Co-development of patient reported-outcome measures

Niamh Molloy, NIHR Maudsley Biomedical Research Centre PhD Student in the Department of Psychology, Institute of Psychiatry, Psychology, & Neuroscience (IoPPN), King’s College London explores in this blog how people with lived experience are contributing to developing outcome measures in mental health research. 

The tools used to evaluate treatment benefits in mental health research or clinical care (called ‘outcome measures’) are often not developed in collaboration with people with lived experience. This means the outcomes may not be relevant or meaningful to the people completing them. This affects research as beneficial effects of a treatment may be missed or counted as a benefit when they are not.  

Recently, researchers have collaborated with people with lived experience when developing new patient-reported outcome measures (PROMs). These are measures that ask for information directly from the person with lived experience completing the measure. The process of collaboration is often called Patient and Public Involvement (PPI), and it isn’t a ‘one-size-fits-all’. It can vary with the amount of time and funding available as well as what is needed for the specific patient group. Our review looked for PROMs in mental health that were co-developed in collaboration with people with lived experience and summarised the methods used to achieve this collaborative method.  

How were outcomes co-developed? 

We found 23 mental health PROMs that were “co-developed”. The methods of collaboration often included service-user researchers in the project team or leading the project, and lived experience groups providing advice through steering groups, expert groups, or advisory groups.  

What were the benefits? 

We reported several benefits from adopting co-development methods, such as those with lived experience rating the measures produced as acceptable and relevant. Collaboration also resulted in adding questions not usually seen in classic measures, like peer support, or re-ordering questions so participants were not distressed after completing the form. It is very likely these new elements would be excluded without the collaboration of those with lived experience.  

What were the challenges? 

Several research papers reported conflicts, often due to differing views and priorities. Discussion often allowed the team to reach consensus, but it was acknowledged that power dynamics between those with lived experience and the remaining researchers can play a role in the conflict. All the different experiences and expertise need to be considered in collaborating towards the one common goal: to produce an outcome measure.  

What were the recommendations? 

We found that lived experience involvement in the psychometric testing phase was low. Some argue that involving those with lived experience in this stage would be costly and time consuming because the data analysis is complex. However, several PROMs avoided this by having service-user researchers conduct the analysis. Service-user researchers are those who have lived experience of mental ill health but are typically in the profession of a researcher. Therefore, they are likely to have prior statistical skills and training, meaning they would not require much training, if any, to conduct analysis. There were other ways to co-develop at this stage, such as reviewing the layout and final items of the measure and deciding which comparison measures to use. We recommend that this area of co-development needs particular attention in the future, so those with lived experience can have a meaningful impact overall on the measure.  

A key highlight from our review was the lack of standardised reporting of lived experience involvement between research papers, which at times made it difficult to understand the co-development methods. Future researchers undertaking co-development should consider in-depth reporting of the roles and methods used, even if it was challenging. Transparency of the co-development process, including what works well, and, importantly, what does not work, will contribute to the expansion of this field by benefiting future projects. While we understand difficulties with this such as journal word limits, we recommend consideration of reporting in other areas, such as in the supplementary information.  

Future work in understanding the importance of treatment outcomes  

While co-developed PROMs have many benefits, unfortunately, these measures are not widely used in research or clinical work yet. This means that other methods of considering which treatment outcomes are important to those with lived experience need to be investigated so the measures can be highlighted for future research, alongside encouraging the use of co-developed PROMs. 

In my PhD, I will address this by investigating the feasibility of a new method in the mental health field called Multi-Criterion Decision Modelling (MCDM) by first eliciting judgements of the importance of outcomes to service-users and service staff from two completed randomised control trials. I will use these rating to create weights of importance to re-analyse the completed trials to see if considering the value of all outcomes change the results.  

Niamh Molloy, Imogen Kilcoyne, Hannah Belcher, Til Wykes, Exploring the involvement of people with lived experience of mental disorders in co-developing outcome measures: a systematic review, The Lancet Psychiatry 2025