{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,5]],"date-time":"2026-07-05T15:15:12Z","timestamp":1783264512835,"version":"3.54.6"},"reference-count":97,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2026,6,21]],"date-time":"2026-06-21T00:00:00Z","timestamp":1782000000000},"content-version":"vor","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T00:00:00Z","timestamp":1780272000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Health Expectations"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>Background<\/jats:title>\n                  <jats:sec>\n                    <jats:label\/>\n                    <jats:p>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\u2010reported 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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\u2010pharmacological 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Of 2328 records screened, 29 trials (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20095697) 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\u2010pharmacological 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\u2010income countries.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Anxiety outcomes in dementia trials remain largely proxy\u2010reported. Existing anxiety PROMs are generic and unvalidated for dementia populations. There is a critical need for dementia\u2010specific, culturally sensitive anxiety PROMs, improved demographic reporting and integration of anxiety assessment within dementia core outcome sets.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patient or Public Contribution<\/jats:title>\n                    <jats:p>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\u2010specific anxiety PROMs identified in this review highlights a broader gap in co\u2010produced 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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/hex.70736","type":"journal-article","created":{"date-parts":[[2026,6,21]],"date-time":"2026-06-21T14:04:59Z","timestamp":1782050699000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Evaluating the Use of Anxiety Patient\u2010Reported Outcome Measures (PROMs) in Dementia Clinical Trials: A Systematic Review"],"prefix":"10.1111","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3655-2849","authenticated-orcid":false,"given":"Jason","family":"Domingo","sequence":"first","affiliation":[{"name":"National Institute for Health and Care Research\u2014Cambridge Clinical Research Facility Cambridge University Hospitals NHS Foundation Trust Cambridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Alves","sequence":"additional","affiliation":[{"name":"Guy's and St Thomas\u2019 NHS Foundation Trust London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Sanders","sequence":"additional","affiliation":[{"name":"Faculty of Nursing, Midwifery &amp; Palliative Care King's College London London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,6,21]]},"reference":[{"key":"e_1_2_13_2_1","unstructured":"Dementia UK. \u201cManaging Anxiety Depression in a Person With Dementia \u201d2024 https:\/\/www.dementiauk.org\/wp-content\/uploads\/dementia-uk-anxiety-and-depression-leaflet.pdf."},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/jgs.19078"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2022.03.010"},{"key":"e_1_2_13_5_1","unstructured":"Alzheimer's Society. \u201cWhat Are the Costs of Dementia Diagnosis and Care in the UK? 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