ID: 213412 Comparison of Remote Programming and On-Site Programming in Patients With SCS and DRG Stimulation

Introduction: Spinal cord and dorsal root ganglion stimulation (SCS and DRG) are standard of care in chronic neuropathic pain. During the COVID-19 pandemic, it was critical to arrange postoperative care. Furthermore, the disparity between travel times and transportation options could influence the decision on seeking healthcare. Lacking financial resources could enhance this issue. Telehealth is usually restricted to video conferences, without interfering with implanted medical devices. Now, there exists a platform for remote programming of those devices. It is accessible via smartphones and allows direct contact between a patient and their doctor. Method(s): We initiated a pilot study for evaluating the performance of remote care in patients with SCS or DRG stimulation. We plan the enrollment of 20 patients, 10 each in the retrospective and the prospective group. Retrospective data has been collected from on-site programmed patients in our outpatient clinic in a large registry study. Prospective data is being collected under the new standard of care in the remotely programmed patients. We assess ten scores and categories to evaluate the status preoperatively, at implantation, and the postoperative course. The postoperative data are assessed in the context of video conferences for remote programming. 12 months after implantation, a final video conference is scheduled. In both groups, the same stimulation systems are used. Result(s): The study is ongoing. In the retrospective group (n=8), the mean duration of the programming appointment including waiting time was 43 minutes and the mean travel time 71 minutes (mean travel distance 106km with corresponding costs). So far, 5 patients have been enrolled for remote programming. Measured with the Telehealth Usability Questionnaire, their overall satisfaction with the system is high. In the Patient Global Impression of Change Scale 6 months after implantation, the retrospective group has a mean of 5 and the prospective group of 6 points. Considering the Visual Analog Scale, there was an improvement in both groups between the baseline and follow-up (in the retrospective group from mean 8 to 5 and in the prospective group from mean 8 to 2). Conclusion(s): The general convenience with the remote programming is high. Compared to the retrospective group, the patients do not experience a lack of efficacy of their stimulation. The use of remote programming offers various advantages, e.g., no travel times nor costs that allow simplified and more frequent programming. Especially in a pandemic or in case of travel limitations it is a very helpful tool. Disclosure: Mareike Mueller, MD: None, Andrea Dreyer: None, Phyllis McPhillips, RN: None, Guilherme Santos Piedade, MD: None, Sebastian Gillner, MD: ABBOTT: Consulting Fee:, Boston Scientific: Consulting Fee:, Philipp Slotty, MD: None, Jan Vesper, MD,PhD: Abbott: Consulting Fee:, Abbott: Fees for Non-CME/CE Services (e.g. advisor):, Medtronic: Fees for Non-CME/CE Services (e.g. advisor):, Boston Scientific: Consulting Fee:, Medtronic: Consulting Fee:, UniQure: Fees for Non-CME/CE Services (e.g. advisor):, ABBOTT: Consulting Fee:, Abbott: Speakers Bureau:, ABBOTT: Consulting Fee: Self, ABBOTT: Speakers Bureau: Self, ABBOTT: Contracted Research: Self, Boston Scientific: Consulting Fee: Self, Boston Scientific: Contracted Research: SelfCopyright © 2023

Changes in Adults' Eating Behaviors During the Initial Months of the COVID-19 Pandemic: A Narrative Review

Factors such as regulations and health concerns shifted daily habits, including eating behaviors, during the early months of the coronavirus disease 2019 (COVID-19) pandemic. This comprehensive narrative review synthesizes research on eating behavior changes during the early months of the pandemic (February to June 2020), including changes in amount, rate, and timing of food consumption, types and healthfulness of foods consumed, the occurrence of other specified eating behaviors (eg, restrained eating or binging), and reasons for eating (eg, stress or cravings), among adults. A literature search using three EBSCOhost databases and Google Scholar was conducted to identify relevant articles made available in 2020. A total of 71 articles representing 250,715 individuals from more than 30 countries were reviewed. Findings show eating behaviors changed little during the early COVID-19 pandemic for most participants. Among those whose eating behaviors changed, increases in both intake and frequency of eating meals and snacks were more common than decreases. Findings on timing of eating and healthfulness of food consumed showed mixed results. How-ever, when changes occurred in the type of food consumed, increases were more common for snacks, homemade pastries, white bread/pasta, legumes, and fruits/vege-tables;decreases were more common for meats, seafood/fish, frozen foods, fast food, dark breads/grains, and dark leafy green vegetables. During the pandemic, binging, uncontrolled eating, and overeating increased, meal skipping decreased, and restrictive eating had mixed findings. Changes in factors such as emotions and mood (eg, depression), cravings, and environmental factors (eg, food insecurity) were related to changes in eating behaviors. Findings can inform clinical practitioners in efforts to mitigate disruptions to normal, healthy eating patterns among adults both in and outside of global health catastrophes. J Acad Nutr Diet. 2023;123(1):144-194.

Improving the timeliness of health expenditure tracking in OECD and low-and middle-income countries

The COVID-19 pandemic has highlighted that access to timely health spending data is crucial for informed policy-making. This Health Working Paper summarises and compares the methodologies applied in around half of OECD countries to estimate public and private health spending for the most recent year (i.e. t-1) as well as the approaches taken by the OECD Secretariat to fill existing data gaps for the remaining OECD countries. For the first time, the paper also explores the feasibility of nowcasting health spending for the current year (i.e. t) and examines data sources that could be potentially useful in such an exercise. While this review should help OECD countries that do not yet have experience in estimating health spending for year t-1 to improve the timeliness in their data reporting, a special focus in this paper lies on testing the applicability of the methods in low- and middle-income countries (LMIC), using the WHO Western Pacific Region (WPRO) as an example. Generally, different data sources exist in many countries that would allow for a more timely estimation for health spending aggregates.

Social Isolation Among Adults Living With Cystic Fibrosis in the United States: A Single-Center Experience

Adults with cystic fibrosis face challenges that may increase social isolation. The goal of this cross-sectional study was to describe social isolation in this population. Participants (N = 34) were recruited from an adult cystic fibrosis clinic. Demographic and clinical data, social isolation scores, coronavirus disease 2019 effects, and quality of life outcomes were collected and compared to describe social isolation. Significant social effects were not found in this group, but preliminary data reveal potential predictors of social isolation. This study provides insight into the predictors of social isolation among adults with cystic fibrosis and lays the groundwork for future studies. © 2023 Elsevier Inc.

E-PACT: EXTENSION TRIAL OF PERMANENT VERSUS DELAYED-ABSORBABLE MONOFILAMENT SUTURE FOR VAGINAL GRAFT ATTACHMENT DURING MINIMALLYINVASIVE TOTAL HYSTERECTOMYAND SACROCOLPOPEXY

Introduction: We previously reported a 6.1% rate of mesh/permanent suture exposure at 1 year after minimally-invasive total hysterectomy and sacrocolpopexy (TLH + SCP) with a light-weight polypropylene mesh. Vaginal mesh exposures may increase over time. Objective: The goal of this extension study was to evaluate total and incident mesh/permanent suture exposure rates at least 2 years after surgery. Our secondary aims were to evaluate surgical success and late adverse events. Methods: This extension study included women previously enrolled in the multicenter randomized trial of permanent (2-0 GoreTex) vs delayed-absorbable (2-0 PDS) suture with Upsylon™ mesh during TLH + SCP for > stage II prolapse (POP), for follow-up at least 24 months after surgery. Due to COVID-19, women were given the option of an in-person (symptoms + exam) or telephone visit (symptoms only). The primary outcome was total and incident permanent suture or mesh exposure, or symptoms suggestive of mesh exposure in women without a pelvic examination (vaginal bleeding, bothersome discharge, partner feeling mesh). Women who did not enter the extension trial but were confirmed to have mesh exposure at 1 year were carried forward as a mesh exposure. Secondary outcomes were: 1) Surgical success, which was defined as no subjective bulge on PFDI questionnaire, no prolapse beyond the hymen, and no POP retreatment and 2) Adverse events, which were classified according to Dindo grading scale. Results: 182/200 previously randomized participants were eligible for inclusion, of which 106 (58%) women (78 in-person and 28 via questionnaire only) agreed to the extension study. Demographic characteristics are presented in Table 1. At a mean of 3.9 years post-surgery, the rate of mesh/suture exposure was 7.7% (14/182): 5 in-person,1 in the questionnaire only group and 8 cases carried forward from 1-year follow-up. Only 2 were incident cases reported after 1-year follow-up. There were 2 cases of suture exposure in the original cohort at 1 year, and 0 suture exposures in the current group, for a carry forward rate of 1.1% (2/182). There was no significant difference in mean age or follow-up time for women with and without an exam. None reported vaginal bleeding/discharge, dyspareunia, or penile dyspareunia. Mesh/suture exposures were managed as follows: 4 (66.7%) vaginal estrogen, 2 (33.3%) office trimming and 1 (16.7%) vaginal mesh excision surgery. For women without a study visit, there was one reported mesh exposure which was treated with office removal. Surgical success was 93/ 106 (87.7%): 13/94 (13.8%) failed by bulge symptoms, 2/78 (2.6%) by prolapse beyond hymen, 1/85 (1.2%) by retreatment with pessary, and 0 retreatment with surgery. There were 34 (32%) subjects who reported an adverse event. The most common were vaginal atrophy (16), pelvic or vaginal pain (7), dyspareunia (5), UTI (3), vaginal bleeding (3), and vaginal discharge (3). There were no serious adverse events. Conclusions: The rate of incident mesh exposure between 1 and 3.9 years postsurgery was low, success rates remained high, and there were no delayed serious adverse events after TLH + SCP with lightweight polypropylene mesh (Table Presented).

PATIENT SATISFACTION WITH TELEHEALTH VISITS FOR NEW PATIENT APPOINTMENTS FOR PELVIC FLOOR DISORDERS: A RANDOMIZED TRIAL OF TELEHEALTH VERSUS STANDARD IN-PERSON OFFICE VISITS

Introduction: Telehealth has emerged as an increasingly useful tool to provide care amidst the COVID-19 pandemic. The acceptability and safety of telehealth has been previously reported in Urogynecology for preoperative counseling and postoperative care but not for new patient evaluation. Objective: To determine if new patient telehealth encounters are non-inferior to inperson office encounters for women presenting to a Urogynecology clinic using a patient satisfaction questionnaire. Secondary objectives were to assess number of follow up visits, phone calls, and travel distance and time. Methods: This was a randomized controlled trial of women presenting to a Urogynecology clinic for a new patient visit. Participants were randomized after appointment scheduling to either telehealth or in-person visits. Telehealth visits were scheduled for 15 minutes and conducted over a video platform by the attending physician. Pelvic exams were not performed over telehealth and patients were counseled and scheduled for follow-up including procedures and treatments. In-person visits included trainees and a pelvic exam. Patients completed the validated Patient Satisfaction Questionnaire-18 (PSQ-18) after their visit. The primary outcome was composite patient satisfaction on the PSQ-18 questionnaire. Demographics and health care utilization data were ed from chart review. Using a non-inferiority margin of 5 points on the PSQ-18 composite score, 25 patients per arm were required with a power of 80% and an alpha of 0.05. Results: From March to September 2021, 133 women were screened for eligibility, 71 were randomized, and 58 were included in the final analysis (30 in telehealth group and 28 in in-person group). Demographic characteristics were similar between groups. Patients overall had a high education level, with 60% having a college degree or higher. Patient satisfaction, as measured on the PSQ-18 questionnaire (maximum score 90), was high for both groups but higher for in-person visits vs telehealth visits (75.68 ± 8.55 vs 66.60 ± 11.80, P = 0.001, difference -9.08, 90% confidence interval -4.57 to -13.6) and our results were inconclusive with respect to determining non-inferiority. Patients ≥60 years reported higher rates of satisfaction overall compared to those younger than 60 years (P = 0.009). Women in the in-person group were more likely to perceive that they had enough time with the provider (P = 0.003) and their visit was timely and efficient (P = 0.016) despite having less attending physician face time. Women in the telehealth group expressed uncertainty regarding the format and the perceived benefits of telehealth. There were no differences in the number of follow up visits (P = 0.81), patient-initiated (P = 0.52) or staff-initiated phone calls (P = 0.07), distance from home to office (P = 0.87), or travel time from home to office (P = 0.94) between groups. There were no differences in treatments (surgical vs non-surgical) chosen based on PSQ-18 scores. Conclusions: Women seen by urogynecologic providers either in person or via telehealth demonstrated high satisfaction with their first visit. Although the results are inconclusive with respect to non-inferiority, telehealth is safe and does not impact conversion to surgical or procedural treatments. As telehealth use continues to demonstrate safety, efficacy, and tolerability by patients, we must educate providers and patients on the utility of this platform.

Camostat Mesylate Versus Lopinavir/Ritonavir in Hospitalized Patients With COVID-19-Results From a Randomized, Controlled, Open Label, Platform Trial (ACOVACT).

Background: To date, no oral antiviral drug has proven to be beneficial in hospitalized patients with COVID-19. Methods: In this randomized, controlled, open-label, platform trial, we randomly assigned patients ≥18 years hospitalized with COVID-19 pneumonia to receive either camostat mesylate (CM) (considered standard-of-care) or lopinavir/ritonavir (LPV/RTV). The primary endpoint was time to sustained clinical improvement (≥48 h) of at least one point on the 7-category WHO scale. Secondary endpoints included length of stay (LOS), need for mechanical ventilation (MV) or death, and 29-day mortality. Results: 201 patients were included in the study (101 CM and 100 LPV/RTV) between 20 April 2020 and 14 May 2021. Mean age was 58.7 years, and 67% were male. The median time from symptom onset to randomization was 7 days (IQR 5-9). Patients in the CM group had a significantly shorter time to sustained clinical improvement (HR = 0.67, 95%-CI 0.49-0.90; 9 vs. 11 days, p = 0.008) and demonstrated less progression to MV or death [6/101 (5.9%) vs. 15/100 (15%), p = 0.036] and a shorter LOS (12 vs. 14 days, p = 0.023). A statistically nonsignificant trend toward a lower 29-day mortality in the CM group than the LPV/RTV group [2/101 (2%) vs. 7/100 (7%), p = 0.089] was observed. Conclusion: In patients hospitalized for COVID-19, the use of CM was associated with shorter time to clinical improvement, reduced need for MV or death, and shorter LOS than the use of LPV/RTV. Furthermore, research is needed to confirm the efficacy of CM in larger placebo-controlled trials. Systematic Review Registration: [https://clinicaltrials.gov/ct2/show/NCT04351724, https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001302-30/AT], identifier [NCT04351724, EUDRACT-NR: 2020-001302-30].

Designing a Choreographic Interface During COVID-19

In 2019, metaLAB (at) Harvard began work on Curatorial A(i)gents, a digital exhibition that was slated to premiere at the Harvard Art Museums' Lightbox Gallery in 2020. Half of the projects would be interactive, using mouse and keyboard conventions. With the advent of Covid-19 and the postponement of the show, the authors set out to develop an interface solution that would enable visitors to interact with the works without having to touch any public devices like a tablet. Toward this end, we prototyped a "choreographic interface"that uses machine vision and machine learning to interpret a full-torso gestural vocabulary, which is then translated into interactions. To make the choreographic interface, we relied on open-source solutions, which have all come with equal limitations and opportunities. In 2022, Curatorial A(i)gents was presented in the Lightbox Gallery, where we had the opportunity to test and demonstrate the interface. This paper discusses our design journey in making a choreographic interface using open-source technologies during Covid-19. © 2022 ACM.

Pharmacokinetics of fentanyl in extracorporeal membrane oxygenation

INTRODUCTION: Extracorporeal membrane oxygenation (ECMO) is used to treat patients with refractory circulatory or respiratory failure as a bridge to recovery, long-term support device (e.g., ventricular assist device), or transplant. Patients on ECMO commonly receive large doses of analgesia and sedation, and prior in vitro studies have been equivocal when evaluating the effect of ECMO therapy on blood concentrations of these medications. Because dose escalations may result in excessive drug exposure, over-sedation, and drug side effects, we seek to quantify the impact of ECMO initiation on plasma concentrations of fentanyl. METHODS: This is preliminary data from a single-center, prospective trial of patients treated with ECMO to evaluate the effects of ECMO therapy on systemic fentanyl levels. Patients ≥ 18 years of age who were cannulated for ECMO and already receiving a continuous fentanyl infusion were considered for enrollment, while patients younger than 18 years of age, pregnant, and/or cannulated at another hospital prior to arrival at our institution were excluded. Whole blood samples were collected within 30 minutes of ECMO cannulation, at the time of initiating ECMO flow, and after initiating flow at 15-, 30-, and 60-minutes. RESULTS: Three patients (two male, one female) were included in this preliminary sample, and all were placed on VV-ECMO for refractory respiratory failure due to COVID-19 pneumonia. Mean fentanyl concentrations were reduced by 13% after 30 minutes and 5% after 60 minutes. However, one of the three patients received a bolus dose of fentanyl during the study period. When assessing fentanyl concentrations from the two patients not receiving an additional fentanyl bolus, mean fentanyl concentrations were reduced by 18% after 30 minutes and 19% after 60 minutes. CONCLUSIONS: In this preliminary data from three patients treated with ECMO for refractory respiratory failure, systemic fentanyl concentrations were reduced after 30- and 60-minutes. While this data is limited to three patients and a greater number of patients are needed to ascertain statistical significance, these data may provide quantitative evidence to support why patients on ECMO require increased doses of fentanyl to maintain adequate analgesia. This study is currently ongoing and enrolling additional patients.

The ad hoc establishment of an acute palliative care (PC) ward for COVID-19 patients in a tertiary university hospital in Germany-the perspective of the staff and stakeholders involved

Background: Due to the steep increase of Covid-19 cases in March 2020, we established a PC ward for dying Covid-19 patients to support emergency/ intensive care medicine in the event of capacity shortages and to create a dignified PC. The station was up and running within 3 days, with both PC team members and volunteer nurses from non-palliative care units working together. Aims: To explore: How did staff and stakeholders experience the ward's ad hoc implementation? What are the lessons learned? Methods: A qualitative study was conducted (May-November 2020). 29 semi-structured interviews were led with PC staff, voluntarily enlisted staff and management, transcribed verbatim and a qualitative content analysis was performed. Results: Patient care and team collaboration were rated positively. Whereas the volunteers had the role of open-minded learners, the PC staff was considered as experts in end-of-life care and approachable instructors. The joint induction training proved to be central. This included a kick-off meeting and equipment training, the familiarization with the ward, training at the patient's bedside by the PC team as well as the support of the nursing/medical management. Named challenges were yet: On the volunteer side an adaption to PC routines and a different culture of care;balancing the high standards of PC against the backdrop of pandemic conditions on the PC team side. Also, criticism was levelled at the rapid opening of the ward as sufficient capacities at the other Covid-19 stations led to a low occupancy of the ward, staff overcrowding and frustration. Conclusion: Our study shows the possibility to establish an ad hoc acute PC unit, where PC staff in a short time can successfully train volunteers. Nevertheless, due to the unpredictable dynamics of a pandemic, management and staff should be prepared for both scenarios: a low as well as a high occupancy of the station and the burden that comes along with each challenge.

Arterial stiffness in acute COVID-19 and potential associations with clinical outcome.

BACKGROUND: Coronavirus disease 2019 (COVID-19) interferes with the vascular endothelium. It is not known whether COVID-19 additionally affects arterial stiffness. METHODS: This case-control study compared brachial-ankle pulse wave (baPWV) and carotid-femoral pulse wave velocities (cfPWV) of acutely ill patients with and without COVID-19. RESULTS: Twenty-two COVID-19 patients (50% females, 77 [67-84] years) were compared with 22 age- and sex-matched controls. In COVID-19 patients, baPWV (19.9 [18.4-21.0] vs. 16.0 [14.2-20.4], P = 0.02) and cfPWV (14.3 [13.4-16.0] vs. 11.0 [9.5-14.6], P = 0.01) were higher than in the controls. In multiple regression analysis, COVID-19 was independently associated with higher cfPWV (ß = 3.164, P = 0.004) and baPWV (ß = 3.532, P = 0.003). PWV values were higher in nonsurvivors. In survivors, PWV correlated with length of hospital stay. CONCLUSION: COVID-19 appears to be related to an enhanced PWV reflecting an increase in arterial stiffness. Higher PWV might be related to an increased length of hospital stay and mortality.