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dc.contributor.authorMoore, HJ
dc.contributor.authorNixon, C
dc.contributor.authorTariq, A
dc.contributor.authorEmery, J
dc.contributor.authorHamilton, W
dc.contributor.authorHoare, Z
dc.contributor.authorKershenbaum, A
dc.contributor.authorNeal, RD
dc.contributor.authorUkoumunne, OC
dc.contributor.authorUsher-Smith, J
dc.contributor.authorWalter, FM
dc.contributor.authorWhyte, S
dc.contributor.authorRubin, G
dc.date.accessioned2016-05-27T12:26:45Z
dc.date.issued2016-04-04
dc.description.abstractBACKGROUND: For most cancers, only a minority of patients have symptoms meeting the National Institute for Health and Clinical Excellence guidance for urgent referral. For gastro-oesophageal cancers, the 'alarm' symptoms of dysphagia and weight loss are reported by only 32 and 8 % of patients, respectively, and their presence correlates with advanced-stage disease. Electronic clinical decision-support tools that integrate with clinical computer systems have been developed for general practice, although uncertainty remains concerning their effectiveness. The objectives of this trial are to optimise the intervention and establish the acceptability of both the intervention and randomisation, confirm the suitability and selection of outcome measures, finalise the design for the phase III definitive trial, and obtain preliminary estimates of the intervention effect. METHODS/DESIGN: This is a two-arm, multi-centre, cluster-randomised, controlled phase II trial design, which will extend over a 16-month period, across 60 general practices within the North East and North Cumbria and the Eastern Local Clinical Research Network areas. Practices will be randomised to receive either the intervention (the electronic clinical decision-support tool) or to act as a control (usual care). From these practices, we will recruit 3000 adults who meet the trial eligibility criteria and present to their GP with symptoms suggestive of gastro-oesophageal cancer. The main measures are the process data, which include the practitioner outcomes, service outcomes, diagnostic intervals, health economic outcomes, and patient outcomes. One-on-one interviews in a sub-sample of 30 patient-GP dyads will be undertaken to understand the impact of the use or non-use of the electronic clinical decision-support tool in the consultation. A further 10-15 GPs will be interviewed to identify and gain an understanding of the facilitators and constraints influencing implementation of the electronic clinical decision-support tool in practice. DISCUSSION: We aim to generate new knowledge on the process measures regarding the use of electronic clinical decision-support tools in primary care in general and to inform a subsequent definitive phase III trial. Preliminary data on the impact of the support tool on resource utilisation and health care costs will also be collected. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN12595588 .en_GB
dc.description.sponsorshipCancer Research UK, Reference number: C6971/A17940. Cancer Research UK is not involved in the research other than to provide funding.en_GB
dc.identifier.citationVol. 17, article 184en_GB
dc.identifier.doi10.1186/s13063-016-1307-3
dc.identifier.urihttp://hdl.handle.net/10871/21731
dc.language.isoenen_GB
dc.publisherBioMed Centralen_GB
dc.relation.urlhttp://www.ncbi.nlm.nih.gov/pubmed/27044367en_GB
dc.rightsOpen access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en_GB
dc.subjectElectronic clinical decision supporten_GB
dc.subjectGastric canceren_GB
dc.subjectGeneral practiceen_GB
dc.subjectOesophageal canceren_GB
dc.subjectPrimary careen_GB
dc.titleEvaluating a computer aid for assessing stomach symptoms (ECASS): study protocol for a randomised controlled trialen_GB
dc.typeArticleen_GB
dc.date.available2016-05-27T12:26:45Z
exeter.place-of-publicationEngland
dc.descriptionThis is the final version of the article. Available from BioMed Central via the DOI in this record.en_GB
dc.identifier.journalTrialsen_GB


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