CoPARC Research Data
- The Translational Informatics function of the Colorado CTSI develops research informatics tools and provides training and support for research informatics needs. To facilitate data sharing between investigators utilizing the collaborative, we have employed REDCap, a web-based, HIPAA-compliant study data management solution that is straightforward and robust and being adopted widely by members of the national CTSA consortium.
- Human participants clinical and survey data, collected as a part of CoPARC investigations, will be organized and stored on the REDCap electronic data capture system. The data can be accessed by designated investigators as part of on-going research efforts.
- REDCap enables password-protected access to CoPARC data, and meets all HIPAA security provisions. Participant type-specific databases are established to collect and store information from enrolled participants.
- Data dictionaries have been created that contain case report form elements and clinical laboratory data. REDCap’s Data Access feature will enable consortium investigators password-protected access to data with approval.
- Through its file repository feature, REDCap will be used to catalog important consortium information, including experimental data generated with CoPARC samples.
- Additionally, a unique database with sample information pertaining to enrolled patients from non-UCD sites will also be housed on REDCap. Descriptions of the type of data being collected are provided below. Please also see "Documents and Resources: Case Report Forms".
A detailed screening exam and data collection will be performed including:
- A full medical history
- Physical exam
- Complete blood count, comprehensive chemistry panel, urine toxicology screen, urine cotinine, and pregnancy test (in women)
- PA/Lateral chest radiograph
- Simple spirometry
After screening is complete, participants will complete additional surveys and questionnaires
- Validated alcohol instruments, including the AUDIT
- Alcohol consumption quantification and pattern of alcohol drinking
- Smoking history, and quantification of use, if present
- Cannabis history, and quantification of use, if present
- Respiratory symptoms surveys
- Inhaled exposure questions
Data from critically ill patients with either respiratory failure or burn injury
Patients will have a complete assessment as soon as possible after admission, preferably within the first 24 hours. This will include collection of data regarding:
- Medical history, including severity of illness scoring, and co-morbid conditions
- Validated alcohol instruments, including the AUDIT (from proxy, confirmed by patient)
- Amount and pattern of alcohol consumption quantification through biological measurements
- Smoking history, and quantification of use, if present
- Cannabis history, and quantification of use, if present
- Physical exam, vitals measurements, and ventilator settings or other oxygen requirements
- Complete blood count, comprehensive chemistry panel, arterial blood gas, urine toxicology screen, blood alcohol level
- Chest radiograph
- Neurocognitive assessments performed by the research team
Patients will be monitored daily for changes in their status. In-hospital outcomes will be assessed in patients including:
- Need for ventilator support
- Length of time on ventilator, in ICU, and in the hospital
- Survival
- Development of pulmonary infection or other intercurrent complications
Additional assessments will be completed during optional long-term follow-up visits at multiple time points after discharge from the hospital. Data collection at each time point will include the following instruments or studies administered by the research team:
- Detailed surveys about alcohol and other substance use and changes in substance use habits
- Amount and pattern of alcohol consumption quantification through biological measurements
- Respiratory symptoms surveys
- Other symptom surveys including the Epworth Sleepiness Scale
- Validated psychological instruments, including the PHQ-9, IES-R, and GAD-7
- 6-minute walk test
- Urine toxicology screen
- Neurocognitive assessments
- CT chest (performed at the first in-person follow-up time point and repeated at subsequent time points if abnormal at 3 months, 6 months, and 12 months)
- Pulmonary function tests (performed at the first in-person follow-up time point and repeated at subsequent time points if abnormal at 3 months, 6 months, and 12 months)