The Senior Scholars Program at UMass Chan Medical School provides an opportunity for scholarly activities that serve not only as an introduction to the philosophy of research based on answering questions through hypothesis generation, information gathering, experimentation, and critical interpretation, but as a tool for growth in an evidence-based health care environment. Each student participates in "Senior Scholars Presentation Day" by preparing a poster about their research project and sharing their learning experience with medical school peers and faculty members. This collection includes student posters, abstracts, and published journal articles authored by Senior Scholars.

HOW TO SUBMIT YOUR SENIOR SCHOLARS PROGRAM POSTER

  • Review the submission guidelines and complete all requirements and the online permission form (Preview permission form)
  • Log into eScholarship@UMassChan using your UMass Chan email address and password
  • Click the "Submissions" link in the left sidebar under "My Account"
  • Click on "start a new submission"
  • Select this collection: UMass Chan Student Research and Publications > T.H. Chan School of Medicine > Senior Scholars Program
  • Fill in submission form and submit
  • You will receive an email with a persistent link to your submission when it is posted.

QUESTIONS?

Contact escholarship@umassmed.edu with your questions.

Recently Published

  • Rigid Plate Fixation for Reconstruction of Symptomatic Sternal Nonunion: A Retrospective Review

    Sjoquist, Jan; Joo, Alex; Bello, Ricardo; Dunn, Raymond M (2023-04-26)
    Background: Median sternotomy, the most common approach to open cardiac surgery, is performed in over 500,000 patients annually in the United States. This approach involves an incision from the manubrium to xyphoid and vertical division of the bony sternum. Wire cerclage remains the standard technique for sternal closure after median sternotomy. Complications following median sternotomy include infection, hematoma, seroma, and sternal nonunion or dehiscence. Sternal nonunion occurs when either significant bony motion, fracture, or separation occurs with the two sternal halves. It is clinically defined as greater than 6 months of pain, clicking, or sternal instability. This represents a failure of primary cerclage “fixation.” Risk factors for nonunion after sternotomy include obesity, bilateral internal mammary artery harvesting, diabetes, and off-midline sternotomy. While sternal nonunion has an incidence of less than 1%, this complication can serve as a nidus for life-threatening infection and can cause significant discomfort for the patient. There is currently no standard-of-care treatment for sternal nonunion after median sternotomy. In fact, sternal nonunion most commonly goes untreated, leaving patients continuously symptomatic. Rigid plate fixation (RPF) has been employed in certain cases for primary sternal closure in patients at higher risk for sternal healing complications. RPF has been shown to significantly reduce the incidence of complications and mortality after median sternotomy in high-risk patients when compared to wire cerclage. We have recently employed traditional orthopedic techniques of bony debridement, anatomic bony reduction, and have extended the use of RPF to patients with symptomatic sternal nonunion. Objectives: The goal of this retrospective review is to investigate and describe long term clinical outcomes in patients at our institution who have undergone RPF for sternal nonunion after median sternotomy. Our objectives are to investigate long term outcomes and complications in patients at our institution who have undergone rigid plate fixation for sternal nonunion after median sternotomy. Methods: All patients who underwent sternal reconstruction for sterile sternal nonunion between 2017 and 2023 were reviewed. Patients were excluded if they underwent prophylactic RPF during primary sternotomy or if they did not meet the clinical definition of sternal nonunion. Data regarding demographics, risk factors, initial sternotomy procedure, nonunion presentation, reconstructive procedure, and clinical and radiographic follow up. For sternal reconstruction, all patients underwent debridement of nonviable sternal tissue, rigid fixation with locking plates and screws with or without pectoralis muscle advancement flaps, layered closure, and incisional negative pressure wound therapy (NPWT). A total of 18 eligible patients, 14 male and 4 female, were identified. Average age was 63 years. Preoperative risk factors included obesity (n = 14), smoking (n = 9), diabetes (n = 8), and LIMA harvest (n = 16). Indication for median sternotomy included coronary artery bypass grafting (n = 16) and aortic valve replacement (n = 2). Patients presented with symptoms of sternal nonunion an average of 4.5 months after initial sternotomy. The most common presenting symptoms were pain (n = 17) and sternal clicking (n = 14). 8 patients (44%) showed evidence of fractured sternal wires. Results: Average time from symptom presentation to sternal reconstruction was 3.2 months. Average time from initial sternotomy to reconstruction was 7.7 months. Regarding the sternal reconstruction procedure, 100% of patients underwent debridement of sternal edges and rigid plate fixation using locking plates and screws. Bilateral pectoralis advancement flaps were performed in 17 patients (94%). The average clinical follow-up period was 3 years, ranging from 39 days to 4.9 years. 100% of patients had sternal nonunion confirmed by CT scan and demonstrated clinical evidence of sternal healing. Complications following RPF included seroma (n=3), hematoma (n = 2), and wound infections (n = 2). One patient presented with osteomyelitis/mediastinitis one month post sternal reconstruction, with full resolution after receiving IV and oral antibiotics. Another patient had all hardware removed after presenting with cellulitis and CT evidence of perihardware infection 3 months post reconstruction. Sternal union was noted at time of hardware removal. Conclusion: Rigid plate fixation is a reliable method of treatment for symptomatic sternal nonunion and should be offered to all patients demonstrating signs and symptoms of sternal nonunion after median sternotomy.
  • Updating and Improving the Capstone Course Experience for Learners and Teachers

    Lin, Ashley; Cooper, Bronwyn (2022-06-30)
    Background:The Capstone Scholarship and Discovery Course (“Capstone course”) is a required four-year course which aims to support students in the design, execution, writing, and presentation of a longitudinal scholarly project. Currently, the Capstone course meets criteria for “underperforming” designation (<75% approval) designationin two areas: Overall, how would you rate this course? | 2.52/4 | 52.77% Feedback on reports supported progress/learning | 2.95/4 | 74.07% The overall medical school curriculum is transitioning to a new curriculum (“Vista”) in which Capstone will fit into the context of student-selected Pathways. As the Capstone student representative responsible for communicating student feedback to Capstone leadership, I became interested in taking advantage of this opportunity to improve the course. I believe that every medical student should feel supported in their Capstone research and finish medical school with a foundational understanding of how to conduct longitudinal scholarly work. Objectives: 1) Identify student and faculty concerns about the Capstone course 2) Propose potential changes to the Capstone course to address the most significant concerns 3) Measure student approval towards these proposed changes 4) Summarize and present the most highly student-approved proposed changes to Capstone Course Leadership Team. Methods: I reviewed all Capstone oasis evaluations from the 2020 – 2021 Academic Year, which included 109 faculty evaluations of students, 133 student evaluations of Capstone faculty (~80% response rate), and 136 student evaluations of the Capstone course (~81% response rate). I also created a pre-survey to assess the most unclear aspects of the Capstone course as well as top barriers to meeting deadlines. I received 44 survey responses from third-year students (~22% response rate) and 47 responses from fourth-year students (~30% response rate). From the oasis evaluations and survey responses, I identified the most significant concerns. I generated twenty-two proposed changes to address these concerns, and created a slideshow that summarizes these proposed changes to the Capstone course. This was distributed to current third- and fourth-year medical students, along with a post-survey where students could vote on the proposed changes and indicate whether these changes addressed the unclear aspects of the Capstone course and top barriers to meeting deadlines. (Terminology note: learning community assigned affiliate = “affiliate”, faculty advisor specific to project = “advisor”). Results: I received 29 post-survey responses from third-year students (~15% response rate) and 37 responses from fourth-year students (~23% response rate). Between the pre- and post-surveys, the average % of students finding certain aspects of Capstone “unclear” decreased by 26.1%, and the average % of students rating certain barriers as significant for meeting Capstone deadlines decreased by 15.5%. Notably, the post-survey found that some students believe the proposed changes would not address their lack of interest in doing a longitudinal project (53.1%), and that certain projects students are interested in would still not meet Capstone requirements (31.3%). An abbreviated summary of the most popular proposed changes (>50% of students agree, and/or >10% of students indicated it as one of their top three changes, highlighted in bold) is below. Proposed Solution | % top 3 | % disagree | % neutral | % agree 1a) Create research project database | 30.4 | 3.1 | 12.3 | 84.6 1b) Create roster of past highly-rated advisors (based on oasis evals) | 7.1 | 4.6 | 24.6 | 70.8 1d) MS1 Capstone curriculum focused on developing research skills | 23.2 | 9.2 | 18.5 | 72.3 1e) Affiliate must give feedback on project feasibility as a Capstone project within a month of project proposal. | 5.4 | 6.2 | 32.3 | 61.5 2a) Add additional, optional Capstone poster presentation session before ERAS deadline so presentation can be on ERAS app | 10.7 | 6.2 | 24.6 | 69.2 2b) Optional workshops (or asynchronous videos) on common issues | 5.4 | 15.4 | 32.3 | 52.3 3a) In place of report submissions, create a live document that can be accessed by affiliate and mentor | 16.1 | 10.8 | 26.2 | 63.1 3b) Flexible format (such as Senior Scholars format: background, objectives, methods, results, conclusion) with no length requirement | 21.4 | 1.5 | 12.3 | 86.2 3c) Rework deadlines to avoid exam dates, Step 1 period, holidays, and flexible range of deadlines provided during clinical rotations | 33.9 | 0 | 3.1 | 96.9 3d) Timeline of deadlines given to affiliates and mentors, with exam dates and Step 1 period marked on timeline | 5.4 | 1.6 | 15.6 | 82.8 3e) No punishment for those who get their work done early | 23.2 | 0 | 4.7 | 95.3 3f) Meeting with affiliate can substitute for an update with affiliate approval | 1.8 | 4.7 | 25 | 70.3 4a) Projects that take place over >1 month should be accepted as “longitudinal” and all affiliates should be on the same page. | 42.9 | 1.5 | 16.9 | 81.5 5a) Students may submit outside project to their affiliate to be approved for Capstone credit as long as they worked on this project during med school | 44.6 | 1.5 | 10.8 | 87.7 5c) Website should be simplified. | 7.1 | 0 | 21.9 | 78.1 Conclusion: Students enter medical school with widely differing levels of experience in conducting scholarly research, and the current Capstone course does not have flexibility for different types of projects, or the resources needed to accommodate student needs. Capstone affiliates and advisors also face difficulties providing optimal assistance to students. Through this work, I have identified solutions that are popular amongst students, which address unclear aspects of the Capstone course and top barriers to meeting deadlines. Bringing these solutions to the Capstone Course Leadership Team is the next step to addressing these concerns. Future goals include asking Capstone affiliates for their input, as this group was not included either in the oasis evaluations or the surveys. Another limitation of this study was the low survey response rates, ranging from 15-30%. I hope that ultimately some of these proposed changes to the Capstone course will be adopted and integrated into the new Vista curriculum.
  • Female Relatives as Lay Doulas and Birth Outcomes: A Systematic Review

    Nguyen, Hau Huu; Heelan-Fancher, Lisa (2022-04-01)
    Continuous labor support provided by professional doulas is associated with improved birth outcomes for pregnant women and their infants. However, there is limited data on the impact of using female relatives as lay doulas. This systematic review included nine published studies that examined the association between use of female relatives as lay doulas with childbirth outcomes. In some study populations, there was a decrease in the number of cesarean births and length of labor, and in all studies, there was improved maternal birth satisfaction. However, the woman's chosen female relative often did not receive education regarding labor support skills before providing continuous support. Educational programs designed to teach labor support skills to female relatives are needed.
  • CENTER-IT: a novel methodology for adapting multi-level interventions using the Consolidated Framework for Implementation Research-a case example of a school-supervised asthma intervention

    Trivedi, Michelle; Hoque, Shushmita; Shillan, Holly N.; Seay, Hannah L.; Spano, Michelle A.; Gaffin, Jonathan; Phipatanakul, Wanda; Rosal, Milagros C.; Garg, Arvin; Gerald, Lynn B.; et al. (2022-03-26)
    BACKGROUND: Implementation science frameworks advise the engagement of multi-level partners (at the patient, provider, and systems level) to adapt and increase the uptake of evidence-based practices (EBPs). However, there is little guidance to ensure that systems-level adaptations reflect the voices of providers who deliver and patients/caregivers who receive EBPs. METHODS: We present a novel methodology, grounded in the Consolidated Framework for Implementation Research (CFIR), which anchors the engagement of multi-level partners to the voices of individuals who deliver and receive EBPs. Using the CFIR domains: intervention adaptation, individuals involved, inner/outer setting, and process, we illustrate our 4-step methodology through a case example of Asthma Link, a school-supervised asthma management intervention. In step 1, we interviewed "individuals involved" in the intervention (providers/caregivers/patients of Asthma Link) to identify implementation barriers. In step 2, we selected systems-level partners in the "inner and outer setting" that could assist with addressing these barriers. In step 3, we presented the barriers to these systems-level partners and conducted semi-structured interviews to elicit their recommended solutions (process). Interviews were audio-recorded, transcribed, and open-coded. A theoretical sampling model and deductive reasoning were used to identify solutions to implementation barriers. In step 4, we utilized multi-level input to adapt the Asthma Link intervention. RESULTS: Identified barriers included inability to obtain two inhalers for home and school use, inconsistent delivery of the inhaler to school by families, and challenges when schools did not have a nurse. Interviews conducted with school/clinic leaders, pharmacists, payors, legislators, and policymakers (n=22) elicited solutions to address provider and patient/caregiver-identified barriers, including (1) establishing a Medicaid-specific pharmacy policy to allow dispensation of two inhalers, (2) utilizing pharmacy-school delivery services to ensure medication reaches schools, and (3) identifying alternate (non-nurse) officials to supervise medication administration. The iterative process of engaging multi-level partners helped to create an adapted Asthma Link intervention, primed for effective implementation. CONCLUSIONS: This novel methodology, grounded in the CFIR, ensures that systems-level changes that require the engagement of multi-level partners reflect the voices of individuals who deliver and receive EBPs. This methodology demonstrates the dynamic interplay of CFIR domains to advance the field of implementation science.
  • Prospective associations between acid suppressive therapy and food allergy in early childhood

    Seay, Hannah L; Martin, Victoria M; Virkud, Yamini V; Marget, Michael; Shreffler, Wayne G; Yuan, Qian (2022-03-13)
    We sought to prospectively evaluate the association between AST in infancy and development of IgE-FA in our healthy infant cohort.
  • Variability of Prognostic Communication in Critically Ill Neurologic Patients: A Pilot Multicenter Mixed-Methods Study

    Ge, Connie; Goss, Adeline L.; Crawford, Sybil L.; Goostrey, Kelsey; Buddadhumaruk, Praewpannarai; Shields, Anne-Marie; Hough, Catherine L.; Lo, Bernard; Carson, Shannon S.; Steingrub, Jay; et al. (2022-02-21)
    IMPORTANCE: Withdrawal-of-life-sustaining treatments (WOLST) rates vary widely among critically ill neurologic patients (CINPs) and cannot be solely attributed to patient and family characteristics. Research in general critical care has shown that clinicians prognosticate to families with high variability. Little is known about how clinicians disclose prognosis to families of CINPs, and whether any associations exist with WOLST. OBJECTIVES: Primary: to demonstrate feasibility of audio-recording clinician-family meetings for CINPs at multiple centers and characterize how clinicians communicate prognosis during these meetings. Secondary: to explore associations of 1) clinician, family, or patient characteristics with clinicians' prognostication approaches and 2) prognostication approach and WOLST. DESIGN SETTING AND PARTICIPANTS: Forty-three audio-recorded clinician-family meetings during which prognosis was discussed from seven U.S. centers for 39 CINPs with 88 family members and 27 clinicians. MAIN OUTCOMES AND MEASURES: Two investigators qualitatively coded transcripts using inductive methods (inter-rater reliability > 80%) to characterize how clinicians prognosticate. We then applied univariate and multivariable multinomial and binomial logistic regression. RESULTS: Clinicians used four distinct prognostication approaches: Authoritative (21%; recommending treatments without discussing values and preferences); Informational (23%; disclosing just the prognosis without further discussions); advisory (42%; disclosing prognosis followed by discussion of values and preferences); and responsive (14%; eliciting values and preferences, then disclosing prognosis). Before adjustment, prognostication approach was associated with center (p < 0.001), clinician specialty (neurointensivists vs non-neurointensivists; p = 0.001), patient age (p = 0.08), diagnosis (p = 0.059), and meeting length (p = 0.03). After adjustment, only clinician specialty independently predicted prognostication approach (p = 0.027). WOLST decisions occurred in 41% of patients and were most common under the advisory approach (56%). WOLST was more likely in older patients (p = 0.059) and with more experienced clinicians (p = 0.07). Prognostication approach was not independently associated with WOLST (p = 0.198). CONCLUSIONS AND RELEVANCE: It is feasible to audio-record sensitive clinician-family meetings about CINPs in multiple ICUs. We found that clinicians prognosticate with high variability. Our data suggest that larger studies are warranted in CINPs to examine the role of clinicians' variable prognostication in WOLST decisions.
  • A response to COVID-19 school closures: The feasibility of a school-linked text message intervention as an adaptation to school-supervised asthma therapy

    Arenas, Juliana; Becker, Sarah; Seay, Hannah; Frisard, Christine F.; Hoque, Shushmita; Spano, Michelle; Lindenauer, Peter K.; Sadasivam, Rajani S.; Pbert, Lori; Trivedi, Michelle (2022-02-01)
    BACKGROUND: School-supervised asthma therapy improves asthma medication adherence and morbidity, particularly among low-income and underrepresented minority (URM) children. However, COVID-19-related school closures abruptly suspended this therapy. In response, we developed a school-linked text message intervention. OBJECTIVE: The purpose of the study is to investigate the feasibility and acceptability of a school-linked text message intervention. METHODS: In December 2020, children previously enrolled in school-supervised asthma therapy in Central Massachusetts were recruited into this school-linked text message intervention. We sent two-way, automated, daily text reminders in English or Spanish to caregivers of these children, asking if they had given their child their daily preventive asthma medicine. Our study team notified the school nurse if the caregiver did not consistently respond to text messages. School nurses performed weekly remote check-ins with all families. The primary outcome of the study was feasibility: recruitment, retention, and intervention fidelity. Secondarily we examined intervention acceptability and asthma health outcomes. RESULTS: Twenty-six children (54% male, 69% Hispanic, 8% Black, 23% White, 93% Medicaid insured) and their caregivers were enrolled in the intervention with 96% participant retention at 6 months. Caregiver response rate to daily text messages was 81% over the study period. Children experienced significant improvements in asthma health outcomes. The intervention was well accepted by nurses and caregivers. CONCLUSION: A school-linked text messaging intervention for pediatric asthma is feasible and acceptable. This simple, accessible intervention may improve health outcomes for low-income and URM children with asthma. It merits further study as a potential strategy to advance health equity.
  • Caregiver-perceived neighborhood safety and pediatric asthma severity: 2017-2018 National Survey of Children's Health

    Hoque, Shushmita; Goulding, Melissa; Hazeltine, Max D.; Ferrucci, Katarina A; Trivedi, Michelle K.; Liu, Shao-Hsien (2022-02-01)
    OBJECTIVE: To examine the association between caregiver-perceived neighborhood safety and pediatric asthma severity using a cross-sectional, nationally representative sample. STUDY DESIGN: Using data from the 2017-2018 National Survey of Children's Health, children aged 6-17 years with primary caregiver report of a current asthma diagnosis were included (unweighted N = 3209; weighted N = 3,909,178). Perceived neighborhood safety, asthma severity (mild vs. moderate/severe), demographic, household, and health/behavioral covariate data were collected from primary caregiver report. Poisson regression with robust error variance was used to estimate the association between perceived neighborhood safety and caregiver-reported pediatric asthma severity. RESULTS: Approximately one-third of children studied had moderate/severe asthma. A total of 42% of children with mild asthma and 52% of children with moderate/severe asthma identified as Hispanic or non-Hispanic Black. Nearly 20% of children with mild asthma and 40% of children with moderate/severe asthma were from families living below the federal poverty level (FPL). Children living in neighborhoods perceived by their caregiver to be unsafe had higher prevalence of moderate/severe asthma compared to those in the safest neighborhoods (adjusted prevalence ratio: 1.34; 95% confidence interval: 1.04-1.74). This association was found to be independent of race/ethnicity, household FPL, household smoking, and child's physical activity level after adjusting for covariates. CONCLUSIONS: Children living in neighborhoods perceived by their caregiver to be unsafe have higher prevalence of moderate or severe asthma. Further investigation of geographic context and neighborhood characteristics that influence childhood asthma severity may inform public health strategies to reduce asthma burden and improve disease outcomes.
  • Clinician perspectives on the need for training on caring for pregnant women with intellectual and developmental disabilities

    Amir, Nili S.; Smith, Lauren; Valentine, Anne M.; Mitra, Monika; Parish, Susan L.; Moore Simas, Tiffany A. (2021-12-17)
    BACKGROUND: Women with intellectual and developmental disabilities (IDDs) experience disparities in obstetric care access and quality, in addition to communication gaps with healthcare providers. Many obstetric providers are untrained and uneducated about critical aspects of providing care to persons with IDDs. OBJECTIVE: The study was conducted to describe obstetric clinicians' training experiences related to providing obstetric care to women with IDDs, to assess the perceived need for formalized training, and to identify recommendations for training content. METHODS: This study involved qualitative individual interviews (n = 9) and one focus group (n = 8) with obstetric clinicians who self-reported experience caring for women with IDDs during pregnancy. Descriptive coding and content analysis techniques were used to develop an iterative codebook related to education and training; codes were applied to the data. Coded data were analyzed for larger themes and relationships. RESULTS: Analysis revealed three main themes: 1. Need for obstetric training and education: No participant reported receiving any training in caring for pregnant women with IDDs. Participants expressed a need for formal education. 2. Recommendations for formal training: Participants noted the need for training during residency and beyond, and all healthcare staff members should be included in training. 3. Training outcomes should increase knowledge, enhance attitudes, and develop practical skills related to care for pregnant women with IDDs. CONCLUSION: Results indicate a need for systematic training efforts regarding obstetric care for women with IDDs. Improved training and education may decrease health inequities and improve the quality of care, and thus pregnancy outcomes, for women with IDDs. LEVEL OF EVIDENCE: VI.
  • In-Office Repair of Tympanic Membrane Perforation

    Roychowdhury, Prithwijit; Polanik, Marc D; Kozin, Elliott D; Remenschneider, Aaron K (2021-12-01)
    BACKGROUND: Chronic tympanic membrane (TM) perforations are a common cause of conductive hearing loss in adult patients. The gold-standard approach to repair of TM perforations involves surgical elevation of the remnant TM via a postauricular or endaural incision to enable grafting (1). Endoscopic TM repair in awake patients in the clinic setting using a novel graft design may permit perforation closure while avoiding general anesthesia and decreasing operative time (2,3). CASE REPORT: A 42-year-old female with a chronic, left sided tympanic membrane perforation in the anterior–inferior quadrant (15% of TM area) presented with a mild conductive hearing loss on audiometry. In-office repair of the perforation was performed with immediate subjective hearing improvement. Four months post-procedure, the TM was intact, and her prior air-bone gap had closed. CONCLUSION: In-office endoscopic repair of TM perforations using a novel graft design in awake patients offers a viable alternative to traditional in-OR approach for tympanoplasty.
  • The Urinary Microbiome of Older Adults Residing in a Nursing Home Varies with Duration of Residence and Shows Increases in Potential Pathogens

    Bradley, Evan; Schell, Brent; Ward, Doyle V.; Bucci, Vanni; Zeamer, Abigail L; Haran, John P (2021-11-13)
    The community of bacteria that colonize the urinary tract, the urinary microbiome, is hypothesized to influence a wide variety of urinary tract conditions. Older adults that reside in nursing homes are frequently diagnosed and treated for urinary tract conditions such as urinary tract infection (UTI). We investigated the urinary microbiome of older adults residing in a nursing home to determine if there are features of the urinary microbiome that are associated specific conditions and exposure in this population. We were also interested in the stability of urinary microbiome over time and in similarities between the urinary and gastrointestinal microbiome. Urine samples were prospectively collected over a period of 10 months from a cohort of 26 older adults (age > 65 years) residing in single nursing home located in Central Massachusetts. Serial samples were obtained from 6 individuals over 10 months and 5 participants were concurrently enrolled in a study of the gastrointestinal microbiome. Information collected on participants included demographics, medical history, duration of residence in the nursing home, frailty, dementia symptoms, urinary symptoms, antibiotic treatment, urinary catherization, and hospitalizations over a 10-month period. Clean catch mid-stream urine samples were collected and stored at -80C. DNA was extracted and 16S rRNA gene sequencing performed. The length of stay in the nursing facility and the Clinical Frailty Scale correlated with significant changes in microbiome composition. An increase in the relative abundance of a putative urinary pathogen, Aerococcus urinae, was the largest factor influencing change that occurred over duration of residence.
  • Effect of Screen Time on Recovery From Concussion: A Randomized Clinical Trial

    Macnow, Theodore; Curran, Tess; Tolliday, Courtney; Martin, Kirsti; McCarthy, Madeline; Ayturk, M. Didem; Babu, Kavita M.; Mannix, Rebekah (2021-11-01)
    Importance: There are limited data to guide screen time recommendations after concussion. Objective: To determine whether screen time in the first 48 hours after concussion has an effect on the duration of concussive symptoms. Design, Setting, and Participants: This randomized clinical trial was conducted in the pediatric and adult emergency departments of a tertiary medical center between June 2018 and February 2020. Participants included a convenience sample of patients aged 12 to 25 years presenting to the emergency department within 24 hours of sustaining a concussion. A total of 162 patients were approached, 22 patients met exclusion criteria, and 15 patients declined participation; 125 participants were enrolled and randomized. Interventions: Patients were either permitted to engage in screen time (screen time permitted group) or asked to abstain from screen time (screen time abstinent group) for 48 hours after injury. Main Outcomes and Measures: The primary outcome was days to resolution of symptoms, defined as a total Post-Concussive Symptom Scale (PCSS) score of 3 points or lower. Patients completed the PCSS, a 22-symptom scale that grades each symptom from 0 (not present) to 6 (severe), each day for 10 days. Kaplan-Meier curves and Cox regression modeling were used to compare the 2 groups. A Wilcoxon rank sum test was also performed among participants who completed the PCSS each day through recovery or conclusion of the study period. Results: Among 125 patients with concussion, the mean (SD) age was 17.0 (3.4) years; 64 participants (51.2%) were male. A total of 66 patients were randomized to the screen time permitted group, and 59 patients were randomized to the screen time abstinent group. The Cox regression model including the intervention group and the patient's self-identified sex demonstrated a significant effect of screen time (hazard ratio [HR], 0.51; 95% CI, 0.29-0.90), indicating that participants who engaged in screen time were less likely to recover during the study period. In total, 91 patients were included in the Wilcoxon rank sum test (47 patients from the screen time permitted group, and 44 patients from the screen time abstinent group). The screen time permitted group had a significantly longer median recovery time of 8.0 days (interquartile range [IQR], 3.0 to > 10.0 days) compared with 3.5 days (IQR, 2.0 to > 10.0 days; P = .03) in the screen time abstinent group. The screen time permitted group reported a median screen time of 630 minutes (IQR, 415-995 minutes) during the intervention period compared with 130 minutes (IQR, 61-275 minutes) in the screen time abstinent group. Conclusions and Relevance: The findings of this study indicated that avoiding screen time during acute concussion recovery may shorten the duration of symptoms. A multicenter study would help to further assess the effect of screen time exposure. Trial Registration: ClinicalTrials.gov Identifier: NCT03564210.
  • Venous thromboembolism risk stratification in trauma using the Caprini risk assessment model

    Hazeltine, Max D; Guber, Robert D; Buettner, Hannah; Dorfman, Jon D (2021-10-23)
    Introduction: The Caprini risk assessment model is widely used for venous thromboembolism (VTE) but has limited data in trauma. The study objective was to determine if the Caprini risk assessment model could effectively risk stratify trauma patients. Materials and methods: We performed a retrospective review of trauma patients aged ≥18 years, admitted for greater than 24 h at a level one trauma center from January 1, 2018, to December 31, 2018. Demographic and clinical data were analyzed to generate Caprini scores. Multiple logistic regression assessed odds of inpatient VTE. Results: A total of 1279 patients met study eligibility, with a total of 33 VTE (2.6%). When comparing those with VTE to those without, the mean age was lower (52.5 vs 59.5, p = 0.06, respectively), sex distribution was similar, but mean body mass index was higher (30.2 vs 27.4, p = 0.019, respectively). The mean Caprini score was 9.9, and 75.5% had a score >4, the traditional Caprini high-risk cutoff. The VTE group had a higher mean Injury Severity Score (17.8 vs 12.6, p = 0.011), and mean Caprini score (16.4 vs 9.8, p < 0.001). Multiple logistic regression found Caprini score, not Injury Severity Score, was associated with higher odds of VTE (adjusted odds ratio 1.06, 95% confidence interval 1.02-1.10), after adjusting for Injury Severity Score, any missed doses of VTE chemoprophylaxis, and VTE prophylaxis type. Conclusions: Higher Caprini scores are associated with elevated odds of inpatient VTE within hospitalized trauma patients. These data support using the Caprini risk assessment model in the trauma population, which may aid in risk stratification.
  • Prognostic Uncertainty in Critically Ill Patients with Traumatic Brain Injury: A Multicenter Qualitative Study

    Jones, Kelsey; Quinn, Thomas; Mazor, Kathleen M.; Muehlschlegel, Susanne (2021-10-01)
    BACKGROUND: Prognostic uncertainty is frequently cited as a barrier to communication between physicians and patients and is particularly burdensome for surrogate decision-makers, who must make choices on behalf of their incapacitated family members. The Conceptual Taxonomy of Uncertainty is one model through which physician and surrogate communication can be analyzed to identify strategies for reducing uncertainty in surrogate decision-making. Our objective was to examine themes of uncertainty in physician communication of prognosis and surrogate goals-of-care decision-making for critically ill patients with traumatic brain injury (TBI). METHODS: We performed a secondary analysis of a previous qualitative study that involved semistructured interviews of 16 surrogates of critically ill patients with TBI from two level 1 trauma centers and 20 TBI expert physicians from seven trauma centers. Open-ended questions about prognostic uncertainty were asked. We identified major themes with an inductive approach. The Conceptual Taxonomy of Uncertainty was applied to further characterize these themes as data-centered, system-centered, and patient-centered issues of uncertainty. RESULTS: Nearly all surrogates (15 of 16) and physicians (19 of 20) recognized the emotional burden of uncertainty in the decision-making process for surrogates. More than three quarters of surrogates (13 of 16) described instances in which a lack of information regarding their loved one's disease or prognosis created uncertainty in their decision-making process, identifying both positive and negative instances of prognostic communication by physicians. We found that physicians used one of three strategies to communicate prognostic uncertainty to surrogates: leaving no room for uncertainty, honesty about uncertainty, and range of possibilities. These strategies did not meet the communication preferences of the majority of surrogates, with more than a third of decision-makers (6 of 15) being frustrated by too much ambiguity about prognosis as well as the failure to acknowledge the existence of uncertainty. CONCLUSIONS: We found that physician communication strategies rarely addressed surrogate needs regarding uncertainty adequately, suggesting an urgent need for future research into improved communication of prognostic uncertainty.
  • Incorporating systems-level stakeholder perspectives into the clinical trial design of school-supervised asthma therapy

    Trivedi, Michelle; Hoque, Shushmita; Luther, Janki; Spano, Michelle; Shillan, Holly; Pearl, Hallie; Seay, Hannah L.; Phipatanakul, Wanda; Gerald, Lynn B.; Pbert, Lori (2021-09-01)
    RATIONALE: Few evidence-based public health interventions are adopted in practice, in part due to a disconnect between the outcomes measured in clinical trials and the outcomes important to stakeholders that determine implementation in real-world practice. AsthmaLink is a school-supervised asthma therapy program which partners pediatric providers, school nurses, and families. To inform the design of a cluster randomized controlled trial of AsthmaLink, we elicited systems-level stakeholder input. METHODS: Maximum variation sampling was used to recruit 18 stakeholders to participate in semi-structured interviews that were recorded, transcribed, and open coded: Department of Public Health officials (n = 4), school officials (n = 4), pediatric practice managers (n = 3), health insurance officials (n = 4), and legislators (n = 3). Thematic analysis was used to identify common themes related to stakeholder priorities for clinical trial design and perceived barriers to AsthmaLink adoption. RESULTS: Stakeholder groups identified common priorities for the clinical trial design, including examination of the extent to which AsthmaLink (1) reduces health care utilization, (2) is cost effective (2) addresses health disparities, (3) reduces school absenteeism, and (4) educates families about asthma. Stakeholder groups reported potential barriers to AsthmaLink adoption, including challenges pertaining to (1) securing resources, staffing, and reimbursement, (2) variability across school districts, and (3) standing out amidst multiple programs vying for resources. CONCLUSIONS: Systems-level stakeholder input informed refinements to the clinical trial design of a school-supervised therapy program including outcome and implementation measures and choice of study population. Incorporating systems-level stakeholder perspectives into clinical trial design is critical to achieve adoption of evidence-based interventions into practice.
  • Complications following hysterectomy in women with intellectual and developmental disabilities

    Amir, Nili; Mitra, Monika; Leung, Katherine; Moore Simas, Tiffany A (2021-08-31)
    Background: Limited data exist on complications following hysterectomy among women with intellectual and developmental disabilities (IDD). Objective: The objective was to assess the frequencies of postoperative complications in women with IDD following hysterectomy. Methods: The National Inpatient Sample from 2014 to 2017 was queried using codes from the International Classification of Disease 9th and 10th revisions to identify women over 15 years of age with a diagnosis of an IDD undergoing hysterectomy. Comparisons were made to women without IDD undergoing the same procedure. Logistic regression analysis was performed to examine between group differences in the frequency of clinical post-surgical complications while adjusting for potential confounding variables. Results: Of eligible women undergoing hysterectomy, 1,370 were identified as having IDD and 624,700 did not. Compared to controls, women with IDD were significantly younger (45 vs. 50 years, p < 0.001). Women with IDD were also more likely to have had governmental health insurance (83% vs. 34%, p < 0.001), an open hysterectomy approach (78% vs. 69%, p = 0.002), and longer hospital stays (4 vs. 3 days, p < 0.001). After adjusting for potential confounders, women with IDD had greater odds of postoperative urinary complications (OR 3.74, 95% CI 1.18-11.83) and complications related to decubitus ulcer formation (OR 8.97, 95% CI 2.10-38.36). Conclusions: Women with IDD have increased odds having urinary and decubitus ulcer complications following hysterectomy, compared to women without IDD. These results inform surgical decision-making and anticipatory guidance for these women and their caregivers.
  • A machine learning approach to predict progression on active surveillance for prostate cancer

    Nayan, Madhur; Salari, Keyan; Bozzo, Anthony; Ganglberger, Wolfgang; Lu, Gordan; Carvalho, Filipe; Gusev, Andrew; Schneider, Adam; Westover, Brandon M; Feldman, Adam S (2021-08-29)
    Purpose: Robust prediction of progression on active surveillance (AS) for prostate cancer can allow for risk-adapted protocols. To date, models predicting progression on AS have invariably used traditional statistical approaches. We sought to evaluate whether a machine learning (ML) approach could improve prediction of progression on AS. Patients and methods: We performed a retrospective cohort study of patients diagnosed with very-low or low-risk prostate cancer between 1997 and 2016 and managed with AS at our institution. In the training set, we trained a traditional logistic regression (T-LR) classifier, and alternate ML classifiers (support vector machine, random forest, a fully connected artificial neural network, and ML-LR) to predict grade-progression. We evaluated model performance in the test set. The primary performance metric was the F1 score. Results: Our cohort included 790 patients. With a median follow-up of 6.29 years, 234 developed grade-progression. In descending order, the F1 scores were: support vector machine 0.586 (95% CI 0.579 - 0.591), ML-LR 0.522 (95% CI 0.513 - 0.526), artificial neural network 0.392 (95% CI 0.379 - 0.396), random forest 0.376 (95% CI 0.364 - 0.380), and T-LR 0.182 (95% CI 0.151 - 0.185). All alternate ML models had a significantly higher F1 score than the T-LR model (all p <0.001). Conclusion: In our study, ML methods significantly outperformed T-LR in predicting progression on AS for prostate cancer. While our specific models require further validation, we anticipate that a ML approach will help produce robust prediction models that will facilitate individualized risk-stratification in prostate cancer AS.
  • Parent-Reported Symptoms and Perceived Effectiveness of Treatment in Children Hospitalized with Advanced Heart Disease

    Molloy, Meaghan A.; DeWitt, Elizabeth S.; Morell, Emily; Reichman, Jeffrey R.; Brown, David W.; Kobayashi, Ryan; Sleeper, Lynn A.; Elia, Eleni G.; Samsel, Chase; Blume, Elizabeth D. (2021-07-01)
    OBJECTIVE: To characterize parent-reported symptom burden and effectiveness of symptom management in children hospitalized with advanced heart disease. STUDY DESIGN: Prospective survey study of 161 parents whose child was admitted to a single institution with AHD between March 2018 and February 2019 using the Survey about Caring for Children with Heart Disease. RESULTS: Of the 161 patients, 54% were under 2 years old with a diagnosis of single ventricle physiology (39%), pulmonary hypertension (12%), and other congenital heart disease (28%). Over half (56%) of parents reported that their child was experiencing a high degree ('a great deal'/'a lot') of symptoms. The most frequently reported symptoms were pain (68%), fatigue (63%), and breathing difficulties (60%). Of the symptoms that were treated, parents perceived successful treatment to be least likely for their child's sleep disturbance (24%), depression (29%), and fatigue (35%). Parents who reported their child's functional status as NYHA class III/IV were more likely to report that their child was experiencing 'a great deal' of symptoms, compared with those who reported class I/II (51% vs. 19%, p<0.001). Parents who reported their child was experiencing a high degree of suffering from fatigue were also more likely to report a high symptom burden (P < .001). CONCLUSIONS: Parents of children with AHD reported high symptom burden with a broad spectrum of symptoms. Parents reported fatigue and psychiatric symptoms frequently and rarely reported treatment as successful. Parents' view of their child's symptom burden was concordant with their perception of their child's functional status.
  • Does stapedotomy improve high frequency conductive hearing?

    Roychowdhury, Prithwijit; Polanik, Marc D.; Kempfle, Judith S.; Castillo-Bustamante, Melissa; Fikucki, Cheryl; Wang, Michael J.; Kozin, Elliott D.; Remenschneider, Aaron K (2021-06-11)
    Objectives: Stapedotomy is performed to address conductive hearing deficits. While hearing thresholds reliably improve at low frequencies (LF), conductive outcomes at high frequencies (HF) are less reliable and have not been well described. Herein, we evaluate post-operative HF air-bone gap (ABG) changes and measure HF air conduction (AC) thresholds changes as a function of frequency. Methods: Retrospective review of patients who underwent primary stapedotomy with incus wire piston prosthesis between January 2016 and May 2020. Pre- and postoperative audiograms were evaluated. LF ABG was calculated as the mean ABG of thresholds at 250, 500, and 1000 Hz. HF ABG was calculated at 4 kHz. Results: Forty-six cases met criteria. Mean age at surgery was 54.0 +/- 11.7 years. The LF mean preoperative ABG was 36.9 +/- 11.0 dB and postoperatively this significantly reduced to 9.35 +/- 6.76 dB, (P < .001). The HF mean preoperative ABG was 31.1 +/- 14.4 dB and postoperatively, this also significantly reduced to 14.5 +/- 12.3 dB, (P < .001). The magnitude of LF ABG closure was over 1.5 times the magnitude of HF ABG closure (P < .001). The gain in AC decreased with increasing frequency (P < .001). Conclusion: Hearing improvement following stapedotomy is greater at low than high frequencies. Postoperative air bone gaps persist at 4 kHz. Further biomechanical and histopathologic work is necessary to localize postoperative high frequency conductive hearing deficits and improve stapedotomy hearing outcomes. Level of Evidence: 4, retrospective study.
  • Prehospital Intubations Are Associated with Elevated Endotracheal Tube Cuff Pressures: A Cross-Sectional Study Characterizing ETT Cuff Pressures at a Tertiary Care Emergency Department

    Chen, Ruo S.; O'Connor, Laurel; Rebesco, Matthew R.; LaBarge, Kara L.; Remotti, Edgar J.; Tennyson, Joseph C. (2021-06-01)
    INTRODUCTION: Emergency Medical Services (EMS) providers are trained to place endotracheal tubes (ETTs) in the prehospital setting when indicated. Endotracheal tube cuffs are traditionally inflated with 10cc of air to provide adequate seal against the tracheal lumen. There is literature suggesting that many ETTs are inflated well beyond the accepted safe pressures of 20-30cmH2O, leading to potential complications including ischemia, necrosis, scarring, and stenosis of the tracheal wall. Currently, EMS providers do not routinely check ETT cuff pressures. It was hypothesized that the average ETT cuff pressure of patients arriving at the study site who were intubated by EMS exceeds the safe pressure range of 20-30cmH2O. OBJECTIVES: While ETT cuff inflation is necessary to close the respiratory system, thus preventing air leaks and aspiration, there is evidence to suggest that over-inflated ETT cuffs can cause long-term complications. The purpose of this study is to characterize the cuff pressures of ETTs placed by EMS providers. METHODS: This project was a single center, prospective observational study. Endotracheal tube cuff pressures were measured and recorded for adult patients intubated by EMS providers prior to arrival at a large, urban, tertiary care center over a nine-month period. All data were collected by respiratory therapists utilizing a cuff pressure measurement device which had a detectable range of 0-100cmH2O and was designed as a syringe. Results including basic patient demographics, cuff pressure, tube size, and EMS service were recorded. RESULTS: In total, 45 measurements from six EMS services were included with ETT sizes ranging from 6.5-8.0mm. Mean patient age was 52.2 years (67.7% male). Mean cuff pressure was 81.8cmH2O with a range of 15 to 100 and a median of 100. The mode was 100cmH2O; 40 out of 45 (88.9%) cuff pressures were above 30cmH2O. Linear regression showed no correlation between age and ETT cuff pressure or between ETT size and cuff pressure. Two-tailed T tests did not show a significant difference in the mean cuff pressure between female versus male patients. CONCLUSION: An overwhelming majority of prehospital intubations are associated with elevated cuff pressures, and cuff pressure monitoring education is indicated to address this phenomenon.

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