Cardiovascular toxicities associated with bispecific T-cell engager therapy.

BACKGROUND: Bispecific T-cell engagers (BTEs) are novel agents used to treat hematological malignancies. Early trials were underpowered to define cardiovascular adverse events (CVAE) and no large-scale studies systematically examined the CVAEs associated with BTEs. METHODS: Leveraging the US Food and Drug Administration's Adverse Event Reporting System-(FAERS), we identified the relative frequency of CVAEs after initiation of five BTE products approved by the Food and Drug Administration between 2014 and 2023 for the treatment of hematological malignancies. Adjusted reporting ORs (aROR) were used to identify disproportionate reporting of CVAEs with BTEs compared with background rates in the database. Fatality rates and risk ratios (RRs) for each adverse event (AE) were calculated. RESULTS: From 3668 BTE-related cases reported to FAERS, 747 (20.4%) involved CVAEs. BTEs as a class were associated with fatal CVAEs (aROR 1.29 (95% CI 1.12 to 1.50)), an association mainly driven by teclistamab (aROR 2.44 (95% CI 1.65 to 3.60)). Teclistamab was also associated with a disproportionate risk of myocarditis (aROR 25.70 (95% CI 9.54 to 69.23)) and shock (aROR 3.63 (95% CI 2.30 to 5.74)), whereas blinatumomab was associated with a disproportionate risk of disseminated intravascular coagulation (aROR 3.02 (95% CI 1.98 to 4.60)) and hypotension (aROR 1.59 (95% CI 1.25 to 2.03)). CVAEs were more fatal compared with non-CVAEs (31.1% vs 17.4%; RR 1.76 (95% CI 1.54 to 2.03)). Most CVAEs (83.3%) did not overlap with cytokine release syndrome. CONCLUSION: In the first postmarketing surveillance study of BTEs, CVAEs were involved in approximately one in five AE reports and carried a significant mortality risk.

Addressing Social Determinants of Health in Maternal Cardiovascular Health.

Cardiovascular diseases (CVDs) remain the number-one cause of maternal mortality, with over two-thirds of cases being preventable. Social determinants of health (SDoH) encompass the nonmedical social and environmental factors that an individual experiences that have a significant impact on their health. These stressors disproportionately affect socially disadvantaged and minority populations. Pregnancy is a physiologically stressful state that can unmask underlying CVD risk factors and lead to adverse pregnancy outcomes (APOs). Disparities in APOs are particularly pronounced among individuals of color and those from economically disadvantaged backgrounds. This variation underscores healthcare inequity and access, a failure of the healthcare system. Besides short-term negative effects, APOs also are associated strongly with long-term CVDs. APOs therefore must be identified as a cue for early intervention, for the prevention and management of CVD risk factors. This review explores the intricate relationship among maternal morbidity and mortality, SDoH, and cardiovascular health, and the implementation of health policy efforts to reduce the negative impact of SDoH in this patient population. The review emphasizes the importance of comprehensive strategies to improve maternal health outcomes.

Clinical Outcomes of ULTRA EZY Bar vs Erich Arch Bar in Conservative Management of Maxillofacial Fractures: A Randomized Controlled Trial.

Objective: Various techniques have been employed from time to time to achieve maxillomandibular fixation, and arch bars provide an effective and versatile means of maxillomandibular fixation, and however, some of the issues occurring with it have been eliminated with the introduction of Ultralock EZY bar. The aim of the present study is to compare the advantages and disadvantages of Ultralock Ezy bar over the Erich arch bar in mid-face fracture or maxillary fracture or mandibular fracture or both requiring conservative treatment. Materials and Methods: A total of 20 patients reported to the Department of Oral and Maxillofacial Surgery in Sudha Rustagi Dental College and Hospital, Faridabad, with mid-face fracture/maxillary fracture, mandibular fracture or both. The treatment plan required intermaxillary fixation. As a part of treatment plan, group was selected randomly divided into 20 arches in each group that is test arch group and control arch group.Test arch group included arches in which Ultralock EZY bar was done. Control arch group included arches in which Erich arch bar was done. The parameters compared in both the groups were surgical time taken, injuries due to wires, arch bar stability, oral hygiene index, patient acceptance and comfort, pulp vitality, and complication (if any). Results: The average surgical time taken was less, and oral hygiene status and patient acceptance were better in test group. There was not much statistically significant difference in pulp vitality but number of cases with absence of pulp vitality were more in test group. Conclusion: This study emphasizes the use of Ultralock Ezy bar as a quick and easy method than Erich arch bar. Oral hygiene maintenance was comparatively better in patients with Ultralock Ezy bar than those with Erich arch bar. For the patients who require long-term IMF, Ultralock Ezy bars can be a viable option. Supplementary Information: The online version contains supplementary material available at 10.1007/s12663-022-01821-3.

Mid-life adherence to the Dietary Approaches to Stop Hypertension (DASH) diet and late-life subjective cognitive complaints in women.

INTRODUCTION: Evidence is limited on the role of mid-life Dietary Approaches to Stop Hypertension (DASH) diet in late-life subjective cognitive complaints (SCCs). METHODS: We included 5116 women (mean age in 1985-1991: 46 years) from the New York University Women's Health Study. SCCs were assessed from 2018 to 2020 (mean age: 79 years) by a 6-item questionnaire. RESULTS: Compared to women in the bottom quartile of the DASH scores, the odds ratio (OR) for having two or more SCCs was 0.83 (95% confidence interval: 0.70-0.99) for women in the top quartile of DASH scores at baseline (P for trend = 0.019). The association was similar with multiple imputation and inverse probability weighting to account for potential selection bias. The inverse association was stronger in women without a history of cancer (P for interaction = 0.003). DISCUSSION: Greater adherence to the DASH diet in mid-life was associated with lower prevalence of late-life SCCs in women.

Concurrent uterine surgery and uptake of hormone therapy in patients undergoing bilateral salpingo-oophorectomy for risk-reducing or therapeutic indications.

OBJECTIVE: This study aimed to analyze factors associated with concurrent uterine surgery in patients undergoing bilateral salpingo-oophorectomy (BSO) for risk reducing or therapeutic purposes. Additionally, trends in surgical choice and uptake of post-operative hormone therapy (HT) were examined. METHODS: A 10-year retrospective study was conducted on patients who underwent risk-reducing or therapeutic BSO at one institution. Multinomial regression analysis of patient and case characteristics was performed evaluating associations with surgery type (BSO, BSO and hysterectomy, or BSO and endometrial sampling). Trends in surgery type and uptake of HT post operatively are described. RESULTS: Among the study sample of 643 patients, 140 (22%) patients underwent therapeutic BSO for a history of hormone receptor (HR) positive breast cancer, while the remainder underwent risk-reducing BSO due to a pathogenic variant and/or family history. Pathogenic variants included BRCA1 (141, 40%) BRCA2 (173, 49%), and Lynch syndrome genes (15, 4%). Regression analysis revealed significant associations between concurrent hysterectomy and Black race (RR = 3.55, CI = 1.51-8.38, p = 0.004), history of HR positive breast cancer (RR = 1.88, CI = 1.03-3.42, p = 0.04), and surgeon (Surgeon 1, RR = 2.43, CI = 1.36-4.35, p = 0.003). Among eligible patients under age 51, 36% initiated HT. Over the study period, concurrent hysterectomy rates declined while endometrial sampling increased. CONCLUSIONS: Rates of hysterectomy declined over the study period and slightly more than one-third of eligible patients utilized post-operative HT. Further research on concurrent uterine surgery is needed to establish standardized treatment recommendations in the risk-reducing and therapeutic BSO population. Additionally, education regarding the benefits of postoperative HT in eligible patients is warranted.

Non-COVID-19 Cutaneous Mucormycosis from a Plastic Surgical Perspective.

Background Cutaneous mucormycosis is a rare and fulminant infection associated with high mortality. Plastic surgeons come across this infection in the settings of road traffic accidents, surgical site infections, and as a secondary infection with underlying bacterial soft tissue infections. Due to this infection's rarity and aggressive course, it is essential to initiate prompt multidisciplinary management at the first presentation. With this study, we aim to present a protocol for managing the condition. Methods This is a retrospective observational study of patients with cutaneous mucormycosis managed at a tertiary care hospital from January 1, 2016 to November 30, 2022 excluding patients with mucormycosis who tested positive for coronavirus disease 2019. Results Of 24 patients, 22 were males, and most were in the age group of 41 to 60 years. Sixteen patients survived and five out of eight deceased had comorbidities, six presented primarily without prior debridement, and six had trunk involvement. Conclusion A high index of clinical suspicion is necessary for early diagnosis and management of patients with invasive cutaneous mucormycosis. A multidisciplinary approach with appropriate medical and surgical management can improve outcomes in cases that otherwise carry a high mortality rate.

Rheumatoid Arthritis and Cognitive Impairment or Dementia: An Updated Review of Epidemiological Data.

Rheumatoid arthritis (RA) is hypothesized to be associated with cognitive impairment and dementia, including Alzheimer's disease, through shared biological processes related to inflammation. It is important to elucidate this potential relationship as both conditions confer increased morbidity and even mortality among older adults. This narrative review provides a survey of recent epidemiologic studies, examining the association between rheumatoid arthritis and either dementia or cognitive impairment. Sixteen studies were included after searching in PubMed and EMBASE. All were published between 2012 and 2022 and were characterized as epidemiologic studies (either cohort, cross-sectional, or case-control). Studies varied in location, design, measures of exposure and outcome, and covariates considered. Of the 16 studies included, only five found statistically significant positive associations between RA and dementia or cognitive impairment. One study found an inverse relationship, while five studies found no associations at all. The remaining five studies found variable statistically significant associations between demographic or RA disease characteristics and cognitive measures. Given these mixed findings, further studies at both the mechanistic and population level are needed to clarify the possible shared biological underpinnings of these two conditions.

Accurate Posterior Fossa Decompression Technique for Chiari Malformation Type I and a Syringomyelia With Navigation: A Technical Note.

BACKGROUND: Posterior fossa decompression (PFD) has been widely accepted for the surgical treatment for Chiari malformation type I (CM1). However, inadequate decompression causes surgical mortality and complications such as cerebrospinal fluid leakage, meningitis, or progression of syrinx and symptoms. The authors report a novel technique of PFD under navigation. METHODS: Five female patients with CM1 who developed severe symptoms and underwent surgical treatment were evaluated (mean age 14.0 years; mean follow-up 1.3 years). Surgical outcomes, surgical time, intraoperative blood loss, and operative complications were assessed. RESULTS: Four patients with CM1 who developed severe symptoms and underwent surgery were evaluated (mean age 14 years; mean follow-up 1.2 years). All patients were treated with PFD, C1 (and partial C2) laminoplasty to decompress the spinal cord under navigation guidance. Suboccipital craniectomy with 3 cm in diameter around the foramen magnum was performed. The postoperative radiograms and computed tomographic images showed adequate bony resection for CM1. Average surgical time was 114 minutes and average blood loss was 82 mL. There were no postoperative complications. After surgery, the numbness and muscle weakness of the patients were improved. The final follow-up magnetic resonance imaging displayed a good decompression of cerebral tonsile, and cervical syringomyelia was decreased. CONCLUSIONS: PFD under navigation guidance can reduce inappropriate decompression and may decrease a revision surgery. During decompression surgery, cerebrospinal fluid leakage can be prevented using an ultrasonic bone cutter and navigation.

Age Estimation Using the Tooth Coronal Index on Mandibular First Premolars on Digital Panoramic Radiographs in an Indian Population.

Objectives: Age estimation is a crucial aspect of forensic odontology, and the Tooth Coronal Index (TCI) has been widely used for forensic purposes in determining age. The aim of this research was to evaluate the effectiveness of TCI in age estimation. Materials and Methods: A retrospective study was conducted, and TCI was calculated for the mandibular first premolar in 700 digital panoramic radiographs. Age was divided into five groups: 20-30 years, 31-40 years, 41-50 years, 51-60 years, and >61 years. Bivariate correlation was used to establish the relationship between TCI and age. Linear regression was calculated for the different age groups and genders. Inter-observer reliability and agreement were assessed using one-way ANOVA. P-values less than 0.05 were considered statistically significant. Results: Comparison of the mean difference from actual age showed underestimation in males aged 20-30 years and overestimation in males over 60 years of age. The least difference between actual and calculated age was found in females aged 31-40 years. Inter-age comparison using ANOVA for females demonstrated a statistically highly significant difference from actual age in all age groups (P<0.01), with the highest mean in females aged 51-60 years and the lowest in females aged 31-40 years. Inter-group comparison of mean TCI revealed statistically non-significant differences in males and statistically highly significant differences in females (P<0.01). Conclusion: Age estimation using TCI on mandibular first premolars can be recommended as an easy, non-invasive, and less time-consuming method. This study suggests that regression formulas were more accurate for males aged 31-40 years.

Blastocyst or Blastomycosis?: A Rare Presentation of Disseminated Blastomycosis With Cardiac Involvement in Pregnancy.

Disseminated blastomycosis with cardiac manifestations is exceedingly rare. Here we present the first known case of disseminated, cardiac blastomycosis in a pregnant patient. Antifungal medications and a multidisciplinary, nonsurgical approach were successful in eradicating the fungal cardiac mass and in preventing vertical transmission to the fetus. (Level of Difficulty: Advanced.).

External Validation of Three Burn-Specific Mortality Prediction Models in Adult Burn Patients at a Tertiary Care Hospital in India.

Background Several burn-specific mortality prediction models have been formulated and validated in the developed countries. There is a dearth of studies validating these models in the Indian population. Our objective was to validate three such models in the Indian burn patients. Methods A prospective observational study was performed after ethical clearance on consecutive eligible consenting burn patients. Patient demographics, vitals, and results of hematological workup were collected. Using these. the Abbreviated Burn Severity Index (ABSI), the revised Baux score (rBaux), and the Fatality by Longevity, APACHE II score, Measured extent of burn, and Sex score (FLAMES) were calculated. The discriminative ability of the ABSI, rBaux, and the FLAMES was tested using the receiver operating characteristic (ROC) curve at 30 days and the area under the ROC curve (AUROC) compared. A p -value ≤ 0.05 was considered significant. Probability of death was calculated using these models. Hosmer-Lemeshow goodness of fit test was run. Results The ABSI (AUROC 0.7497, 95% CI 0.67796-0.82141), rBaux (AUROC 0.7456, 95% CI 0.67059-0.82068) and FLAMES (AUROC 0.7119, 95% CI 0.63209-0.79172), had fair discriminative ability. The Hosmer-Lemeshow test reported that ABSI and rBaux were a good fit for the Indian population, while FLAMES was not a good fit. Conclusion The ABSI and rBaux had a fair discriminative ability and were a good fit for the adult patients with 30 to 60% thermal and scald burn patients. FLAMES despite having fair discriminative ability was not a good fit for the study population.

A cohort-based nutrition ECHO for community health workers.

Project Extension for Community Healthcare Outcomes (ECHO) Nevada applied the ECHO virtual hub-and-spoke telementoring model over nine 6-week cohorts (between November 2019 and November 2021) supporting community health workers (CHWs) who advise clients with diabetes or pre-diabetes. This study describes the program implementation, including evaluation data collection efforts. Didactic topics included 'Intro to Healthy Eating and Easy Wins' to 'Grocery Shopping, Cooking Tips, Reading Labels, Meal Plans' and 'Reducing Bias and Being a Good Role Model'. Spoke participants signed up to review cases. Seventy-three of the enrolled participants (n = 100) attended three or more of the six sessions. Spoke participants completed 42 case presentations. The average self-efficacy increased from 2.7 [standard deviation (SD): 1.1] before completing the program to 4.1 (SD: 0.8) after completing the program. Average knowledge scores increased from 71 (SD: 16) before completing the program to 83 (SD: 14) after completing the program. Five group interviews drew actionable feedback that was incorporated into the program. Key elements of the ECHO model were successfully incorporated to support educational goals of a cohort of CHWs in nutritional coaching. Our program evaluation data tracking system shows non-significant but encouraging results regarding self-efficacy improvement and knowledge retention.

Incidence and Clinical Presentation of Temporo-Mandibular Joint Disorders and their Association with Psychological Distress and Para-Functional Habits in a Non-Patient Population.

Purpose: The study aims at finding the incidence of temporo-mandibular joint disorders (TMDs) in a non-patient population and relates their association with psychological distress and parafunctional habits. Materials and Methods: A DC/TMD questionnaire and DASS-21 scale survey were completed by selected participants followed by clinical examination of TMDs symptoms in sample population. Results: A study sample of 855 participants revealed 36.65% population with various TMDs symptoms, while 63.5% population had no TMDs symptoms. 50.8% study participants were men, and 49.2% were women. Of all affected population, 16.2% had pain-related TMDs, 12.39% had intra-articular TMDs symptoms, and 8.07% had TMJ pain associated with pain or dysfunction. For all TMDs symptoms groups, the strongest correlations were for depression, while no significant associations were observed with parafunctional habits in all groups. Conclusions: Overall psychological distress and anxiety increased the prospects of TMDs symptoms. Clinical factors like muscle tenderness, crossbite and deep vertical overlap seem to be significant etiological factors, while angle molar relationship and parafunctional habits do not seem to be significant etiologic factors in TMDs.

Minimally traumatic extraction techniques in nonrestorable endodontically treated teeth: A comparative study.

Aim: The goal of this study was to assess the effectiveness of piezotome as compared to periotome extractions of nonrestorable endodontic treatment of teeth in terms of operational time, pain control, and postoperative bone loss considering the prosthetic rehabilitation in future. Materials and Methods: A double-blind, randomized controlled trial was conducted with 100 patients who wanted single-rooted teeth to be extracted (which failed endodontically). The participants have been randomized into two equal groups named as - (i) a periotome group (ii) and a piezotome group. Duration of the surgery, postoperative pain within 7 days, complications (if any) associated with the extraction process were performed as a part of clinical assessment. Bone loss has been analyzed 6 months after the surgery radiographically. The data have been recorded and analyzed using the version 22.0 of the SPSS software package. Results: All parameters in the periotome category (P < 0.05) were statistically significant except for bone loss and gingival laceration in comparison to piezotome group. In the piezotome group, a longer time was observed for surgery and delayed pain control was achieved. In our study, we found statistically significant more marginal bone loss in piezotome group in comparison with periotome group. Conclusion: The findings of this study indicate that for intraoperative and postoperative comfort periotome could be used as a safer and cheaper option for atraumatic extractions but piezosurgery may prove as a better choice soon for surgeries in the maxillofacial region to maintain soft-tissue integrity.

Sex-disaggregated data matters: tracking the impact of COVID-19 on the health of women and men.

Sex and gender matter to health outcomes, but despite repeated commitments to sex-disaggregate data in health policies and programmes, a persistent and substantial absence of such data remains especially in lower-income countries. This represents a missed opportunity for monitoring and identifying gender-responsive, evidence-informed solutions to address a key driver of the pandemic. In this paper we review the availability of national sex-disaggregated surveillance data on COVID-19 and examine trends on the testing-to-outcome pathway. We further analyse the availability of data according to the economic status of the country and investigate the determinants of sex differences, including the national gender inequality status (according to a global index) in each country. Results are drawn from 18 months of global data collection from over 200 countries. We find differences in COVID-19 prevention behaviours and illness outcomes by sex, with lower uptake of vaccination and testing plus an elevated risk of severe disease and death among men. Supporting and maintaining the collection, collation, interpretation and presentation of sex-disaggregated data requires commitment and resources at subnational, national and global levels, but provides an opportunity for identifying and taking gender-responsive action on health inequities. As a first step the global health community should recognise, value and support the importance of sex-disaggregated data for identifying and tackling an inequitable pandemic.

Correlation of Clinical Features in Oral Submucous Fibrosis: A 9-Year Retrospective Study.

BACKGROUND: Oral Submucous Fibrosis is a chronic debilitating disease and potentially malignant disorder of the oral cavity known in medical literature for a long time. The study aims to correlate the clinical staging of Oral Submucous Fibrosis with various clinical findings of the oral mucosa like hyperpigmentation, erosions, ulcerations, VAS score, tongue protrusion, and cheek flexibility. METHODS: A retrospective observational study was undertaken and records of 1267 clinically diagnosed cases of OSMF were included in the study. Clinical grading was done as per criteria by Lai DR et al. The observations were tabulated and subjected to statistical analysis using SPSS software. RESULTS: In our study, the incidence of hyperpigmentation, erosions, and ulcerations was higher in Group C OSMF. Visual analog scores in the range of 5-6 was noted in 40.9% of the total subjects, out of which 36.2% belonged to Group C OSMF. Tongue protrusion of less than 25 mm was seen in 10.65% of the subjects. Cheek flexibility of less than 0.6 cm was seen in 19.62% of the subjects, most of which belonged to Group D. CONCLUSION: In our study, we found an increase in the occurrence and severity of symptoms with an increase in grades of OSMF, but this increase was not observed to be consistent. Hence classification based on a single clinical entity cannot be sufficient and correlations to other clinical findings should be studied over a large population and a multi-tier classification could be proposed in the future.

COVID-19 Detection: A Systematic Review of Machine and Deep Learning-Based Approaches Utilizing Chest X-Rays and CT Scans.

This review study presents the state-of-the-art machine and deep learning-based COVID-19 detection approaches utilizing the chest X-rays or computed tomography (CT) scans. This study aims to systematically scrutinize as well as to discourse challenges and limitations of the existing state-of-the-art research published in this domain from March 2020 to August 2021. This study also presents a comparative analysis of the performance of four majorly used deep transfer learning (DTL) models like VGG16, VGG19, ResNet50, and DenseNet over the COVID-19 local CT scans dataset and global chest X-ray dataset. A brief illustration of the majorly used chest X-ray and CT scan datasets of COVID-19 patients utilized in state-of-the-art COVID-19 detection approaches are also presented for future research. The research databases like IEEE Xplore, PubMed, and Web of Science are searched exhaustively for carrying out this survey. For the comparison analysis, four deep transfer learning models like VGG16, VGG19, ResNet50, and DenseNet are initially fine-tuned and trained using the augmented local CT scans and global chest X-ray dataset in order to observe their performance. This review study summarizes major findings like AI technique employed, type of classification performed, used datasets, results in terms of accuracy, specificity, sensitivity, F1 score, etc., along with the limitations, and future work for COVID-19 detection in tabular manner for conciseness. The performance analysis of the four majorly used deep transfer learning models affirms that Visual Geometry Group 19 (VGG19) model delivered the best performance over both COVID-19 local CT scans dataset and global chest X-ray dataset.

Oral submucous fibrosis and its impact on psychological stress: a case-control study.

Our aim was to evaluate the impact of OSF on psychological stress. Ninety OSF cases and age and sex-matched controls, enrolled from relatives or accompanying person were included in the study. Psychological stress was evaluated by the Psychological General Well Being Index short version (PGWBI-S). Sets of the psychological component were generated by principal component analysis (PCA). Association between components was accommodated for confounder and interaction was evaluated by conditional stepwise logistic regression analysis. Psychological component generated was component 1 (depressed mood, lack of positive well being, low vitality, anxiety, low vitality, and low self-control). The odds ratio (OR) of low score of component 1 for OSF was 3.66. Depressed mood, lack of positive well being, low vitality, anxiety, low vitality, and low self-control were associated with OSF. Psychological intervention should, therefore, be included in the management of OSF.

The prevalence of oral squamous cell carcinoma with oral submucous fibrosis.

OBJECTIVE: The objective of the study was to find out the prevalence of oral squamous cell carcinoma (OSCC) with oral submucous fibrosis (OSF) in patients with OSF. MATERIALS AND METHODS: Of 48,757 patients, we found 300 OSF subjects. Three hundred patients of OSF were checked for OSCC. Both OSF and OSCC with OSF (OSCCwOSF) were diagnosed histopathologically. The prevalence of OSCCwOSF was calculated. Descriptive analysis was done. Chi-square test and t-test were calculated for proportions and mean, respectively, to check any difference among OSF and OSCCwOSF groups. Age-specific relative risk was calculated in OSF and OSCCwOSF groups. Multiple logistic regression analysis was done among odd ratios of the different variable between OSF and OSCCwOSF groups. RESULTS: The prevalence of OSCCwOSF among OSF was 13.7% over a period of 1 year. The mean age of OSCCwOSF group was 43.95 ± 10.22 years in comparison to the OSF group that was 35.51 ± 11.26 years (P < 0.00). The mean habit duration was significantly less in the OSF group when compared to OSCCwOSFgroup for mishri (P = 0.002). Age-specific adjusted relative risk of OSCC in OSF patient increases from 0.33 (18-34 years) to 3.86 (≥65 years). CONCLUSION: It could be concluded that a 13.7% prevalence rate of OSCCwOSF in OSF patients should alert the clinician. Clinicians should, therefore, anticipate OSSC in OSF patients. This awareness could lead to the early diagnosis and management of such OSCC.

Six-Month Outcomes in Patients Hospitalized with Severe COVID-19.

BACKGROUND: Previous work has demonstrated that patients experience functional decline at 1-3 months post-discharge after COVID-19 hospitalization. OBJECTIVE: To determine whether symptoms persist further or improve over time, we followed patients discharged after hospitalization for severe COVID-19 to characterize their overall health status and their physical and mental health at 6 months post-hospital discharge. DESIGN: Prospective observational cohort study. PARTICIPANTS: Patients ≥ 18 years hospitalized for COVID-19 at a single health system, who required at minimum 6 l of supplemental oxygen during admission, had intact baseline functional status, and were discharged alive. MAIN MEASURES: Overall health status, physical health, mental health, and dyspnea were assessed with validated surveys: the PROMIS® Global Health-10 and PROMIS® Dyspnea Characteristics instruments. KEY RESULTS: Of 152 patients who completed the 1 month post-discharge survey, 126 (83%) completed the 6-month survey. Median age of 6-month respondents was 62; 40% were female. Ninety-three (74%) patients reported that their health had not returned to baseline at 6 months, and endorsed a mean of 7.1 symptoms. Participants' summary t-scores in both the physical health and mental health domains at 6 months (45.2, standard deviation [SD] 9.8; 47.4, SD 9.8, respectively) remained lower than their baseline (physical health 53.7, SD 9.4; mental health 54.2, SD 8.0; p<0.001). Overall, 79 (63%) patients reported shortness of breath within the prior week (median score 2 out of 10 (interquartile range [IQR] 0-5), vs 42 (33%) pre-COVID-19 infection (0, IQR 0-1)). A total of 11/124 (9%) patients without pre-COVID oxygen requirements still needed oxygen 6 months post-hospital discharge. One hundred and seven (85%) were still experiencing fatigue at 6 months post-discharge. CONCLUSIONS: Even 6 months after hospital discharge, the majority of patients report that their health has not returned to normal. Support and treatments to return these patients back to their pre-COVID baseline are urgently needed.