Optimizing the operation of an electrodiagnostic laboratory during the COVID-19 pandemic: A 6-month single-center experience.

INTRODUCTION/AIMS: The initial surge of the coronavirus disease-2019 (COVID-19) pandemic in early 2020 led to widespread cancellation of elective medical procedures in the United States, including nonurgent outpatient and inpatient electrodiagnostic (EDx) studies. As certain regions later showed a downtrend in daily new cases, EDx laboratories have reopened under the guidance of the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM). In our reopening experience guided by the AANEM, we measured relevant outcomes to determine further workflow adaptations. We aimed to detail our experience and share the lessons learned. METHODS: We reviewed the clinical volumes, billing data, diagnosis distributions, and rates of COVID-19 exposure and transmission among patients and staff in our EDx laboratory during the first 6 months of reopening, starting on June 1, 2020. For context, we detailed the recent AANEM guidelines we adopted at our laboratory, supplemented by other consensus statements. RESULTS: We completed 816 outpatient studies from June 1 to December 1, 2020, reaching 97% of the total volume and 97% of total billing compared with the same time period in 2019. The average relative value units per study were similar. There were no major shifts in diagnosis distributions. We completed 10 of 12 requested inpatient studies during this period. There were no known COVID-19 transmissions between patients and staff. DISCUSSION: Our experience suggests that it is possible to safely operate an EDx laboratory under the guidance of the AANEM and other experts, with clinical volume and billing rates comparable to pre-pandemic baselines.

Clinical outcomes, management, and treatment patterns in patients with metastatic castration-resistant prostate cancer treated with radium-223 in community compared to academic settings.

BACKGROUND: The most common site of disease in metastatic castration-resistant prostate cancer (mCRPC) is the bone. The ALSYMPCA study demonstrated that radium-223 significantly improved overall survival (OS) in mCRPC patients with symptomatic bone metastases and without visceral metastases. However, administration requires a multidisciplinary approach and an infrastructure that supports coordination of care, which may differ by practice site. We aimed to evaluate practice patterns and treatment outcomes in patients with mCRPC treated at a community practice (CP) compared with those treated at an academic center (AC). METHODS: This retrospective review included 200 adult mCRPC patients receiving radium-223 between January 2014 and June 2017. The primary endpoint, OS, was estimated from the date of radium-223 initiation. Secondary outcomes included a comparison of baseline characteristics, reasons for initiation and discontinuation of radium-223, and treatment sequencing. A subset analysis of OS based on the number of radium-223 doses and on sequencing of radium-223 either before or after chemotherapy was also conducted. RESULTS: Most patients were treated at a CP (57%). Patients treated at CP sites were significantly older (74.9 vs. 71.9 years; p = .031) and had more comorbidities (Klabunde score 1.1 vs. 0.7; p = .020) than those in an AC but initiated treatment within a shorter period of time from diagnosis of mCRPC (1.3 vs. 1.9 years; p < .001) and received a greater mean number of radium-223 doses (5.4 vs. 4.8; p = .001). There were no observed differences in OS between CPs versus ACs (21.6 vs. 20.7 months; p = .306). Overall, patients who received 5-6 doses versus 1-4 doses of radium-223 had a longer median OS (23.3 vs. 6.4 months; p < .001). The most common reason for discontinuation in patients who did not complete treatment was disease progression. Overall, 43% of patients received radium-223 monotherapy and 57% concurrently with other agents. CONCLUSIONS: Most patients received radium-223 concurrently with abiraterone acetate or enzalutamide and were able to complete 5-6 doses of radium-223. Despite differences in the populations and treatment patterns, no survival differences between patients treated in ACs versus CPs were observed. Additional real-world data are needed to validate these findings.

Patient Adherence in an Academic Medical Center's Low-dose Computed Tomography Screening Program.

OBJECTIVES: Low-dose computed tomography (LDCT) screening is an important tool for reducing lung cancer mortality. This study describes a single center's experience with LDCT and attempts to identify any barriers to compliance with standard guidelines. MATERIALS AND METHODS: This is a retrospective review of a single university-based hospital system from 2015 to 2019. All individuals who met eligibility for lung cancer screening were entered into a database. The definition of adherence with the screening program was determined by the recommended timeline for the follow-up LDCT. Cohorts were split by adherence and demographics were compared. RESULTS: A total of 203 LDCTs were performed in 121 patients who met eligibility for LDCT and had appropriate surveillance from 2015 to 2019. The average age was 64 years old. The overall adherence rate for prescribed LDCTs was 59.1%. Patients with Lung-RADS score 2 had 2.43 times higher odds of adherence relative to patients with Lung-RADS score 1 (odds ratio [OR]=2.43; 95% confidence interval [CI]: 1.23-4.83; P=0.011). African American patients had 42% lower odds of adherence relative to white patients (OR=0.58; 95% CI: 0.32-1.06; P=0.076). Patients with non-District of Columbia zip codes had 57% higher odds of adherence relative to those with District of Columbia zip codes, although this did not reach statistical significance (OR=1.57; 95% CI: 0.87-2.82; P=0.136). CONCLUSIONS: Despite the implementation of a multidisciplinary, academic LDCT screening program, overall adherence rate to prescribed follow-up scans was suboptimal. Socioeconomic disparities and African American race may negatively affect adherence to lung cancer screening LDCT guidelines. Patients with concerning findings on initial LDCT had a higher association of adherence to guidelines.

Effects of the COVID-19 Pandemic on Operative Volume and Residency Training at Two Academic Neurosurgery Centers in New Orleans.

BACKGROUND: Medical subspecialties including neurosurgery have seen a dramatic shift in operative volume in the wake of the coronavirus disease 2019 (COVID-19) pandemic. The goal of this study was to quantify the effects of the COVID-19 pandemic on operative volume at 2 academic neurosurgery centers in New Orleans, Louisiana, USA from equivalent periods before and during the COVID-19 pandemic. METHODS: A retrospective review was conducted analyzing neurosurgical case records for 2 tertiary academic centers from March to June 2020 and March to June 2019. The records were reviewed for variables including institution and physician coverage, operative volume by month and year, cases per subspecialty, patient demographics, mortality, and morbidity. RESULTS: Comparison of groups showed a 34% reduction in monthly neurosurgical volume per institution during the pandemic compared with earlier time points, including a 77% decrease during April 2020. There was no change in mortality and morbidity across institutions during the pandemic. CONCLUSIONS: The COVID-19 pandemic has had a significant impact on neurosurgical practice and will likely continue to have long-term effects on patients at a time when global gross domestic products decrease and relative health expenditures increase. Clinicians must anticipate and actively prepare for these impacts in the future.

Literature Review and Knowledge Distribution During an Outbreak: A Methodology for Managing Infodemics.

PROBLEM: The COVID-19 pandemic has challenged health care systems in an unprecedented way by imposing new demands on health care resources and scientific knowledge. There has also been an exceedingly fast accumulation of new information on this novel virus. As the traditional peer-review process takes time, there is currently a significant gap between the ability to generate new data and the ability to critically evaluate them. This problem of an excess of mixed-quality data, or infodemic, is echoing throughout the scientific community. APPROACH: The authors aimed to help their colleagues at the Rambam Medical Center, Haifa, Israel, manage the COVID-19 infodemic with a methodologic solution: establishing an in-house mechanism for continuous literature review and knowledge distribution (March-April 2020). Their methodology included the following building blocks: a dedicated literature review team, artificial intelligence-based research algorithms, brief written updates in a graphical format, large-scale webinars and online meetings, and a feedback loop. OUTCOMES: During the first month (April 2020), the project produced 21 graphical updates. After consideration of feedback from colleagues and final editing, 13 graphical updates were uploaded to the center's website; of these, 31% addressed the clinical presentation of the disease and 38% referred to specific treatments. This methodology as well as the graphical updates it generated were adopted by the Israeli Ministry of Health and distributed in a hospital preparation kit. NEXT STEPS: The authors believe they have established a novel methodology that can assist in the battle against COVID-19 by making high-quality scientific data more accessible to clinicians. In the future, they expect this methodology to create a favorable uniform standard for evidence-guided health care during infodemics. Further evolution of the methodology may include evaluation of its long-term sustainability and impact on the day-to-day clinical practice and self-confidence of clinicians who treat COVID-19 patients.

Embracing diversity and inclusivity in an academic setting: Insights from the Organization for Human Brain Mapping.

Scientific research aims to bring forward innovative ideas and constantly challenges existing knowledge structures and stereotypes. However, women, ethnic and cultural minorities, as well as individuals with disabilities, are systematically discriminated against or even excluded from promotions, publications, and general visibility. A more diverse workforce is more productive, and thus discrimination has a negative impact on science and the wider society, as well as on the education, careers, and well-being of individuals who are discriminated against. Moreover, the lack of diversity at scientific gatherings can lead to micro-aggressions or harassment, making such meetings unpleasant, or even unsafe environments for early career and underrepresented scientists. At the Organization for Human Brain Mapping (OHBM), we recognized the need for promoting underrepresented scientists and creating diverse role models in the field of neuroimaging. To foster this, the OHBM has created a Diversity and Inclusivity Committee (DIC). In this article, we review the composition and activities of the DIC that have promoted diversity within OHBM, in order to inspire other organizations to implement similar initiatives. Activities of the committee over the past four years have included (a) creating a code of conduct, (b) providing diversity and inclusivity education for OHBM members, (c) organizing interviews and symposia on diversity issues, and (d) organizing family-friendly activities and providing childcare grants during the OHBM annual meetings. We strongly believe that these activities have brought positive change within the wider OHBM community, improving inclusivity and fostering diversity while promoting rigorous, ground-breaking science. These positive changes could not have been so rapidly implemented without the enthusiastic support from the leadership, including OHBM Council and Program Committee, and the OHBM Special Interest Groups (SIGs), namely the Open Science, Student and Postdoc, and Brain-Art SIGs. Nevertheless, there remains ample room for improvement, in all areas, and even more so in the area of targeted attempts to increase inclusivity for women, individuals with disabilities, members of the LGBTQ+ community, racial/ethnic minorities, and individuals of lower socioeconomic status or from low and middle-income countries. Here, we present an overview of the DIC's composition, its activities, future directions and challenges. Our goal is to share our experiences with a wider audience to provide information to other organizations and institutions wishing to implement similar comprehensive diversity initiatives. We propose that scientific organizations can push the boundaries of scientific progress only by moving beyond existing power structures and by integrating principles of equity and inclusivity in their core values.

The Psychopharmacology Algorithm Project at the Harvard South Shore Program: An update on management of behavioral and psychological symptoms in dementia.

Geriatric patients with dementia frequently present with agitation, aggression, psychosis, and other behavioral and psychological symptoms of dementia (BPSD). We present an update of our previously published algorithms for the use of psychopharmacologic agents in these patients taking into account more recent studies and findings in meta-analyses, reviews, and other published algorithms. We propose three algorithms: BPSD in an emergent, urgent, and non-urgent setting. In the emergent setting when intramuscular (IM) administration is necessary, the first-line recommendation is for olanzapine (since IM aripiprazole, previously favored, is no longer available) and haloperidol injection is the second choice, followed by possible consideration of an IM benzodiazepine. In the urgent setting, the first line would be oral second-generation antipsychotics (SGAs) aripiprazole and risperidone. Perhaps next could be then prazosin, and lastly electroconvulsive therapy is a consideration. There are risks associated with these agents, and adverse effects can be severe. Dosing strategies, discontinuation considerations, and side effects are discussed. In the non-emergent setting, medications are proposed for use in the following order: trazodone, donepezil and memantine, antidepressants such as escitalopram and sertraline, SGAs, prazosin, and carbamazepine. Other options with less support but potential future promise are discussed.

Residency training in the time of COVID-19: A framework for academic medical centers dealing with the pandemic.

BACKGROUND: As cases of COVID-19 climb worldwide, academic medical centers (AMCs) are scrambling to balance the increasing demand for medical services while maintaining safe learning environments. The scale and nature of the current pandemic, limitations on key resources, risks of transmission, and the impact on trainee wellbeing pose additional challenges to AMCs. We propose a framework for AMCs to utilize in facilitating health system, organization and program-level adjustments to meet the needs of medical trainees during the pandemic. APPROACH: In February 2020, we developed a three-level approach to the pandemic response of training programs at our AMC. The first level involved AMC alignment and engagement with regulatory stakeholders. The second level utilized the graduate medical education committee and leveraged organizational functions such as human resources, finance, and clinical departments. The third level of intervention focused on common approaches used by programs to ensure continuity of learning in the context of dynamic changes in workflows and service operations. EVALUATION: Outcomes at each level are reported. These include the co-development of a national framework on medical trainee responses to COVID-19, the composition of an operational guidance document, organizational protocols to accommodate novel challenges posed by the pandemic, and multiple program-level interventions. REFLECTION: This methodical approach, employed during a global crisis, was critical in facilitating interventions required to fulfill the mission of AMCs. Future steps include assessing the impact of these changes on trainee performance and the applicability of the approach in diverse settings.

Early Outcomes in an Emerging Facial Nerve Center: The Oregon Health and Science University (OHSU) Experience.

OBJECTIVES: Nerve transfer (NT) and free gracilis muscle transfer (FGMT) are procedures for reanimation of the paralyzed face. Assessing the surgical outcomes of these procedures is imperative when evaluating the effectiveness of these interventions, especially when establishing a new center focused on the treatment of patients with facial paralysis. We desired to discuss the factors to consider when implementing a facial nerve center and the means by which the specialist can assess and analyze outcomes. METHODS: Patients with facial palsy secondary to multiple etiologies, including cerebellopontine angle tumors, head and neck carcinoma, and trauma, who underwent NT or FGMT between 2014 and 2019 were included. Primary outcomes were facial symmetry and smile excursion, calculated using FACE-gram and Emotrics software. Subjective quality of life outcomes, including the Facial Clinimetric Evaluation (FaCE) Scale and Synkinesis Assessment Questionnaire (SAQ), were also assessed. RESULTS: 14/22 NT and 6/6 FGMT patients met inclusion criteria having both pre-and postoperative photo documentation. NT increased oral commissure excursion from 0.4 mm (SD 5.3) to 2.9 mm (SD 6.8) (P = 0.05), and improved symmetry of excursion (P < 0.001) and angle (P < 0.001). FGMT increased oral commissure excursion from -1.4 mm (SD 3.9) to 2.1 mm (SD 3.7), (P = 0.02), and improved symmetry of excursion (P < 0.001). FaCE scores improved in NT patients postoperatively (P < 0.001). CONCLUSIONS: Measuring outcomes, critical analyses, and a multidisciplinary approach are necessary components when building a facial nerve center. At our emerging facial nerve center, we found NT and FGMT procedures improved smile excursion and symmetry, and improved QOL following NT in patients with facial palsy secondary to multiple etiologies.

Tanta Protocol for Management of COVID-19: Perspectives from a Developing Country.

In late 2019, SARS-COV-2 disease was firstly discovered in Wuhan, China and then it infected millions of people worldwide. Later, the World Health Organization (WHO) described COVID-19 as the first pandemic invading the world in the 21st century. The WHO has declared that the emerging infection will last long enough to force adjustments not only in people's lifestyles but also in the health care system. This amendment is expected to spread through many medical practices and specialties. A lot of diagnostic and therapeutic modalities have been proposed for COVID-19 management. The best strategy for the management of patients requires a multi-disciplinary team approach with correct decisions regarding the right timing of each modality of treatment. The participating multidisciplinary team for COVID-19 management includes six infectious diseases experts in Tanta University; one critical care management expert, an emergency medicine expert and two pharmacists in Tanta University. In this review, we reported our multi-disciplinary team experience with up to date literature guidance to propose a valid protocol for the management of COVID-19 patients in a limited resources setting.

Clinical Magnetoencephalography Practice in the United States Ten Years Later: A Survey-Based Reappraisal.

PURPOSE: Broader utilization of magnetoencephalography (MEG) and optimization of clinical practice remain strategic goals of the American Clinical Magnetoencephalography Society. Despite the implementation of the first MEG Clinical Practice Guidelines, clinical adoption has been less than expected, prompting a reassessment. METHODS: Twenty-five clinical MEG centers were invited to participate anonymously in a survey of clinical practice. RESULTS: Centers (N = 18) mostly operated within an academic medical center (10/18), were owned by the "hospital" (10/18), associated with a level 4 National Association of Epilepsy center (15/18), and directed by neurologists (10/18). A total of 873 (median 59) epilepsy studies, 1,179 evoked fields (of all types), and 1,607 (median 30) research MEG studies were reported. Fourteen of 17 centers serve children (median 35%), but only 5 of 14 sedate children for MEG. All (N = 14) centers record EEG simultaneous with MEG, and 57% used dipole source localization. The median reporting time for epilepsy studies was 12 and 10 days for presurgical mapping studies. Most (12/14) were favorable toward the Clinical Practice Guidelines and "formalized certification" but were against mandating the latter. CONCLUSIONS: A plateau in MEG volumes suggests that MEG has not become a part of the standard of care, and correspondingly, the Clinical Practice Guidelines appeared to have had little impact on clinical practice. The American Clinical Magnetoencephalography Society must continue to engage magnetoencephalographers, potential referrers, and vendors.

Utilization of MEG Among the US Epilepsy Centers: A Survey-Based Appraisal.

PURPOSE: The purported underutilization of magnetoencephalography (MEG) among the USA epilepsy centers has never been studied, and any evidence-based understanding of its magnitude is lacking. METHODS: Two hundred twenty-five National Association of Epilepsy Centers centers (2016) were invited to participate anonymously in a 13-question web-based survey of clinical practice focused on MEG use. RESULTS: On average, centers (N = 70; 61 of which were level 4) reported <6 epileptologists, >7 dedicated epilepsy monitoring unit beds, 206 phase 1 studies, 15 phase 2 studies, 10 direct resections, and 9 indirect resections; 27% owned MEG. On average, 11.2 MEGs per year were ordered for epilepsy localization and 7.6 for any presurgical mapping modalities. Wada test aka the intracarotid sodium amobarbital procedure (ISAP) (43%) and functional MRI (29%) were preferred over MEG (4%) for language mapping. The number of epileptologists and the number of epilepsy monitoring unit beds correlated positively with the most clinical volumes. The centers who own a MEG had surgical volumes significantly higher than those without. The number and complexity of patients as well as the proximity of a MEG were perceived as significant contributors/obstacles to increased MEG use. CONCLUSIONS: Only the centers with larger surgical volumes incorporate MEG regularly in presurgical evaluation of patients with drug-resistant epilepsy. A reversal of the pervasive underutilization of epilepsy surgery can benefit from MEG, but this requires a sustained concerted promotion by the epilepsy and MEG communities.

Patient Satisfaction in Academic Pain Management Centers: How Do We Compare?

PURPOSE OF REVIEW: The aim of the study was to investigate patient satisfaction amongst academic pain management centers and associated factors. RECENT FINDINGS: Approximately 25% of pain management centers perform better than other practices on Press Ganey surveys. The majority of respondents (96%) indicated that pain management practices were uniquely positioned to receive poorer scores on patient satisfaction surveys. The majority of respondents (20/26), who reported a reason, indicated that limiting opioid prescribing led to poor patient satisfaction scores. Eighty-three percent of respondents indicated that they received pressure from administrators to improve patient satisfaction scores. The opioid epidemic in the USA must be addressed in order to diminish the senseless loss of life that is occurring in staggering numbers. The quality of care physicians provide has increasingly been assessed via patient satisfaction surveys. The results of these surveys often are utilized to provide financial incentives to physicians to obtain higher satisfaction scores. In the field of pain management, physicians may experience pressure to prescribe opioids in order to obtain higher patient satisfaction scores.

Rapid telemedicine implementation in the context of the COVID-19 pandemic in an academic pediatric otolaryngology practice.

OBJECTIVE: To describe the implementation of telemedicine in a pediatric otolaryngology practice during the coronavirus disease 2019 (COVID-19) global pandemic. METHODS: A descriptive paper documenting the development and application of telemedicine in a tertiary academic pediatric otolaryngology practice. RESULTS: A total of 51 established patients were seen via telemedicine within the first 2 weeks of telemedicine implementation. Seven (7) patients were no shows to the appointment. The median patient age was 5 years old, with 55% male patients. Common diagnoses for the visits included sleep disordered breathing/obstructive sleep apnea (25%) and hearing loss (19.64%). Over half (50.98%) of visits were billed at level 4 visit code. DISCUSSION: The majority (88%) of visits during the first 2 weeks of telemedicine implementation in our practice were completed successfully. Reasons that patients did not schedule telemedicine appointments included preference for in person appointments, and lack of adequate device at home to complete telemedicine visit. Limitations to our telemedicine practice included offering telemedicine only to patients who had home internet service, were established patients, and English-speaking. Trainees were not involved in this initial implementation of telemedicine. CONCLUSIONS: COVID-19 has driven the rapid adoption of telemedicine in outpatient medicine. Our group was able to institute an effective telemedicine practice during this time.

Emory university telehealth neuropsychology development and implementation in response to the COVID-19 pandemic.

Objectives: Emory University has modified its clinical practices across specialties in response to the 2020 COVID-19 pandemic to provide service delivery while maintaining patient, staff, and faculty safety. This report shares current solutions and workarounds associated with telehealth neuropsychology (teleNP) while also recognizing teleNP opportunities.Results: We modified many measures from our traditional assessment protocols so they could be administered through Zoom. To maximize quality control, formal how-to coversheets and manuals were developed for both training and task administration (i.e. navigating Zoom assessment interfaces, practicing adapted test instructions, and troubleshooting).Conclusions: TeleNP has been successfully used to answer referral questions regarding deep brain stimulation (DBS) candidacy in Parkinson's disease patients and presence of mild neurocognitive impairment in patients with subjective memory decline. Our current protocols will continue to evolve with greater experience and are not considered to be a finished product. Nevertheless, development of robust teleNP protocols should expand availability of neuropsychology in both clinical and research applications while simultaneously decreasing assessment burden associated with traveling - sometimes long distances - for diagnostic neuropsychological evaluation.

Developing Appropriateness Criteria for Pediatric Vascular Access.

OBJECTIVES: To describe the methodology undertaken to provide guidance on the appropriateness, as well as inappropriateness, of vascular access device selection, characteristics, and insertion technique for pediatric patients. METHODS: The RAND Corporation-University of California, Los Angeles Appropriateness Method was used. After definition of key terms and scope, a systematic review of the pediatric vascular access literature was undertaken. Clinical scenarios were developed to reflect the common indications for vascular access across pediatric health care. These were sectioned according to (1) device selection, (2) device characteristics, and (3) insertion technique. An interdisciplinary panel of experts (N = 14) consisting of leading experts representing diverse pediatric clinical disciplines including anesthesiology, cardiology and cardiac surgery, critical care and emergency, general surgery, hematology and oncology, hospital medicine, infectious disease, interventional radiology, pharmacology, regional pediatric hospitalist, and vascular access nursing specialties was convened. The scenarios were rated for appropriateness by the panel over 2 rounds (1 [highly inappropriate] to 9 [highly appropriate]). Round 1 ratings were completed anonymously and independently by panel members and classified into 3 levels of appropriateness: appropriate, uncertain, and inappropriate, or disagreement. For round 2, panelists met in-person to discuss the round 1 ratings and independently rerated the indications. All indications were reclassified into 3 levels of appropriateness or disagreement. CONCLUSIONS: The RAND Corporation-University of California, Los Angeles Appropriateness Method provides a rigorous, in-depth and transparent methodology to develop the first appropriateness criteria for the selection of pediatric vascular access devices in a range of patient groups.

Clinical Trials for COVID-19: Can we Better Use the Short Window of Opportunity?

The scientific community has risen to the coronavirus disease 2019 (COVID-19) challenge, coming up with an impressive list of candidate drugs and vaccines targeting an array of pharmacological and immunological mechanisms. Yet, generating clinical evidence of efficacy and safety of these candidate treatments may be frustrated by the absence of comprehensive trial coordination mechanisms. Many small stand-alone trials and observational studies of single-agent interventions are currently running or in planning; many of these will likely not deliver robust results that could support regulatory and patient-level treatment decisions. In this paper, we discuss actions that all stakeholders in the clinical trial ecosystem need to take to ensure that the window of opportunity during this pandemic will not shut, both for patients in need of treatment and for researchers to conduct decision-relevant clinical trials.

Safety and tolerability of i.v. push piperacillin/tazobactam within an emergency department.

PURPOSE: Piperacillin/tazobactam is a broad-spectrum antibiotic that is widely used and commonly administered via the intravenous (i.v.) piggyback route over 0.5 to 4.0 hours. Recommendations for i.v. push (IVP) administration of piperacillin/tazobactam are lacking due to the high osmolality of the solution. The primary objective of this study was to retrospectively assess the safety and tolerability of piperacillin/tazobactam administered peripherally by IVP. Methods. A retrospective chart review was conducted to evaluate adverse drug reactions after administration of a single dose of IVP piperacillin/tazobactam through a peripheral line in an emergency department from August 2016 through November 2017. RESULTS: A total of 1,813 patients received 1 dose of IVP piperacillin/tazobactam during the study timeframe. Three hundred patients were randomly selected for assessment of safety and tolerability. Two hundred ninety-nine patients (99.7%) tolerated IVP piperacillin/tazobactam. One patient had an allergic reaction that included itching and hives. No infusion-related reactions were documented. CONCLUSION: IVP administration of piperacillin/tazobactam through a peripheral site is safe and tolerable for adult patients.

A rationale and framework for seeking remote electronic or phone consent approval in endovascular stroke trials - special relevance in the COVID-19 environment and beyond.

BACKGROUND: Enrollment in time-sensitive endovascular stroke trials can be challenging because of an inability to consent a debilitated patient. Often the legally authorized representative is not on site. Remote consent procedures in the US are inconsistent with the majority of sites shunning these approaches. The current pandemic with visitor restrictions highlights the need for enhancing these options. METHODS: Remote electronic and phone consent procedures specifically for endovascular stroke trials from two comprehensive stroke centers (CSC) are presented. An overview of the genesis of informed consent procedures in the US is also included. RESULTS: The two CSCs identified as Institution-1 and Institution-2 are large tertiary systems. Institution-1 is a non-profit university-affiliated academic medical center in rural geography. Institution-2 is an HCA hospital in an urban environment. Both serve patients through a spoke-and-hub network, have participated in multiple randomized endovascular stroke trials, and have successfully used these remote options for enrollment. A tiered approach is employed at both institutions with an emphasis on obtaining informed consent in person and resorting to alternatives methods when efforts to that are unsuccessful. A rationale for electronic and phone consent is included, followed by step-by-step illustration of the process at each institution. CONCLUSION: Two examples of remote electronic or phone consent procedures from institutions in different geographic environments and organization structures demonstrate that these options can be successfully used for enrollment in stroke trials. The current pandemic highlights the need to enhance these approaches while maintaining appropriate adherence to ethical and legal frameworks.