants shared their experiences with micro- and macroaggressions in training and the workplace, as well as their thoughts on intervention and education. Qualitative interviews; grounded theory approach KEY RESULTS: A total of 14 physicians and trainees (5 faculty, 2 fellows, 5 residents, 2 students; 11 [79%] women) participated. Four themes with multiple subthemes surfaced: definition, the moment an aggression is experienced, aftereffect of an aggression, and education and training. While general definitions of micro- and macroaggressions were similar among participants, some may have overlooked the inclusion of a marginalized group as central to each term. Both types of aggressions had a range of effects on participants, with faculty noting a cumulative effect. Institutional diversity was identified as a key source of support. Ideas on how to combat such acts included mandatory educational programs and policies, with the acknowledgment that much effort and time are necessary to change mindset and culture. Faculty physicians and medical trainees shared their personal experiences with micro- and macroaggressions during work and training. Participants described various emotions in the moment but also noted that these aggressions often had lasting impacts. They recognized the challenges of finding a solution to micro- and macroaggressions. Institution-wide education was favored by many as a first step.

Maintenance of Wellness in Patients With Obsessive-Compulsive Disorder Who Discontinue Medication After Exposure/Response Prevention Augmentation

Serotonin reuptake inhibitors (SRIs) are the only medications approved for obsessive-compulsive disorder (OCD), yet most patients taking SRIs exhibit significant symptoms. Adding exposure/response prevention (EX/RP) therapy improves symptoms, but it is unknown whether patients maintain wellness after discontinuing SRIs. To assess whether patients with OCD who are taking SRIs and have attained wellness after EX/RP augmentation can discontinue their SRI with noninferior outcomes compared with those who continue their SRI therapy. A 24-week, double-blind, randomized clinical trial was performed from May 3, 2013, to June 25, 2018. The trial took place at US academic medical centers. Participants included 137 adults with a principal diagnosis of OCD (≥1 year) who were taking an SRI (≥12 weeks), had at least moderate symptoms (defined as Yale-Brown Obsessive-Compulsive Scale [Y-BOCS] score ≥18 points), and received as many as 25 sessions of EX/RP therapy. Those who attained wellness (Y-BOCS score ≤14 points; 103 patients [75.2%]) were study eligible. Data were analyzed from June 29, 2019, to October 2, 2021. Participants were randomly assigned either to receive taper to placebo (taper group) or to continue their SRI (continuation group) and monitored for 24 weeks. The Y-BOCS score (range, 0-40 points) was the primary outcome; the Hamilton Depression Rating Scale (HDRS; range, 0-52 points) and the Quality-of-Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF; range, 0%-100%) scores were secondary outcomes. Outcomes were assessed at 8 time points by independent evaluators who were blinded to randomization. The taper regimen was hypothesized to be noninferior to continuation at 24 weeks using a 1-sided α value of .05. A total of 101 patients (mean [SD] age, 31.0 [11.2] years; 55 women [54.5%]) participated in the trial: 51 patients (50.5%) in the taper group and 50 patients (49.5%) in the continuation group. At 24 weeks, patients in the taper group had noninferior results compared with patients in the continuation group (mean [SD] Y-BOCS score: taper group, 11.47 [6.56] points; continuation group: 11.51 [5.97] points; difference, -0.04 points; 1-sided 95% CI, -∞ to 2.09 points [below the noninferiority margin of 3.0 points]; mean [SD] HDRS score: taper group, 5.69 [3.84] points; continuation group, 4.61 [3.46] points; difference, 1.08 points; 1-sided 95% CI, -∞ to 2.28 points [below the noninferiority margin of 2.5 points]; mean [SD] Q-LES-Q-SF score: taper group, 68.01% [15.28%]; continuation group, 70.01% [15.59%]; difference, 2.00%; 1-sided 95% CI, -∞ to 6.83 [below the noninferiority margin of 7.75]). However, the taper group had higher rates of clinical worsening (23 of 51 [45%] vs 12 of 50 [24%]; P = .04). Results of this randomized clinical trial show that patients with OCD who achieve wellness after EX/RP therapy could, on average, discontinue their SRI with noninferior outcomes compared with those who continued their SRI. Those who tapered the SRI had higher clinical worsening rates. Future research should evaluate if SRI half-life alters these rates. ClinicalTrials.gov Identifier: NCT01686087.

Mortality, In-Hospital Morbidity, Care Practices, and 2-Year Outcomes for Extremely Preterm Infants in the US, 2013-2018

Despite improvement during recent decades, extremely preterm infants continue to contribute disproportionately to neonatal mortality and childhood morbidity. To review survival, in-hospital morbidities, care practices, and neurodevelopmental and functional outcomes at 22-26 months' corrected age for extremely preterm infants. Prospective registry for extremely preterm infants born at 19 US academic centers that are part of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. The study included 10 877 infants born at 22-28 weeks' gestational age between January 1, 2013, and December 31, 2018, including 2566 infants born before 27 weeks between January 1, 2013, and December 31, 2016, who completed follow-up assessments at 22-26 months' corrected age. The last assessment was completed on August 13, 2019. Outcomes were compared with a similar cohort of infants born in 2008-2012 adjusting for gestational age. Extremely preterm birth. Survival and 12 in-hospital morbidities were assessed, including necrotizing enterocolitis, infection, intracranial hemorrhage, retinopathy of prematurity, and bronchopulmonary dysplasia. Infants were assessed at 22-26 months' corrected age for 12 health and functional outcomes, including neurodevelopment, cerebral palsy, vision, hearing, rehospitalizations, and need for assistive devices. The 10 877 infants were 49.0% female and 51.0% male; 78.3% (8495/10848) survived to discharge, an increase from 76.0% in 2008-2012 (adjusted difference, 2.0%; 95% CI, 1.0%-2.9%). Survival to discharge was 10.9% (60/549) for live-born infants at 22 weeks and 94.0% (2267/2412) at 28 weeks. Survival among actively treated infants was 30.0% (60/200) at 22 weeks and 55.8% (535/958) at 23 weeks. All in-hospital morbidities were more likely among infants born at earlier gestational ages. Overall, 8.9% (890/9956) of infants had necrotizing enterocolitis, 2.4% (238/9957) had early-onset infection, 19.9% (1911/9610) had late-onset infection, 14.3% (1386/9705) had severe intracranial hemorrhage, 12.8% (1099/8585) had severe retinopathy of prematurity, and 8.0% (666/8305) had severe bronchopulmonary dysplasia. Among 2930 surviving infants with gestational ages of 22-26 weeks eligible for follow-up, 2566 (87.6%) were examined. By 2-year follow-up, 8.4% (214/2555) of children had moderate to severe cerebral palsy, 1.5% (38/2555) had bilateral blindness, 2.5% (64/2527) required hearing aids or cochlear implants, 49.9% (1277/2561) had been rehospitalized, and 15.4% (393/2560) required mobility aids or other supportive devices. Among 2458 fully evaluated infants, 48.7% (1198/2458) had no or mild neurodevelopmental impairment at follow-up, 29.3% (709/2419) had moderate neurodevelopmental impairment, and 21.2% (512/2419) had severe neurodevelopmental impairment. Among extremely preterm infants born in 2013-2018 and treated at 19 US academic medical centers, 78.3% survived to discharge, a significantly higher rate than for infants born in 2008-2012. Among infants born at less than 27 weeks' gestational age, rehospitalization and neurodevelopmental impairment were common at 2 years of age.

Efficacy and safety of oral immunotherapy in children aged 1–3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study

For young children with peanut allergy, dietary avoidance is the current standard of care. We aimed to assess whether peanut oral immunotherapy can induce desensitisation (an increased allergic reaction threshold while on therapy) or remission (a state of non-responsiveness after discontinuation of immunotherapy) in this population. We did a randomised, double-blind, placebo-controlled study in five US academic medical centres. Eligible participants were children aged 12 to younger than 48 months who were reactive to 500 mg or less of peanut protein during a double-blind, placebo-controlled food challenge (DBPCFC). Participants were randomly assigned by use of a computer, in a 2:1 allocation ratio, to receive peanut oral immunotherapy or placebo for 134 weeks (2000 mg peanut protein per day) followed by 26 weeks of avoidance, with participants and study staff and investigators masked to group treatment assignment. The primary outcome was desensitisation at the end of treatment (week 134), and remission after avoidance (week 160), as the key secondary outcome, were assessed by DBPCFC to 5000 mg in the intention-to-treat population. Safety and immunological parameters were assessed in the same population. This trial is registered on ClinicalTrials.gov, NCT03345160. Between Aug 13, 2013, and Oct 1, 2015, 146 children, with a median age of 39·3 months (IQR 30·8-44·7), were randomly assigned to receive peanut oral immunotherapy (96 participants) or placebo (50 participants). At week 134, 68 (71%, 95% CI 61-80) of 96 participants who received peanut oral immunotherapy compared with one (2%, 0·05-11) of 50 who received placebo met the primary outcome of desensitisation (risk difference [RD] 69%, 95% CI 59-79; p<0·0001). The median cumulative tolerated dose during the week 134 DBPCFC was 5005 mg (IQR 3755-5005) for peanut oral immunotherapy versus 5 mg (0-105) for placebo (p<0·0001). After avoidance, 20 (21%, 95% CI 13-30) of 96 participants receiving peanut oral immunotherapy compared with one (2%, 0·05-11) of 50 receiving placebo met remission criteria (RD 19%, 95% CI 10-28; p=0·0021). The median cumulative tolerated dose during the week 160 DBPCFC was 755 mg (IQR 0-2755) for peanut oral immunotherapy and 0 mg (0-55) for placebo (p<0·0001). A significant proportion of participants receiving peanut oral immunotherapy who passed the 5000 mg DBPCFC at week 134 could no longer tolerate 5000 mg at week 160 (p<0·001). The participant receiving placebo who was desensitised at week 134 also achieved remission at week 160. Compared with placebo, peanut oral immunotherapy decreased peanut-specific and Ara h2-specific IgE, skin prick test, and basophil activation, and increased peanut-specific and Ara h2-specific IgG4 at weeks 134 and 160. By use of multivariable regression analysis of participants receiving peanut oral immunotherapy, younger age and lower baseline peanut-specific IgE was predictive of remission. Most participants (98% with peanut oral immunotherapy vs 80% with placebo) had at least one oral immunotherapy dosing reaction, predominantly mild to moderate and occurring more frequently in participants receiving peanut oral immunotherapy. 35 oral immunotherapy dosing events with moderate symptoms were treated with epinephrine in 21 participants receiving peanut oral immunotherapy. In children with a peanut allergy, initiation of peanut oral immunotherapy before age 4 years was associated with an increase in both desensitisation and remission. Development of remission correlated with immunological biomarkers. The outcomes suggest a window of opportunity at a young age for intervention to induce remission of peanut allergy. National Institute of Allergy and Infectious Disease, Immune Tolerance Network.

An Analysis of US Academic Medical Center Websites: Usability Study

BackgroundHealth care organizations are tasked with providing web-based health resources and information. Usability refers to the ease of user experience on a website. In this study, we conducted a usability analysis of academic medical centers in the United States, which, to the best of our knowledge, has not been previously carried out.ObjectiveThe primary aims of the study were to the following: (1) adapt a preexisting usability scoring methodology to academic medical centers; (2) apply and test this methodology on a sample set of academic medical center websites; and (3) make recommendations from these results on potential areas of improvements for our sample of academic medical center websites.MethodsAll website usability testing took place from June 1, 2020, to December 15, 2020. We replicated a methodology developed in previous literature and applied it to academic medical centers. Our sample included 73 US academic medical centers. Usability was split into four broad categories: accessibility (the ability of those with low levels of computer literacy to access and navigate the hospital’s website); marketing (the ability of websites to be found through search engines and the relevance of descriptions to the links provided); content quality (grammar, frequency of information updates, material relevancy, and readability); and technology (download speed, quality of the programming code, and website infrastructure). Using these tools, we scored each website in each category. The composite of key factors in each category contributed to an overall “general usability” score for each website. An overall score was then calculated by applying a weighted percentage across all factors and was used for the final “overall usability” ranking.ResultsThe category with the highest average score was technology, with a 0.82 (SD 0.068, SE 0.008). The lowest-performing category was content quality, with an average of 0.22 (SD 0.069, SE 0.008). As these numbers reflect weighted percentages as an integer, the higher the score, the greater the overall usability in that category.ConclusionsOur data suggest that technology, on average, was the highest-scored variable among academic medical center websites. Because website functionality is essential to a user’s experience, it is justified that academic medical centers invest in optimal website performance. The overall lowest-scored variable was content quality. A potential reason for this may be that academic medical center websites are usually larger in size, making it difficult to monitor the increased quantity of content. An easy way to improve this variable is to conduct more frequent website audits to assess readability, grammar, and relevance. Marketing is another area in which these organizations have potential for improvement. Our recommendation is that organizations utilize search engine optimization techniques to improve their online visibility and discoverability.

Estimating the environmental impact of disposable endoscopic equipment and endoscopes

ObjectiveProcedure-intense specialties, such as surgery or endoscopy, are a major contributor to the impact of the healthcare sector on the environment. We aimed to measure the amount of waste generated...

An Interprofessional Group Intervention to Promote Faculty Well-Being: A Randomized Clinical Trial.

To evaluate the effect on engagement, relational connection, and burnout of an intervention involving clinical faculty meeting in interprofessional self-facilitated groups and to determine whether a written discussion guide is necessary to achieve benefit. This is a randomized controlled trial, conducted at a large US academic medical center from May to August 2018. Subjects included 25 clinical physicians, nurse practitioners, and certified nurse midwives. The intervention involved three monthly self-facilitated groups for faculty. Groups were randomized to have no discussion guide, or to receive a one-page guide. Outcomes of burnout, engagement, and empowerment in work, and stress from uncertainty were assessed using validated metrics. Rates of emotional exhaustion and depersonalization decreased significantly over the course of the 3-month study (56%-36%; P < .001; and 20%-15%; P = .006) and overall burnout decreased from 56% to 41% of faculty (P = .002). The percentage of faculty who felt engaged in their work increased from 80% to 96% (P = .03). No statistically significant differences in empowerment at work or in reaction to uncertainty were seen. The groups without a discussion guide had equivalent outcomes and benefits. Cost per participant was under $100. A three-month, low-cost, self-facilitated series of dinner meetings for interprofessional clinical faculty decreased burnout and improved engagement, sense of connection to colleagues, and sense of departmental commitment to well-being. Structured discussion guides were not necessary to achieve benefit. This study broadens the possibilities for cost-effective opportunities to transform institutional culture and effectively enhance faculty well-being.

Outcomes and Treatment Patterns in Patients with Aggressive B-Cell Lymphoma after Failure of Anti-CD19 CAR T-Cell Therapy

Outcomes and Treatment Patterns in Patients with Aggressive B-Cell Lymphoma after Failure of Anti-CD19 CAR T-Cell Therapy