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8_Health fo Clinical Research Informatics (Clinical research (Randomized…
8_Health fo Clinical Research Informatics
Clinical research
Evidence based medicine
The steps
Acquire evidence
Appraise found evidence
Ask a question
Apply to patient
Acknowledge uncertainty
Assess practice
Randomized controlled studies
The need:
Randomization
Control group
Blindness
What is it? type of scientific experiment
classification
Cross over design
Factorial design
Parallel design
Cluster trials
Bias
Selection
Allocation
Assessment
Stopping
Pubblication
The process
Preparatory Phase
Protocol Development (Output: protocol documents and artifacts)
def. of treatment
Def. incasino/exclusion criteria
Def. of outcome measures
definition of the hypotesis to test
sample size calculation (formula)
Participant Recruitment (output: partecipanti)
Participants are enrolled after signing a written informed consent
Enrolled patients are assigned with an ID, randomized and assigned and assigned to a study group
Active Phase
Intervantion and/or Data collection (Output:Raw Data)
Monitoring and /r Quality Assurance (Output:Monitored Data)
Dissemination Phase
Result Analysis (Output:Information)
Reporting (Output:Knowledge)
Classification
International clinical Guidelines
Clinical Pathways
Clinical research informatics
Tools to support RCT
CRF TO eCRF
ePROM, Bring your own device approach
EDC
Subdomain Of biomedical informatics
Clinical Trial Management Systems
Electronic Data Capture
Monitoring Tool
Participant calendaring
Query and reporting tools
Participant screening and registration
Protocol Management
Case Report Form -> to eCRF
Securing and auditing
Integration of m-health in RCT
Interventi erogati tramite dispositivi mobili
Valutazione o monitoraggio effettuati tramite dispositivi mobili
dichiarazione CONSORT e health
