414. Observed Time Burden with Nursing Practices in an Emergency Room COVID-19 Isolation Zone at a University Affiliated Hospital in Korea

Background The coronavirus disease 2019 (COVID-19) has caused great burdens on emergency room (ER) and front-line ER healthcare personnel faced with great challenges, including threats to their safety. This study aimed to provide a basis for additional workload of ER nurses who are charged with providing care for COVID-19 confirmed or suspicious cases. Table 1. Summary of Frequency and Time Burden with Nursing Practices in an Emergency Room COVID-19 Isolation Zone. Note. IV, intravenous; IM, intramuscular; ID, intradermal; SC, subcutaneous; PPE, personal protective equipment; CPR, cardiopulmonary resuscitation Methods With institutional review board approval, we recruited ER nurses who were assigned to COVID-19 isolation zone with more than 6 months’ ER work experience. After their demographic information were collected through a questionnaire, their nursing practices and practice time during their 1 shift (day or evening) were recorded by one researcher using a stopwatch and an observation form. For each observation shift, unit-related information was collected, including the numbers of hospitalized patients, admission, discharge, and transfer of patients. For each nursing practice, frequency and total time spent were analyzed using descriptive statistics with SPSS 26.0 program. Results From January 4 to February 22, 2021, a total 18 nurses (27.4 years old on average with 25.2 months of ER experience) were observed from 20 different shifts. During the observation period, the average number of nurses’ working hours was 8.27 ± 0.39 hours. A total of 6,567 tasks were monitored with 337,703 seconds (93.81 hours) of the total time spent. Infection control practices were most frequent (33.88%) followed by nursing management (27.80%), assessment and observation (11.07%), medication (10.35%), pre and post examination care(4.86%), education (4.37%), communication (4.10%), safety care (1.10%), and others (0.03; Table 1). Nursing management (e.g., nursing recording) was most time-consuming (49.29%) followed by assessment and observation (15.03%), medication (12.94%), patient education (6.10%), infection control (5.30%), and safety care (1.64%). Conclusion This study showed that infection control practices were most frequent while time spent was relatively insignificant among ER nurses in charge of COVID-19 isolation zones. Further studies for more observations or with different study designs at other ER settings are necessary to understand nurse’s burdens with COVID-19 emergency care. Disclosures All Authors: No reported disclosures

Generating the International Knee Documentation Committee Score using PROMIS Computer Adaptive Testing with Multivariable Predictive Models: Reduce Survey Burden with Comparable Data (102)

Objectives: Patient reported outcomes (PROs) serve as a means of measuring improvement and quality of care. Legacy PROs rely on a list of questions that have had to demonstrate accuracy, responsiveness, and validity in testing for intended measurements. While certain legacy PROs such as the International Knee Documentation Committee (IKDC) survey have demonstrated these properties well, a lengthy PRO creates a time burden on patients, making patient adherence and completion a challenge. In recent years, PROs such as the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) surveys have been developed which leverage computer adaptive testing that produce equivalent accuracy, responsiveness, and validity of legacy PROs, but use only 4-12 questions per survey. This results in significant reduction in time to complete. As these new PROs are now being adopted, the ability to compare outcomes to prior studies that relied on legacy PROs is necessary. While prior studies have examined correlation between legacy PROs and PROMIS computer adaptive tests, no studies to date have developed effective prediction models utilizing PROMIS surveys to create an IKDC index score. The objective of this study was to develop a predictive model utilizing PROMIS PF and PI to effectively recreate IKDC survey scores. Methods: The Military Orthopaedics Tracking Injuries and Outcomes Network (MOTION) database is a prospectively collected repository of patient reported outcomes and intraoperative variables. As part of inclusion in MOTION, research patients who underwent knee surgery were asked to complete the IKDC as well as the PROMIS PF and PROMIS PI at varying time points. This cohort of patients that completed both IKDC and PROMIS scores were included in the present analysis. Nonlinear multivariable predictive models using both Gaussian and beta distributions were created to establish an IKDC index score, which was then validated using leave-one-out techniques and minimal clinically important difference (MCID) analysis. Results: A total of 1,011 knee patients (Age: 37.7±14.4 years; 30% Female) completed the IKDC, PROMIS PF, and PROMIS PI providing 1,618 complete observations. The algorithms for both the Gaussian and beta distribution were strongly validated to predict the IKDC (Table 1). The MCID for IKDC was 27.0 (95% confidence intervals: 15.0-39.7) whereas the IKDC-index MCIDs for the Gaussian and beta distribution models were both 13.3 (95% confidence intervals 2.7-27.9), suggesting that the derived IKDC-index is effective and can reliably re-create IKDC scores. The surface plots of this nonlinear multivariable model also confirm the necessity that nonlinear prediction is necessary for effective modeling of legacy PRO scores (Figures 1 & 2). Conclusions: PROMIS PF and PI predictive models are able to approximate the IKDC score within 9.3-10.0 points. Given the 27.0 point minimally clinically important difference for the IKDC survey in this cohort, the results of this study can be used to compare PROMIS PF and PI scores to prior IKDC data by creating an IKDC index score. Moreover, repeated use of the IKDC-index from PROMIS PF and PI allows for a lower MCID than using the conventional IKDC survey. PROMIS PF and PI scores can be substituted in both clinical and research settings to reduce patient time burden, increase completion rates, and still create data that can effectively be compared with studies utilizing legacy IKDC scores.

Time burden and logistical intensity of early-phase clinical trials (EP-CTs).

84 Background: EP-CTs are increasingly important options for patients with cancer and often involve intensive monitoring. Thus, characterizing the time burden and logistical intensity of EP-CTs could help patients and clinicians make informed decisions regarding trial participation. Methods: We retrospectively reviewed the electronic health records of consecutive patients enrolled in EP-CTs at Massachusetts General Hospital from 2017-2019 to obtain baseline characteristics (demographics and clinical factors), EP-CT investigational agent (immunomodulatory therapy [IM], targeted inhibitor(s) [TI], antibody drug conjugate [ADC]/chemotherapy prodrug), and logistical intensity (trial visit frequency, presence of extended visits, distance traveled in one direction from home zip code to trial site). We defined visit frequency as the number of visits per protocol within the first 28 days on trial. We defined an extended visit as six or more hours in clinic on at least one day during the first 28 days on study. We investigated associations among patient characteristics, investigational agent, and logistical intensity. Results: Among 421 patients (median age=60.6 years, 55.8% female, 97.4% metastatic disease), most (73.6%) had two or more sites of metastatic disease. EP-CTs included 43.2% IM, 43.0% TI, and 13.8% ADC/chemotherapy prodrug. Patients enrolled in ADC/prodrug trials had the highest burden of metastatic disease (mean sites: 2.8 [ADC] vs 2.4 [TI] vs 2.3 [IM], p = 0.007) and oldest age (mean years: 64.0 [ADC] vs 61.7 [IM] vs 58.5 [TI], p = 0.003). Patients enrolled on TI trials had the highest visit frequency compared with those enrolled on other trials (mean visits: 5.5 [TI] vs 5.3 [ADC] vs 5.0 [IM], p = 0.027) and the fewest days spent on trial (mean days: 78.3 [TI] vs 102.2 [IM] vs 131.8 [ADC], p = 0.003). Patients enrolled on TI trials were also most likely to have an extended visit (82.3% [TI] vs 58.2% [IM] vs 29.3% [ADC], p < 0.001) and least likely to receive first in human therapy (38.1% [TI] vs 74.1% [ADC] vs 74.2% [IM], p < 0.001). Distance traveled from home to clinic did not significantly differ across trial type (median miles traveled: 35.1 [TI] vs 34.1 [IM] vs 33.2 [ADC], p = 0.884). Conclusions: In this cohort of patients participating in EP-CTs, we found that a plurality enrolled in IM studies. Those receiving ADC/prodrug regimens were older and had a higher burden of disease. On average, patients participating in EP-CTs had over five visits in the first month, with those enrolled on TI trials having the highest visit frequency and greatest likelihood of extended visits. Patients on TI trials also spent the fewest total days on trial. Despite the lack of significant differences in distance traveled, most patients were still traveling over 30 miles to get to the trial site. These data highlight the time burden and logistical intensity of various EP-CTs, which may help inform patient-clinician discussions about trial participation.

Time Burden of Bladder Management in Individuals With Spinal Cord Injury

Background: While clean intermittent catheterization (CIC) is the gold standard for bladder management after spinal cord injury (SCI), many individuals with SCI, for reasons not fully understood, choose alternative bladder management. We hypothesized that CIC is associated with an increased time burden in individuals with SCI. Objectives: To investigate the time required to perform neurogenic bladder management in individuals with SCI. Methods: An electronic nonvalidated questionnaire was designed to determine the self-reported time spent performing bladder management. It was sent to participants in the Neurogenic Bladder Research Group SCI Registry, a national quality of life study of individuals with SCI. Results: Eighty-seven individuals responded to the survey. CIC was the most common bladder management (76%). Men and women performing independent CIC had similar average times with each catheterization episode (8.8 vs. 8.5 minutes, p = .864) as did women with a catheterizable stoma compared to women catheterizing per urethra (8.2 minutes, p = .913). Longer catheterization times were associated with cervical spine injury (mean 12.4 minutes per catheterization) and women requiring caregiver assistance (mean 20 minutes per catheterization). In addition, obese/overweight women had longer CIC times than normal weight women (14.5 minutes vs. 7 minutes; p = .036), while catheterization time was similar for all men regardless of body mass index. Individuals with indwelling catheters spent less than a third of the time on bladder management per day compared to those doing CIC (17 vs. 53 minutes per day, p &lt; .001). Conclusion: Management of neurogenic bladder after SCI, especially in those performing CIC, is time consuming. This time burden may play a role in long-term bladder management decisions.

Evaluation of an effective detection and quantification method for particular microorganisms by comparing NGS-based metagenome profiling data

Metagenome profiling research using next-generation sequencing (NGS), a technique widely used to analyze the diversity and composition of microorganisms living in the human body, especially the gastrointestinal tract, has been activated, and there is a growing interest in the quantitative and diagnostic technology for specific microorganisms. According to recent trends, quantitative real-time PCR (qRT-PCR) are still of considerable technique in detecting and quantifying bacteria associated with the human mouth, nasal cavity, and pharynx due to analytical cost and time burden of NGS technology. Here, based on NGS metagenome profiling data produced by utilizing 100 gut microbiota samples, we conducted a comparative analysis of identifying for five bacterial genera proportions (Akkermansia, Bacteroides, Bifidobacterium, Phascolarctobacterium, and Roseburia) within same metagenomic DNA samples through qRT-PCR assay in parallel. Genus-specific primer, targeting the particular gene of each genus for qRT-PCR assay, allowed a statistically consistent quantification pattern with the metagenome profiling data. Furthermore, results of bacterial identification through Sanger validation demonstrated the high genus-specificity of each primer set. Therefore, our study suggests that an approach to quantifying specific microorganisms by applying qRT-PCR method can compensate for the concerns (potential issues) of NGS while also providing efficient benefits to various microbial industries

A Short Form of the Children’s Experiences of Dental Anxiety Measure (CEDAM): Validation and Evaluation of the CEDAM-8

Background: The Children’s Experiences of Dental Anxiety Measure (CEDAM-14) is a child-centred measure of dental anxiety which assesses a range of behaviours, thoughts and feelings/physical symptoms related to dental anxiety. A short form of the CEDAM-14, which places less time burden on patients and clinicians, could promote the feasibility and applicability of the CEDAM in clinical settings. The aim of the study was to develop a short version of the CEDAM that can be used to assess children’s dental anxiety in clinical practice. Methods: A short version of the CEDAM was developed using a combination of item impact and regression methods. Measurement properties including floor/ceiling effects, variance, criterion validity, construct validity and internal consistency was calculated for the short form. Results: An eight-item CEDAM short form was developed (CEDAM-8) that had good psychometric properties, was significantly correlated with the CEDAM measure (r = 0.90; p < 0.01), had minimal floor and ceiling effects (3.5% and 1.2%, respectively) and was sensitive to change. Conclusion: The CEDAM-8 is a useful assessment tool for clinicians that is easy and quick to administer and could help to understand children’s experiences of dental anxiety and changes in anxiety over time and following intervention.

Opportunity costs of undergoing surgical resection and perioperative chemotherapy for pancreatic adenocarcinoma.

398 Background: Treatment of early stage pancreatic ductal adenocarcinoma (PDAC) includes surgical resection and either neoadjuvant or adjuvant chemotherapy. Due to the intensity of treatment and perioperative morbidity rates of pancreatic resection, patients may spend a significant portion of their survival time in receipt of clinical care. However, time spent in receipt of care has not been previously described in patients with early stage PDAC. The primary aim of this study was to determine the total time spent in receipt of surgical and perioperative chemotherapy in patients with resectable PDAC. Methods: A retrospective cohort study was performed of patients diagnosed with PDAC who underwent curative-intent resection at a single institution tertiary care center between January 2015 and October 2019. Patients who died within 30 days of surgery were excluded. Total care time, including all relevant clinician visits, laboratory, radiologic and procedural studies, and treatment visits, was abstracted from the primary medical record. Care time included estimated travel time based on patient address. Care time was divided into preoperative, surgical, and systemic therapy phases of care. Time spent in surgical care included the hospital length of stay, postoperative follow-up visits, and admissions for postoperative complications. Results: A total of 86 patients were identified. Median total preoperative care time was 29 hours (IQR 11-135; 0.4% of survival time, range 0% - 72.7%). Median total time spent in surgical care was 216 hours (IQR 164-371; 2% of survival time, range 0.3% - 68.4%). Among the patients who received systemic chemotherapy care within the same institutional health system (N = 41), median total time spent in receipt of systemic therapy was 447 hours (IQR 194-647; 3% of survival time, range 0.1% - 55.4%). 10.5% of patients (N = 9) spent more than 10% of total survival time in surgical care and 5.8% (N = 5) patients spent more than 10% of survival time in receipt of systemic care. Median cumulative travel time for patients was 19 hours (IQR 10.2-37.6). Conclusions: For the majority of patients undergoing resection for PDAC, time spent in receipt of surgical care does not appear to represent a substantial time burden relative to survival time. However, for a subset of patients, the time burden is considerable. Further research to determine predictors of increased time spent in receipt of multimodality cancer care is warranted to better inform patient and surgeon communication and decision-making.