Citations

Objective To develop and implement criteria for description of post COVID syndrome based on analysis of patients presenting for evaluation at Mayo Clinic Rochester between November 2019 and August 2020. Methods A total of 465 patients with a history of testing positive for COVID-19 were identified and their medical records reviewed. After a thorough review, utilizing the DELPHI methods by an expert panel, 42 (9%) cases were identified with persistent central sensitization (CS) symptoms persisting after the resolution of acute COVID-19, herein referred to as Post COVID syndrome (PoCoS). In this report we describe the baseline characteristics of these PoCoS patients. Results Among these 42 PoCoS patients, the mean age was 46.2 years (median age was 46.5 years). Pain (90%), fatigue (74%), dyspnea (43%), and orthostatic intolerance (38%) were the most common symptoms. The characteristics of an initial 14 patients were utilized for the development of clinical criteria via a modified Delphi Method by a panel of experts in central sensitization disorders. These criteria were subsequently applied in the identification of 28 additional cases of suspected PoCoS. A 2-reviewer system was used to analyze agreement with using the criteria, with all 28 cases determined to be either probable or possible cases by the reviewers. Inter-reviewer agreement using these proposed defining criteria was high with a Cohen’s alpha of .88. Conclusions Here we present what we believe to be the first definitional criteria for Post COVID syndrome. These may be useful in clinical phenotyping of these patients for targeted treatment and future research.

Objective Persistent post-COVID symptoms are estimated to occur in up to 10% of patients who have had COVID-19. These lingering symptoms may persist for weeks to months after resolution of the acute illness. This study aimed to add insight into our understanding of certain post-acute conditions and clinical findings. The primary purpose was to determine the persistent post COVID impairments prevalence and characteristics by collecting post COVID illness data utilizing Patient-Reported Outcomes Measurement Information System (PROMIS ® ). The resulting measures were used to assess surveyed patients physical, mental, and social health status. Methods A cross-sectional study and 6-months Mayo Clinic COVID recovered registry data were used to evaluate continuing symptoms severity among the 817 positive tested patients surveyed between March and September 2020. The resulting PROMIS ® data set was used to analyze patients post 30 days health status. The e-mailed questionnaires focused on fatigue, sleep, ability to participate in social roles, physical function, and pain. Results The large sample size (n = 817) represented post hospitalized and other managed outpatients. Persistent post COVID impairments prevalence and characteristics were determined to be demographically young (44 years), white (87%), and female (61%). Dysfunction as measured by the PROMIS ® scales in patients recovered from acute COVID-19 was reported as significant in the following domains: ability to participate in social roles (43.2%), pain (17.8%), and fatigue (16.2%). Conclusion Patient response on the PROMIS ® scales was similar to that seen in multiple other studies which used patient reported symptoms. As a result of this experience, we recommend utilizing standardized scales such as the PROMIS ® to obtain comparable data across the patients’ clinical course and define the disease trajectory. This would further allow for effective comparison of data across studies to better define the disease process, risk factors, and assess the impact of future treatments.

Abstract The raging COVID-19 pandemic in India and reports of “vaccine breakthrough infections” globally have raised alarm mandating the characterization of the immuno-evasive features of SARS-CoV-2. Here, we systematically analyzed over 1.3 million SARS-CoV-2 genomes from 178 countries and performed whole-genome viral sequencing from 53 COVID-19 patients, including 20 vaccine breakthrough infections. We identified 116 Spike protein mutations that increased in prevalence during at least one surge in SARS-CoV-2 test positivity in any country over a three-month window. Deletions in the Spike protein N-terminal domain (NTD) are highly enriched for these ‘surge-associated mutations’ (Odds Ratio = 18.2, 95% CI: 7.53-48.7; p=1.465x10-18). In the recent COVID-19 surge in India, an NTD deletion (ΔF157/R158) increased over 10-fold in prevalence from February 2021 (1.1%) to April 2021 (15%). During the recent surge in Chile, an NTD deletion (Δ246-253) increased rapidly over 30-fold in prevalence from January 2021 (0.86%) to April 2021 (33%). Strikingly, these simultaneously emerging deletions associated with surges in different parts of the world both occur at an antigenic supersite that is targeted by neutralizing antibodies. Finally, we generated clinically annotated SARS-CoV-2 whole genome sequences and identified deletions within this NTD antigenic supersite in a patient with vaccine breakthrough infection (Δ156-164) and other deletions from unvaccinated severe COVID-19 patients that could represent emerging deletion-prone regions. Overall, the expanding repertoire of Spike protein deletions throughout the pandemic and their association with case surges and vaccine breakthrough infections point to antigenic minimalism as an emerging evolutionary strategy for SARS-CoV-2 to evade immune responses. This study highlights the urgent need to sequence SARS-CoV-2 genomes at a larger scale globally and to mandate a public health policy for transparent reporting of relevant clinical annotations (e.g. vaccination status) in order to aid the development of comprehensive therapeutic strategies.

Abstract Background Home enteral nutrition (HEN) use continues to increase in children unable to meet nutritional needs through oral intake. Some patients do not tolerate standard polymeric formula (SPF), which may lead to malnutrition. Use of peptide‐based diet (PBD) has demonstrated benefits in adults, however there remains a paucity of data in pediatric population. Methods Retrospective review of medical records of children receiving HEN between October 2015 and October 2019 was conducted. Nutrition, tolerance, and healthcare utilization was tracked through May 2020. Children receiving PBD as initial formula or transitioned to PBD from SPF were included. Our objective was to assess gastrointestinal tolerance and impact on healthcare utilization in children receiving PBD. Results During study period, 30 children (mean age, 9 ± 5.44 years; 20 of 30 [66.7%] male) utilized PBDs. Twenty‐one patients started PBD directly with malnutrition as primary indication. Nine patients transitioned from SPF to PBD, most often due to intolerance of SPF (66%). After transition to PBD, no symptoms were reported in 6 of 9 (66.7%) patients, and symptoms of SPF intolerance resolved in 4 of 9 (44.5%) patients. Healthcare utilization declined significantly after transition to PBD, including mean numbers of emergency room visits (0.78 ± 1.09 to 0.11 ± 0.33; P = .025), provider visits (1.67 ± 1.32 to 0.56 ± 0.73; P = .007), and phone calls (1.22 ± 1.39 to 0.33 ± 0.50; P = .026). Conclusions PBD is well tolerated and can result in significant reduction in healthcare utilization in children intolerant to SPF.

Abstract Background: In MONARCH 2, abemaciclib plus fulvestrant significantly improved median progression-free survival (PFS, 16.4 vs 9.3 months, hazard ratio [HR], 0.553) and overall survival (OS, 46.7 vs 37.3 months; HR, 0.757) compared with placebo plus fulvestrant in hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) advanced breast cancer (ABC) patients who were endocrine therapy (ET) resistant, regardless of menopausal status. Here, we report findings in the premenopausal subgroup of the MONARCH 2 trial. Methods: The premenopausal subgroup included patients with natural menstrual bleeding who received a gonadotropin-releasing hormone agonist at least 4 weeks prior to study treatment start date and for the entire study duration. Of the 669 patients enrolled in the MONARCH 2 trial, 114 were premenopausal (abemaciclib plus fulvestrant, n=72; placebo plus fulvestrant, n=42), and were included in this analysis. The primary objective was investigator-assessed PFS and secondary objectives were OS, objective response rate, and safety and tolerability. Exploratory analyses included time to second disease progression (PFS2), time to chemotherapy (TTC), and chemotherapy-free survival (CFS). Results: At the primary objective cutoff (14 February, 2017), median PFS was not reached for the abemaciclib plus fulvestrant arm versus 10.52 months for the placebo plus fulvestrant arm (HR, 0.415; 95% CI, 0.246-0.698). At the pre-specified OS interim cutoff (20 June, 2019), median PFS was 28.6 months in the abemaciclib plus fulvestrant arm compared with 10.26 months in the placebo plus fulvestrant arm (HR, 0.477; 95% CI, 0.302-0.755). OS benefit was observed in the abemaciclib plus fulvestrant compared to fulvestrant alone (HR, 0.689; 95% CI, 0.379-1.252, median, not reached vs 47.3 months). Improvements were also observed for the exploratory outcomes of PFS2 (HR, 0.599), TTC (HR, 0.674), and CFS (HR, 0.642) with the addition of abemaciclib to fulvestrant. The safety profile was generally consistent with results disclosed previously. Conclusions: Results of the premenopausal subgroup in the MONARCH 2 trial were consistent with the improved clinical outcomes observed in the intent-to-treat population. The analysis provides support for the use of abemaciclib plus fulvestrant (with ovarian suppression) as an effective treatment option for premenopausal patients with HR+, HER2- ABC who are ET-resistant. Clinical trial registration: NCT02107703. Registered 08 April 2014- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02107703

Purpose The purpose of the present study was to investigate body mass index, multi-morbidity, and COVID-19 Risk Score as predictors of severe COVID-19 outcomes. Patients Patients from this study are from a well-characterized patient cohort collected at Mayo Clinic between January 1, 2020 and May 23, 2020; with confirmed COVID-19 diagnosis defined as a positive result on reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assays from nasopharyngeal swab specimens. Measures Demographic and clinical data were extracted from the electronic medical record. The data included: date of birth, gender, ethnicity, race, marital status, medications (active COVID-19 agents), weight and height (from which the Body Mass Index (BMI) was calculated, history of smoking, and comorbid conditions to calculate the Charlson Comorbidity Index (CCI) and the U.S Department of Health and Human Services (DHHS) multi-morbidity score. An additional COVID-19 Risk Score was also included. Outcomes included hospital admission, ICU admission, and death. Results Cox proportional hazards models were used to determine the impact on mortality or hospital admission. Age, sex, and race (white/Latino, white/non-Latino, other, did not disclose) were adjusted for in the model. Patients with higher COVID-19 Risk Scores had a significantly higher likelihood of being at least admitted to the hospital (HR = 1.80; 95% CI = 1.30, 2.50; P < .001), or experiencing death or inpatient admission (includes ICU admissions) (HR = 1.20; 95% CI = 1.02, 1.42; P = .028). Age was the only statistically significant demographic predictor, but obesity was not a significant predictor of any of the outcomes. Conclusion Age and COVID-19 Risk Scores were significant predictors of severe COVID-19 outcomes. Further work should examine the properties of the COVID-19 Risk Factors Scale.

Objective The purpose of this study was to determine self-reported knowledge, attitudes, prior experience, and perceived needs for the management of overweight and obese patients within a General Internal Medicine Practice. Patients and Methods An emailed cross-sectional survey was sent between June 20, 2019 and September 12, 2019 to 194 healthcare workers (93 primary care providers (PCPs) and 101 nurses) which focused on management of patients with weight issues. Results In total, 80 of the eligible 194 participants completed the survey (nurses = 42, PCPs = 38). Up to 87% were white, 74.7% female (74.7%). Most of the responders were either in the age group of 30’s (30%) or 50’s (30%). Among the responders, 48.8% reported some type of specialty training in weight management since their medical training with lectures being the most common form of training (36%). When asked about their interest in either weight management training or strategies to initiate weight conversations, 79% of the respondents reported an interest in education on weight management or strategies to initiate weight conversations, while 65.8% indicated they would be interested in both topics. Conclusion Our study suggests that healthcare workers have a self-reported need for further training in management of overweight and obese patients, irrespective of previous training in this area.

Objective To describe the process and outcome of creating a patient cohort in the early stages of the COVID-19 pandemic in order to better understand the process of and predict the outcomes of COVID-19. Patients and Methods A total of 1169 adults aged 18 years of age or older who tested positive in Mayo Clinic Rochester or the Mayo Clinic Midwest Health System between January 1 and May 23 of 2020. Results Patients were on average 43.9 years of age and 50.7% were female. Most patients were white (69.0%), and Blacks (23.4%) and Asians (5.8%) were also represented in larger numbers. Hispanics represented 16.3% of the sample. Just under half of patients were married (48.4%). Common comorbid conditions included: cardiovascular diseases (25.1%), dyslipidemia (16.0%), diabetes mellitus (11.2%), chronic obstructive pulmonary disease (6.6%), asthma (7.5%), and cancer (5.1%). All other comorbid conditions were less the 5% in prevalence. Data on 3 comorbidity indices are also available including the: DHHS multi-morbidity score, Charlson Comorbidity Index, and Mayo Clinic COVID-19 Risk Factor Score. Conclusion In addition to managing the ever raging pandemic and growing death rates, it is equally important that we develop adequate resources for the investigation and understanding of COVID-19-related predictors and outcomes.

AbstractEnteral nutrition (EN) is a widely used therapeutic tool to provide nutrition support for patients with various clinical conditions, including different types of cancer. Head and neck cancers, often complicated by dysphagia, are among leading indications for enteral feeding. Percutaneous endoscopic gastrostomy (PEG) and percutaneous endoscopic jejunostomy (PEJ) tubes are typically used to deliver EN. This article presents a case report of a young male with squamous cell carcinoma of the tongue. Unfortunately, he developed metastasis of his cancer at the right lateral side of the PEG placement site, requiring surgical resection of seeded growth at the PEG site. This rare complication can be challenging, as it requires a high index of suspicion to diagnose and can potentially limit nutrition support options. A number of theories have been proposed to explain seeding during PEG/PEJ placement, including direct repositioning of malignant cells during instrumentation. A specific placement technique has not been shown to be superior, as seeding was reported with all placement techniques. However, given the lack of statistically powerful studies to describe this entity, there are still gaps we need to explore to better understand seeding of feeding tubes and best practices around diagnosis and early treatment. EN continues to be an important part of caring for patients with cancer during active or palliative treatments. Understanding potential risks in the setting of cancer metastasis is beneficial to the patients and multidisciplinary teams involved. Early recognition of possible seeding of feeding tube sites is necessary to ensure subsequent timely surgical intervention.

Abstract The purpose of this scoping review by the American Society for Parenteral and Enteral Nutrition (ASPEN) Coronavirus Disease 2019 (COVID‐19) Nutrition Task Force was to examine nutrition research applicable to the COVID‐19 pandemic. The rapid pace of emerging scientific information has prompted this activity to discover research/knowledge gaps. This methodology adhered with recommendations from the Joanna Briggs Institute. There were 2301 citations imported. Of these, there were 439 articles fully abstracted, with 23 main topic areas identified across 24 article types and sourced across 61 countries and 51 specialties in 8 settings and among 14 populations. Epidemiological/mechanistic relationships between nutrition and COVID‐19 were reviewed and results mapped to the Population, Intervention, Comparator, Outcome, and Time (PICO‐T) questions. The aggregated data were analyzed by clinical stage: pre–COVID‐19, acute COVID‐19, and chronic/post–COVID‐19. Research gaps were discovered for all PICO‐T questions. Nutrition topics meriting urgent research included food insecurity/societal infrastructure and transcultural factors (pre–COVID‐19); cardiometabolic‐based chronic disease, pediatrics, nutrition support, and hospital infrastructure (acute COVID‐19); registered dietitian nutritionist counseling (chronic/post–COVID‐19); and malnutrition and management (all stages). The paucity of randomized controlled trials (RCTs) was particularly glaring. Knowledge gaps were discovered for PICO‐T questions on pediatrics, micronutrients, bariatric surgery, and transcultural factors (pre–COVID‐19); enteral nutrition, protein‐energy requirements, and glycemic control with nutrition (acute COVID‐19); and home enteral and parenteral nutrition support (chronic/post–COVID‐19). In conclusion, multiple critical areas for urgent nutrition research were identified, particularly using RCT design, to improve nutrition care for patients before, during, and after COVID‐19.