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1.
Trials ; 21(1): 1028, 2020 Dec 22.
Article in English | MEDLINE | ID: covidwho-992539

ABSTRACT

BACKGROUND: Randomised controlled trials (RCTs) provide valuable information and inform the development of harm profiles of new treatments. Harms are typically assessed through the collection of adverse events (AEs). Despite AEs being routine outcomes collected in trials, analysis and reporting of AEs in journal articles are continually shown to be suboptimal. One key challenge is the large volume of AEs, which can make evaluation and communication problematic. Prominent practice is to report frequency tables of AEs by arm. Visual displays offer an effective solution to assess and communicate complex information; however, they are rarely used and there is a lack of practical guidance on what and how to visually display complex AE data. METHODS: In this article, we demonstrate the use of two plots identified to be beneficial for wide use in RCTs, since both can display multiple AEs and are suitable to display point estimates for binary, count, or time-to-event AE data: the volcano and dot plots. We compare and contrast the use of data visualisations against traditional frequency table reporting, using published AE information in two placebo-controlled trials, of remdesivir for COVID-19 and GDNF for Parkinson disease. We introduce statistical programmes for implementation in Stata. RESULTS/CASE STUDY: Visualisations of AEs in the COVID-19 trial communicated a risk profile for remdesivir which differed from the main message in the published authors' conclusion. In the Parkinson's disease trial of GDNF, the visualisation provided immediate communication of harm signals, which had otherwise been contained within lengthy descriptive text and tables. Asymmetry in the volcano plot helped flag extreme events that were less obvious from review of the frequency table and dot plot. The dot plot allowed a more comprehensive representation by means of a more detailed summary. CONCLUSIONS: Visualisations can better support investigators to assimilate large volumes of data and enable improved informal between-arm comparisons compared to tables. We endorse increased uptake for use in trial publications. Care in construction of visual displays needs to be taken as there can be potential to overemphasise treatment effects in some circumstances.


Subject(s)
Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Data Display , Data Visualization , Drug-Related Side Effects and Adverse Reactions/diagnosis , Glial Cell Line-Derived Neurotrophic Factor/adverse effects , Parkinson Disease/drug therapy , Research Design/standards , Adenosine Monophosphate/adverse effects , Alanine/adverse effects , Antiparkinson Agents/adverse effects , Antiviral Agents/adverse effects , Computer Graphics , Data Accuracy , Data Analysis , Drug Monitoring/methods , Humans , Randomized Controlled Trials as Topic
2.
Medicine (Baltimore) ; 99(43): e22840, 2020 Oct 23.
Article in English | MEDLINE | ID: covidwho-894696

ABSTRACT

Up-to-date information on the current progress made in the research and development to control the global COVID-19 pandemic is important. The study aimed to analyze the clinical trial characteristics and vaccine development progress of the new Coronavirus Disease 2019 (COVID-19) registered with the World Health Organization International Clinical Trial Registry Platform (WHO ICTRP).A comprehensive search of COVID-19 clinical trials since the establishment of the ICTRP to June 11, 2020, was conducted to record and analyze relevant characteristics. Chi-Squared test was used to compare the statistical differences between different research types, interventions, and sources.A total of 3282 COVID-19 clinical trials in 17 clinical trial registration centers were registered with the WHO ICTRP. The main research sources for the present study were ClinicalTrials.gov and ChiCTR. There were significant differences in the parameters of study location (P = .000), number of participants (P = .000), study duration (P = .001), research stage (P = .000), randomization procedure (P = .000), and blinding method (P = .000) between the 2 registration sources. There were significant differences in all the parameters between different kinds of intervention methods. Hydroxychloroquine, plasma therapy, and Xiyanping injection were the high-frequency research drugs used. Ten different vaccine studies were registered under phases I-II.Amongst the studies researched, heterogeneity existed for various parameters. Differences in the type of study, interventions, and registration sources of the studies led to significant differences in certain parameters of the COVID-19 clinical trials. The statistics of high-frequency drugs and the progress of vaccine trials may provide an informative reference for the prevention and control of COVID-19.


Subject(s)
Betacoronavirus , Clinical Trials as Topic/methods , Coronavirus Infections/therapy , Pneumonia, Viral/therapy , Registries , Research Design , World Health Organization , Clinical Trials as Topic/standards , Clinical Trials as Topic/statistics & numerical data , Coronavirus Infections/prevention & control , Humans , Pandemics , Quality Improvement , Research Design/standards , Research Design/statistics & numerical data , Viral Vaccines
6.
J Am Med Inform Assoc ; 27(9): 1476-1487, 2020 07 01.
Article in English | MEDLINE | ID: covidwho-780409

ABSTRACT

OBJECTIVE: The 2019 novel coronavirus disease (COVID-19) outbreak progressed rapidly from a public health (PH) emergency of international concern (World Health Organization [WHO], 30 January 2020) to a pandemic (WHO, 11 March 2020). The declaration of a national emergency in the United States (13 March 2020) necessitated the addition and modification of terminology related to COVID-19 and development of the disease's case definition. During this period, the Centers for Disease Control and Prevention (CDC) and standard development organizations released guidance on data standards for reporting COVID-19 clinical encounters, laboratory results, cause-of-death certifications, and other surveillance processes for COVID-19 PH emergency operations. The CDC COVID-19 Information Management Repository was created to address the need for PH and health-care stakeholders at local and national levels to easily obtain access to comprehensive and up-to-date information management resources. MATERIALS AND METHODS: We introduce the clinical and health-care informatics community to the CDC COVID-19 Information Management Repository: a new, national COVID-19 information management tool. We provide a description of COVID-19 informatics resources, including data requirements for COVID-19 data reporting. RESULTS: We demonstrate the CDC COVID-19 Information Management Repository's categorization and management of critical COVID-19 informatics documentation and standards. We also describe COVID-19 data exchange standards, forms, and specifications. CONCLUSIONS: This information will be valuable to clinical and PH informaticians, epidemiologists, data analysts, standards developers and implementers, and information technology managers involved in the development of COVID-19 situational awareness and response reporting and analytics.


Subject(s)
Betacoronavirus , Coronavirus Infections , Health Information Management , Pandemics , Pneumonia, Viral , Vocabulary, Controlled , Centers for Disease Control and Prevention, U.S. , Coronavirus Infections/epidemiology , Delivery of Health Care , Health Information Interoperability , Health Information Management/organization & administration , Health Information Management/standards , Humans , Information Dissemination , Laboratories , Pneumonia, Viral/epidemiology , Public Health , Research Design/standards , United States
9.
Lancet Infect Dis ; 20(10): e251-e260, 2020 10.
Article in English | MEDLINE | ID: covidwho-693775

ABSTRACT

The term metagenomics refers to the use of sequencing methods to simultaneously identify genomic material from all organisms present in a sample, with the advantage of greater taxonomic resolution than culture or other methods. Applications include pathogen detection and discovery, species characterisation, antimicrobial resistance detection, virulence profiling, and study of the microbiome and microecological factors affecting health. However, metagenomics involves complex and multistep processes and there are important technical and methodological challenges that require careful consideration to support valid inference. We co-ordinated a multidisciplinary, international expert group to establish reporting guidelines that address specimen processing, nucleic acid extraction, sequencing platforms, bioinformatics considerations, quality assurance, limits of detection, power and sample size, confirmatory testing, causality criteria, cost, and ethical issues. The guidance recognises that metagenomics research requires pragmatism and caution in interpretation, and that this field is rapidly evolving.


Subject(s)
Metagenomics/methods , Metagenomics/statistics & numerical data , Computational Biology , Humans , Molecular Epidemiology , Research Design/standards
12.
J Am Coll Radiol ; 17(8): 1056-1060, 2020 08.
Article in English | MEDLINE | ID: covidwho-593328

ABSTRACT

PURPOSE: The aim of this study was to evaluate the adoption and outcomes of locally designed reporting guidelines for patients with possible coronavirus disease 2019 (COVID-19). METHODS: A departmental guideline was developed for radiologists that specified reporting terminology and required communication for patients with imaging findings suggestive of COVID-19, on the basis of patient test status and imaging indication. In this retrospective study, radiology reports completed from March 1, 2020, to May 3, 2020, that mentioned COVID-19 were reviewed. Reports were divided into patients with known COVID-19, patients with "suspected" COVID-19 (having an order indication of respiratory or infectious signs or symptoms), and "unsuspected patients" (other order indications, eg, trauma or non-chest pain). The primary outcome was the percentage of COVID-19 reports using recommended terminology; the secondary outcome was percentages of suspected and unsuspected patients diagnosed with COVID-19. Relationships between categorical variables were assessed using the Fisher exact test. RESULTS: Among 77,400 total reports, 1,083 suggested COVID-19 on the basis of imaging findings; 774 of COVID-19 reports (71%) used recommended terminology. Of 574 patients without known COVID-19 at the time of interpretation, 345 (60%) were eventually diagnosed with COVID-19, including 61% (315 of 516) of suspected and 52% (30 of 58) of unsuspected patients. Nearly all unsuspected patients (46 of 58) were identified on CT. CONCLUSIONS: Radiologists rapidly adopted recommended reporting terminology for patients with suspected COVID-19. The majority of patients for whom radiologists raised concern for COVID-19 were subsequently diagnosed with the disease, including the majority of clinically unsuspected patients. Using unambiguous terminology and timely notification about previously unsuspected patients will become increasingly critical to facilitate COVID-19 testing and contact tracing as states begin to lift restrictions.


Subject(s)
Coronavirus Infections/diagnostic imaging , Guideline Adherence/statistics & numerical data , Pneumonia, Viral/diagnostic imaging , Practice Guidelines as Topic , Radiologists/standards , Radiology Department, Hospital/standards , Research Design/standards , Cohort Studies , Coronavirus Infections/epidemiology , Female , Humans , Male , Outcome Assessment, Health Care , Pandemics , Pneumonia, Viral/epidemiology , Predictive Value of Tests , Radiography, Thoracic/methods , Radiography, Thoracic/statistics & numerical data , Retrospective Studies , Tomography, X-Ray Computed/methods , Tomography, X-Ray Computed/statistics & numerical data , United States
13.
J Crohns Colitis ; 14(Supplement_3): S815-S819, 2020 Oct 21.
Article in English | MEDLINE | ID: covidwho-592380

ABSTRACT

The severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]-causing coronavirus disease [COVID]-19 pandemic poses major challenges for patients with inflammatory bowel disease [IBD] to be recruited and maintained in clinical trials. However, clinical trials offer patients who have failed multiple drugs access to study medications with alternative modes of action and the potential for relief from inflammation-mediated symptoms. Therefore, the continuation of clinical trials in IBD during the COVID-19 pandemic is important both for participants and for the community of IBD patients, due to the dire need for an expanded therapeutic armamentarium. As the safety of patients in clinical trials is the leading principle, we are providing ten specific rules to guide patients and principal investigators safely through the challenging time.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , Betacoronavirus , Clinical Trials as Topic/standards , Coronavirus Infections/prevention & control , Gastrointestinal Agents/therapeutic use , Inflammatory Bowel Diseases/drug therapy , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Research Design/standards , Clinical Trials as Topic/methods , Coronavirus Infections/complications , Global Health , Humans , Infection Control/methods , Infection Control/standards , Inflammatory Bowel Diseases/complications , Pneumonia, Viral/complications , Risk Management/methods , Risk Management/standards
14.
Clin Cancer Res ; 26(16): 4198-4200, 2020 08 15.
Article in English | MEDLINE | ID: covidwho-535418

ABSTRACT

The novel coronavirus disease-2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), is a global health threat (1). Patients with cancer are one of the most vulnerable populations. During this pandemic, clinical trial accrual to NCI studies has fallen dramatically. Investigators quickly turned to regulatory bodies to simplify treatment schedules, facilitate telemedicine, and decrease required data collection. Going forward, the oncology research community must use the lessons learned to focus on redesigning studies to ensure that critical scientific questions are answered safely while expanding access and increasing partnerships with community physicians. These changes will accelerate clinical progress while protecting our patients.


Subject(s)
Betacoronavirus/pathogenicity , Clinical Trials as Topic/standards , Coronavirus Infections/prevention & control , Medical Oncology/trends , Neoplasms/therapy , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Coronavirus Infections/epidemiology , Coronavirus Infections/transmission , Coronavirus Infections/virology , Humans , Infection Control/standards , Medical Oncology/standards , National Cancer Institute (U.S.)/standards , National Cancer Institute (U.S.)/trends , Patient Safety/standards , Patient Selection , Pneumonia, Viral/epidemiology , Pneumonia, Viral/transmission , Pneumonia, Viral/virology , Research Design/standards , Research Design/trends , Telemedicine/standards , Telemedicine/trends , United States/epidemiology
15.
Eur Heart J ; 41(22): 2109-2117, 2020 06 07.
Article in English | MEDLINE | ID: covidwho-526858

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has important implications for the safety of participants in clinical trials and the research staff caring for them and, consequently, for the trials themselves. Patients with heart failure may be at greater risk of infection with COVID-19 and the consequences might also be more serious, but they are also at risk of adverse outcomes if their clinical care is compromised. As physicians and clinical trialists, it is our responsibility to ensure safe and effective care is delivered to trial participants without affecting the integrity of the trial. The social contract with our patients demands no less. Many regulatory authorities from different world regions have issued guidance statements regarding the conduct of clinical trials during this COVID-19 crisis. However, international trials may benefit from expert guidance from a global panel of experts to supplement local advice and regulations, thereby enhancing the safety of participants and the integrity of the trial. Accordingly, the Heart Failure Association of the European Society of Cardiology on 21 and 22 March 2020 conducted web-based meetings with expert clinical trialists in Europe, North America, South America, Australia, and Asia. The main objectives of this Expert Position Paper are to highlight the challenges that this pandemic poses for the conduct of clinical trials in heart failure and to offer advice on how they might be overcome, with some practical examples. While this panel of experts are focused on heart failure clinical trials, these discussions and recommendations may apply to clinical trials in other therapeutic areas.


Subject(s)
Betacoronavirus , Clinical Trials as Topic/methods , Coronavirus Infections , Heart Failure , Pandemics , Pneumonia, Viral , Research Design/standards , Clinical Trials as Topic/ethics , Clinical Trials as Topic/standards , Europe , Heart Failure/complications , Heart Failure/therapy , Humans , Informed Consent/ethics , Informed Consent/standards , Patient Safety , Patient Selection/ethics
16.
Oncologist ; 25(7): e1013-e1020, 2020 07.
Article in English | MEDLINE | ID: covidwho-506429

ABSTRACT

Northern Italy has been one of the European regions reporting the highest number of COVID-19 cases and deaths. The pandemic spread has challenged the National Health System, requiring reallocation of most of the available health care resources to treat COVID-19-positive patients, generating a competition with other health care needs, including cancer. Patients with cancer are at higher risk of developing critical illness after COVID-19 infection. Thus, mitigation strategies should be adopted to reduce the likelihood of infection in all patients with cancer. At the same time, suboptimal care and treatments may result in worse cancer-related outcome. In this article, we attempt to estimate the individual risk-benefit balance to define personalized strategies for optimal breast cancer management, avoiding as much as possible a general untailored approach. We discuss and report the strategies our Breast Unit adopted from the beginning of the COVID-19 outbreak to ensure the continuum of the best possible cancer care for our patients while mitigating the risk of infection, despite limited health care resources. IMPLICATIONS FOR PRACTICE: Managing patients with breast cancer during the COVID-19 outbreak is challenging. The present work highlights the need to estimate the individual patient risk of infection, which depends on both epidemiological considerations and individual clinical characteristics. The management of patients with breast cancer should be adapted and personalized according to the balance between COVID-19-related risk and the expected benefit of treatments. This work also provides useful suggestions on the modality of patient triage, the conduct of clinical trials, the management of an oncologic team, and the approach to patients' and health workers' psychological distress.


Subject(s)
Betacoronavirus/pathogenicity , Breast Neoplasms/therapy , Coronavirus Infections/prevention & control , Infection Control/standards , Medical Oncology/organization & administration , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Adult , Age Factors , Aged , Clinical Trials as Topic/organization & administration , Clinical Trials as Topic/standards , Continuity of Patient Care/organization & administration , Continuity of Patient Care/standards , Coronavirus Infections/epidemiology , Coronavirus Infections/transmission , Coronavirus Infections/virology , Female , Humans , Infection Control/organization & administration , Italy/epidemiology , Medical Oncology/standards , Middle Aged , Pneumonia, Viral/epidemiology , Pneumonia, Viral/transmission , Pneumonia, Viral/virology , Research Design/standards , Risk Assessment , Risk Factors , Telemedicine/organization & administration , Telemedicine/standards
20.
J Clin Epidemiol ; 123: 120-126, 2020 07.
Article in English | MEDLINE | ID: covidwho-209356

ABSTRACT

OBJECTIVES/BACKGROUND AND OBJECTIVES: Prior epidemics of high-mortality human coronaviruses, such as the acute respiratory syndrome coronavirus (SARS-CoV or SARS-1) in 2003, have driven the characterization of compounds that could be possibly active against the currently emerging novel coronavirus SARS-CoV-2 (COVID-19). Presently, no approved treatment or prophylaxis is available for COVID-19. We comment on the existing COVID-19 research methodologies in general and the published reporting. Given the media attention and claims of effectiveness, we chose chloroquine and hydroxychloroquine, in combination with azithromycin, as an area of COVID-19 research to examine. METHODS/STUDY DESIGN AND SETTING: MEDLINE and EMBASE electronic databases were searched from 2019 to present (April 3rd, 2020) using a mix of keywords such as COVID-19 and chloroquine and hydroxychloroquine. We also searched the largest clinical medicine preprint repository, medRxiv.org. RESULTS: We found 6 studies, 3 randomized control trials and 3 observational studies, focusing on chloroquine and hydroxychloroquine (with azithromycin). We critically appraised the evidence. CONCLUSION: We found that the COVID-19 research methodology is very poor in the area of chloroquine/hydroxychloroquine research. In screening the literature, we observed the same across COVID-19 research in relation to potential treatments. The reporting is very poor and sparse, and patient-important outcomes needed to discern decision-making priorities are not reported. We do understand the barriers to perform rigorous research in health care settings overwhelmed by a novel deadly disease. However, this emergency pandemic situation does not transform flawed methods and data into credible results. The adequately powered, comparative, and robust clinical research that is needed for optimal evidence-informed decision-making remains absent in COVID-19.


Subject(s)
Biomedical Research/methods , Coronavirus Infections/drug therapy , Pneumonia, Viral/drug therapy , Research Design/standards , Chloroquine/therapeutic use , Coronavirus Infections/epidemiology , Humans , Hydroxychloroquine/therapeutic use , Observational Studies as Topic , Pandemics , Pneumonia, Viral/epidemiology , Randomized Controlled Trials as Topic
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