Short course

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

Start date
11th - 12th December 2024
Two days
Patient-reported outcomes, quality of life, clinical trials
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.


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 comprehensively assessed.

Programme team:

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

Dates of the course:

11th - 12th December 2024

Place availability:

15 attendees

Sample course programme:

 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  
 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:

For enquiries, please complete our enquiry form

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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. 


The course is not accredited.

Course results:

Certificate of completion

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