Statistical Issues and Recommendations for Clinical Trials Conducted During the COVID-19 Pandemic.
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ABSTRACT:
SUBMITTER: Meyer RD
PROVIDER: S-EPMC8011486 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description: Not available
| S-EPMC7340035 | biostudies-literature
Project description:Dental clinics were suspected to be a hotspot for nosocomial transmission of coronavirus disease 19 (COVID-19), yet there has been no clear recommendation about emergency dental care and appropriate personal protective equipment during pandemics. In this paper, we aim to summarize recommendations for (i) patient risk assessment, (ii) patient triage, and (iii) measures to prevent infection of health professionals and nosocomial transmission in dental clinics. The available evidence was collected by performing searches on PubMed, Embase, and Cochrane databases. We reviewed papers on COVID-19, severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), influenza, and related respiratory viral diseases. Legal and ethical frameworks, as well as international (e.g., World Health Organization (WHO)) and national (e.g., public health institutes, dental associations) guidelines were screened to summarize recommendations related to dental emergency care. To assess the patient risk, a questionnaire was developed to classify patients at unknown, high, and very high risk. Patient triage recommendations were summarized in a flow chart that graded the emergency level of treatments (i.e., urgent, as soon as possible, and postpone). Measures to prevent disease transmission based on current evidence were grouped for dental health professionals, dental clinics, and patients. The present recommendations may support health professionals implement preventative measures during the pandemic.
| S-EPMC7357003 | biostudies-literature
Project description:The coronavirus disease 2019 crisis has had a major and highly complex impact on the clinical practice of radiation oncology worldwide. Spain is one of the countries hardest hit by the virus, with devastating consequences. There is an urgent need to share experiences and offer guidance on decision-making with regard to the indications and standards for radiation therapy in the treatment of lung cancer. In the present article, the Oncological Group for the Study of Lung Cancer of the Spanish Society of Radiation Oncology reviews the literature and establishes a series of consensus-based recommendations for the treatment of patients with lung cancer in different clinical scenarios during the present pandemic.
| S-EPMC7443829 | biostudies-literature
Project description: Not available
| S-BSST1055 | biostudies-other
Project description:BackgroundThe therapeutic evidence collected from well-designed studies is needed to help manage the global pandemic of the coronavirus disease 2019 (COVID-19). Evaluating the quality of therapeutic data collected during this most recent pandemic is important for improving future clinical research under similar circumstances.ObjectiveTo assess the methodological quality and variability in implementation of randomized controlled trials (RCTs) for treating COVID-19, and to analyze the support that should be provided to improve data collected during an urgent pandemic situation.Search strategyPubMed, Excerpta Medica Database, China National Knowledge Infrastructure, Wanfang, and Chongqing VIP, and the preprint repositories including Social Science Research Network and MedRxiv were systematically searched, up to September 30, 2020, using the keywords "coronavirus disease 2019 (COVID-19)," "2019 novel coronavirus (2019-nCoV)," "severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2)," "novel coronavirus pneumonia (NCP)," "randomized controlled trial (RCT)" and "random."Inclusion criteriaRCTs studying the treatment of COVID-19 were eligible for inclusion.Data extraction and analysisScreening of published RCTs for inclusion and data extraction were each conducted by two researchers. Analysis of general information on COVID-19 RCTs was done using descriptive statistics. Methodological quality was assessed using the risk-of-bias tools in the Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0). Variability in implementation was assessed by comparing consistency between RCT reports and registration information.ResultsA total of 5886 COVID-19 RCTs were identified. Eighty-one RCTs were finally included, of which, 45 had registration information. Methodological quality of the RTCs was not optimal due to deficiencies in five main domains: allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, and selective reporting. Comparisons of consistency between published protocols and registration information showed that the 45 RCTs with registration information had common deviations in seven items: inclusion and exclusion criteria, sample size, outcomes, research sites of recruitment, interventions, and blinding.ConclusionThe methodological quality of COVID-19 RCTs conducted in early to mid 2020 was consistently low and variability in implementation was common. More support for implementing high-quality methodology is needed to obtain the quality of therapeutic evidence needed to provide positive guidance for clinical care. We make an urgent appeal for accelerating the construction of a collaborative sharing platform and preparing multidisciplinary talent and professional teams to conduct excellent clinical research when faced with epidemic diseases of the future. Further, variability in RCT implementation should be clearly reported and interpreted to improve the utility of data resulting from those trials.
| S-EPMC7970417 | biostudies-literature
Project description: Not available
| S-EPMC8694703 | biostudies-literature
Project description:To understand and analyse the global impact of COVID-19 on outpatient services, inpatient care, elective surgery, and perioperative colorectal cancer care, a DElayed COloRectal cancer surgery (DECOR-19) survey was conducted in collaboration with numerous international colorectal societies with the objective of obtaining several learning points from the impact of the COVID-19 outbreak on our colorectal cancer patients which will assist us in the ongoing management of our colorectal cancer patients and to provide us safe oncological pathways for future outbreaks.
| 2346925 | ecrin-mdr-crc
Project description:With a scientific background from filoviruses, paramyxoviruses, SARS-CoV, and MERS-CoV, remdesivir entered into the COVID-19 battle to become one of the favorable therapeutic candidates with potential antiviral activity in the treatment of this disease. Globally, remdesivir was accessed and investigated through clinical research (clinical trials) and clinical practice (compassionate use, expanded access, early access scheme, and emergency use). Currently, remdesivir approval status differs between states. This paper aims to review and analyze regulatory approaches for accessing and investigating remdesivir, by communicating regulatory variability between countries in terms of terminology, modalities, and protocols.
| S-EPMC7503054 | biostudies-literature
Project description:BackgroundCancer screening tests are recommended to prevent cancer-associated mortality by detecting precancerous and cancerous lesions in early stages. The COVID-19 pandemic disrupted the use of preventive health care services. Although there was an increase in the number of cancer screening tests beginning in late 2020, screenings remained 29% to 36% lower than in the prepandemic era.ObjectiveThe aim of this review is to assist health care providers in identifying approaches for prioritizing patients and increasing breast, cervical, and colorectal cancer screening during the uncertainty of the COVID-19 pandemic.MethodsWe used the scoping review framework to identify articles on PubMed and EBSCO databases. A total of 403 articles were identified, and 23 articles were selected for this review. The literature review ranged from January 1, 2020, to September 30, 2021.ResultsThe articles included two primary categories of recommendations: (1) risk stratification and triage to prioritize screenings and (2) alternative methods to conduct cancer screenings. Risk stratification and triage recommendations focused on prioritizing high-risk patients with an abnormal or suspicious result on the previous screening test, patients in certain age groups and sex, patients with a personal medical or family cancer history, patients that are currently symptomatic, and patients that are predisposed to hereditary cancers and cancer-causing mutations. Other recommended strategies included identifying areas facing the most disparities, creating algorithms and using artificial intelligence to create cancer risk scores, leveraging in-person visits to assess cancer risk, and providing the option of open access screenings where patients can schedule screenings and can be assigned a priority category by health care staff. Some recommended using telemedicine to categorize patients and determine screening eligibility for patients with new complaints. Several articles noted the importance of implementing preventive measures such as COVID-19 screening prior to the procedures, maintaining hygiene measures, and social distancing in waiting rooms. Alternative screening methods that do not require an in-person clinic visit and can effectively screen patients for cancers included mailing self-collection sampling kits for cervical and colorectal cancers, and implementing or expanding mobile screening units.ConclusionsAlthough the COVID-19 pandemic had devastating effects on population health globally, it could be an opportunity to adapt and evolve cancer screening methods. Disruption often creates innovation, and focus on alternative methods for cancer screenings may help reach rural and underresourced areas after the pandemic has ended.
| S-EPMC8914792 | biostudies-literature
Project description:PurposeThe global coronavirus disease 2019 (COVID-19) pandemic and the search for ways in which to provide the best available care have created unprecedented times in terms of rapidly evolving reports of available treatment options. The primary objective of our analysis was to categorize online, open-source guidance to determine how US institutions approached their recommendations for management of patients with COVID-19 in the early weeks of the pandemic.MethodsA search for open-source, online institutional guidelines for the treatment of COVID-19 was conducted using predefined criteria. The search was limited to the United States and conducted from April 12 through 14, 2020, and again on April 22, 2020. Searches were conducted at 2 points in time in order to identify changes in treatment recommendations due to evolving literature or institutional experience. Treatment recommendations, including guidance on antiviral therapy, corticosteroid and interleukin-6 inhibitor use, and nutritional supplementation were compared.ResultsOf the 105 institutions that met initial screening criteria, 14 institutions (13.3%) had online COVID-19 guidance available. Supportive care and clinical trial enrollment were the primary recommendations in all evaluated guidance. Recommendations to consider antimicrobial and adjunctive therapy varied. Eighty-six percent of guidelines contained recommendations for use, or consideration of use, of hydroxychloroquine. Guidance from 2 institutions mentioned use of hydroxychloroquine and azithromycin in combination. Of the 13 institutions listing hydroxychloroquine dosing recommendations, 62% recommended maintenance dosing of 200 mg twice daily. Infectious diseases or other specialty consultation was required by 89% of institutions using interleukin-6 inhibitors for COVID-19 management.ConclusionOverall, the analysis revealed variability in treatment or supplemental pharmacologic therapy for the management of COVID-19.
| S-EPMC7454286 | biostudies-literature