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1.
JAMA Intern Med ; 182(1): 42-49, 2022 01 01.
Article in English | MEDLINE | ID: covidwho-1527389

ABSTRACT

Importance: Systemic corticosteroids are commonly used in treating severe COVID-19. However, the role of inhaled corticosteroids in the treatment of patients with mild to moderate disease is less clear. Objective: To determine the efficacy of the inhaled steroid ciclesonide in reducing the time to alleviation of all COVID-19-related symptoms among nonhospitalized participants with symptomatic COVID-19 infection. Design, Setting, and Participants: This phase 3, multicenter, double-blind, randomized clinical trial was conducted at 10 centers throughout the US and assessed the safety and efficacy of a ciclesonide metered-dose inhaler (MDI) for treating nonhospitalized participants with symptomatic COVID-19 infection who were screened from June 11, 2020, to November 3, 2020. Interventions: Participants were randomly assigned to receive ciclesonide MDI, 160 µg per actuation, for a total of 2 actuations twice a day (total daily dose, 640 µg) or placebo for 30 days. Main Outcomes and Measures: The primary end point was time to alleviation of all COVID-19-related symptoms (cough, dyspnea, chills, feeling feverish, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell) by day 30. Secondary end points included subsequent emergency department visits or hospital admissions for reasons attributable to COVID-19. Results: A total of 413 participants were screened and 400 (96.9%) were enrolled and randomized (197 [49.3%] in the ciclesonide arm and 203 [50.7%] in the placebo arm; mean [SD] age, 43.3 [16.9] years; 221 [55.3%] female; 2 [0.5%] Asian, 47 [11.8%] Black or African American, 3 [0.8%] Native Hawaiian or other Pacific Islander, 345 [86.3%] White, and 1 multiracial individuals [0.3%]; 172 Hispanic or Latino individuals [43.0%]). The median time to alleviation of all COVID-19-related symptoms was 19.0 days (95% CI, 14.0-21.0) in the ciclesonide arm and 19.0 days (95% CI, 16.0-23.0) in the placebo arm. There was no difference in resolution of all symptoms by day 30 (odds ratio, 1.28; 95% CI, 0.84-1.97). Participants who were treated with ciclesonide had fewer subsequent emergency department visits or hospital admissions for reasons related to COVID-19 (odds ratio, 0.18; 95% CI, 0.04-0.85). No participants died during the study. Conclusions and Relevance: The results of this randomized clinical trial demonstrated that ciclesonide did not achieve the primary efficacy end point of reduced time to alleviation of all COVID-19-related symptoms. Trial Registration: ClinicalTrials.gov Identifier: NCT04377711.


Subject(s)
COVID-19/drug therapy , Pregnenediones/standards , Administration, Inhalation , Adolescent , Adult , Ambulatory Care Facilities/organization & administration , Ambulatory Care Facilities/statistics & numerical data , Ambulatory Care Facilities/trends , COVID-19/epidemiology , Double-Blind Method , Female , Glucocorticoids/standards , Glucocorticoids/therapeutic use , Humans , Male , Metered Dose Inhalers , Middle Aged , Outpatients/statistics & numerical data , Pregnenediones/therapeutic use
2.
Am J Public Health ; 111(8): 1504-1512, 2021 08.
Article in English | MEDLINE | ID: covidwho-1456157

ABSTRACT

Objectives. To examine changes in abortions in Louisiana before and after the COVID-19 pandemic onset and assess whether variations in abortion service availability during this time might explain observed changes. Methods. We collected monthly service data from abortion clinics in Louisiana and neighboring states among Louisiana residents (January 2018‒May 2020) and assessed changes in abortions following pandemic onset. We conducted mystery client calls to 30 abortion clinics in Louisiana and neighboring states (April‒July 2020) and examined the percentage of open and scheduling clinics and median waits. Results. The number of abortions per month among Louisiana residents in Louisiana clinics decreased 31% (incidence rate ratio = 0.69; 95% confidence interval [CI] = 0.59, 0.79) from before to after pandemic onset, while the odds of having a second-trimester abortion increased (adjusted odds ratio [AOR] = 1.91; 95% CI = 1.10, 3.33). The decrease was not offset by an increase in out-of-state abortions. In Louisiana, only 1 or 2 (of 3) clinics were open (with a median wait > 2 weeks) through early May. Conclusions. The COVID-19 pandemic onset was associated with a significant decrease in the number of abortions and increase in the proportion of abortions provided in the second trimester among Louisiana residents. These changes followed service disruptions.


Subject(s)
Abortion, Legal/trends , Ambulatory Care Facilities/trends , COVID-19/epidemiology , Health Services Accessibility/trends , Adolescent , Adult , Female , Humans , Louisiana , Pregnancy , Pregnancy Trimester, Second , United States
3.
Dermatol Clin ; 39(4): 587-597, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1343177

ABSTRACT

The impact of the COVID-19 pandemic on dermatology practice cannot be overstated. At its peak, the pandemic resulted in the temporary closure of ambulatory sites as resources were reallocated towards pandemic response efforts. Many outpatient clinics have since reopened and are beginning to experience a semblance of pre-pandemic routine, albeit with restrictions in place. We provide an overview of how COVID-19 has affected dermatology practice globally beginning with the rise of teledermatology. A summary of expert recommendations that shape the "new normal" in various domains of dermatology practice, namely, dermatology consultation, procedural dermatology, and phototherapy, is also provided.


Subject(s)
Ambulatory Care Facilities/trends , Dermatology/standards , Primary Health Care/trends , Skin Diseases/therapy , Telemedicine/trends , COVID-19/epidemiology , Dermatology/trends , Health Services Accessibility/trends , Humans , Office Visits/trends , Skin Diseases/epidemiology
5.
Epilepsy Behav ; 116: 107740, 2021 03.
Article in English | MEDLINE | ID: covidwho-1062655

ABSTRACT

OBJECTIVE: To assess feasibility, patient satisfaction, and financial advantages of telemedicine for epilepsy ambulatory care during the current COVID-19 pandemic. METHODS: The demographic and clinical characteristics of all consecutive patients evaluated via telemedicine at a level 4 epilepsy center between March 20 and April 20, 2020 were obtained retrospectively from electronic medical records. A telephone survey to assess patient satisfaction and preferences was conducted within one month following the initial visit. RESULTS: Among 223 telehealth patients, 85.7% used both synchronous audio and video technology. During the visits, 39% of patients had their anticonvulsants adjusted while 18.8% and 11.2% were referred to laboratory/diagnostic testing and specialty consults, respectively. In a post-visit survey, the highest degree of satisfaction with care was expressed by 76.9% of patients. The degree of satisfaction tended to increase the further a patient lived from the clinic (p = 0.05). Beyond the pandemic, 89% of patients reported a preference for continuing telemedicine if their epilepsy symptoms remained stable, while only 44.4% chose telemedicine should their symptoms worsen. Inclement weather and lack of transportation were factors favoring continued use of telemedicine. An estimated cost saving to patient attributed to telemedicine was $30.20 ±â€¯3.8 per visit. SIGNIFICANCE: Our findings suggest that epilepsy care via telemedicine provided high satisfaction and economic benefit, without compromising patients' quality of care, thereby supporting the use of virtual care during current and future epidemiological fallouts. Beyond the current pandemic, patients with stable seizure symptoms may prefer to use telemedicine for their epilepsy care.


Subject(s)
Ambulatory Care Facilities , Ambulatory Care/methods , COVID-19/epidemiology , Epilepsy/epidemiology , Epilepsy/therapy , Telemedicine/methods , Adult , Ambulatory Care/trends , Ambulatory Care Facilities/trends , COVID-19/prevention & control , Electronic Health Records/trends , Female , Humans , Male , Middle Aged , Pandemics/prevention & control , Patient Satisfaction , Referral and Consultation/trends , Retrospective Studies , Surveys and Questionnaires , Telemedicine/trends
6.
Toxins (Basel) ; 13(2)2021 01 29.
Article in English | MEDLINE | ID: covidwho-1055117

ABSTRACT

Botulinum neurotoxin type A (BoNT/A) injections have to be administered repeatedly to achieve a rather stable, high level of improvement. This study aimed to take a look at changes in the daily routine of a BoNT/A outpatient clinic due to the SARS-CoV-2 pandemic lockdown, analyze the impact of SARS-CoV-2-induced re-injection delay on outcomes in patients with cervical dystonia (CD) (n = 36) and four other disease entities (n = 58), and study the influence of covariables, including previous injections and doses. For the present observational study, the first 100 patients who were scheduled to have an appointment between April 20 and May 18 during the partial lockdown and also had been treated regularly before the lockdown were recruited. Clinical and demographical characteristics and treatment-related data from the previous visits were extracted from charts. Time delay, symptom severity assessment, and TSUI score (if applicable) were gathered at the first coronavirus pandemic lockdown emergency visit for each patient. Of the 94 patients who could come to the clinic, 48 reported a delay and 44 reported worsening during the delay. Delays ranged from 1 to 63 days, the mean delay was 23 days, and the mean worsening was 26% compared to the previous visit. A significant correlation was found between the duration of the delay and the patient's rating of worsening (PwP). In CD patients, the physician´s rating of CD worsening by the TSUI score (ATUSI-PTSUI) was significantly correlated with general worsening (DwP) and the TSUI at the last visit (PTSUI). A small delay of a few weeks led to a similar worsening of symptoms in CD and all other disease entities and to relapse on a higher level of severity. This relapse can only be compensated by continuous treatment up to at least 1 year until patients reach the same level of treatment efficacy as that before the SARS-CoV-2 pandemic.


Subject(s)
Ambulatory Care Facilities/trends , COVID-19/epidemiology , Delivery of Health Care/trends , Pandemics , Quarantine , SARS-CoV-2 , Botulinum Toxins, Type A/administration & dosage , Botulinum Toxins, Type A/therapeutic use , COVID-19/prevention & control , Continuity of Patient Care/trends , Germany , Humans , Neuromuscular Agents/administration & dosage , Neuromuscular Agents/therapeutic use , Time-to-Treatment
8.
Int J Environ Res Public Health ; 17(17)2020 08 26.
Article in English | MEDLINE | ID: covidwho-730626

ABSTRACT

The pandemic outbreak of coronavirus disease 2019 (COVID-19) affects health care systems globally and leads to other challenges besides infection and its direct medical consequences. The aim of this study was to investigate the impact of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) pandemic on the university dermatology outpatient clinic (UDOC) of the Technical University of Munich, Germany. We analyzed datasets from 2015 until 2020 extracted from the hospital information system database and our documented outpatient files regarding patient numbers, gender, age, and diagnoses. In 2020, case numbers of outpatient care declined significantly (p = 0.021) compared to previous years and was related to the timing of political announcements answering SARS-CoV-2 pandemic. Additionally, during calendar week 10 to 15-the peak time of the spread of COVID-19 in Germany-the proportion of patients missing their consultation was significantly higher in 2020 than in 2019 (22.4% vs. 12.4%; p < 0.001). Gender-associated differences regarding absences were not detected, but patients aged 85 years or older were significantly more likely to miss their consultation compared to all other age groups (p = 0.002). Regarding different disease clusters, patients with chronic inflammatory skin diseases and infectious and malignant diseases were more likely to miss their consultation (p = 0.006). Noticeably, less patients with malignant diseases, and particularly malignant melanoma, were registered during this pandemic. Our data support the hypothesis that medically constructive prioritization might not be implemented properly by patients themselves. Identifying missed patients and catching up on their medical care apart from COVID-19 will pose an enormous challenge for health care systems globally.


Subject(s)
Ambulatory Care Facilities/trends , Coronavirus Infections/epidemiology , Dermatology , Pneumonia, Viral/epidemiology , Aged, 80 and over , Betacoronavirus , COVID-19 , Germany/epidemiology , Humans , Pandemics , Referral and Consultation , SARS-CoV-2 , Universities
9.
J Neural Transm (Vienna) ; 127(9): 1271-1274, 2020 09.
Article in English | MEDLINE | ID: covidwho-688803

ABSTRACT

The SARS-CoV-2 virus pandemic has provoked drastic countermeasures including shutdowns of public services. We wanted to describe the effects of a 6 week shutdown of a large German botulinum toxin (BT) outpatient clinics on patients and their well-being. 45 patients (age 61.9 ± 9.8 years, 29 females, 16 males) receiving BT therapy (319.3 ± 201.9MU-equivalent, treatment duration 8.3 ± 5.5 years) were surveyed with a standardised questionnaire. The shutdown delayed BT therapy by 6.6 ± 2.3 weeks. 93% of the patients noticed increased muscle cramps and 82% increased pain reducing their quality of life by 40.2 ± 19.5%. For 23 patients with cervical dystonia this reduction was 41.1 ± 18.3%, for 3 patients with blepharospasm 33.3 ± 15.3%, for 9 patients with spasticity 37.8 ± 15.6%, for 4 patients with pain conditions 37.4 ± 35.7% and for 3 patients with hemifacial spasm 27.5 ± 17.1%. After the shutdown 66% of patients perceived BT therapy as more important than before, 32% perceived it as unchanged. For all patients long-term availability of BT therapy was very important or important. 98% of the patients perceived the shutdown as inadequate and felt their patient rights not respected. The shutdown confirmed the considerable burden of disease caused by dystonia, spasticity, hemifacial spasm and various pain conditions and the importance of BT therapy to treat them. Any shutdown severely affects these patients and needs to be avoided.


Subject(s)
Ambulatory Care Facilities/trends , Betacoronavirus , Botulinum Toxins, Type A/administration & dosage , Coronavirus Infections/epidemiology , Pandemics , Patient Satisfaction , Pneumonia, Viral/epidemiology , Aged , COVID-19 , Cohort Studies , Female , Germany/epidemiology , Humans , Male , Middle Aged , Neuromuscular Diseases/drug therapy , Neuromuscular Diseases/epidemiology , Neuromuscular Diseases/psychology , Pandemics/prevention & control , SARS-CoV-2 , Surveys and Questionnaires
10.
Am J Health Syst Pharm ; 77(15): 1213-1230, 2020 07 23.
Article in English | MEDLINE | ID: covidwho-276198

ABSTRACT

PURPOSE: To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2020 in the United States, with a focus on the nonfederal hospital and clinic sectors. METHODS: Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2020 were reviewed, including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for specialty drugs, biosimilars, and diabetes medications. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2020 were based on a combination of quantitative analyses and expert opinion. RESULTS: In 2019, overall US pharmaceutical expenditures grew 5.4% compared to 2018, for a total of $507.9 billion. This increase was driven to similar degrees by prices, utilization, and new drugs. Adalimumab was the top drug in US expenditures in 2019, followed by apixaban and insulin glargine. Drug expenditures were $36.9 billion (a 1.5% increase from 2018) and $90.3 billion (an 11.8% increase from 2018) in nonfederal hospitals and clinics, respectively. In clinics, growth was driven by new products and increased utilization, whereas in hospitals growth was driven by new products and price increases. Several new drugs that will likely influence spending are expected to be approved in 2020. Specialty and cancer drugs will continue to drive expenditures. CONCLUSION: For 2020 we expect overall prescription drug spending to rise by 4.0% to 6.0%, whereas in clinics and hospitals we anticipate increases of 9.0% to 11.0% and 2.0% to 4.0%, respectively, compared to 2019. These national estimates of future pharmaceutical expenditure growth may not be representative of any particular health system because of the myriad of local factors that influence actual spending.


Subject(s)
Ambulatory Care Facilities/economics , Ambulatory Care Facilities/trends , Drug Costs/trends , Economics, Hospital/trends , Prescription Drugs/economics , Databases, Factual/trends , Humans , Prescription Drugs/therapeutic use , United States
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