Herrin, Jeph

Abstract Objective To emulate the GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) trial using real world data before its publication. GRADE directly compared second line glucose lowering drugs for their ability to lower glycated hemoglobin A 1c (HbA 1c ). Design Observational study. Setting OptumLabs® Data Warehouse (OLDW), a nationwide claims database in the US, 25 January 2010 to 30 June 2019. Participants Adults with type 2 diabetes and HbA 1c 6.8-8.5% while using metformin monotherapy, identified according to the GRADE trial specifications, who also used glimepiride, liraglutide, sitagliptin, or insulin glargine. Main outcome measures The primary outcome was time to HbA 1c ≥7.0%. Secondary outcomes were time to HbA 1c >7.5%, incident microvascular complications, incident macrovascular complications, adverse events, all cause hospital admissions, and all cause mortality. Propensity scores were estimated using the gradient boosting machine method, and inverse propensity score weighting was used to emulate randomization of the treatment groups, which were then compared using Cox proportional hazards regression. Results 8252 people were identified (19.7% of adults starting the study drugs in OLDW) who met eligibility criteria for the GRADE trial (glimepiride arm=4318, liraglutide arm=690, sitagliptin arm=2993, glargine arm=251). The glargine arm was excluded from analyses owing to small sample size. Median times to HbA 1c ≥7.0% were 442 days (95% confidence interval 394 to 480 days) for glimepiride, 764 (741 to not calculable) days for liraglutide, and 427 (380 to 483) days for sitagliptin. Liraglutide was associated with lower risk of reaching HbA 1c ≥7.0% compared with glimepiride (hazard ratio 0.57, 95% confidence interval 0.43 to 0.75) and sitagliptin (0.55, 0.41 to 0.73). Results were consistent for the secondary outcome of time to HbA 1c >7.5%. No significant differences were observed among treatment groups for the remaining secondary outcomes. Conclusions In this emulation of the GRADE trial, liraglutide was statistically significantly more effective at maintaining glycemic control than glimepiride or sitagliptin when added to metformin monotherapy. Generating timely evidence on medical treatments using real world data as a complement to prospective trials is of value.

Background: While implantation of left ventricular assist devices (LVAD) improves survival and quality of life in patients with advanced heart failure, very little is known about healthcare resource utilization, including hospital readmissions, post-LVAD. Methods: Administrative claims data from a large, national US health plan were used to identify privately insured and Medicare Advantage patients that received an LVAD (ICD-9-CM code 37.66) and survived to hospital discharge from January 1, 2006 through 31 August 31, 2013, and had at least six months coverage pre-LVAD. The individuals covered by this health plan, about 88 million in years 2003 to 2013, are geographically dispersed across the United States, with greatest representation in the South and Midwest census regions. Reasons for subsequent readmissions were categorized according to the AHRQ Clinical Classifications Software and risk factors for readmission analyzed using multiple failure Cox regression analysis. Patients were censored at the time of heart transplantation or end of coverage through November 30, 2013. Results: In total, 857 patients received an LVAD, of whom 693 (81%) survived to hospital discharge without undergoing heart transplantation (mean age 56 years, 77% male). After a median follow-up of 0.69 (interquartile range [IQR]: 0.31, 1.50) years, 1,659 readmissions occurred among 509 patients. Over this period, patients spent a median of 10.5 days (IQR: 0 -40 days) per followup year hospitalized. The number of readmissions per patient varied widely (0 to 20 per person), with 184 (26.6%) patients experiencing no readmissions, while 112 (16.2%) had 5 or more readmissions during follow-up. The most common reasons for readmission were device complications (291 readmissions in 155 patients), heart failure (246 readmissions in 135 patients), gastrointestinal bleeding (90 readmissions in 52 patients), and arrhythmia (88 readmissions in 55 patients). Readmission risk was higher in patients who had longer initial length of stay and more comorbid conditions. Discussion: There is tremendous variability in the readmission burden experienced post-LVAD, with some patients experiencing no readmissions while others are repeatedly hospitalized. LVAD therapy introduces a unique set of problems that often prompt readmission including device complications and gastrointestinal bleeding.

Background/Aims: Clinical trials evaluating facility-to-facility telemedicine may include sites that have limited research experience. For the trial to be successful, these sites must correctly perform research-related tasks. This study aimed to determine whether health care professionals at community hospitals could accurately identify simulated study eligible patients and submit data to a research coordinating center. Methods: Twenty-seven community hospitals in the United States and Canada participated in this study. An electronic survey was sent to one designated health care professional at each site. The survey included a description of trial eligibility criteria and five written neonatal resuscitation scenarios. For each scenario, the participant determined whether the neonate was study eligible. One scenario required participants to submit 14 data elements to the coordinating center. Accuracy of study eligibility and data submission was summarized using standard descriptive statistics. Results: The survey response rate was 100% (27/27). Overall accuracy in determining study eligibility was 89% (120/135), and accuracy varied across the five scenarios (range 82–93%). Overall accuracy of data submission was 92% (310/336). Data were >95% accurate for 9 of the 14 data elements, with 100% accuracy achieved for 6 data elements. These results were used to clarify eligibility criteria, inform database design, and improve training materials for the subsequent clinical trial. Conclusions: Health care professionals at community hospitals accurately determined trial eligibility and submitted study data based on written clinical scenarios. Research teams conducting telemedicine trials with community hospitals should consider completing pre-trial simulation activities to identify opportunities for improving trial processes and materials.

AbstractEnvironments that are hostile to one or more marginalized groups are known to have a negative effect on the mental health and well‐being of both targets and observers. Anti‐fat attitudes have been well documented in medical education, including the use of derogatory humor and discriminatory treatment toward higher‐weight patients. However, to date, it is not known what effect observing weight stigma and discrimination during medical school has on medical students’ psychological health and wellbeing, sense of belonging, and medical school burnout. The present study surveyed a total of 3994 students enrolled across 49 US medical schools at the start of their first year and at the end of their fourth year. Participants reported the frequency with which they had observed stigmatizing and discriminatory behaviors targeted at both higher‐weight patients and higher‐weight students during their four years of medical school. Observed weight stigma was prevalent, and was associated with worse psychological and general health, reduced medical school belonging and increased medical school burnout. The indirect effects of observed weight stigma on medical school burnout, via belonging, psychological health, and general health, were statistically significant in the sample as a whole, but were more pronounced in higher‐weight students. This effect may be explained, in part, by the relationship between observed stigma and medical school belonging. Higher levels of observed stigma were associated with reduced feelings of belonging in higher‐weight but not normative‐weight students. Top‐down institutional culture change is needed to rectify this situation, which is detrimental to both students and patients.

Objective We aimed to measure provider perspectives on the acceptability, appropriateness, and feasibility of teleneonatology in neonatal intensive care units (NICUs) and community hospitals. Study Design Providers from five academic tertiary NICUs and 27 community hospitals were surveyed using validated implementation measures to assess the acceptability, appropriateness, and feasibility of teleneonatology. For each of the 12 statements, scale values ranged from 1 to 5 (1 = strongly disagree; 5 = strongly agree), with higher scores indicating greater positive perceptions. Survey results were summarized, and differences across respondents assessed using generalized linear models. Results The survey response rate was 56% (203/365). Respondents found teleneonatology to be acceptable, appropriate, and feasible. The percent of respondents who agreed with each of the twelve statements ranged from 88.6 to 99.0%, with mean scores of 4.4 to 4.7 and median scores of 4.0 to 5.0. There was no difference in the acceptability, appropriateness, and feasibility of teleneonatology when analyzed by professional role, years of experience in neonatal care, or years of teleneonatology experience. Respondents from Level I well newborn nurseries had greater positive perceptions of teleneonatology than those from Level II special care nurseries. Conclusion Providers in tertiary NICUs and community hospitals perceive teleneonatology to be highly acceptable, appropriate, and feasible for their practices. The wide acceptance by providers of all roles and levels of experience likely demonstrates a broad receptiveness to telemedicine as a tool to deliver neonatal care, particularly in rural communities where specialists are unavailable. Key Points

Objective We aimed to measure provider perspectives on the acceptability, appropriateness, and feasibility of teleneonatology in neonatal intensive care units (NICUs) and community hospitals. Study Design Providers from five academic tertiary NICUs and 27 community hospitals were surveyed using validated implementation measures to assess the acceptability, appropriateness, and feasibility of teleneonatology. For each of the 12 statements, scale values ranged from 1 to 5 (1 = strongly disagree; 5 = strongly agree), with higher scores indicating greater positive perceptions. Survey results were summarized, and differences across respondents assessed using generalized linear models. Results The survey response rate was 56% (203/365). Respondents found teleneonatology to be acceptable, appropriate, and feasible. The percent of respondents who agreed with each of the twelve statements ranged from 88.6 to 99.0%, with mean scores of 4.4 to 4.7 and median scores of 4.0 to 5.0. There was no difference in the acceptability, appropriateness, and feasibility of teleneonatology when analyzed by professional role, years of experience in neonatal care, or years of teleneonatology experience. Respondents from Level I well newborn nurseries had greater positive perceptions of teleneonatology than those from Level II special care nurseries. Conclusion Providers in tertiary NICUs and community hospitals perceive teleneonatology to be highly acceptable, appropriate, and feasible for their practices. The wide acceptance by providers of all roles and levels of experience likely demonstrates a broad receptiveness to telemedicine as a tool to deliver neonatal care, particularly in rural communities where specialists are unavailable. Key Points

Abstract Background The symptom burden associated with cancer and its treatment can negatively affect patients’ quality of life and survival. Symptom-focused collaborative care model (CCM) interventions can improve outcomes, but only if patients engage with them. We assessed the receptivity of severely symptomatic oncology patients to a remote nurse-led CCM intervention. Methods In a pragmatic, cluster-randomized, stepped-wedge trial conducted as part of the National Cancer Institute IMPACT Consortium (E2C2, NCT03892967), patients receiving cancer care were asked to rate their sleep disturbance, pain, anxiety, emotional distress, fatigue, and limitations in physical function. Patients reporting at least 1 severe symptom (≥7/10) were offered phone consultation with a nurse symptom care manager (RN SCM). Initially, patients had to “opt-in” to receive a call, but the protocol was later modified so they had to “opt-out” if they did not want a call. We assessed the impact of opt-in vs opt-out framing and patient characteristics on receptiveness to RN SCM calls. All statistical tests were 2-sided. Results Of the 1204 symptom assessments (from 864 patients) on which at least 1 severe symptom was documented, 469 (39.0%) indicated receptivity to an RN SCM phone call. The opt-out period (odds ratio [OR] = 1.61, 95% confidence interval [CI] = 1.12 to 2.32, P = .01), receiving care at a tertiary care center (OR = 3.59, 95% CI = 2.18 to 5.91, P < .001), and having severe pain (OR = 1.80, 95% CI = 1.24 to 2.62, P = .002) were associated with statistically significantly greater willingness to receive a call. Conclusions Many severely symptomatic patients were not receptive to an RN SCM phone call. Better understanding of reasons for refusal and strategies for improving patient receptivity are needed.