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Short course

Successfully incorporating patient-reported outcomes (PROs) in clinical trials

Start date
To be confirmed
Duration
Two days
Mode
Face-to-face
Cost
£295
Level
Postgraduate Short-Course (CPD)
This 2-day course will provide a detailed understanding of the importance of PROs in clinical trials and best practices for their selection and successful incorporation into a trial. The course will also consider the capture of PROs, their analysis and reporting and how their impact on clinical practice can be maximised.

 

Course Overview

Outcomes assessment is a fundamental aspect of clinical trial design and implementation. Patient reported outcomes (PROs) provide unique information on the impact of a medical condition and its treatment from the patient’s perspective and are increasingly recognized by regulators, clinicians, and patients as valuable tools to collect patient-centred data. PROs should be included as primary or secondary outcomes in clinical trials to ensure the impact of a trial intervention is comprehensivelyassessed.

Learning outcomes

  • Identify the different types of Patient-Reported Outcomes (PRO) and when to use them in clinical trials
  • Describe approaches to selecting an appropriate PRO measure for a study
  • Recognise and describe PRO-specific components that should be included in a trial protocol using the SPIRIT-PRO Extension
  • Describe approaches to minimising missing data and enhancing data quality
  • Describe the challenges and potential management strategies for PRO Alerts
  • Recognise basic methods of PRO analysis
  • Critique the reporting of a trial using the CONSORT-PRO extension
  • Evaluate ways to maximise the impact of PRO trial data to inform clinical practice and health-policy

Course Faculty

The course will be delivered by Professor Melanie Calvert and colleagues from the Centre for Patient-Reported Outcome Research (CPROR), University of Birmingham. 

Is this course accredited?

The course is not accredited.

Who is the course for?

This course is aimed at Chief and Principal Investigators, trial managers, clinical researchers, research nurses, data managers, study co-ordinators and academics working within clinical trials. 

Dates

To be confirmed

Sample Course Programme

Wednesday 8th December   
 09.30  Introduction to Patient-Reported Outcomes (PROs)  Public Health G03-4-5
 10.30  Break  
 10.45  PRO Protocol Components  Public Health G03-4-5
 12.15  Lunch  
 13.15  Outcome Masurement Properties  Public Health G03-4-5
 14.45  Break  
 15.00  Selecting the right PROM  Public Health G03-4-5
 16.15  Basic PRO Analysis  CANVAS
 17.00  Close of Day 1  
Thursday 9th December   
 09.30  Basic PRO Analysis continued  CANVAS
 10.30  Recap of Day 1  Public Health G03-4-5
 11.00  Q&A: Basic PRO Analysis  Public Health G03-4-5
 11.30  Break  
 11.45  Data Capture/eData Capture  Public Health G03-4-5
 12.45  Lunch  
 13.45  Reporting PRO trial results/CONSORT-PRO  Public Health G03-4-5
 15.00  Break  
 15.15  Maximising PRO Impact  Public Health G03-4-5
 17.00 Close of course  

How to apply

Registration using a credit/debit card at the university online shop. The courses have minimum required attendance levels and the University reserves the right to cancel or postpone the course if the minimum required number of delegates has not been achieved for the course.

See how the University of Birmingham uses your data, view the Event attendee privacy notice.

 

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