A review shows we need more use of person-reported outcomes, for better insights into lived experiences
By Sienna Russell-Green and Jennifer Halliday
A person-reported outcome (PRO) is any outcome that is best assessed by asking the person. This is because it is about their experience, perspective or perception. PROs are useful in clinical trials because they enable us to understand how interventions (e.g. medications or technologies) affect a person in ways that matter to them every day.
PROs can include:
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- quality of life (general and diabetes-specific)
- physical function and health status (e.g. physical symptoms, sleep)
- psychological function (e.g. diabetes distress, emotional well-being)
- social and family functioning (e.g. loneliness, family conflict)
- health behaviours (e.g. diabetes self-care, physical activity)
- treatment satisfaction (e.g. how well a person’s diabetes treatment suits them).
But, are researchers using PROs in diabetes clinical trials? Dr Maartje de Wit and colleagues set out to answer this question. They searched for clinical trials involving people with type 1 or type 2 diabetes, published January 2018 to January 2023. They found that use of PROs in research has increased, but remains low.
Of 1,543 diabetes trials identified, they found that PROs were assessed in:
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- 44% of all trials
- 71% of trials of behavioural interventions (405 out of 571 trials)
- 54% of trials of medical devices (99 out of 182)
- 38% of trials of weight loss surgery (3 out of 8)
- 23% of trials of supplements (e.g. vitamins) (49 out of 211)
- 20% of trials of medications (112 out of 556).
The main focus of a clinical trial is known as the ‘primary outcome’. PROs were the primary outcome in:
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- 10% of all trials
- 26% of trials of behavioural interventions
- 8% of trials of medical devices
- 0% of trials of weight loss surgery
- 4% trials of supplements
- 2% of trials of medications.
The PRO assessed most often was psychological functioning (in 22% of trials). This was followed by quality of life or health-related quality of life (15%). Medication trials focused more on physical and functional health (9%) and treatment satisfaction (8%). Medical device trials focused more often on psychological functioning (30%) and satisfaction with the device (30%).
Across the trials, 545 unique PRO measures (PROMs) were used. Of these, 120 (22%) were diabetes-specific PROMs.
The participants in the trials were people with:
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- type 2 diabetes (75% of trials)
- type 1 diabetes (21% of trials)
- type 1 or type 2 diabetes (4% of trials).
Most of the trials had adult participants (93% of trials).
In summary, in the past five years, less than half of diabetes clinical trials assessed PROs. Many trials of medications and medical devices did not assess PROs. This is a problem because it suggests that medications and technologies are not being assessed in terms of how they affect people’s daily life and well-being. These are outcomes that matter to people living with diabetes, and they can only be assessed by asking the individual directly. We encourage further uptake of PROs in future clinical trials.
Want to know more about PROs?
Check out this blog, which looks at how technologies affect PROs such as quality of life among adults with type 1 diabetes. Or this blog, which explores use of PROs to measure depression and diabetes distress in clinical practice.
Reference:
de Wit M, van Luik S, Marrero D, Barnard-Kelly K, Snoek FJ. Person-reported outcomes in registered randomised diabetes trials: A mapping review of constructs. Diabetic Medicine, 2024; 41(9) doi.org/10.1111/dme.15385
