What are they, why do they matter, and how do you choose them?
By Professor Jane Speight and Dr Elizabeth Holmes-Truscott
When new diabetes treatments, technologies, or behavioural interventions are evaluated, the focus is often on their impact on blood glucose — typically measured by HbA1c or, more recently, time-in-range. While these outcomes are important, they don’t tell the whole story.
It is important to understand how the intervention affects the person as a whole, in ways that matter to them. To do this, we use Person-Reported Outcome and Experience Measures (PROMs and PREMs).
What Are PROMs and PREMs?
They are standardised sets of questions that are answered directly by the person with diabetes.
PROMs help us to understand the effect of an intervention on various outcomes:
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- Health status – e.g. how does it affect a person’s perception of their own health?
- Quality of life – e.g. how does it affect aspects of life important to the person, such as family life, work, finances, freedom, spontaneity, or independence?
- Emotional well-being – e.g. how does it affect their mood, their worries about hypos, or their level of diabetes distress?
- Functioning – e.g. how does it affect their daily activities, or the time they spend thinking about, making decisions about, or managing diabetes?
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PREMs focus on how people experience interventions more broadly. These measures can be used to explore how and why interventions are effective or ineffective. Commonly used PREMs in diabetes assess treatment satisfaction and engagement with healthcare.
How do I choose PROMs and PREMs?
There are lots of PROMs and PREMs available. One review found that more than 500 PROMs had been used across more than 1,500 diabetes clinical trials between 2018 and 2023. These tools differ in their focus, who they’re designed for, their length, and more. Choosing the right one can be challenging.
Start with a clear goal
When choosing a PROM or PREM, ask yourself:
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- What do I want to measure, and why?
- What matters to people with diabetes and others involved?
- How will the findings be used?
- Do I need a general measure or ones that’s specific to diabetes?
- General (generic) measures are often used to assess well-being, health status or quality of life overall. They can be used to compare results across multiple health conditions and treatments.
- Diabetes-specific measures are often more sensitive to the impacts of diabetes. They ask the person to assess how their diabetes, or a new treatment or device, affects them.
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Also think about:
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- What kind of answer do I need? That is, what unit of measurement is most useful. e.g. how often something happens, how severe it is, how much of a problem it is, or something else?
- When will I collect the information? Consider the recall period and timing. e.g. experiences over the past week, month, six months, year, or longer? Will I be assessing change over time?
- Who will complete it? Measures are designed with and for specific populations. e.g. what is the person’s age, diabetes type, diabetes treatment, language, culture, or country?
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Then, choose the best fit
Once you know what you are looking for, check which PROMs or PREMs are available. Look at the research and ask people with diabetes what they think. To be meaningful and useful, PROMS and PREMS need to be:
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- valid – they measure what they claim to measure
- acceptable – they are easy to read, understand and complete; include all relevant issues (without asking more questions than necessary) and they don’t leave out important issues.
- reliable – they produce consistent results if nothing has changed
- responsive – they can pick up differences when something does change. e.g. a new treatment.
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Why do PROMs and PREMs matter?
PROMs and PREMs place the individual’s lived experience at the heart of research and healthcare. They ensure that diabetes care is developed with real-world needs in mind.
PROMs help determine whether a treatment is truly beneficial. A new medication, device, or program may improve glucose levels, but if it adds stress or complexity, is it really an improvement? PROMs provide critical evidence for regulatory approvals. If the treatment benefits quality of life, it strengthens the case for government agencies to approve and fund the treatment.
PROMs and PREMs help explain how, why, and for whom, a treatment may be effective or not. This process evaluation can inform refinements to an intervention and inform implementation strategies.
The bottom line
PROMs and PREMs enable people with diabetes to shape the future of diabetes care. By capturing meaningful data about a person’s subjective outcomes and experiences, they ensure that new treatments and technologies are valued not just for improving glucose levels but also for making life better.
Our role
At the ACBRD, we use many PROMs and PREMS in our research. We design new PROMs, we test existing PROMS, and we compare PROMs to identify which is the ‘best’ for which situation. That is which is most acceptable and has strong psychometric properties. We work with other researchers to identify the tools that best suit their needs. Importantly, we work with people with diabetes to understand what matters to them, and how to measure this in a way that is acceptable to them.
Read more about our work with PROMs and PREMs:
- Scale and measures developed by the ACBRD
- Measuring what matters: how do we show the benefits of cell therapy for adults with type 1 diabetes?
- What is the ‘best’ tool to measure the impact of type 1 diabetes on quality of life?
- A new questionnaire examines satisfaction with glucose monitoring experience
- Can a brief, positively-worded questionnaire be used to screen for depression in people with diabetes?
* Acknowledgment: This blog post was drafted with the assistance of an AI language model, which helped with structuring and refining content. It was refined by humans (JS and EHT) to improve accuracy and relevance.