{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,7]],"date-time":"2026-07-07T06:46:32Z","timestamp":1783406792679,"version":"3.54.6"},"reference-count":33,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2024,1,12]],"date-time":"2024-01-12T00:00:00Z","timestamp":1705017600000},"content-version":"unspecified","delay-in-days":11,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100012317","name":"UCLH Biomedical Research Centre","doi-asserted-by":"publisher","award":["NIHR-INF-1873"],"award-info":[{"award-number":["NIHR-INF-1873"]}],"id":[{"id":"10.13039\/501100012317","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,12,11]]},"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Acute heart failure (HF) is a major cause of unplanned hospitalisation characterised by excess body water. A restriction in oral fluid intake is commonly imposed on patients as an adjunct to pharmacological therapy with loop diuretics, but there is a lack of evidence from traditional randomised controlled trials (RCTs) to support the safety and effectiveness of this intervention in the acute setting.<\/jats:p>\n                  <jats:p>This study aims to explore the feasibility of using computer alerts within the electronic health record (EHR) system to invite clinical care teams to enrol patients into a pragmatic RCT at the time of clinical decision-making. It will additionally assess the effectiveness of using an alert to help address the clinical research question of whether oral fluid restriction is a safe and effective adjunct to pharmacological therapy for patients admitted with fluid overload.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>THIRST (Randomised Controlled <jats:bold>T<\/jats:bold>rial within the electronic <jats:bold>H<\/jats:bold>ealth record of an <jats:bold>I<\/jats:bold>nterruptive alert displaying a fluid <jats:bold>R<\/jats:bold>estriction <jats:bold>S<\/jats:bold>uggestion in patients with the treatable <jats:bold>T<\/jats:bold>rait of congestion) Alert is a single-centre, parallel-group, open-label pragmatic RCT embedded in the EHR system that will be conducted as a feasibility study at an National Health Service (NHS) hospital in London. The clinical care team will be invited to enrol suitable patients in the study using a point-of-care alert with a target sample size of 50 patients. Enrolled patients will then be randomised to either restricted or unrestricted oral fluid intake. Two primary outcomes will be explored (1) the proportion of eligible patients enrolled in the study and (2) the mean difference in oral fluid intake between randomised groups. A series of secondary outcomes are specified to evaluate the effectiveness of the alert, adherence to the randomised treatment allocation and the quality of data generated from routine care, relevant to the outcomes of interest.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>This study was approved by Riverside Research Ethics Committee (Ref: 22\/LO\/0889) and will be published on completion.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05869656\">NCT05869656<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-080410","type":"journal-article","created":{"date-parts":[[2024,1,12]],"date-time":"2024-01-12T00:05:32Z","timestamp":1705017932000},"page":"e080410","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Rationale and design of the THIRST Alert feasibility study: a pragmatic, single-centre, parallel-group randomised controlled trial of an interruptive alert for oral fluid restriction in patients treated with intravenous furosemide"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct05869656","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05869656","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6032-3387","authenticated-orcid":false,"given":"Yang","family":"Chen","sequence":"first","affiliation":[{"name":"Institute of Health Informatics, University College London, London, UK"},{"name":"Clinical and Research Informatics Unit, NIHR UCLH Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anoop","family":"Shah","sequence":"additional","affiliation":[{"name":"Institute of Health Informatics, University College London, London, UK"},{"name":"Clinical and Research Informatics Unit, NIHR UCLH Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5927-5429","authenticated-orcid":false,"given":"Yogini","family":"Jani","sequence":"additional","affiliation":[{"name":"Centre for Medicines Optimisation Research & Education - CMORE, University College London Hospitals NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Higgins","sequence":"additional","affiliation":[{"name":"Clinical and Research Informatics Unit, NIHR UCLH Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nausheen","family":"Saleem","sequence":"additional","affiliation":[{"name":"Clinical and Research Informatics Unit, NIHR UCLH Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kris","family":"Chafer","sequence":"additional","affiliation":[{"name":"Clinical and Research Informatics Unit, NIHR UCLH Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9323-1371","authenticated-orcid":false,"given":"Matthew Robert","family":"Sydes","sequence":"additional","affiliation":[{"name":"Institute of Clinical Trials and Methodology, Medical Research Council Clinical Trials Unit at University College London, London, UK"},{"name":"Health Data Research UK, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Folkert W","family":"Asselbergs","sequence":"additional","affiliation":[{"name":"Institute of Health Informatics, University College London, London, UK"},{"name":"Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R Thomas","family":"Lumbers","sequence":"additional","affiliation":[{"name":"Institute of Health Informatics, University College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,1,11]]},"reference":[{"key":"2025101814581672000_14.1.e080410.1","doi-asserted-by":"crossref","first-page":"3272","DOI":"10.1093\/cvr\/cvac013","article-title":"Global burden of heart failure: A comprehensive and updated review of epidemiology","volume":"118","author":"Savarese","year":"2023","journal-title":"Cardiovasc Res"},{"key":"2025101814581672000_14.1.e080410.2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehab368"},{"key":"2025101814581672000_14.1.e080410.3","doi-asserted-by":"crossref","first-page":"141","DOI":"10.1159\/000526902","article-title":"Diagnosis of fluid overload: from conventional to contemporary concepts","volume":"12","author":"Koratala","year":"2022","journal-title":"Cardiorenal Med"},{"key":"2025101814581672000_14.1.e080410.4","doi-asserted-by":"crossref","first-page":"1058","DOI":"10.1001\/jamainternmed.2013.552","article-title":"Aggressive fluid and sodium restriction in acute decompensated heart failure: a randomized clinical trial","volume":"173","author":"Aliti","year":"2013","journal-title":"JAMA Intern Med"},{"key":"2025101814581672000_14.1.e080410.5","doi-asserted-by":"crossref","first-page":"111","DOI":"10.1016\/j.nut.2018.02.007","article-title":"Aggressive fluid and sodium restriction in decompensated heart failure with preserved ejection fraction: results from a randomized clinical trial","volume":"54","author":"Machado d\u2019Almeida","year":"2018","journal-title":"Nutrition"},{"key":"2025101814581672000_14.1.e080410.6","doi-asserted-by":"publisher","DOI":"10.1016\/j.cardfail.2006.10.012"},{"key":"2025101814581672000_14.1.e080410.7","doi-asserted-by":"crossref","unstructured":"Sedgwick P , Greenwood N . Understanding the Hawthorne effect. BMJ 2015:h4672. doi:10.1136\/bmj.h4672","DOI":"10.1136\/bmj.h4672"},{"key":"2025101814581672000_14.1.e080410.8","doi-asserted-by":"publisher","DOI":"10.1016\/j.cardfail.2022.02.010"},{"key":"2025101814581672000_14.1.e080410.9","doi-asserted-by":"crossref","DOI":"10.1136\/openhrt-2020-001258","article-title":"Research priorities in advanced heart failure: James LIND alliance priority setting partnership","volume":"7","author":"Taylor","year":"2020","journal-title":"Open Heart"},{"key":"2025101814581672000_14.1.e080410.10","doi-asserted-by":"publisher","DOI":"10.1093\/eurjhf\/hfq118"},{"key":"2025101814581672000_14.1.e080410.11","doi-asserted-by":"publisher","DOI":"10.1067\/mhj.2000.107177"},{"key":"2025101814581672000_14.1.e080410.12","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2020-321790"},{"key":"2025101814581672000_14.1.e080410.13","unstructured":"NICE guideline NG107 . RRT and conservative management evidence review for dietary management and fluid restriction. n.d. Available: https:\/\/www.nice.org.uk\/guidance\/ng107\/evidence\/i-dietary-management-and-fluid-restriction-pdf-235524385620"},{"key":"2025101814581672000_14.1.e080410.14","unstructured":"Nice guideline NG203 . Chronic kidney disease: assessment and management. n.d. Available: https:\/\/www.nice.org.uk\/guidance\/ng203\/resources\/chronic-kidney-disease-assessment-and-management-pdf-66143713055173"},{"key":"2025101814581672000_14.1.e080410.15","doi-asserted-by":"crossref","first-page":"641","DOI":"10.1038\/s41569-020-0379-7","article-title":"Congestion in heart failure: a contemporary look at physiology, diagnosis and treatment","volume":"17","author":"Boorsma","year":"2020","journal-title":"Nat Rev Cardiol"},{"key":"2025101814581672000_14.1.e080410.16","doi-asserted-by":"publisher","DOI":"10.1093\/eurjhf\/hfq045"},{"key":"2025101814581672000_14.1.e080410.17","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.01359-2015"},{"key":"2025101814581672000_14.1.e080410.18","doi-asserted-by":"crossref","first-page":"737","DOI":"10.1038\/s41569-022-00705-w","article-title":"The need for increased pragmatism in cardiovascular clinical trials","volume":"19","author":"Usman","year":"2022","journal-title":"Nat Rev Cardiol"},{"key":"2025101814581672000_14.1.e080410.19","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0150205","article-title":"Defining feasibility and pilot studies in preparation for randomised controlled trials: development of a conceptual framework","volume":"11","author":"Eldridge","year":"2016","journal-title":"PLoS ONE"},{"key":"2025101814581672000_14.1.e080410.20","unstructured":"NHS England . Acute global Digital Exemplars. 2022. Available: https:\/\/www.england.nhs.uk\/digitaltechnology\/connecteddigitalsystems\/exemplars\/acute-global-digital-exemplars\/ [Accessed 17 May 2022]."},{"key":"2025101814581672000_14.1.e080410.21","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-3-201302050-00583"},{"key":"2025101814581672000_14.1.e080410.22","doi-asserted-by":"publisher","DOI":"10.4103\/2229-3485.140555"},{"key":"2025101814581672000_14.1.e080410.23","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.n2061","article-title":"A new framework for developing and evaluating complex interventions: update of medical research Council guidance","volume":"374","author":"Skivington","year":"2021","journal-title":"BMJ"},{"key":"2025101814581672000_14.1.e080410.24","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.h2147","article-title":"The PRECIS-2 tool: designing trials that are fit for purpose","volume":"350","author":"Loudon","year":"2015","journal-title":"BMJ"},{"key":"2025101814581672000_14.1.e080410.25","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.m4786","article-title":"Electronic health record alerts for acute kidney injury: multicenter, randomized clinical trial","volume":"372","author":"Wilson","year":"2021","journal-title":"BMJ"},{"key":"2025101814581672000_14.1.e080410.26","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2018-022233","article-title":"Role of feasibility and pilot studies in randomised controlled trials: a cross-sectional study","volume":"8","author":"Blatch-Jones","year":"2018","journal-title":"BMJ Open"},{"key":"2025101814581672000_14.1.e080410.27","unstructured":"NHS Health Research Authority . Safety and progress reports (other research) procedural table. Available: https:\/\/www.hra.nhs.uk\/approvals-amendments\/managing-your-approval\/safety-reporting\/safety-and-progress-reports-other-research-procedural-table\/ [Accessed 10 May 2023]."},{"key":"2025101814581672000_14.1.e080410.28","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0278260","article-title":"Digital technology and patient and public involvement (PPI) in routine care and clinical research\u2014A pilot study","volume":"18","author":"Chen","year":"2023","journal-title":"PLoS ONE"},{"key":"2025101814581672000_14.1.e080410.29","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2017-017124","article-title":"Reviewing progress in public involvement in NIHR research: developing and implementing a new vision for the future","volume":"8","author":"Staniszewska","year":"2018","journal-title":"BMJ Open"},{"key":"2025101814581672000_14.1.e080410.30","unstructured":"NHS Digital . Dcb0160: clinical risk management: its application in the deployment and use of health IT systems. 2023. Available: https:\/\/digital.nhs.uk\/data-and-information\/information-standards\/information-standards-and-data-collections-including-extractions\/publications-and-notifications\/standards-and-collections\/dcb0160-clinical-risk-management-its-application-in-the-deployment-and-use-of-health-it-systems [Accessed 3 Feb 2023]."},{"key":"2025101814581672000_14.1.e080410.31","unstructured":"Medicines and Healthcare products Regulatory Agency . Public access registration database. 2023. Available: https:\/\/pard.mhra.gov.uk\/manufacturer-details\/33914 [Accessed 2 Sep 2023]."},{"key":"2025101814581672000_14.1.e080410.32","unstructured":"Medicines and Healthcare products Regulatory Agency . Guidance:medical Devicee stand-alone including Apps (including Ivdmds). 2023. Available: https:\/\/assets.publishing.service.gov.uk\/government\/uploads\/system\/uploads\/attachment_data\/file\/1105233\/Medical_device_stand-alone_software_including_apps.pdf [Accessed 3 Feb 2023]."},{"key":"2025101814581672000_14.1.e080410.33","doi-asserted-by":"crossref","first-page":"1296","DOI":"10.1093\/eurheartj\/ehac030","article-title":"Nudging within learning health systems: next generation decision support to improve cardiovascular care","volume":"43","author":"Chen","year":"2022","journal-title":"Eur Heart J"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2023-080410","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T21:58:27Z","timestamp":1760824707000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2023-080410"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1]]},"references-count":33,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,1,11]]},"published-print":{"date-parts":[[2024,1]]}},"alternative-id":["10.1136\/bmjopen-2023-080410"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2023-080410","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1]]}}}