Impact of the COVID-19 pandemic on clinical research in hospitals: observational study in the first epicenter of the epidemic during the general lockdown in France.

OBJECTIVE: The COVID-19 epidemic has had a strong impact on the entire healthcare sector in France with priority being given to research for new therapeutic options for COVID-19. Nevertheless, continuity of care for patients suffering from other diseases represents a crucial challenge, and clinical research is no exception in this respect. This study aims to assess the impact of the strict Covid-19 lockdown on non-Covid-19 clinical research in the French University Hospital of Strasbourg. MATERIALS AND METHODS: Clinical research activity (non-Covid-19) from the point of view of pharmacy department was estimated and compared to the pre-lockdown period. The impact of lockdown was assessed through five indicators: site initiation visits, the initiation of experimental therapies in non-Covid-19 patients, the delivery of non-Covid-19 investigational medical products, the number of drug shipments to patients' homes, and the number of monitoring or closure visits. RESULTS: During the study period, the number of site initiation visits decreased by 90%, total inclusions by 72%, and delivery of investigational medical products by 30%. During the lockdown period, 15 treatments were sent to patients' homes. Monitoring activity decreased by 98%. CONCLUSIONS: Although the COVID-19 outbreak has created an incredible momentum in the field of clinical research, research not focused on SaRS-CoV-2 has suffered greatly from this situation. The impact on patients is difficult to estimate but should be further investigated.

Reduced Rate of Inpatient Hospital Admissions in 18 German University Hospitals During the COVID-19 Lockdown.

The COVID-19 pandemic has caused strains on health systems worldwide disrupting routine hospital services for all non-COVID patients. Within this retrospective study, we analyzed inpatient hospital admissions across 18 German university hospitals during the 2020 lockdown period compared to 2018. Patients admitted to hospital between January 1 and May 31, 2020 and the corresponding periods in 2018 and 2019 were included in this study. Data derived from electronic health records were collected and analyzed using the data integration center infrastructure implemented in the university hospitals that are part of the four consortia funded by the German Medical Informatics Initiative. Admissions were grouped and counted by ICD 10 chapters and specific reasons for treatment at each site. Pooled aggregated data were centrally analyzed with descriptive statistics to compare absolute and relative differences between time periods of different years. The results illustrate how care process adoptions depended on the COVID-19 epidemiological situation and the criticality of the disease. Overall inpatient hospital admissions decreased by 35% in weeks 1 to 4 and by 30.3% in weeks 5 to 8 after the lockdown announcement compared to 2018. Even hospital admissions for critical care conditions such as malignant cancer treatments were reduced. We also noted a high reduction of emergency admissions such as myocardial infarction (38.7%), whereas the reduction in stroke admissions was smaller (19.6%). In contrast, we observed a considerable reduction in admissions for non-critical clinical situations, such as hysterectomies for benign tumors (78.8%) and hip replacements due to arthrosis (82.4%). In summary, our study shows that the university hospital admission rates in Germany were substantially reduced following the national COVID-19 lockdown. These included critical care or emergency conditions in which deferral is expected to impair clinical outcomes. Future studies are needed to delineate how appropriate medical care of critically ill patients can be maintained during a pandemic.

The challenge of maintaining necessary vascular and endovascular services at a referral center in Northern Italy during the COVID-19 outbreak.

OBJECTIVES: The Padova Hospital Vascular Surgery Division is located in Veneto, one of the area of the Northern Italy most hit by the Coronavirus disease 2019 outbreak. The aim of this paper is to describe the protocols adopted and to evaluate their impact during the acute phase of Coronavirus spread, focusing on the management of elective and urgent/emergent surgery, outpatients activity, and also health staff preservation from intra-hospital Coronavirus disease 2019 infection. METHODS: Several measures were progressively adopted in the Padova University Hospital to front the Coronavirus disease 2019 outbreak, with a clear strong asset established by 9 March 2020, after the Northern Italy lockdown. Since this date, the Vascular Surgery Unit started a "scaled-down" activity, both for elective surgical procedures and for the outpatient Clinical activities; different protocols were developed for health preservation of staff and patients. We compared a two months period, 30 days before and 30 days after this time point. In particular, emergent vascular surgery was regularly guaranteed as well as urgent surgery (to be performed within 24 h). Elective cases were scheduled for "non-deferrable" pathology. A swab test protocol for COVID-19 was applied to health-care professionals and hospitalized patients. RESULTS: The number of urgent or emergent aortic cases remained stable during the two months period, while the number of Hospital admissions via Emergency Room related to critical limb ischemia decreased after national lockdown by about 20%. Elective vascular surgery was scaled down by 50% starting from 9 March; 35% of scheduled elective cases refused hospitalization during the lockdown period and 20% of those contacted for hospitalization where postponed due to fever, respiratory symptoms, or close contacts with Coronavirus disease 2019 suspected cases. Elective surgery reduction did not negatively influence overall carotid or aortic outcomes, while we reported a higher major limb amputation rate for critical limb ischemia (about 10%, compared to 4% for the standard practice period). We found that 4 out of 98 (4%) health-care providers on the floor had an asymptomatic positive swab test. Among 22 vascular doctors, 3 had a confirmed Coronavirus disease 2019 infection (asymptomatic); a total of 72 swab were performed (mean = 3.4 swab/person/month) during this period; no cases of severe Coronavirus disease 2019 (deaths or requiring intensive care treatment) infection were reported within this period for the staff or hospitalized patients. CONCLUSIONS: Elective vascular surgery needs to be guaranteed as possible during Coronavirus disease 2019 outbreak. The number of truly emergent cases did not reduce, on the other side, Emergency Room accesses for non-emergent cases decreased. Our preliminary results seem to describe a scenario where, if the curve of the outbreak in the regional population is flattened, in association with appropriate hospitals containment rules, it may be possible to continue the activity of the Vascular Surgery Units and guarantee the minimal standard of care.

Rapid Adaptation of a Surgical Research Unit to Conduct Clinical Trials During the COVID-19 Pandemic.

The coronavirus disease 2019 (COVID-19) pandemic has brought most ongoing clinical trials to a standstill, while at the same time emphasizing the need for new therapeutic treatments and strategies to mitigate the morbidity and mortality related to COVID-19. Recent publication of several observational studies has generated much discussion surrounding efficacy of drugs including hydroxychloroquine, azithromycin, and remdesivir, stressing the need for high-quality prospective, randomized control trials in patients with COVID-19. Ongoing "stay at home" orders and institutional policies mandating "work from home" for nonessential employees, which includes most research personnel, have impacted the ability to implement and conduct clinical studies. This article discusses the approach of an experienced clinical trials unit to make adjustments for ongoing studies and ensure the safety of study participants. At the same time, plans were implemented to continue collection of data to achieve endpoints, safely enroll and follow participants in studies offering potential benefit, and quickly implement new COVID-19 clinical trials. The existence of a Division of Clinical Research with regulatory, budgeting, contracting, and coordinating expertise within a department of surgery can successfully accommodate a crisis situation and rapidly adapt to new requirements for the safe, efficient, and effective conversion to a remote work force without compromising the research process.

The most common pediatric and adult dermatology patient complaints in a month of the COVID-19 pandemic in Turkey.

Severe acute respiratory syndrome coronavirus 2 is the coronavirus strain that causes coronavirus disease 2019 (COVID-19). The World Health Organization (WHO) has designated the ongoing COVID-19 outbreak a Public Health Emergency of International Concern. WHO declared COVID-19 as a pandemic on 11 March 2020. During the pandemic and lockdown period, many dermatologic clinics were temporarily closed in Turkey as well as all over the world. Taking the necessary precautions, the hospital continued to examine all emergent and elective patients who applied to our dermatology clinic. We investigated the most common reasons for admission of pediatric and adult patients who were admitted to our outpatient clinic between 30 March and 30 April 2020, the period with the highest number of COVID-19 patients in Turkey. In children and adult age groups, the most common reason for admission was acne (N: 10 [16.4%] and N: 89 [20.9%], respectively). Of the 99 acne patients, 70 (70.7%) were using systemic isotretinoin and applied to our clinic to repeat the prescription or continue the agent. The number of pediatric patients admitted to the dermatology department drastically reduced during the lockdown period, which was attributed to the curfew for children in the country.