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Evaluating the Use of Anxiety Patient-Reported Outcome Measures (PROMs) in Dementia Clinical Trials: A Systematic
Jason Domingo1, Ana Alves2, Julie Sanders3
1National Institute for Health and Care Research-Cambridge Clinical Research Facility, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Abstract:
Anxiety is a common but underdetected or underdiagnosed symptom in dementia, affecting quality of life and care outcomes. Clinical trials are essential for informing effective management, yet the use of patient-reported outcome measures (PROMs) in dementia trials remains unclear. This review examined how validated PROMs are used to assess anxiety in dementia trials, including measurement tools, methods, demographic representation and evidence gaps.
Methods:
A systematic review was conducted following PRISMA and Cochrane Handbook guidance, with protocol registration on PROSPERO (CRD42025649920). Randomised controlled trials published between January 2015 and February 2025 were included if they assessed anxiety in mild to moderate dementia using validated PROMs within pharmacological or non-pharmacological interventions. Searches were conducted across MEDLINE, Embase, PsycINFO, Cochrane Library and ClinicalTrials.gov, supplemented by citation tracking. Two reviewers independently undertook study selection, data extraction and risk of bias assessment. Due to heterogeneity, findings were narratively synthesised.
Results:
Of 2328 records screened, 29 trials (n = 5697) met inclusion criteria. While 93.1% used validated anxiety measurement tools, only 44.4% employed PROMs, most frequently the Hospital Anxiety and Depression Scale, mainly in non-pharmacological trials. Women and individuals of White ethnicity were overrepresented, and no studies examined PROM effectiveness by sex and ethnicity. Most trials showed moderate to high risk of bias, and evidence was confined to high-income countries.
Conclusions:
Anxiety outcomes in dementia trials remain largely proxy-reported. Existing anxiety PROMs are generic and unvalidated for dementia populations. There is a critical need for dementia-specific, culturally sensitive anxiety PROMs, improved demographic reporting and integration of anxiety assessment within dementia core outcome sets.
Patient Or Public Contribution:
Feedback from research participants in dementia studies, who reported experiencing anxiety, motivated this systematic review. Patient and public involvement was examined across all included studies. The lack of validated dementia-specific anxiety PROMs identified in this review highlights a broader gap in co-produced outcome development within dementia research. These findings emphasise the need for meaningful involvement of people living with dementia and care partners in the development, validation and cultural adaptation of anxiety PROMs to ensure that trial outcomes are relevant, acceptable and representative.
