PROs for patient advocates - University of Birmingham

Are you a patient advocate involved in co-production of research or review?

Patient-reported outcomes (PROs), such as health-related quality of life (HRQOL), symptoms or health status, are reported directly by the patient and provide a systematic way of measuring patients’ views about the impact of disease and treatment on their health and well-being. More information for those new to PROs.

Making patient care a reality

In this video, CPROR Patient Partner Gary Price gives a patient perspective on why patient-reported outcomes matter.

Integrating Patient Reported Outcomes into Research and Beyond: The Role of the Patient Advocate

In this video, Professor Mel Calvert talks to patient advocates about their role in the co-design and reviewing research.

Introduction to patient-reported outcome research for patient and public contributors

In this video, Dr Sarah Hughes provides a general introduction to patient-reported outcomes and their importance in research and clinical practice.

Equitable patient-reported outcome research for patient and public contributors.

In this video, Dr Ameeta Retzer talks about patient-reported outcomes, equity and health inequality.

'I'm a patient advocate involved in the design or review of a study using PROs. What should I consider?'

Patient and public involvement (PPI) in the design of studies can help ensure that the research is relevant and meaningful to patients. You may be involved in research design as a participant in a PPI group or as formal member of the research team.

Has the team stated, and have, a clear reason for assessing PROs in the trial?

It is essential that the team has a clear rationale for assessment
Has the team specified what exactly going to be measured by the PRO questionnaire? For instance; quality of life, physical function, pain and/or fatigue, etc.
How do they plan to use the PRO data that they collect in the trial?

Which questionnaire(s) are they considering using?

What do the questionnaires include? Are they relevant for the patient group?
Are the questionnaires validated/available in more than one language?
Do the questionnaires seem acceptable – how long will they take to complete?

Are there any reasons why a patient might not be able to complete the PRO questionnaire?

Cultural considerations
Cognition considerations
Poor literacy
Language/communication difficulties
Condition or illness
Has the research team made clear when it is possible for someone other than the patient to complete the questionnaire from the patient’s point of view (proxy)?

How often, when and where will patients be asked to complete the questionnaire(s)?

How long will patients have to complete the questionnaire? Is the timeframe too short? Does it need a weekend?
Electronic or paper based or both? What are the practicalities of this for patients?
Will the PRO questionnaire completion coincide with clinic visits or will it take place at another time (e.g. home)?

What languages are the chosen questionnaire(s) available in?

Have they got questionnaires available for the trial population?
Are there groups of the population that require a translated version?
Are they following translation guidelines?
Have they costed for this?

How can the team ensure high quality data that meaningfully informs future patient care?

What plans do the team have to train staff and minimise missing data e.g. reminders for patients?
PPI volunteers can provide input into developing a process for patients that stop receiving treatment in a way different to planned. This should link to the original research question

Other considerations

Is the required participant number feasible to recruit based on the assessed population?

Are there cultural reasons why people may not take part in the trial?
Other reasons to consider include: age, geography, frailty, language, health condition, working status
Are the exclusion criteria too restrictive (i.e. are they excluding too many people?

Other resources

Participant information sheet (PIS)

How long is going to take to complete the PRO questionnaire(s)?
How many times do patients need to complete the questionnaire(s)?
Have patients been informed of why PROs are being collected?
Have patients been informed of the importance of completing PRO questionnaire(s) and given guidance on completion?
State why we need as complete data as possible and how the data will be used.
What are resources are available to support in case of patient deterioration or distress (e.g. trial emergency number)

ePROVIDE to facilitate access to information to stakeholders in Patient-Centered Outcomes

ePROVIDE is an online resource that can be used to facilitate access to information to all stakeholders in the field of Patient-Centered Outcomes, particularly for Clinical Outcome Assessment. Although patient partners are not expected to use this resource, they can signpost it to the research leads.

Tools to improve reporting of patient and public involvement in research

Any research involving patient and public involvement (PPI) should be reported according to GRIPP2 reporting checklists; which aim to improve quality, transparency and consistency of PPI evidence base.

'I’m a patient advocate involved in the dissemination of clinical trial results – including PROs'

Many trials do not publish their PRO data which limits their ability to benefit future patients. It is important to work closely with the trial team to ensure results are published in accordance with CONSORT-PRO.

Get involved

There are a number of ways to get involved in research as detailed on the INVOLVE website.
Please contact the Centre for Patient Reported Outcomes Research, University of Birmingham if you are interested in getting involved in research design focussed on PROs: cpror@contacts.bham.ac.uk
If you are a patient/member of the public that would like to get involved in our research programme please contact us directly.