Unexpected, but consistent and pre-registered: Experimental evidence on interview language and Latino views of COVID-19

Much uncertainty remains about effective messaging to boost public support for COVID-19 mitigation efforts, especially among people of color. We investigate the relationship between interview language and expressed support for COVID-19 public health protocols among Latinos: America's largest ethnic group. Prior work establishes that interview language shapes opinions by cognitively structuring which considerations people use to express attitudes. Yet other work suggests interview language shapes opinions by activating specific cultural norms associated with a tongue. We predicted that interviewing in Spanish (versus English) would boost support for COVID-19 protocols by activating pro-social norms known to be strongly associated with that language. We uncover null support for this prediction in a pre-registered experiment on bilingual Latino adults (N = 1645). Instead, we find that Latinos assigned to interview in Spanish report weaker support for COVID-19 protocols, regardless of which cultural norms are primed. We discuss implications for COVID-19 attitudes in linguistically diverse polities.

HTA189 Implications of the French Temporary Authorisation for Use Reform for the Pharma Industry

Objectives: In July 2021, the temporary authorisation for use (Autorisation Temporaire d'Utilisation, ATU) system was the subject of a major reform, initially published within the 2021 healthcare plan in December 2020. The presumption of innovation for the products compared with the most clinically relevant comparator was introduced among other evaluation criteria. What are the implications of this reform and what does this mean for the pharma industry? Methods: This study scrutinizes the application of all non-COVID related medications submitted for an Autorisation d'acces precoce (AAP, which includes the previous cohort ATU) between July 2021 and July 2022. The three evaluation criteria of the presumption of innovation (i.e. new treatment approach with an appropriate development plan and that addresses an unmet medical need) were analysed and linked to the decision outcomes of the Haute Autorite de Sante (HAS) for each product. Result(s): This study shows that most products assessed post-ATU reform met all three evaluation criteria and were granted AAP approval. In their evaluation, consideration of unmet medical need was particularly important for oncology products for HAS. The HAS showed to accept the absence of comparative data in the case of concurrent development of comparative studies vs. standard of care and with additional input from external experts. However, the absence of novel mode of action or treatment approach and / or the lack evidence of comparative clinical efficacy data without appropriate clinical development plans were key factors leading to product rejection. Conclusion(s): This study shows that the majority of non-COVID related products were granted AAP approval in the first months post-reform. Although this remains an initial observation, this research suggests that the reforms to the French early access programme, whilst more restrictive, have not significantly impacted patient access. Copyright © 2022

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).

COST ANALYSIS OF MINIMALLY-INVASIVE SACROCOLPOPEXY COMPARED TO NATIVE TISSUE VAGINAL REPAIR IN THE ERA OF ERAS

Introduction: Minimally invasive sacrocolpopexy (SCP) is the gold-standard treatment for patients with apical prolapse and is increasingly used as a primary intervention in women with uterovaginal prolapse. There is a lack of comparative data evaluating costs between SCP versus native tissue vaginal repair in the post-ERAS implementation era. Objective: The primary aim was to determine the cost difference between performing hysterectomy and minimally-invasive sacrocolpopexy as compared to vaginal hysterectomy with native tissue vaginal repair for uterovaginal prolapse. We hypothesized that minimally-invasive sacral colpopexy has a higher cost when compared to native tissue repair but when failure rates of native tissue repair approach 15%, costs equilibrate. Methods: This was a retrospective cohort study at a tertiary care center. The electronic medical record system was queried for women who underwent native tissue vaginal repair or minimally invasive SCP with concomitant hysterectomy for uterovaginal prolapse in calendar year 2021 (post-COVID enhanced recovery after surgery implementation). We excluded all patients who had concomitant colorectal procedures and where billing was not complete or re-imbursement was not received. Hospital charges, direct and indirect costs and operating margin (net revenue minus all costs) were obtained from Strata Jazz and were compared using R statistical program. Net revenue (reimbursement) was directly obtained from the record as the total payment received by the hospital from the payor. Results: A total of 81 women were included, (33 SCP (25 robotic and 8 laparoscopic) versus 48 native tissue). Payor mix included 27% Medicare, 5% medicaid, 61% employer-based and 7% private insurance. Demographic and surgical data is presented in Table 1. The mean total charge per case for services was higher in the SCP group compared to the vaginal repair group ($119,863 vs. $82,205, P < 0.01). Cost of supplies was more in the SCP group ($4429 vs. $2108, P < 0.01), but the cost of operating room time and staff was similar ($7926 vs. $7216, P = 0.06). Controlling for surgeon, age and BMI, the direct and indirect costs were also higher in the SCP group ($13,649 vs. $10,168, P < 0.01 and $5068 vs. $3685, P < 0.01, respectively). Net revenue was lower for the vaginal repair group compared to the SCP group ($14,614 vs. $31,618, P < 0.01). The operating margin was significantly higher in the SCP group ($11,770 vs. $ 517, P < 0.01). Additionally, there were no significant differences in the net revenue between different payors (P = 0.8997). Same-day discharge and EBL were similar among both groups with operative time being higher in the SCP group (204 vs. 161, P < 0.01). Using the means of the direct costs between groups, a re-operation rate of 25.5% would be needed for the native tissue repair costs to equilibrate to the SCP group. From a hospital perspective, due to the low operating margins experienced with native tissue vaginal repair, 227 native tissue vaginal repairs would need to be performed for the same net return as 10 minimally-invasive SCP's. Conclusions: Vaginal hysterectomy with native tissue repair had lower direct and indirect costs compared to minimally-invasive SCP. However, operating margins are significantly higher for SC P due to net revenue received. (Table Presented).

Assessment of sleep disturbances in children and adolescents with inflammatory bowel disease

Background: Poor sleep has been well described in the adult inflammatory bowel disease (IBD) population. Few studies in the pediatric population have demonstrated a similar relationship. The aim of this study was to assess the prevalence of sleep disturbances and sleep-related daytime impairments in children and adolescents with IBD. Methods: This pilot, prospective cross-sectional study included pediatric IBD patients seen in the GI clinic or infusion center at The American Family Children's Hospital in Madison, Wisconsin between February and April of 2021. Patients completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance-Short Form and Pediatric Sleep-Related Impairment-Short Form questionnaires at the time of their visits. The questionnaires assessed difficulties with sleep at night, and daytime symptoms associated with poor sleep. The disease activity was scored using the Abbreviated Pediatric Crohn's Disease Index (PCDAI) for Crohn's Disease and the Pediatric Ulcerative Colitis Activity Index (PUCAI) for Ulcerative and Indeterminate Colitis. Demographics, disease-related information, and laboratory data within the past 6 months from time of the patient visit were acquired from medical charts. Iron deficiency was determined by ferritin <30 ng/mL or iron saturation <20% with a normal CRP or ferritin <100 ng/mL with an elevated CRP. Vitamin D deficiency was determined by 25-hydroxy-vitamin D ≤30 ng/mL. All data was analyzed using Fisher's exact test and a p-value <0.05 was used to define statistical significance. Results: Forty-four patients (mean age 14.7, SD 2.8) with IBD (68.2% with Crohn's Disease, 25.0% with Ulcerative Colitis, 6.8% with Indeterminate Colitis) were enrolled. Of those with Crohn's Disease, 73.3% had inactive disease and 26.6% had active disease based on PCDAI score. For those with Ulcerative and Indeterminate Colitis, 57.1% were in remission and 42.8% had active disease based on PUCAI scores. Of all patients, 29.6% had some degree of sleep disturbance and 50.0% had sleep-related daytime impairments. Additionally, 13.6% of patients were currently taking a sleep medication and 20.5% had been on oral steroids within the last 3 months. Among the patients, 44.2% had iron deficiency and 61.9% had vitamin D deficiency. Patients with active disease reported more sleep disturbances (43% vs 23%, p=0.2878) and sleep-related daytime impairments (71% vs 40%, p=0.0520), however the results were not statistically significant. Patients with vitamin D deficiency reported fewer sleep disturbances than those with no vitamin D deficiency, which was statistically significant (19% vs 50%, p=0.0472). There was no significant difference in sleep-related daytime impairments between those groups (38% vs 69%, p=0.1109). Statistical analysis showed that age, iron deficiency, and current/recent use of oral steroids were not significantly correlated with sleep disturbances or sleep-related daytime impairments. Conclusions: Despite the previously reported correlation between IBD and sleep, our pilot study does not demonstrate a strong correlation between sleep disturbances and disease activity. However, this relationship may be shown among a larger patient population than seen in this study. There was a higher prevalence of sleep-related daytime impairments rather than sleep disturbances among all enrolled IBD patients. This could reflect the overlap between sleepiness and fatigue as these are difficult to distinguish. In addition, there are numerous cofactors that can cause sleep problems in pediatric patients. These include variables such as age, oral steroids, iron deficiency, and vitamin D deficiency. To our surprise, our patients with vitamin D deficiency reported better sleep compared to patients with normal vitamin D levels;however, vitamin D levels were obtained anywhere up to 6 months prior to sleep questionnaire completion. Sample size of the study was limited due to a 2-month data collection period, and the ongoing COVID-19 pandemic restricting in-person visi s. Other limitations include the accurateness of self-reported answers on the sleep questionnaires and the time variability between laboratory values and administration of the sleep questionnaires. Future research may be helpful to further study sleep issues in pediatric IBD patients.

Evaluation of pediatric therapists' use of virtual health due to the COVID-19 pandemic

Background and Objective(s): Coronavirus disease-2019 (COVID-19) led to the suspension of in-person therapy sessions in March 2020 in British Columbia (BC), Canada. This necessitated the use of virtual visits, defined as face-to-face consultation completed remotely. Here we report the assessment of pediatric physical therapists and occupational therapists use of virtual visits, barriers to virtual care, and their perceived impact on completion of community-based hip surveillance during the COVID-19 pandemic. Study Design: Cross-sectional survey. Study Participants & Setting: All pediatric therapists in the province were invited to participate. The survey was emailed to approximately 130 therapists in June 2020 using known email distribution lists. Therapists were asked to forward the survey to colleagues. Materials/Methods: An anonymous online survey assessing therapists' knowledge and learning needs related to hip surveillance was completed as part of continuous quality improvement for the Child Health BC Hip Surveillance Program for Children with Cerebral Palsy. Questions related to the provision of virtual visits during the COVID-19 pandemic were included in this survey. Therapists were also asked to rate their confidence and satisfaction in using virtual visits, identify barriers to virtual visits, and the impact of virtual visits on completing community based hip surveillance. Results: The survey was completed by 64 participants (60 physical therapists, 1 occupational therapist, 3 duel trained). Respondents were from varied practice settings: 48% metro, 30% urban, 19% rural and 3% remote. Prior to the pandemic, 6% (4) of respondents reported using virtual health with 5% (3) reporting being very confident and 22% (14) confident in using healthcare technology. Since the start of the pandemic, 86% (55) of therapists have been providing virtual visits. Eight different platforms for these visits were identified. Of those providing virtual visits, 44% were satisfied/very satisfied with their experience in providing virtual care. Barriers to providing virtual care included families not being familiar with the virtual platforms (35), not wanting to be seen virtually (34), or being able to afford technology (26) and lack of wireless internet or poor connection (19). Additionally, therapists identified completing a physical assessment (12), privacy and security concerns (9), engaging the child and family (6), and their own learning needs related to using virtual care (3) as barriers. When asked how the pandemic would affect their practice related to hip surveillance, 65% (40) reported completion of the clinical exam would be affected while 25% (16) felt identifying children that require surveillance would be impacted. The most requested resources to support virtual visits were improved access to virtual platforms and online technology tools. Conclusions/Significance: Therapists rapidly switched to using virtual healthcare due to the COVID-19 pandemic. Less than half were satisfied with their experience. Reported barriers to virtual care suggest virtual visits are not always easily accessible for families. Practical tools and strategies to facilitate access to continuing care are required when virtual visits are required.

Impact of telemedicine on the surgical management of pelvic floor disorders

Objective: Our department rapidly adopted a telemedicine option for outpatient evaluation of women with pelvic floor disorders during the pandemic. Our objective was to determine the proficiency of telemedicine in diagnosis of pelvic floor disorders and if an initial telemedicine visit impacted the rate of surgical management compared to an in-person evaluation. Methods: We performed a retrospective cohort study of all new patients referred to a single attending provider in female pelvic medicine at a tertiary care referral center who were seen via a telemedicine visit in the first 2 months of telehealth adoption during the COVID pandemic. New telemedicine patients were then compared to patients seen for a new in-person visit over the same time period the previous year. Via chart review, we collected demographic data, primary diagnoses rendered following visit completion and treatment (medical versus surgical) chosen. We compared the rate of surgical posting, number of visits from initial visit until the date of surgery, and rate of surgery cancellation in women seen for a pelvic floor disorder as a new in-person versus by telemedicine. Results: A total of 310 new patient visits were queried: 182 (59%) that took place in person between June 1 and July 30, 2019 and 128 via telemedicine over the same timeframe in 2020 (41%). Table 1 presents comparative demographic data, primary diagnoses and surgical procedures that resulted in each cohort. For women with a diagnosis of stress or mixed urinary incontinence, the rate of surgical posting for a sling procedure in-person- v. by telemedicine was 25% and 38%, P = 0.176. For women with a diagnosis of pelvic organ prolapse, the rate of surgical posting in-person v. by-telemedicine was 42% and 47%, P = 0.578. The median total number of outpatient visits required from initial visit to day of surgery was 2 in both groups, and the rate of surgery cancellation was 26% (in-person) and 12%(telemedicine), P = 0.168. Conclusions: New patient visits conducted via telemedicine resulted in similar rates of accurate surgical postings for both urinary incontinence and pelvic organ prolapse despite the absence of a pelvic examination. This data is useful for continuation of telemedicine platforms post pandemic.

Patient satisfaction following implementation of a nursing preparation protocol for telehealth visits

Objective: The Covid-19 pandemic prompted broad adoption of telehealth platforms. Our goals were to determine effectiveness of a telemedicine nursing protocol in patient engagement, preparation, and satisfaction. Methods: We implemented a standardized telemedicine nursing protocol prior to a scheduled telehealth visit with a urologic provider at a tertiary care center. Demographic data, telehealth platform and smart device preference, requirement of set up assistance, and rate of success were reviewed. We prospectively administered the Telehealth Usefulness Questionnaire (TUQ), a validated 21-item survey assessing patient satisfaction in 6 domains: Usefulness, Ease of use, Interface quality, Interaction quality, Reliability, and Future use. Scores >105 (>5 for individual items) correlate with high satisfaction. Results: From April - May 2020, 265 patients were included. Demographic data is provided in Table 1. The most commonly used platform for audiovisual visits was Doximity Dialer (85.7%) via Android (50.2%) or Apple (43.0%) smartphone. Eighteen (6.8%) patients reported setup assistance from family/friends. Only 4 (1.8%) were unsuccessful and required conversion to a non-visual phone visit (3 for lack of access to a compatible device;1 for inability to understand instructions). Of these, 186 (70.1%) patients completed the post-visit questionnaire. Mean TUQ scores were 118.31 ± 23.44. Nineteen of 21 individual items had mean scores >5.0. The Usefulness (5.936 ± 1.231) and Interaction Quality (5.89 ± 1.412) subdomains had the highest mean scores. The Reliability subdomain had the lowest mean score (4.715 ± 1.593). Increased TUQ scores were associated with decreased age (P = 0.02) and female gender (P = 0.02). Patients reported high satisfaction with their telemedicine experience regardless of race, marital status, annual income, education level, employment status, or physical distance from clinic but younger age and female gender were associated with greater satisfaction. Conclusions: A standardized nursing protocol designed to maximize patient engagement with telehealth was successful in achieving patient-provider connectivity in 98% of subjects with high patient satisfaction. A team approach to telehealth is recommended.

Implementation of an early recoveryafter surgery (ERAS) protocol in patients undergoing female pelvic reconstructive Surgery: Impact on complications, hospital stayand cost

Objective: Minimizing hospital admission and maximizing utilization of outpatient surgery facilities are critical for patients undergoing elective surgery during the COVID-19 pandemic in order to prevent viral spread within healthcare facilities and maximize inpatient hospital bed availability. Methods: We implemented an early recovery after surgery (ERAS) protocol for all patients undergoing female pelvic reconstructive surgery starting on June 1st, 2020 by a single surgeon. The protocol included pre-op hydration, a urinary anesthetic, pre- and post-op acetaminophen and ibuprofen, postop perineal ice and bowel regimen, identification and enrollment of family members to assist with care, and communication regarding planned sameday discharge. We compared demographic, operative, hospital stay, complications, and cost data in patients pre (PRE) and post (POST) ERAS implementation. Results: In all, 173 patients (82 PRE Nov 2019 - Feb 2020, 91 POST June - Sept 2020) were included. There were no differences in age, body mass index, ASA score, smoking history, surgery type, operative time, intra-op complications, and post-op complications between the PRE and POST groups (P > 0.05). POST patients had a higher mean Charlson Comorbidity Index (2.6 vs 1.9, P = 0.0132). Significantly more surgeries were done in an outpatient setting in the POST group (73.6% vs 48.8%, P = 0.0008), and significantly more patients were discharged on the day of surgery in the POST group (80.2% vs 50.0%, P = 0.0003). There were no differences in the rates of unexpected emergency room or clinic visits (P > 0.05). Both peri-op and discharge opiate requirements did not significantly differ but trended towards being reduced in POST patients (P = 0.0782 and 0.0926, respectively). Post-op opiate requirement was significantly reduced in the POST group (P < 0.0001). There were no significant differences between revenues, expenses, and margins between the two groups (P > 0.05);however, there was a trend towards an increased operating margin in the POST group ($4,554 vs $2,151, p = 0.1163). Bed unit cost was significantly lower in the POST group ($210 vs $533, P < 0.0001). Conclusions: In patients undergoing female pelvic reconstructive surgery, an early recovery after surgery protocol facilitated transfer of procedures to an outpatient surgical site and permitted same-day discharge without increasing complications, clinic visits, or emergency room visits. It may also reduce cost and improve operating margins to hospital systems.

Doing Remote Controlled Studies with Humans: Tales from the COVID Trenches

How should empirical researchers conduct controlled, remote 'lab' studies in the uncontrolled, noisy conditions of each participant's own home? Volatility in participant home environments, hardware, internet connection, and surrounding distractions takes the 'controlled' out of controlled studies. This paper recounts our in-The-Trenches mitigations for designing and conducting two complex controlled studies under COVID, in which participants, from home, interactively localized faults in an AI system. The studies with our COVID-era mitigations in 5 categories-Privacy/Security, Data Collection, Control, Technology Issues, Payment-ultimately produced crisp results beyond what we thought possible under such uncontrolled circumstances. © 2021 IEEE.