Person‐reported outcomes in registered randomised diabetes trials: A mapping review of constructs
Authors' conclusion
We noticed an increase in the inclusion of PROs in diabetes RCTs. However, PROs are rarely included as primary outcomes in the majority of studies, particularly in drug trials. The heterogeneity of PROMs used in RCTs underscores the need for standardisation of PROs.
Study context
- Population
- Registered randomised clinical trials (RCTs) in people with T1D and/or T2D of all ages, 2018–2023 (ClinicalTrials.gov, International Clinical Trial Platform, ISRCTN)
- Participants
- 1,543 trials
- Primary endpoint
- Inclusion of PROs in registered RCTs and mapping of PROMs onto predefined PRO domains
Methodological detailssystematic registry search
- Systematic registry search
Primary result
As reported in the abstract
Inclusion of PROs
- Trials including person-reported outcomes (PROs)
- n = 673 (44%)
- Different PRO measures (PROMs) used
- 545
- Drug trials including PROs
- Twenty per cent (n = 112)
- Behavioural interventions including PROs
- 71% (n = 405)
- Trials with a PRO as primary outcome
- 149 (9.6%)
- Psychological functioning domain, most often assessed across all trials
- 21.6%
- Psychological functioning domain in behavioural interventions
- 44.8%
- Psychological functioning domain in medical device interventions
- 29.7%
- Physical functioning and functional health domain, most included in drug trials
- 9%
- Social and family functioning domain, least assessed across all trials
- 3%
Original publication
Person‐reported outcomes in registered randomised diabetes trials: A mapping review of constructs. Diabet Med. Published 14 June 2024. doi:10.
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