Patient Reported Outcome Assessment in the PEGASUS trial:

A practical guide for researchers.

Quality of Life in Burns Management

An important part of burns management is to improve patient quality of life – including physical, psychological and social wellbeing. The objective of collecting quality of life data in this trial is to understand the patients’ perspective surrounding burns management to inform future research and patient care.

Site Staff

Play an essential role in collecting these data, often referred to as patient reported outcomes. Your role is to ensure that the data is of the highest quality to inform future patient care and research. Missing data is problematic– you can help reduce this. Each centre will have an identified lead for outcome data management responsible for quality assurance.

Which questionnairesshould I use?

We have selected a number of validated questionnaires to use in the study – which questionnaire you use will depend on the age of the burns patient. Please refer to the pinwheel below to see which questionnaires should be used with your participant. Typically all questionnaires will take less than 10 minutes to complete.

Age at Randomisation / PedsQL
Parent Reported / CHU-9D Parent Version / CHU-9D Child Version / EQ-5D-5L / Notes
1 / Not available for this age range
2-4 /  /  /  /  / Continue with PedsQL at all follow-up points
5-6 /  /  /  /  / Continue with parent reported CHU-9D at all follow-up points
7-10 /  /  /  /  / Continue with parent and child reported CHU-9D at all follow-up points
11-15 /  /  /  /  / Continue with child reported CHU-9D at all follow-up points
16 /  /  /  /  / Continue to complete child CHU-9D and EQ-5D-5L at all follow-up points
17 and above /  /  /  /  / Continue to complete EQ-5D-5L at all follow-up points

Quality of life questionnaires in PEGASUS by age (years).

Please note that for children aged 7-10 we require 2 versions of the CHU-9D to be used (one to be completed by the child and one by the parent). Upon completion of our qualitative research we may also ask you to use additional questionnaires BCTU will contact you regarding this if necessary.

16 year olds will be required to complete both the CHU-9D and EQ-5D

When should I collect the quality of life data?

  • Questionnaires need to be completed at baseline, week 1 & months: 1, 3, 6 and 12.
  • During the Baseline visit the participant will complete the QoL questionnaire after consent but prior to randomisation.
  • The participant (or carer/guardian) is to complete the QoLquestionnaire(s) prior to completing any visit procedures (a good time is whilst waiting for the consultation). This is because the clinical consultation may affect the way people feel.

Should I help the participant answer the questionnaire?

  • No – we really want to know about the participant views.
  • It is ok to provide clarification on what needs to be completed or what a question means but you need to ensure that this is done in a neutral tone without suggesting answers.
  • Study participants should be encouraged to provide their own view without interference from anyone else.

What happens if I forget to hand out the questionnaire or the participant is unable to complete it?

  • If you forget to hand out the questionnaire please do so at the next earliest opportunity and let the trials office know: . It is important that we know that this has occurred so that we can consider the impact that in may have on data quality but also so that we can work with the site to help improve trial processes.
  • If a participant is unable to complete the questionnaire please document the reason for this on the CRF. It is important that we understand why participants haven’t completed questionnaires. This will help us design future research.

Will the quality of life questionnaire be used to inform the participants care?

  • No. Participants should be advised that their responses will not be used to inform clinical care and provided with information regarding available support services.

If you have any further questions please contact BCTU: Telephone: 0121 415 8445

Email:

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