Citations

Objectives: Traditional hospital at home models often have high patient experience scores. The purpose of this study is to look at the patient experience of a new virtual hybrid model of hospital at home called Advanced Care at Home. Methods: Patients in Mayo Clinic’s Advanced Care at Home program received a survey via email from 1 January–31 May 2021. Each survey consisted of 20 questions divided into 18 multiple-choice and two open-ended questions. Results: Ninety-nine surveys were sent and 41 partially or completely finished surveys were returned for a response rate of 41.4%. Patients responded positively, denoted by answering “strongly agree or somewhat agree,” with regard to the ability to reach the team right away 100% of the time, being kept informed 92% of the time, the command center responding promptly to their needs 95% of the time, the team providing comfort and support 98% of the time, feeling comfortable with interacting with their provider by phone or tablet 95% of the time, the ease of use from the equipment 97% of the time, the virtual and in-person staff working well together 98% of the time, the staff treating patients with courtesy and respect 100% of the time, and the ease of understanding the discharge process and feeling ready to leave the program 100% of the time. All providers received positive responses on listening ⩾88% of the time. Patients gave a top rating in likelihood to recommend the program 100% of the time. Conclusion: Overall, the Advanced Care at Home model of hospital at home was highly recommended by patients. Patients scored the program high on responsiveness, staff engagement and communication, ease of equipment use, and readiness for discharge, strengthening the overall confidence in this novel program.

AbstractDrug‐resistant epilepsy (DRE) is characterized by recurrent seizures despite appropriate treatment with antiseizure medication (ASM). Due to their regenerative and immunomodulatory potential, therapies with biologics such as mesenchymal stem cells (MSCs) offer a potential therapeutic benefit for structural causes of epilepsy, such as hippocampal sclerosis. In this article, we report a systematic review of the literature evaluating the preclinical and clinical studies of MSCs for DRE. Medline, Ovid EMBASE, Scopus, and the Cochrane Databases were searched electronically from their dates of inception to November 2021 using the following keywords: ((“mesenchymal”) AND (“stem cell”)) AND ((“epilepsy”) OR (“convulsion”) OR (“seizures”)). This review followed Preferred Reporting Items for Systemic Reviews and Meta‐Analyses (PRISMA) guidelines. The initial query identified 488 studies representing 323 unique manuscripts. After application of selection criteria, 15 studies were included in this systematic review; 11 were preclinical studies and 4 were clinical studies. All preclinical studies were performed in rodents and all clinical studies were phase 1 trials. Thus far, therapy with MSCs appears to be safe for use in humans, as no severe adverse events related directly to the therapy were reported. Furthermore, MSC therapy appears to provide a statistically significant clinical benefit by reducing the seizure burden of patients, reducing the electrophysiological biomarkers of epilepsy, and improving their comorbidities, such as depression and anxiety. In addition, animal studies reveal that the therapy exerts its effect by reducing aberrant mossy fiber sprouting (reduce excitatory pathways) and increasing γ‐aminobutyric acid (GABA)ergic interneurons (increase inhibitory pathways). Both preclinical and clinical studies have shown MSC therapy to be safe and preliminary effective, thus warranting further studies to investigate its therapeutic potential.

Background Patients with mild to severe chronic systemic disease undergoing low-risk procedures are often hospitalized for observation. The Care Hotel is a novel virtual medicine hybrid model of care that offers patients a comfortable, out of hospital environment where they can receive both in-person and virtual care after a surgery or procedure. This study aimed to analyze if virtual hybrid post-procedure care in a hotel could be both conducted on and accepted by patients, even those with moderate to severe chronic diseases. Methods This retrospective cohort study was conducted between July 23, 2020 and June 4, 2021 at Mayo Clinic in Florida, a 306-bed community academic hospital. We collected the sex, age, race, ethnicity, acceptance rate, ASA score, and primary procedure of patients using the Care Hotel. Results Out of 392 patients, 272 (69.4%) opted for care in the program. Median patient age was 61.5 years, 59.56% were males, and 86.40% were white. We found that 50.37% had an ASA score of 2 and 43.4% had an ASA score of 3. Ten different surgical specialties were able to utilize the Care Hotel for care in 47 different procedure types. Urology had the most patients (n=70, 25.7%). Post-electrophysiologic procedures were the most common procedures (n=39, 14.3%). Conclusion Our virtual hybrid Care Hotel program was widely accepted by patients and could care for a multitude of post-operative procedures. Additionally, this novel program can care for patients with both mild and severe systemic diseases.

AbstractInhaled treprostinil is an approved therapy for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease in the United States. Studies have confirmed the robust benefits and safety of nebulized inhaled treprostinil, but it requires a time investment for nebulizer preparation, maintenance, and treatment. A small, portable treprostinil dry powder inhaler has been developed for the treatment of PAH. The primary objective of this study was to evaluate the safety and tolerability of treprostinil inhalation powder (TreT) in patients currently treated with treprostinil inhalation solution. Fifty‐one patients on a stable dose of treprostinil inhalation solution enrolled and transitioned to TreT at a corresponding dose. Six‐minute walk distance (6MWD), device preference and satisfaction (Preference Questionnaire for Inhaled Treprostinil Devices [PQ‐ITD]), PAH Symptoms and Impact (PAH‐SYMPACT®) questionnaire, and systemic exposure and pharmacokinetics for up to 5 h were assessed at baseline for treprostinil inhalation solution and at Week 3 for TreT. Adverse events (AEs) were consistent with studies of inhaled treprostinil in patients with PAH, and there were no study drug‐related serious AEs. Statistically significant improvements occurred in 6MWD, PQ‐ITD, and PAH‐SYMPACT. Forty‐nine patients completed the 3‐week treatment phase and all elected to participate in an optional extension phase. These results demonstrate that, in patients with PAH, transition from treprostinil inhalation solution to TreT is safe, well‐tolerated, and accompanied by statistically significant improvements in key clinical assessments and patient‐reported outcomes with comparable systemic exposure between the two formulations at evaluated doses (trial registration: clinicaltrials.gov identifier: NCT03950739).

Objective: Controversy exists as to whether platelet inhibition testing is necessary prior to aneurysm treatment in patients premedicated with antiplatelet agents. Using the IntrePED ( Int ernational Re trospective Study of P ipeline E mbolization D evice) registry, we studied complication rates in platelet-testing and non-platelet testing groups to determine if platelet testing is associated with improved outcomes. Materials and Methods: Patients with unruptured intracranial aneurysms from the INTREPED registry were divided into those who received platelet testing (testing group) and those who did not (nontesting group). Morbidity, mortality and thrombotic and hemorrhagic complication rates were studied. Comparisons between groups for continuous variables were evaluated using t -tests and Fisher’s exact test or Pearson’s chi-square for binary categorical variables. Multivariate logistic regression analysis was performed to determine if platelet function testing was independently associated with poor outcomes adjusting for age, number of devices, aneurysm location, size, and use of multiple exchange wires. Results: When compared to the non-testing group, the platelet testing group suffered higher rates of ipsilateral intracranial hemorrhage (12/511, 2.3% versus 0/187, 0.0%, P=0.04), neurological morbidity (42/511, 8.2% versus 4/187, 2.1%, P=0.01), and combined neurological morbidity and mortality (45/511, 8.8% versus 6/187, 3.2%, P=0.01). More patients in the testing group were treated with multiple PEDs (228 patients, 38.1% versus 57 patients, 28.4%, P=0.01). On multivariate analysis, the platelet testing group had a higher odds of total major morbidity (OR=3.80, 95%CI=1.30=11.08, P=0.01) and total major morbidity and neurological mortality (OR=2.74, 95%CI=1.11-6.79). Conclusion: Our findings caution against blind acceptance of platelet testing in Pipeline patients. Further prospective studies are needed to determine if and when platelet testing in Pipeline patients is appropriate.

Objective: This study seeks to investigate the impact of antithrombotics, including Aspirin, Clopidogrel, and Warfarin, on the severity of bleeding and outcomes in patients with subarachnoid hemorrhage (SAH). We hypothesize that patients with a history of antithrombotic use have a more severe injury from SAH. Methods: Two hundred twenty-eight patients admitted to the Mayo Clinic Florida consecutively between July 2008 and July 2011 were studied retrospectively. Of this group, 77 patients had a known history of antithrombotic use while 151 did not. Both aneurysmal and non-aneurysmal cases were included in the study. Each patient’s Hunt and Hess Score, Fisher Grade, modified Rankin Scale (mRS) and Glasgow Coma Scale (GCS) were evaluated. Associations between history of antithrombotic use and severity of SAH were assessed using Spearman’s test of correlation and Mann-Whitney tests. Results: There was strong evidence of higher mRS grades in patients with a history of antithrombotic use compared to other patients (Median: 3 vs. 2, P=0.001). There was no significant difference between patients with and without a history of antithrombotic use regarding SAH Fisher grade (Median: 3 vs. 3, P=0.31) and Hunt and Hess score (Median: 2 vs. 2, P=0.93). The difference in GCS score was not statistically significant (Median: 14 vs. 15, P=0.20). Conclusion: This analysis found a significant effect of previous use of antithrombotics on overall outcome following SAH. Further analysis is needed to correlate the outcomes with specific medications and investigate the role of aggressive reversal of coagulopathy on overall outcomes.

Evidence has raised concerns regarding the association between funding sources and doubtful data. Our main outcome was to analyze trends on funding sources in articles published from 1990 to 2020 in the more influential journals of internal and general medicine. In this meta-epidemiological study, we included peer-reviewed studies from the 10 highest impact journals in general and internal medicine published between January 1990 and February 2020 based on published original research according to the 2018 InCites Journal of Citation Reports, these consisted of the following: The New England Journal of Medicine, The Lancet, JAMA, BMJ, JAMA Internal Medicine, Annals of Internal Medicine, PLOS Medicine, Cachexia, BMC Medicine, and Mayo Clinic Proceedings. Two reviewers working in duplicate extracted data regarding year of publication, study design, and sources of funding. In total, 496 articles were found; of these, 311 (62.7%) were observational studies, 167 (33.7%) were experimental, and 16 (3.2%) were secondary analyses. Percentages of grant sources through the years were predominantly from government (60%), industry (23.83%), and non-governmental (16.06%) organizations. The percentage of industry subsidies tended to decrease, but this was not significant in a linear regression model (r=0.02, p≥0.05). Government and non-government funding sources showed a trend to decrease in the same univariate analysis with both significant associations (r=0.21, p ≤0.001 and r=0.10, p≤0.001, respectively). The main funding source in medical research has consistently been government aid. Despite previous reported data, no association was found between the source of funding and statistically significant results favoring study authors’ hypothesis.

Abstract Background: Endocrine therapy (ET) reduces breast cancer (BC) recurrence risk and improves BC outcomes. However, patients (pts) may refuse ET, potentially impacting their outcomes. However, the exact incidence and factors associated with ET refusal are largely unknown. Methods: We conducted a retrospective study of BC pts in the National Cancer Data Base between 2003 and 2017. Demographic, socioeconomic, co-morbidity index and tumor-specific data were compared between BC pts who refused ET versus those who agreed to ET using bivariate and multivariate models. Female pts 18 to 89 years of age with stage I, II, and III were included. Logistic regression was used to determine associations with ET refusal. Results: Among 463,228 pts, the incidence of ET refusal was 5.26% (24, 401). Of these pts, 85% were non-Hispanic White, 7.9% were Non-Hispanic Black, 3.1% non-Hispanic Asian/pacific islander, and 3.6% were Hispanic. A majority (56.9%) had government insurance, and 87.2% were from a metro residential area. Infiltrating ductal carcinoma BC subtype comprised 78% of pts. Most pts were 51-89 years of age (80%), and 20% were 18-50 years of age. On multivariable analysis (Table 1), non-Hispanic black (OR 0.82), non-Hispanic Asian (OR 0.72), and Hispanic (OR 0.84) pts had a reduced odds of refusing ET than non-Hispanic white pts. Pts with government insurance (OR 1.6, p<0.001) and noninsured pts (OR 1.3, p<0.001) had increased odds of refusing ET compared to privately insured pts. Estrogen receptor (ER) -/Progesterone (PR) +, and ER +/PR - had increased odds of refusing therapy (OR 2.9, and 1.1 respectively, p<0.001) than ER +/PR + pts. Patients with positive lymph nodes had reduced odds of refusing ET than those with negative lymph nodes (p<0.001). Additionally, pts with a 2.1-5 cm (OR 0.92) or >5 cm (OR 0.87) tumor size had a reduced odd of refusing ET than those with tumors less than 2 cm (p<0.001). Finally, patients with well-differentiated BC (grade I) had increased odds of refusing ET (OR 1.2, p<0.001) than moderately differentiated (grade II) BC. Conclusions: The incidence of ET therapy refusal is relatively low; however, survival outcomes may be negatively impacted. This is the first study to evaluate specific demographic and disease-specific factors associated with ET refusal, which can inform strategies to improve ET acceptance rate. Table 1.Multivariable Logistic Regression – ET Therapy Acceptance (Referent) vs. Refusal.VariableOR95% CIp-valueAge51 - 89 years18 - 50 years0.940.900.970.001Race/EthnicityWhite Non-HispanicBlack Non-Hispanic0.820.760.88<0.001Pacific Islander Non-Hispanic0.720.660.76<0.001Hispanic0.840.790.87<0.001InsurancePrivateGovernment1.61.521.61<0.001Not insured1.31.181.47<0.001ResidenceMetroUrban0.900.870.87<0.001Rural0.870.780.970.014HistologyInfiltrating ductal carcinomaLobular carcinoma0.840.800.87<0.001Infiltrating duct and lobular carcinoma0.900.850.95<0.001Others1.171.101.24<0.001Positive Nodes01 - 30.620.600.65<0.0014 - 90.610.570.66<0.00110 +0.610.550.68<0.001VariableOR95% CIp-valueER/PR ExpressionER +/PR +ER -/PR +2.92.563.18<0.001ER +/PR -1.11.061.14<0.001Tumor size≤ 2 cm2.1 - 5 cm0.920.880.94<0.001> 5 cm0.870.800.93<0.001GradeIII1.211.181.25<0.001III0.980.951.020.518Charlson-Deyo Score010.940.910.980.00421.070.991.150.071≥31.120.981.280.079 Citation Format: Pooja P Advani, Ricardo Torres Guzman, Francisco Avila Verduzco, Karla Maita, John Garcia, Abdullah Eldaly, Antonio Forte, Aaron Spaulding. Factors associated with endocrine therapy refusal in hormone receptor-positive breast cancer patients [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P5-14-16.