Until recently, many Patient-Reported Outcome Measures (PROMs) were developed primarily by clinicians, with limited or no patient input (1). These PROMs often reflected priorities and terminology familiar to healthcare professionals but failed to adequately capture what truly matters to patients. This disconnect created barriers to patient engagement and limited the relevance of the outcomes being measured.

Recognising this gap, there is now a growing effort to involve patients in the development, evaluation, and refinement of PROMs. However, meaningful involvement still comes with challenges—especially in terms of the time and budget required for meaningful involvement [1][2]. 

💡 What Can Patient Groups Do?

Patient organisations can play a key role before, during, and after the development of PROMs by engaging in the following areas: 

1. Identifying the Need for PROMs
  • Especially relevant in early-stage medicines development, where selecting the right outcome measures is critical. 
  • Involving patients at this stage helps ensure that PROMs align with real-life experiences and priorities.
2. Shaping the Research Question & Output

Patient insights can influence both what is asked and how it is measured:

  • Research that better reflects the patient experience.
  • More targeted investigation in complex R&D settings.
  • Greater transparency around what patients can expect from participation—supporting more honest and effective recruitment. 
3. Evaluating & Reviewing PROMs

Patient groups can assess existing PROMs to guide acceptability and usability, especially for clinical trials:

  • Comprehensiveness — Does the PROM adequately cover the concept it intends to measure? 
  • Acceptability — Is the PROM user-friendly and accessible to patients? 
  • Feedback on Items — Are individual questions well-understood? Are there recurring misunderstandings or suggestions for improvement? 
  • Critical Review — Are the instructions, response options, and recall periods appropriate? 
4. Developing & Validating Frameworks

Building or validating PROMs requires qualitative research involving patients—not just consultation, but true collaboration. This helps ensure that the conceptual and theoretical foundations of the PROMs reflect lived experiences. 

5. Driving Meaningful Use

When patients see how their data directly informs care or decisions, it reinforces the importance of their input and can trigger: 

  • Greater trust in PROMs.
  • Opportunities for further education and engagement. 
  • More responsive and patient-centred care delivery. 

🛠️ Points to Consider When Adapting PROMs

Users may feel inclined to adapt established Patient-Reported Outcome Measures (PROMs)—for example, by translating them into a local language or converting them from paper-based to electronic formats (ePROMs). While these modifications may seem minor, they can significantly affect how a tool performs and how its results are interpreted. 

⚠️ Any change in the application or format of a PRO instrument requires rigorous re-validation and testing, as it may result in a new PROM. This applies not only to different modes of administration but also when using the instrument in a different therapeutic area than originally intended. 

[1] Wiering, B., de Boer, D. & Delnoij, D. Patient involvement in the development of patient-reported outcome measures: The developers’ perspective. BMC Health Serv Res 17, 635 (2017). https://doi.org/10.1186/s12913-017-2582-8 ;

[2] Carlton, J., Peasgood, T., Khan, S. et al. An emerging framework for fully incorporating public involvement (PI) into patient-reported outcome measures (PROMs). J Patient Rep Outcomes 4, 4 (2020). https://doi.org/10.1186/s41687-019-0172-8 ;