WTP?!? What the Predict: How the NIAID tested and stretched the limitations of DataFax
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1 WTP?!? What the Predict: How the NIAID tested and stretched the limitations of DataFax Michael Duvenhage Leidos Biomedical Research contracted to the National Institute of Allergy and Infections Diseases
2 Content 2016: TB Epidemic / Multi-drug resistant TB PredictTB protocol objectives / overview PET/CT randomization & PET/CT scan replication process PET/CT automated data consensus checking between Image reviewers Participant randomizations PET/CT image header data extration (DICOM) and automatic importation into DataFax Drug Adherence (the MERM) & Drug Adherence data flow DataFax automated notification for clinical study management DataFax Demo
3 2016: Status of the TB epidemic and MDR-TB 10.4 Million new cases 1.4 million deaths 0.4 million TB+HIV deaths Treatment too long: Drug susceptible TB tx takes 6 months Under treatment fuels concerns about resistant TB strains: Pathology mini tutorials MDR treatment > 12 months 580,000 new cases of MDR TB 45% of the MDR TB cases are in India, China, and the Russian Federation Source - WHO Global Tuberculosis Report
4 PredictTB: Research Objective Shortening treatment duration/lower TB drug resistance ~620 participants 5 sites in South Africa, 4 sites in China Most patients don t require extensive treatment duration, identifying those cured before 6 months has proven challenging PredictTB uses tools (e.g. PET/CT images) to identify participants with lower disease burden who has strong early response to treatment Study tests whether TB treatment can be shortened to 16 weeks (4 months) in this lower risk cohort
5 PredictTB: Global footprint North Asia North America USA 2 PET/CT Image reviewers Europe Central Asia Southwest Asia South Asia East Asia China 4 Sites enrolling patients 2 PET/CT scan institutions 1 PET/CT upload hub 1 PET/CT Image reviewer Africa Project Overview ~620 Participants 9 Sites Hybrid CRF (Paper & edc) CRF, Imaging, Adherence and Randomization data in CDMS South America South Africa 5 Sites enrolling patients 2 PET/CT scan institution 1 PET/CT upload team 2 PET/CT Image reviewers
6 PET/CT Randomization & Sync process
7 PET/CT Randomization & Sync process 2x CRF Trigger Image Randomization Assignments 2x Reviewer Assignment File
8 PET/CT Automated consensus checking
9 PET/CT Automated consensus checking PET/CT Image Review 1 DataFax edc Entry Image review consistency checks 3 rd Image Reviewer Assignment CRF Auto completion PET/CT Image Review 2 DataFax edc Entry
10 Participant Randomizations Randomization Counter Page
11 PET/CT DICOM data extraction / importation
12 The MERM (Medication Event Reminder Monitor) The MERM device is used to (i) store medication, (ii) medication reminder, (iii) record dosing history, and (iv) refill medication reminder (next visit date) Types of Alerts: o Daily Medication Reminder: Green LED & Buzzer o Medication Refill Reminder: Yellow LED o Low Battery Alert: Red LED MERM data automatically transferred to Clinical Data Management System
13 The MERM Participant usage 1. At preprogrammed time, Green LED lights up and Buzzer activated to alert participant of dosing time 2. Participant opens MERM container by opening the box to access the stored medication 3. Participants follows the medication taking instructions 4. Upon completion of medication taking, participant closes the box and stores the MERM to be used again the next day
14 The MERM Participant Dosing Reminders Medication Reminding Period lasts for a total 30 minutes as follows 3 cycles (10 minutes each) of the following: i.for first 5 minutes: the Green LED will flash + the Buzzer will sound ii.for next 5 minutes: all alerts will stay OFF (no flash or sound) iii. After a total of 30 minutes the Medication Reminding Period will end and no further alerts will occur until the next day 3 x
15 Drug adherence data flow
16 MERM Visual Data Analytics MERM User Interface Very basic user interface to setup and test the alarm reminders Also links the Participant ID to the MERM data Drug Adherence Visual Graph Graph will show all days where pill box (MERM) was opened Different color graph if there are gaps in drug adherence compliance Enhances the drug adherence interview with participant to determine final compliance
17 DataFax Automated notifications ~20 Automated s assist with clinical study management Enrollment, Randomization, Image assignment, Reminders, SAE Alerts, etc.
18 DataFax Automated notifications PET and DT DICOM Imported data PET/CT scan settings warnings/alerts
19 DataFax Demo
20 Acknowledgements NIAID TB Research Section Dr. Clifton Barry III Dr. Ray Chen Dr. Laura Via Chrissie Cai Kriti Arora Hong Zhu Jingcai Gao Wisepill James Deck NIAID Office of Cyberinfrastructure and Computational Biology Michael Tartakovsky, CIO Amy Gentzel Chris Whalen Brian Moyer Kanwaldeep Bajwa Francis Appiah Michael Holdsworth Michael Hurst David Ireland Sergey Grinkrug Vadim Provotorov University of Cape Town (Cliff Barry Lab) Taeksun Song NIAID Biostatistics Research Branch Dr. Lori Dodd Jing Wang Keith Lumbard TASK Shera Weyers
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