A Pharmacist-Initiated Method to Improve Venous Thromboembolic Prophylaxis Rates in Medically Ill Patients

2006 ◽  
Vol 19 (5) ◽  
pp. 275-279 ◽  
Author(s):  
Jennifer E. Stark ◽  
Kimi S. Vesta
Keyword(s):  
Risk Factors ◽  
Medical Center ◽  
Academic Medical Center ◽  
Screening Method ◽  
Bleeding Risk ◽  
Pilot Project ◽  
Hospital Death ◽  
Thromboembolic Prophylaxis ◽  
Vte Prophylaxis ◽  
The Impact

Venous thromboembolism (VTE) is among the most preventable causes of hospital death; however, there is a significant underuse of VTE prophylaxis. The purpose of this study was to determine the impact of a pharmacist-initiated screening method on VTE prophylaxis rates. Clinical pharmacists practicing in an internal medicine teaching service at an academic medical center conducted a 6-month pilot project. Consecutive patients admitted to the service were screened for VTE and bleeding risk factors. Pharmacists made recommendations to the physicians in person, provided monthly educational presentations, and monitored patients daily until discharge to confirm continued appropriateness of recommendations. Of the 444 patients who were screened, 107 were identified to be candidates for VTE prophylaxis, and 21 of these patients also had bleeding risk factors. Appropriate use was significantly better after the screening intervention (37% before vs 85% after; P < .05). Moreover, inappropriate use in patients with bleeding risk factors was avoided by the screening intervention (29% before vs 0% after; P < .05). Clear improvements in VTE prophylaxis rates were observed. This pharmacist-initiated screening method presents unique opportunities for pharmacists.

Association between Interruptions in Chemical Prophylaxis and VTE Formation

2015 ◽  
Vol 81 (7) ◽  
pp. 732-737 ◽  
Author(s):  
Rajesh Ramanathan ◽  
Zirui Gu ◽  
Ashley J. Limkemann ◽  
Shillika Chandrasekhar ◽  
Edna Rensing ◽  
...  
Keyword(s):  
Hospital Admissions ◽  
Medical Center ◽  
Academic Medical Center ◽  
Vte Prophylaxis ◽  
Academic Medical ◽  
Lower Likelihood ◽  
Delayed Initiation ◽  
Prolonged Hospital ◽  
The Impact ◽  
Chemical Prophylaxis

Venous thromboembolisms (VTE) are considered preventable events with appropriate mechanical or chemical prophylaxis. However, chemical prophylaxis is frequently delayed or interrupted during hospitalization. We investigated the impact of delayed initiation and interruption of chemical prophylaxis on VTE rates. The incidence of VTE at an urban academic medical center was measured in patients hospitalized for >2 days between November 2013 and May 2014. Patients receiving prophylaxis were grouped as complete (started within 24 hours of admission and no interruptions), delayed (started >24 hours and no interruptions), and interrupted (interruption for >24 hours with or without delay). There were 9961 hospital admissions and 33 VTE (3.3 per 1000 admissions). 25.2 per cent had complete, 16.4 per cent had delayed, and 11.8 per cent had interrupted prophylaxis. 36.8 per cent received no prophylaxis. Interrupted prophylaxis was associated with more VTE than complete (10.2 vs 2.0 per 1000, P < 0.01) and 5.2 greater odds. Admission to a surgical service and prolonged hospital stay were independently associated with increased likelihood of VTE. There was a lower likelihood of getting complete prophylaxis among patients admitted to orthopedic, transplant, cardiac, plastic, and vascular surgery. Surgical patients are at higher risk for VTE and interruptions in VTE prophylaxis significantly increase the risk of VTE.

scholarly journals Using evidence-based debriefing to combat moral distress in critical care nurses: A pilot project

2019 ◽  
Vol 9 (12) ◽  
pp. 1 ◽  
Author(s):  
Nicole M. Fontenot ◽  
Krista A. White
Keyword(s):  
Critical Care ◽  
Moral Distress ◽  
Medical Center ◽  
Academic Medical Center ◽  
Pilot Project ◽  
Critical Care Nurses ◽  
Evidence Based ◽  
Self Awareness ◽  
Post Intervention ◽  
The Impact

Objective: Moral distress (MD) is a problem for nurses that may cause despair or disempowerment. MD can have consequences like dissatisfaction or resignation from the nursing profession. Techniques such as evidence-based debriefing may help nurses with MD. Creating opportunities for critical care nurses to debrief about their MD might equip them with the tools needed to overcome it. Measuring MD by using the Moral Distress Thermometer (MDT) could provide insight into how debriefings help nurses. The purpose of this pilot project was to examine the impact of evidence-based debriefing sessions on critical care nurses’ sense of MD.Methods: This pilot project used a quasi-experimental, one-group, before-during-after design. Critical care nurses (N = 21) were recruited from one unit at a large academic medical center. Four debriefing sessions were held every 2 weeks. Participants completed the MDT 2 weeks before the first session, at the end of each session they attended, and 1 month after the debriefing sessions.Results: In the pilot project, participants felt that debriefing was helpful by increasing their self-awareness, giving them time to commune with colleagues, and encouraging them to improve self-care habits; however, MDT scores did not change significantly when comparing pre with post intervention scores (t(12) = 0.78, p = .450).Conclusions: The use of debriefing may help nurses gain self-awareness of MD and it may offer nurses strategies to build moral resilience.

scholarly journals 70. Impact of Fluoroquinolone Susceptibility Suppression on Discharge Prescribing for Acute Uncomplicated Cystitis

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S53-S54
Author(s):  
Dillon Hayden ◽  
Bryan White ◽  
Stephen Neely ◽  
Kiya Bennett
Keyword(s):  
Risk Factors ◽  
Medical Center ◽  
Academic Medical Center ◽  
Antibiotic Use ◽  
Chi Square ◽  
Adjusted Risk ◽  
E Coli ◽  
Acute Uncomplicated Cystitis ◽  
Uncomplicated Cystitis ◽  
The Impact

Abstract Background Fluoroquinolones (FQ) are associated with multiple adverse effects and increasing resistance. Acute uncomplicated cystitis (AUC) treatment remains a frequent reason for FQ use. Previous data suggests that suppression of FQ susceptibility results can decrease inpatient use, but may not reduce prescribing at discharge. The purpose of this study was to investigate the impact of FQ susceptibility suppression on discharge prescribing for AUC. Methods This was a retrospective, quasi-experimental study in adult patients at a 350-bed academic medical center. The effect of suppression of FQ susceptibilities on pan-susceptible urine isolates for Klebsiella sp. and E. coli on FQ prescribing and appropriateness at discharge was compared one year before and after the intervention, starting in March 2018. Risk factors for FQ use were also examined. Exclusion criteria included pyelonephritis, urinary hardware, pregnancy, concomitant infections treated with FQ, and organisms not susceptible to FQ. Risk ratios of FQ use were calculated for pre-/post-groups and stratified by discharging team for adjusted rates (aRR) using a Cochran-Mantel-Haenszel approach. For secondary outcomes, Chi-Square statistics and generalized regression models were used to assess odds of FQ use among variables. Results Overall discharge FQ prescribing decreased from 41.1% to 21.1% after the intervention, corresponding to a 53% lower adjusted risk (aRR 0.47 [95% CI 0.28–0.81]). One-hundred percent of FQ use was inappropriate, largely due to organism susceptibility to a guideline-preferred agent (n = 33/38). After adjusting for the intervention and clustering of discharge team, the odds of outpatient FQ use was 3.46 times higher for uninsured vs. insured patients, and 13.4 times higher among those who received FQ while inpatient. FQ Use at Discharge Other Antibiotic Use Risk Factors for FQ Use at Discharge Conclusion Suppression of FQ susceptibilities on pan-susceptible urine isolates for Klebsiella sp. and E. coli was associated with a decrease in FQ prescribing at discharge for AUC. Patients who received FQ while inpatient were 13.4 times more likely to be continued on FQ at discharge. Overall, prescribing of FQ for AUC was inappropriate, and stewardship programs should implement FQ suppression policies to improve FQ prescribing at discharge. Disclosures All Authors: No reported disclosures

scholarly journals Risk factors associated with physician trainee concern over missed educational opportunities during the COVID-19 pandemic

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Sunny S. Lou ◽  
Charles W. Goss ◽  
Bradley A. Evanoff ◽  
Jennifer G. Duncan ◽  
Thomas Kannampallil
Keyword(s):  
Risk Factors ◽  
Clinical Education ◽  
Medical Center ◽  
Clinical Care ◽  
Academic Medical Center ◽  
Clinical Work ◽  
Educational Opportunities ◽  
Missed Opportunities ◽  
Physician Trainee ◽  
At Home

Abstract Background The COVID-19 pandemic resulted in a transformation of clinical care practices to protect both patients and providers. These changes led to a decrease in patient volume, impacting physician trainee education due to lost clinical and didactic opportunities. We measured the prevalence of trainee concern over missed educational opportunities and investigated the risk factors leading to such concerns. Methods All residents and fellows at a large academic medical center were invited to participate in a web-based survey in May of 2020. Participants responded to questions regarding demographic characteristics, specialty, primary assigned responsibility during the previous 2 weeks (clinical, education, or research), perceived concern over missed educational opportunities, and burnout. Multivariable logistic regression was used to assess the relationship between missed educational opportunities and the measured variables. Results 22% (301 of 1375) of the trainees completed the survey. 47% of the participants were concerned about missed educational opportunities. Trainees assigned to education at home had 2.85 [95%CI 1.33–6.45] greater odds of being concerned over missed educational opportunities as compared with trainees performing clinical work. Trainees performing research were not similarly affected [aOR = 0.96, 95%CI (0.47–1.93)]. Trainees in pathology or radiology had 2.51 [95%CI 1.16–5.68] greater odds of concern for missed educational opportunities as compared with medicine. Trainees with greater concern over missed opportunities were more likely to be experiencing burnout (p = 0.038). Conclusions Trainees in radiology or pathology and those assigned to education at home were more likely to be concerned about their missed educational opportunities. Residency programs should consider providing trainees with research or at home clinical opportunities as an alternative to self-study should future need for reduced clinical hours arise.

scholarly journals Alcohol Hand Rub Significantly Reduces Overall Bacterial Bioburden on Stethoscopes in a Real-World Clinical Setting

2020 ◽  
Vol 41 (S1) ◽  
pp. s114-s115
Author(s):  
Alexandra Johnson ◽  
Bobby Warren ◽  
Deverick John Anderson ◽  
Melissa Johnson ◽  
Isabella Gamez ◽  
...  
Keyword(s):  
Real World ◽  
Medical Center ◽  
Academic Medical Center ◽  
Randomized Study ◽  
Healthcare Providers ◽  
Clinical Workflow ◽  
Provider Type ◽  
Academic Medical ◽  
Rn Students ◽  
The Impact

Background: Stethoscopes are a known vector for microbial transmission; however, common strategies used to clean stethoscopes pose certain barriers that prevent routine cleaning after every use. We aimed to determine whether using readily available alcohol-based hand rub (ABHR) would effectively reduce bacterial bioburden on stethoscopes in a real-world setting. Methods: We performed a randomized study on inpatient wards of an academic medical center to assess the impact of using ABHR (AlcareExtra; ethyl alcohol, 80%) on the bacterial bioburden of stethoscopes. Stethoscopes were obtained from healthcare providers after routine use during an inpatient examination and were randomized to control (no intervention) or ABHR disinfection (2 pumps applied to tubing and bell or diaphragm by study personnel, then allowed to dry). Cultures of the tubing and bell or diaphragm were obtained with premoistened cellulose sponges. Sponges were combined with 1% Tween20-PBS and mixed in the Seward Stomacher. The homogenate was centrifuged and all but ~5 mL of the supernatant was discarded. Samples were plated on sheep’s blood agar and selective media for clinically important pathogens (CIPs) including S. aureus, Enterococcus spp, and gram-negative bacteria (GNB). CFU count was determined by counting the number of colonies on each plate and using dilution calculations to calculate the CFU of the original ~5 mL homogenate. Results: In total, 80 stethoscopes (40 disinfection, 40 control) were sampled from 46 physicians (MDs) and MD students (57.5%), 13 advanced practice providers (16.3%), and 21 nurses (RNs) and RN students (26.3%). The median CFU count was ~30-fold lower in the disinfection arm compared to control (106 [IQR, 50–381] vs 3,320 [986–4,834]; P < .0001). The effect was consistent across provider type, frequency of recent usual stethoscope cleaning, age, and status of pet ownership (Fig. 1). Overall, 26 of 80 (33%) of stethoscopes harbored CIP. The presence of CIP was lower but not significantly different for stethoscopes that underwent disinfection versus controls: S. aureus (25% vs 32.5%), Enterococcus (2.5% vs 10%), and GNB (2.5% vs 5%). Conclusions: Stethoscopes may serve as vectors for clean hands to become recontaminated immediately prior to performing patient care activities. Using ABHR to clean stethoscopes after every use is a practical and effective strategy to reduce overall bacterial contamination that can be easily incorporated into clinical workflow. Larger studies are needed to determine the efficacy of ABHR at removing CIP from stethoscopes as stethoscopes in both arms were frequently contaminated with CIP. Prior cleaning of stethoscopes on the study day did not seem to impact contamination rates, suggesting the impact of alcohol foam disinfection is short-lived and may need to be repeated frequently (ie, after each use).Funding: NoneDisclosures: NoneDisclosures: NoneFunding: None

scholarly journals Communications and Screening for 2019 Novel Coronavirus at a Tertiary-Care Medical Center

2020 ◽  
Vol 41 (S1) ◽  
pp. s84-s84
Author(s):  
Lorinda Sheeler ◽  
Mary Kukla ◽  
Oluchi Abosi ◽  
Holly Meacham ◽  
Stephanie Holley ◽  
...  
Keyword(s):  
Screening Tool ◽  
Medical Center ◽  
Academic Medical Center ◽  
Tertiary Care ◽  
The United States ◽  
World Health ◽  
Communication Campaign ◽  
Electronic Screening ◽  
Novel Coronavirus ◽  
The Impact

Background: In December of 2019, the World Health Organization reported a novel coronavirus (severe acute respiratory coronavirus virus 2 [SARS-CoV-2)]) causing severe respiratory illness originating in Wuhan, China. Since then, an increasing number of cases and the confirmation of human-to-human transmission has led to the need to develop a communication campaign at our institution. We describe the impact of the communication campaign on the number of calls received and describe patterns of calls during the early stages of our response to this emerging infection. Methods: The University of Iowa Hospitals & Clinics is an 811-bed academic medical center with >200 outpatient clinics. In response to the coronavirus disease 2019 (COVID-19) outbreak, we launched a communications campaign on January 17, 2020. Initial communications included email updates to staff and a dedicated COVID-19 webpage with up-to-date information. Subsequently, we developed an electronic screening tool to guide a risk assessment during patient check in. The screening tool identifies travel to China in the past 14 days and the presence of symptoms defined as fever >37.7°C plus cough or difficulty breathing. The screening tool was activated on January 24, 2020. In addition, university staff contacted each student whose primary residence record included Hubei Province, China. Students were provided with medical contact information, signs and symptoms to monitor for, and a thermometer. Results: During the first 5 days of the campaign, 3 calls were related to COVID-19. The number of calls increased to 18 in the 5 days following the implementation of the electronic screening tool. Of the 21 calls received to date, 8 calls (38%) were generated due to the electronic travel screen, 4 calls (19%) were due to a positive coronavirus result in a multiplex respiratory panel, 4 calls (19%) were related to provider assessment only (without an electronic screening trigger), and 2 calls (10%) sought additional information following the viewing of the web-based communication campaign. Moreover, 3 calls (14%) were for people without travel history but with respiratory symptoms and contact with a person with recent travel to China. Among those reporting symptoms after travel to China, mean time since arrival to the United States was 2.7 days (range, 0–11 days). Conclusion: The COVID-19 outbreak is evolving, and providing up to date information is challenging. Implementing an electronic screening tool helped providers assess patients and direct questions to infection prevention professionals. Analyzing the types of calls received helped tailor messaging to frontline staff.Funding: NoneDisclosures: None

scholarly journals Demographic and Risk Factor Differences between Children with “One-Time” and “Repeat” Visits to the Emergency Department for Asthma

2021 ◽  
Vol 18 (2) ◽  
pp. 486
Author(s):  
Pavani Rangachari ◽  
Jie Chen ◽  
Nishtha Ahuja ◽  
Anjeli Patel ◽  
Renuka Mehta
Keyword(s):  
Risk Factors ◽  
Emergency Department ◽  
Risk Factor ◽  
Childhood Asthma ◽  
Medical Center ◽  
Academic Medical Center ◽  
Retrospective Chart Review ◽  
Primary Research ◽  
Ed Visits ◽  
The Individual

This retrospective study examines demographic and risk factor differences between children who visited the emergency department (ED) for asthma once (“one-time”) and more than once (“repeat”) over an 18-month period at an academic medical center. The purpose is to contribute to the literature on ED utilization for asthma and provide a foundation for future primary research on self-management effectiveness (SME) of childhood asthma. For the first round of analysis, an 18-month retrospective chart review was conducted on 252 children (0–17 years) who visited the ED for asthma in 2019–2020, to obtain data on demographics, risk factors, and ED visits for each child. Of these, 160 (63%) were “one-time” and 92 (37%) were “repeat” ED patients. Demographic and risk factor differences between “one-time” and “repeat” ED patients were assessed using contingency table and logistic regression analyses. A second round of analysis was conducted on patients in the age-group 8–17 years to match another retrospective asthma study recently completed in the outpatient clinics at the same (study) institution. The first-round analysis indicated that except age, none of the individual demographic or risk factors were statistically significant in predicting of “repeat” ED visits. More unequivocally, the second-round analysis revealed that none of the individual factors examined (including age, race, gender, insurance, and asthma severity, among others) were statistically significant in predicting “repeat” ED visits for childhood asthma. A key implication of the results therefore is that something other than the factors examined is driving “repeat” ED visits in children with asthma. In addition to contributing to the ED utilization literature, the results serve to corroborate findings from the recent outpatient study and bolster the impetus for future primary research on SME of childhood asthma.

scholarly journals 154. Antibiotic Use During Three Separate Waves of the COVID-19 Pandemic at a Large Academic Medical Center in Detroit, MI

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S188-S189
Author(s):  
Deepika Sivakumar ◽  
Shelbye R Herbin ◽  
Raymond Yost ◽  
Marco R Scipione
Keyword(s):  
Retrospective Review ◽  
Bacterial Pneumonia ◽  
Medical Center ◽  
Academic Medical Center ◽  
Antibiotic Use ◽  
Percent Change ◽  
Academic Medical ◽  
Days Of Therapy ◽  
Time Periods ◽  
The Impact

Abstract Background Inpatient antibiotic use early on in the COVID-19 pandemic may have increased due to the inability to distinguish between bacterial and COVID-19 pneumonia. The purpose of this study was to determine the impact of COVID-19 on antimicrobial usage during three separate waves of the COVID-19 pandemic. Methods We conducted a retrospective review of patients admitted to Detroit Medical Center between 3/10/19 to 4/24/21. Median days of therapy per 1000 adjusted patient days (DOT/1000 pt days) was evaluated for all administered antibiotics included in our pneumonia guidelines during 4 separate time periods: pre-COVID (3/3/19-4/27/19); 1st wave (3/8/20-5/2/20); 2nd wave (12/6/21-1/30/21); and 3rd wave (3/7/21-4/24/21). Antibiotics included in our pneumonia guidelines include: amoxicillin, azithromycin, aztreonam, ceftriaxone, cefepime, ciprofloxacin, doxycycline, linezolid, meropenem, moxifloxacin, piperacillin-tazobactam, tobramycin, and vancomycin. The percent change in antibiotic use between the separate time periods was also evaluated. Results An increase in antibiotics was seen during the 1st wave compared to the pre-COVID period (2639 [IQR 2339-3439] DOT/1000 pt days vs. 2432 [IQR 2291-2499] DOT/1000 pt days, p=0.08). This corresponded to an increase of 8.5% during the 1st wave. This increase did not persist during the 2nd and 3rd waves of the pandemic, and the use decreased by 8% and 16%, respectively, compared to the pre-COVID period. There was an increased use of ceftriaxone (+6.5%, p=0.23), doxycycline (+46%, p=0.13), linezolid (+61%, p=0.014), cefepime (+50%, p=0.001), and meropenem (+29%, p=0.25) during the 1st wave compared to the pre-COVID period. Linezolid (+39%, p=0.013), cefepime (+47%, p=0.08) and tobramycin (+47%, p=0.05) use remained high during the 3rd wave compared to the pre-COVID period, but the use was lower when compared to the 1st and 2nd waves. Figure 1. Antibiotic Use 01/2019 to 04/2019 Conclusion Antibiotics used to treat bacterial pneumonia during the 1st wave of the pandemic increased and there was a shift to broader spectrum agents during that period. The increased use was not sustained during the 2nd and 3rd waves of the pandemic, possibly due to the increased awareness of the differences between patients who present with COVID-19 pneumonia and bacterial pneumonia. Disclosures All Authors: No reported disclosures

The Impact of Delayed Symptomatic Treatment Implementation in the Intensive Care Unit

Healthcare ◽  
2021 ◽  
Vol 10 (1) ◽  
pp. 35
Author(s):  
Lesley Meng ◽  
Krzysztof Laudanski ◽  
Mariana Restrepo ◽  
Ann Huffenberger ◽  
Christian Terwiesch
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Medical Center ◽  
Academic Medical Center ◽  
Symptomatic Treatment ◽  
Medication Administration ◽  
Average Delay ◽  
Treatment Implementation ◽  
Medication Delivery ◽  
The Impact

We estimated the harm related to medication delivery delays across 12,474 medication administration instances in an intensive care unit using retrospective data in a large urban academic medical center between 2012 and 2015. We leveraged an instrumental variables (IV) approach that addresses unobserved confounds in this setting. We focused on nurse shift changes as disruptors of timely medication (vasodilators, antipyretics, and bronchodilators) delivery to estimate the impact of delay. The average delay around a nurse shift change was 60.8 min (p < 0.001) for antipyretics, 39.5 min (p < 0.001) for bronchodilators, and 57.1 min (p < 0.001) for vasodilators. This delay can increase the odds of developing a fever by 32.94%, tachypnea by 79.5%, and hypertension by 134%, respectively. Compared to estimates generated by a naïve regression approach, our IV estimates tend to be higher, suggesting the existence of a bias from providers prioritizing more critical patients.

Abstract 16125: Impact of COVID-19 on Echocardiography Volume at a Large Academic Medical Center

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Merilyn S Varghese ◽  
Jordan B Strom ◽  
Sarah Fostello ◽  
Warren J Manning
Keyword(s):  
Patient Outcomes ◽  
Hospital Admissions ◽  
Medical Center ◽  
Academic Medical Center ◽  
Academic Medical ◽  
Hospital Systems ◽  
The Impact ◽  
At Home

Introduction: COVID-19 has significantly impacted hospital systems worldwide. The impact of statewide stay-at-home mandates on echocardiography volumes is unclear. Methods: We queried our institutional echocardiography database from 6/1/2018 to 6/13/2020 to examine rates of transthoracic (TTE), stress (SE), and transesophageal echocardiograms (TEE) prior to and following the COVID-19 Massachusetts stay-at-home order on March 15, 2020. Results: Among 36,377 total studies performed during the study period, mean weekly study volume dropped from 332 + 3 TTEs/week, 30 + 1 SEs/week, and 21 + 1 TEEs/week prior to the stay-at-home order (6/1/2018-3/15/2020) to 158 + 13 TTEs/week, 8 + 2 SEs/week, and 8 + 1 TEEs/week after (% change, -52%, -73%, and -62% respectively, all p < 0.001 when comparing volume prior to March 15 versus after). Weekly TTEs correlated strongly with hospital admissions throughout the study period (r = 0.93, 95% CI 0.89-0.95, p < 0.001) ( Figure ). Outpatient TTEs declined more than inpatient TTEs (% change, -74% vs. -39%, p <0.001). As of 3 weeks following the cessation of the stay-at-home order, TTE, SE, and TEE weekly volumes have increased to 73%, 66%, and 81% of pre-pandemic levels, respectively. Conclusions: Echocardiography volumes fell precipitously following the Massachusetts stay-at-home order, strongly paralleling declines in overall hospitalizations. Outpatient TTEs declined more than inpatient TTEs. Despite lifting of the order, echocardiography volumes remain substantially below pre-pandemic levels. The impact of the decreased use of echocardiographic services on patient outcomes remains to be determined.

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