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View article: Evaluating the discoverability of supporting research materials in ClinicalTrials.gov for US federally funded COVID-19 clinical studies
Evaluating the discoverability of supporting research materials in ClinicalTrials.gov for US federally funded COVID-19 clinical studies Open
Objective: The objective of this study was to evaluate the discoverability of supporting research materials, including supporting documents, individual participant data (IPD), and associated publications, in US federally funded COVID-19 cl…
View article: Variation in Phenotype Definitions in Observational Clinical Research: A Review of Three Conditions.
Variation in Phenotype Definitions in Observational Clinical Research: A Review of Three Conditions. Open
Our study examined the heterogeneity of phenotype algorithms (PA) in literature on Alzheimer's disease (AD), major depressive disorder (MDD), and pulmonary arterial hypertension (PAI), focusing on the impact of PA differences on patient ov…
View article: Learning important common data elements from shared study data: The All of Us program analysis
Learning important common data elements from shared study data: The All of Us program analysis Open
There are many initiatives attempting to harmonize data collection across human clinical studies using common data elements (CDEs). The increased use of CDEs in large prior studies can guide researchers planning new studies. For that purpo…
View article: regCOVID: Tracking publications of registered COVID-19 studies
regCOVID: Tracking publications of registered COVID-19 studies Open
View article: Harmonization of Measurement Codes for Concept-Oriented Lab Data Retrieval
Harmonization of Measurement Codes for Concept-Oriented Lab Data Retrieval Open
Measurement concepts are essential to observational healthcare research; however, a lack of concept harmonization limits the quality of research that can be done on multisite research networks. We developed five methods that used a combina…
View article: Effect of common maintenance drugs on the risk and severity of COVID-19 in elderly patients
Effect of common maintenance drugs on the risk and severity of COVID-19 in elderly patients Open
Background Maintenance drugs are used to treat chronic conditions. Several classes of maintenance drugs have attracted attention because of their potential to affect susceptibility to and severity of COVID-19. Methods Using claims data on …
View article: Unraveling COVID-19: A Large-Scale Characterization of 4.5 Million COVID-19 Cases Using CHARYBDIS
Unraveling COVID-19: A Large-Scale Characterization of 4.5 Million COVID-19 Cases Using CHARYBDIS Open
We constructed a global, multi-centre view to describe trends in COVID-19 progression, management and evolution over time. By characterising baseline variability in patients and geography, our work provides critical context that may otherw…
View article: Effect of common maintenance drugs on the risk and severity of COVID-19 in elderly patients
Effect of common maintenance drugs on the risk and severity of COVID-19 in elderly patients Open
Background Maintenance drugs are used to treat chronic conditions. Several classes of maintenance drugs have attracted attention because of their potential to affect susceptibility to and severity of COVID-19. Methods Using claims data on …
View article: regCOVID: Tracking publications of registered COVID-19 studies
regCOVID: Tracking publications of registered COVID-19 studies Open
In response to the COVID-19 pandemic many clinical studies have been initiated leading to the need for efficient ways to track and analyze study results. We expanded our previous project that tracked registered COVID-19 clinical studies to…
View article: CONSIDER Statement: Consolidated Recommendations for Sharing Individual Participant Data from Human Clinical Studies.
CONSIDER Statement: Consolidated Recommendations for Sharing Individual Participant Data from Human Clinical Studies. Open
Many research sponsors require sharing of data from human clinical trials. We created the CONSIDER statement, a set of recommendations to improve data sharing practices and increase the availability and re-usability of individual participa…
View article: Linking Provider Specialty and Outpatient Diagnoses in Medicare Claims Data: Data Quality Implications
Linking Provider Specialty and Outpatient Diagnoses in Medicare Claims Data: Data Quality Implications Open
Background With increasing use of real world data in observational health care research, data quality assessment of these data is equally gaining in importance. Electronic health record (EHR) or claims datasets can differ significantly in …
View article: Discoverability of information on clinical trial data-sharing platforms
Discoverability of information on clinical trial data-sharing platforms Open
Objective: This study was intended to (1) provide clinical trial data-sharing platform designers with insight into users’ experiences when attempting to evaluate and access datasets, (2) spark conversations about improving the transparency…
View article: Characterization of long-term patient-reported symptoms of COVID-19: an analysis of social media data
Characterization of long-term patient-reported symptoms of COVID-19: an analysis of social media data Open
As the SARS-CoV-2 virus (COVID-19) continues to affect people across the globe, there is limited understanding of the long term implications for infected patients 1–3 . While some of these patients have documented follow-ups on clinical re…
View article: Thirty-Day Outcomes of Children and Adolescents With COVID-19: An International Experience
Thirty-Day Outcomes of Children and Adolescents With COVID-19: An International Experience Open
OBJECTIVES To characterize the demographics, comorbidities, symptoms, in-hospital treatments, and health outcomes among children and adolescents diagnosed or hospitalized with coronavirus disease 2019 (COVID-19) and to compare them in seco…
View article: The changing patterns of comorbidities associated with human immunodeficiency virus infection, a longitudinal retrospective cohort study of Medicare patients
The changing patterns of comorbidities associated with human immunodeficiency virus infection, a longitudinal retrospective cohort study of Medicare patients Open
The objective of this paper is to determine the temporal trend of the association of 66 comorbidities with human immunodeficiency virus (HIV) infection status among Medicare beneficiaries from 2000 through 2016. We harvested patient level …
View article: Unraveling COVID-19: a large-scale characterization of 4.5 million COVID-19 cases using CHARYBDIS
Unraveling COVID-19: a large-scale characterization of 4.5 million COVID-19 cases using CHARYBDIS Open
View article: Association between tendon ruptures and use of fluoroquinolone, and other oral antibiotics: a 10-year retrospective study of 1 million US senior Medicare beneficiaries
Association between tendon ruptures and use of fluoroquinolone, and other oral antibiotics: a 10-year retrospective study of 1 million US senior Medicare beneficiaries Open
Objectives To assess the association of fluoroquinolone use with tendon ruptures compared with no fluoroquinolone and that of the four most commonly prescribed non-fluoroquinolone antibiotics in the USA. Design Retrospective observational …
View article: Baseline characteristics, management, and outcomes of 55,270 children and adolescents diagnosed with COVID-19 and 1,952,693 with influenza in France, Germany, Spain, South Korea and the United States: an international network cohort study
Baseline characteristics, management, and outcomes of 55,270 children and adolescents diagnosed with COVID-19 and 1,952,693 with influenza in France, Germany, Spain, South Korea and the United States: an international network cohort study Open
Objectives To characterize the demographics, comorbidities, symptoms, in-hospital treatments, and health outcomes among children/adolescents diagnosed or hospitalized with COVID-19. Secondly, to describe health outcomes amongst children/ad…
View article: Baseline phenotype and 30-day outcomes of people tested for COVID-19: an international network cohort including >3.32 million people tested with real-time PCR and >219,000 tested positive for SARS-CoV-2 in South Korea, Spain and the United States
Baseline phenotype and 30-day outcomes of people tested for COVID-19: an international network cohort including >3.32 million people tested with real-time PCR and >219,000 tested positive for SARS-CoV-2 in South Korea, Spain and the United States Open
Early identification of symptoms and comorbidities most predictive of COVID-19 is critical to identify infection, guide policies to effectively contain the pandemic, and improve health systems’ response. Here, we characterised socio-demogr…
View article: Peer Review #2 of "Computerized monitoring of COVID-19 trials, studies and registries in ClinicalTrials.gov registry (v0.1)"
Peer Review #2 of "Computerized monitoring of COVID-19 trials, studies and registries in ClinicalTrials.gov registry (v0.1)" Open
Clinical trial registries can provide important information about relevant studies for a given condition to other researchers and the public.We developed a computerized informatics based approach to provide an overview and analysis of COVI…
View article: Computerized monitoring of COVID-19 trials, studies and registries in ClinicalTrials.gov registry
Computerized monitoring of COVID-19 trials, studies and registries in ClinicalTrials.gov registry Open
Clinical trial registries can provide important information about relevant studies for a given condition to other researchers and the public. We developed a computerized informatics based approach to provide an overview and analysis of COV…
View article: Peer Review #2 of "Computerized monitoring of COVID-19 trials, studies and registries in ClinicalTrials.gov registry (v0.2)"
Peer Review #2 of "Computerized monitoring of COVID-19 trials, studies and registries in ClinicalTrials.gov registry (v0.2)" Open
Clinical trial registries can provide important information about relevant studies for a given condition to other researchers and the public.We developed a computerized informatics based approach to provide an overview and analysis of COVI…
View article: Deep phenotyping of 34,128 adult patients hospitalised with COVID-19 in an international network study
Deep phenotyping of 34,128 adult patients hospitalised with COVID-19 in an international network study Open
View article: Analysis of data dictionary formats of HIV clinical trials
Analysis of data dictionary formats of HIV clinical trials Open
We saw features of data dictionaries that made them difficult to use and understand. This included multiple data dictionary files or non-machine-readable documents, data elements included in data but not in the dictionary or missing data t…
View article: The case for open science: rare diseases
The case for open science: rare diseases Open
The premise of Open Science is that research and medical management will progress faster if data and knowledge are openly shared. The value of Open Science is nowhere more important and appreciated than in the rare disease (RD) community. …
View article: Comparative safety and effectiveness of alendronate versus raloxifene in women with osteoporosis
Comparative safety and effectiveness of alendronate versus raloxifene in women with osteoporosis Open
View article: Demographic and Clinical Characteristics of COPD Medication Users in the Sentinel Distributed Database
Demographic and Clinical Characteristics of COPD Medication Users in the Sentinel Distributed Database Open
View article: Deep phenotyping of 34,128 patients hospitalised with COVID-19 and a comparison with 81,596 influenza patients in America, Europe and Asia: an international network study
Deep phenotyping of 34,128 patients hospitalised with COVID-19 and a comparison with 81,596 influenza patients in America, Europe and Asia: an international network study Open
Background In this study we phenotyped individuals hospitalised with coronavirus disease 2019 (COVID-19) in depth, summarising entire medical histories, including medications, as captured in routinely collected data drawn from databases ac…
View article: A Descriptive Study of HIV Patients Highly Adherent to Antiretroviral.
A Descriptive Study of HIV Patients Highly Adherent to Antiretroviral. Open
HIV medication adherence is a topic of major public health concern in the United States. Adherent patients may be less likely to experience treatment failure, AIDS presentations and extreme medical costs. We evaluate a cohort of highly adh…
View article: Identification of Common Data Elements from Pivotal FDA Trials.
Identification of Common Data Elements from Pivotal FDA Trials. Open
It is difficult to arrive at an efficient and widely acceptable set of common data elements (CDEs). Trial outcomes, as defined in a clinical trial registry, offer a large set of elements to analyze. However, all clinical trial outcomes is …