Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19.

BACKGROUND: Prior studies of therapeutic-dose anticoagulation in patients with COVID-19 have reported conflicting results. OBJECTIVES: We sought to determine the safety and effectiveness of therapeutic-dose anticoagulation in noncritically ill patients with COVID-19. METHODS: Patients hospitalized with COVID-19 not requiring intensive care unit treatment were randomized to prophylactic-dose enoxaparin, therapeutic-dose enoxaparin, or therapeutic-dose apixaban. The primary outcome was the 30-day composite of all-cause mortality, requirement for intensive care unit-level of care, systemic thromboembolism, or ischemic stroke assessed in the combined therapeutic-dose groups compared with the prophylactic-dose group. RESULTS: Between August 26, 2020, and September 19, 2022, 3,398 noncritically ill patients hospitalized with COVID-19 were randomized to prophylactic-dose enoxaparin (n = 1,141), therapeutic-dose enoxaparin (n = 1,136), or therapeutic-dose apixaban (n = 1,121) at 76 centers in 10 countries. The 30-day primary outcome occurred in 13.2% of patients in the prophylactic-dose group and 11.3% of patients in the combined therapeutic-dose groups (HR: 0.85; 95% CI: 0.69-1.04; P = 0.11). All-cause mortality occurred in 7.0% of patients treated with prophylactic-dose enoxaparin and 4.9% of patients treated with therapeutic-dose anticoagulation (HR: 0.70; 95% CI: 0.52-0.93; P = 0.01), and intubation was required in 8.4% vs 6.4% of patients, respectively (HR: 0.75; 95% CI: 0.58-0.98; P = 0.03). Results were similar in the 2 therapeutic-dose groups, and major bleeding in all 3 groups was infrequent. CONCLUSIONS: Among noncritically ill patients hospitalized with COVID-19, the 30-day primary composite outcome was not significantly reduced with therapeutic-dose anticoagulation compared with prophylactic-dose anticoagulation. However, fewer patients who were treated with therapeutic-dose anticoagulation required intubation and fewer died (FREEDOM COVID [FREEDOM COVID Anticoagulation Strategy]; NCT04512079).

Time intervals in the care pathway to cancer diagnosis during the COVID-19 pandemic: A large retrospective study from a high-volume center.

Despite extensive research on cancer care during the COVID-19 pandemic, evidence on the impact on prediagnostic time intervals is lacking. To better understand how COVID-19 changed the pathway to diagnosis of cancer, we examined the length of intervals from symptom onset to diagnosis for 13 common cancer types with known clinical stage over 1-year nonpandemic period (March 2019 to March 2020; N = 844) and three biannual COVID periods (March 2020 to September 2021; N = 1172). We analyzed the patient interval (from first symptoms to presentation to a physician), the primary care/emergency department interval (from presentation with relevant symptoms to a primary care or emergency department physician to referral to a hospital-based diagnosis center) and the hospital interval (from referral to diagnosis). Compared to nonpandemic data, there were significant changes across COVID periods. The pandemic mostly impacted patient intervals for cancers diagnosed over the first 6 months after onset in March 2020. Overall median patient intervals were longest in the early COVID period (39 [IQR 22-64] days) and shortest in the nonpandemic period (20 [IQR 13-30] days; Kruskal-Wallis test [χ2 ], P < .0001). Differences in clinical stage between periods were relevant, with cancers from the mid-period (September 2020 to March 2021) showing the most advanced stage. A shift to later stage was plausibly a result of delayed intervals in the early COVID period. Since intervals are eventually relevant to prognosis, our results provide a baseline against which the impact of improvement strategies to minimize the negative outcomes of COVID-19-associated cancer delays can be assessed and implemented.

Modifications in self-care, quality of life and therapeutic adherence in patients with rheumatoid arthritis during the SARS-CoV-2 pandemic treated by telehealth Modificaciones en el autocuidado, calidad de vida y adherencia terapéutica en pacientes con artritis reumatoide durante la pandemia por SARS-CoV-2 atendidos por telesalud

Introduction Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic inflammation, causing pain and stiffness in the joints. SARS-CoV-2 increases the clinical vulnerability of the population with RA and has led to the implementation and/or development of telemedicine. Objective To describe changes in level of therapeutic adherence, quality of life and capacity for self-care agency, during the follow-up period of a group of patients linked to a non-face-to-face multidisciplinary consultation model during the SARS-CoV-2 pandemic. Methodology Descriptive cohort study (July to October 2020). Description of the level of therapeutic adherence (Morisky Green Test), quality of life (EuroQOL-5-Dimensions-3-Level-version) and self-care capacity (ASA-R Scale) in the context of a telehealth model. A univariate and bivariate analysis was performed (Stata Software, Considered p-value <.05) Results Of 71 patients treated under the telehealth model, 85.9% were women, the age range was between 33 and 86 years with a median of 63. The most prevalent comorbidity was arterial hypertension (35.2%). Quality of life did not change during follow-up nor did adherence to treatment, apart from in one item [the patients did not stop taking the medication when they were well (P = .029)]. In self-care capacity, there were significant improvements in five dimensions (P < .05), without significant differences in the global score. Conclusion Patients with RA evaluated in the context of telehealth in a period of pandemic did not present significant changes in quality of life, adherence to treatment, or capacity for self-care, and remained close to baseline values when they attended a traditional face-to-face assessment.

Modifications in self-care, quality of life and therapeutic adherence in patients with rheumatoid arthritis during the SARS-CoV-2 pandemic treated by telehealth

Introduction Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic inflammation, causing pain and stiffness in the joints. SARS-CoV-2 increases the clinical vulnerability of the population with RA and has led to the implementation and/or development of telemedicine. Objective To describe changes in level of therapeutic adherence, quality of life and capacity for self-care agency, during the follow-up period of a group of patients linked to a non-face-to-face multidisciplinary consultation model during the SARS-CoV-2 pandemic. Methodology Descriptive cohort study (July to October 2020). Description of the level of therapeutic adherence (Morisky Green Test), quality of life (EuroQOL-5-Dimensions-3-Level-version) and self-care capacity (ASA-R Scale) in the context of a telehealth model. A univariate and bivariate analysis was performed (Stata Software, Considered p-value <.05) Results Of 71 patients treated under the telehealth model, 85.9% were women, the age range was between 33 and 86 years with a median of 63. The most prevalent comorbidity was arterial hypertension (35.2%). Quality of life did not change during follow-up nor did adherence to treatment, apart from in one item [the patients did not stop taking the medication when they were well (P = .029)]. In self-care capacity, there were significant improvements in five dimensions (P < .05), without significant differences in the global score. Conclusion Patients with RA evaluated in the context of telehealth in a period of pandemic did not present significant changes in quality of life, adherence to treatment, or capacity for self-care, and remained close to baseline values when they attended a traditional face-to-face assessment. Resumen Introducción La artritis reumatoide (AR) es una enfermedad autoinmune caracterizada por una inflamación crónica que produce dolor y rigidez articular. El SARS-CoV-2 aumenta la vulnerabilidad clínica en pacientes con AR, lo que ha conllevado la implementación o el desarrollo de la telesalud. Objetivo Describir los cambios en el nivel de adherencia terapéutica, la calidad de vida y la capacidad de autocuidado durante el periodo de seguimiento, en un grupo de pacientes con AR vinculados con un modelo de consulta multidisciplinar no presencial, en el curso de la pandemia por SARS-CoV-2. Metodología Estudio de cohorte descriptiva (julio a octubre del 2020). Descripción del nivel de adherencia terapéutica (Test Morisky Green), calidad de vida (EuroQOL-5-Dimensions–3-Level-version) y capacidad de autocuidado (Escala ASA-R) en el contexto de un modelo de telesalud. Se realizó análisis univariado y bivariado (software Stata®, valor de p considerado < 0,05). Resultados De 71 pacientes atendidos en modalidad de telesalud, el 85,9% fueron mujeres, la mediana de la edad fue de 63 (33-86) años. La comorbilidad más prevalente fue la hipertensión (35,2%). La calidad de vida no tuvo cambios durante el seguimiento, al igual que la adherencia al tratamiento, excepto en uno de los ítems (los pacientes no dejaron de tomar la medicación cuando se encontraban bien;p = 0,029). En la capacidad de autocuidado hubo mejoras significativas en 5 dimensiones (p < 0,05), sin diferencias significativas en el puntaje global. Conclusión Los pacientes con AR evaluados en el contexto de la telesalud, en un periodo de pandemia, no presentaron cambios significativos en la calidad de vida, la adherencia al tratamiento y la capacidad de autocuidado;se mantuvieron en niveles similares a los valores basales cuando asistían a valoración tradicional presencial.

Vascular Age, Metabolic Panel, Cardiovascular Risk and Inflammaging in Patients With Rheumatoid Arthritis Compared With Patients With Osteoarthritis.

Introduction: The risk of cardiovascular disease (CVD) in patients with rheumatoid arthritis (RA) is 1.5-2 times higher than the general population. The fundamental risk factor for CVD is age, related to alterations at the arterial level. The aim of the study was to compare vascular age (VA) in RA patients under a strict treat-to-target (T2T) strategy with Osteoarthritis (OA) patients without strict follow up and to assess the influence of inflammaging (chronic, sterile, low-grade inflammation related to aging) and metabolic markers on VA. Materials and Methods: This was an analytical cross-sectional study. Patients with RA (under a strict a T2T strategy) and OA patients without strict clinical follow-up were included. Patients with a history of uncontrolled hypertension, CVD, and/or current smoking were excluded. Sociodemographic, physical activity, and toxic exposure data were obtained. Waist-hip ratio and body mass index (BMI) were measured. DAS-28 (RA) and inflammatory markers, lipid profile, and glycaemia were analyzed. Pulse wave velocity (PWV) was measured (oscillometric method, Arteriograph-TensioMed®). VA was calculated based on PWV. Eleven components of inflammaging [six interleukins, three metalloproteinases (MMP), and two tissue inhibitors of metalloproteinases (TIMP)] were evaluated (Luminex® system). Univariate and bivariate analyzes (Mann Whitney U and chi-square) and correlations (Spearmans Rho) were done to compare the two groups. Results: A total of 106 patients (74% women) were included, 52/RA and 54/OA. The mean age was 57 (Interquartile range - IQR 9 years). The BMI, waist circumference, and weight were higher in patients with OA (p < 0.001). RA patients had low disease activity (DAS-28-CRP). There were no differences in VA, inflammaging nor in PWV between the two groups. VA had a positive, but weak correlation, with age and LDL. In group of RA, VA was higher in those who did not receive methotrexate (p = 0.013). LDL levels correlated with MMP1, TIMP1, and TIMP2. Conclusions: When comparing RA patients with low levels of disease activity with OA patients with poor metabolic control, there are no differences in VA. Furthermore, methotrexate also influences VA in RA patients. This shows that implemented therapies may have an impact on not only the inflammatory state of the joint but also CVD risk.

Modificaciones en el autocuidado, calidad de vida y adherencia terapéutica en pacientes con artritis reumatoide durante la pandemia por SARS-CoV-2 atendidos por telesalud Modifications in self-care, quality of life and therapeutic adherence in patients with Rheumatoid arthritis during the Sars-CoV-2 pandemic treated by telehealth

Introducción La artritis reumatoide (AR) es una enfermedad autoinmune caracterizada por una inflamación crónica que produce dolor y rigidez articular. El SARS-CoV-2 aumenta la vulnerabilidad clínica en pacientes con AR, lo que ha conllevado la implementación o el desarrollo de la telesalud. Objetivo Describir los cambios en el nivel de adherencia terapéutica, la calidad de vida y la capacidad de autocuidado durante el periodo de seguimiento, en un grupo de pacientes con AR vinculados con un modelo de consulta multidisciplinar no presencial, en el curso de la pandemia por SARS-CoV-2. Metodología Estudio de cohorte descriptiva (julio a octubre del 2020). Descripción del nivel de adherencia terapéutica (Test Morisky Green), calidad de vida (EuroQOL-5-Dimensions–3-Level-version) y capacidad de autocuidado (Escala ASA-R) en el contexto de un modelo de telesalud. Se realizó análisis univariado y bivariado (software Stata, valor p considerado < 0,05) Resultados De 71 pacientes atendidos en modalidad de telesalud, el 85,9% fueron mujeres, la mediana de la edad fue de 63(33-86) años. La comorbilidad más prevalente fue la hipertensión (35,2%). La calidad de vida no tuvo cambios durante el seguimiento, al igual que la adherencia al tratamiento, excepto en uno de los ítems [los pacientes no dejaron de tomar la medicación cuando se encontraban bien (p = 0,029)]. En la capacidad de autocuidado, hubo mejoras significativas en 5 dimensiones (p < 0,05), sin diferencias significativas en el puntaje global. Conclusión Los pacientes con AR evaluados en el contexto de la telesalud, en un periodo de pandemia, no presentaron cambios significativos en la calidad de vida, la adherencia al tratamiento y la capacidad de autocuidado;se mantuvieron en niveles similares a los valores basales cuando asistían a valoración tradicional presencial.

Modificaciones en el autocuidado, calidad de vida y adherencia terapéutica en pacientes con artritis reumatoide durante la pandemia por SARS-CoV-2 atendidos por telesalud

Resumen Introducción La artritis reumatoide (AR) es una enfermedad autoinmune caracterizada por una inflamación crónica que produce dolor y rigidez articular. El SARS-CoV-2 aumenta la vulnerabilidad clínica en pacientes con AR, lo que ha conllevado la implementación o el desarrollo de la telesalud. Objetivo Describir los cambios en el nivel de adherencia terapéutica, la calidad de vida y la capacidad de autocuidado durante el periodo de seguimiento, en un grupo de pacientes con AR vinculados con un modelo de consulta multidisciplinar no presencial, en el curso de la pandemia por SARS-CoV-2. Metodología Estudio de cohorte descriptiva (julio a octubre del 2020). Descripción del nivel de adherencia terapéutica (Test Morisky Green), calidad de vida (EuroQOL-5-Dimensions–3-Level-version) y capacidad de autocuidado (Escala ASA-R) en el contexto de un modelo de telesalud. Se realizó análisis univariado y bivariado (software Stata, valor p considerado<0,05) Resultados De 71 pacientes atendidos en modalidad de telesalud, el 85,9% fueron mujeres, la mediana de la edad fue de 63(33-86) años. La comorbilidad más prevalente fue la hipertensión (35,2%). La calidad de vida no tuvo cambios durante el seguimiento, al igual que la adherencia al tratamiento, excepto en uno de los ítems [los pacientes no dejaron de tomar la medicación cuando se encontraban bien (p=0,029)]. En la capacidad de autocuidado, hubo mejoras significativas en 5 dimensiones (p<0,05), sin diferencias significativas en el puntaje global. Conclusión Los pacientes con AR evaluados en el contexto de la telesalud, en un periodo de pandemia, no presentaron cambios significativos en la calidad de vida, la adherencia al tratamiento y la capacidad de autocuidado;se mantuvieron en niveles similares a los valores basales cuando asistían a valoración tradicional presencial. Introduction Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic inflammation, causing pain and stiffness in the joints. SARS-CoV-2 increases the clinical vulnerability of the population with RA and has led to the implementation and/or development of telemedicine. Objective To describe changes in level of therapeutic adherence, quality of life and capacity for self-care agency, during the follow-up period of a group of patients linked to a non-face-to-face multidisciplinary consultation model during the SARS-CoV-2 pandemic. Methodology Descriptive cohort study (July to October 2020). Description of the level of therapeutic adherence (Morisky Green Test), quality of life (EuroQOL-5-Dimensions-3-Level-version) and self-care capacity (ASA-R Scale) in the context of a telehealth model. A univariate and bivariate analysis was performed (Stata Software, Considered p-value<05) Results Of 71 patients treated under the telehealth model, 85.9% were women, the age range was between 33 and 86 years with a median of 63. The most prevalent comorbidity was arterial hypertension (35.2%). Quality of life did not change during follow-up nor did adherence to treatment, apart from in one item [the patients did not stop taking the medication when they were well (p=.029)]. In self-care capacity, there were significant improvements in five dimensions (p<.05), without significant differences in the global score. Conclusion Patients with RA evaluated in the context of telehealth in a period of pandemic did not present significant changes in quality of life, adherence to treatment, or capacity for self-care, and remained close to baseline values when they attended a traditional face-to-face assessment.

Anticoagulation in Patients With COVID-19: JACC Review Topic of the Week.

Clinical, laboratory, and autopsy findings support an association between coronavirus disease-2019 (COVID-19) and thromboembolic disease. Acute COVID-19 infection is characterized by mononuclear cell reactivity and pan-endothelialitis, contributing to a high incidence of thrombosis in large and small blood vessels, both arterial and venous. Observational studies and randomized trials have investigated whether full-dose anticoagulation may improve outcomes compared with prophylactic dose heparin. Although no benefit for therapeutic heparin has been found in patients who are critically ill hospitalized with COVID-19, some studies support a possible role for therapeutic anticoagulation in patients not yet requiring intensive care unit support. We summarize the pathology, rationale, and current evidence for use of anticoagulation in patients with COVID-19 and describe the main design elements of the ongoing FREEDOM COVID-19 Anticoagulation trial, in which 3,600 hospitalized patients with COVID-19 not requiring intensive care unit level of care are being randomized to prophylactic-dose enoxaparin vs therapeutic-dose enoxaparin vs therapeutic-dose apixaban. (FREEDOM COVID-19 Anticoagulation Strategy [FREEDOM COVID]; NCT04512079).

Evaluation of a Non-Face-to-Face Multidisciplinary Health Care Model in a Population with Rheumatoid Arthritis Vulnerable to COVID-19 in a Health Emergency Situation.

This study evaluated a non-face-to-face-multidisciplinary consultation model in a population with rheumatoid arthritis (RA) during the COVID-19 pandemic. This is an analytical observational study of a prospective cohort with simple random sampling. RA patients were followed for 12 weeks (Jul-Oct 2020). Two groups were included: patients in telemedicine care (TM), and patients in the usual face-to-face care (UC). Patients could voluntarily change the care model (transition model (TR)). Activity of disease, quality of life, disability, therapeutic adherence, and self-care ability were analyzed. Bivariate analysis was performed. A qualitative descriptive exploratory study was conducted. At the beginning, 218 adults were included: (109/TM-109/UC). The groups didn't differ in general characteristics. At the end of the study, there were no differences in TM: (n = 71). A significant (p < 0.05) decrease in adherence, and increase in self-care ability were found in UC (n = 18) and TR (n = 129). Seven patients developed COVID-19. Four categories emerged from the experience of the subjects in the qualitative assessment (factors present in communication, information and communication technologies management, family support and interaction, and adherence to treatment). The telemedicine model keeps RA patients stable without major differences compared to the usual care or mixed model.

Delays in Cancer Diagnostic Testing at a Quick Referral Unit in Spain during COVID-19.

Although COVID-19 has had dire consequences on diagnosis of cancer, little data assessing its impact on the whole range of diagnostic activity relevant to cancer are available. We examined trends in the provision of full diagnostic tests for consecutive patients with suspected cancer referred to an academic hospital-based Quick Diagnosis Unit from January 2019 to December 2020. As weekly volumes declined, waiting times for endoscopic, imaging and biopsy/cytology procedures increased steeply during the COVID-impacted period (26 February-28 April 2020). The average weekly increase compared with the same period in 2019 was substantial for invasive procedures requiring admission (200.70%), CT scans (171.20%), GI endoscopy (161.50%), PET/CT scans (152.50%), ultrasonography (148.40%), and ambulatory biopsy/cytology procedures (111.20%). Volumes and waiting times to other procedures showed similar trends. There was a remarkable downward trend in cancer diagnosis during the COVID-impacted period, with a 54.07% reduction compared with the same weeks in 2019. Despite a modest recovery in the following months, the decline in weekly activity and cancer rates persisted until 30 December. Providing insight into how COVID-19 changed the full spectrum of diagnostic activity for suspected cancer informs resilience-building interventions to guarantee access to fast and efficient diagnostics ahead of new threats.

The impact of Covid-19 on patients with suspected cancer: An analysis of ED presentation and referrals to a quick diagnosis unit.

PURPOSE: Patients evaluated in the emergency department (ED) who have concerning symptoms suggestive of a cancer diagnosis are mostly referred to the quick diagnosis unit of our tertiary hospital. This study analyzed the impact of the Covid-19 pandemic on the volume, disease patterns, and accessibility to essential investigations of patients with suspected cancer referred by the ED to this unit. METHODS: Trends in referrals were analyzed from January 1 to July 8, 2020 and the corresponding dates of 2019. Only non-Covid-19 conditions were evaluated. Three time-based cohorts were defined: prepandemic (January 1-February 19), pandemic (February 19-April 22), and postpandemic (April 22-July 8). Along with descriptive statistics, linear regression was used to test for time trends with weekly referrals as the dependent variable. RESULTS: There were 384, 193, and 450 patients referred during the prepandemic, pandemic, and postpandemic periods, respectively. Following an increasing rate, referrals decreased to unprecedented levels in the pandemic period (average weekly slope: -2.1 cases), then increasing again until near normalization. Waiting times to most diagnostic procedures including radiology, endoscopic, nuclear medicine, and biopsy/cytology during the pandemic period were significantly delayed and time-to-diagnosis was considerably longer (19.72 ± 10.37 days vs. 8.33 ± 3.94 days in prepandemic and 13.49 ± 6.45 days in postpandemic period; P < 0.001 in both). Compared to other cohorts, pandemic cohort patients were more likely to have unintentional weight loss and fever of unknown origin as referral indications while anemia and lymphadenopathy were less common. Patients from the pandemic cohort had a significantly lower rate of malignancies and higher of benign gastrointestinal disorders (40.93% vs. 19.53% and 20.89% in prepandemic and postpandemic periods, respectively; P < 0.001 in both), most notably irritable bowel disease, and of mental and behavioral disorders (15.54% vs. 3.39% and 6.00% in prepandemic and postpandemic periods, respectively; P < 0.001 in both). CONCLUSIONS: As our hospital switched its traditional care to one focused on Covid-19 patients, recognized indicators of healthcare quality of quick diagnosis units were severely disrupted. The clinical patterns of presentation and diagnosis of the pandemic period suggested that mass media-generated mental and behavioral responses with distressing symptoms played a significant role in most of these patients.

Anticoagulation, Bleeding, Mortality, and Pathology in Hospitalized Patients With COVID-19.

BACKGROUND: Thromboembolic disease is common in coronavirus disease-2019 (COVID-19). There is limited evidence on the association of in-hospital anticoagulation (AC) with outcomes and postmortem findings. OBJECTIVES: The purpose of this study was to examine association of AC with in-hospital outcomes and describe thromboembolic findings on autopsies. METHODS: This retrospective analysis examined the association of AC with mortality, intubation, and major bleeding. Subanalyses were also conducted on the association of therapeutic versus prophylactic AC initiated ≤48 h from admission. Thromboembolic disease was contextualized by premortem AC among consecutive autopsies. RESULTS: Among 4,389 patients, median age was 65 years with 44% women. Compared with no AC (n = 1,530; 34.9%), therapeutic AC (n = 900; 20.5%) and prophylactic AC (n = 1,959; 44.6%) were associated with lower in-hospital mortality (adjusted hazard ratio [aHR]: 0.53; 95% confidence interval [CI]: 0.45 to 0.62 and aHR: 0.50; 95% CI: 0.45 to 0.57, respectively), and intubation (aHR: 0.69; 95% CI: 0.51 to 0.94 and aHR: 0.72; 95% CI: 0.58 to 0.89, respectively). When initiated ≤48 h from admission, there was no statistically significant difference between therapeutic (n = 766) versus prophylactic AC (n = 1,860) (aHR: 0.86; 95% CI: 0.73 to 1.02; p = 0.08). Overall, 89 patients (2%) had major bleeding adjudicated by clinician review, with 27 of 900 (3.0%) on therapeutic, 33 of 1,959 (1.7%) on prophylactic, and 29 of 1,530 (1.9%) on no AC. Of 26 autopsies, 11 (42%) had thromboembolic disease not clinically suspected and 3 of 11 (27%) were on therapeutic AC. CONCLUSIONS: AC was associated with lower mortality and intubation among hospitalized COVID-19 patients. Compared with prophylactic AC, therapeutic AC was associated with lower mortality, although not statistically significant. Autopsies revealed frequent thromboembolic disease. These data may inform trials to determine optimal AC regimens.