title: Evaluating a computer aid for assessing stomach symptoms (ECASS): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ISRCTN Registry, ISRCTN12595588 .
authors.affiliation: School of Medicine, Pharmacy & Health, Durham University, Wolfson Research Institute, Queens Campus, Thornaby, TS17 6BH, UK.
authors.forename: Helen J
authors.initials: HJ
authors.lastname: Moore
authors.affiliation: School of Medicine, Pharmacy & Health, Durham University, Wolfson Research Institute, Queens Campus, Thornaby, TS17 6BH, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Nixon
authors.affiliation: School of Medicine, Pharmacy & Health, Durham University, Wolfson Research Institute, Queens Campus, Thornaby, TS17 6BH, UK.
authors.forename: Anisah
authors.initials: A
authors.lastname: Tariq
authors.affiliation: General Practice and Primary Health Care Academic Centre, The University of Melbourne, 200 Berkeley St, Carlton, VIC, 3053, Australia.
authors.forename: Jon
authors.initials: J
authors.lastname: Emery
authors.affiliation: The Veysey Building, University of Exeter, College House, Exeter, EX1 2LU, UK.
authors.forename: Willie
authors.initials: W
authors.lastname: Hamilton
authors.affiliation: NWORTH Clinical Trials Unit, Bangor University, Y Wern, Normal Site, Holyhead Road, Bangor, LL57 2PZ, UK.
authors.forename: Zoë
authors.initials: Z
authors.lastname: Hoare
authors.affiliation: Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, 2 Worts Causeway, Cambridge, CB1 8RN, UK.
authors.forename: Anne
authors.initials: A
authors.lastname: Kershenbaum
authors.affiliation: North Wales Centre for Primary Care Research, Bangor University, Gwenfro Units 4-8, Wrexham Technology Park, Wrexham, LL13 7YP, UK.
authors.forename: Richard D
authors.initials: RD
authors.lastname: Neal
authors.affiliation: NIHR CLAHRC South West Peninsula (PenCLAHRC), University of Exeter, South Cloisters Building, St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
authors.forename: Obioha C
authors.initials: OC
authors.lastname: Ukoumunne
authors.affiliation: Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, 2 Worts Causeway, Cambridge, CB1 8RN, UK.
authors.forename: Juliet
authors.initials: J
authors.lastname: Usher-Smith
authors.affiliation: Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge, 2 Worts Causeway, Cambridge, CB1 8RN, UK.
authors.forename: Fiona M
authors.initials: FM
authors.lastname: Walter
authors.affiliation: School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.
authors.forename: Sophie
authors.initials: S
authors.lastname: Whyte
authors.affiliation: School of Medicine, Pharmacy & Health, Durham University, Wolfson Research Institute, Queens Campus, Thornaby, TS17 6BH, UK. g.p.rubin@durham.ac.uk.
authors.forename: Greg
authors.initials: G
authors.lastname: Rubin
mesh_terms: D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D020000:Decision Support Systems, Clinical / Q000191:economics; D003661:Decision Support Techniques; D003936:Diagnosis, Computer-Assisted / Q000191:economics; D004739:England; D004938:Esophageal Neoplasms / Q000150:complications* / Q000175:diagnosis / Q000191:economics / Q000628:therapy; D058005:General Practitioners; D017048:Health Care Costs; D006295:Health Resources / Q000191:economics / Q000706:statistics & numerical data; D006801:Humans; D011237:Predictive Value of Tests; D011379:Prognosis; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013272:Stomach Diseases / Q000175:diagnosis / Q000191:economics / Q000209:etiology* / Q000628:therapy; D013274:Stomach Neoplasms / Q000150:complications* / Q000175:diagnosis / Q000191:economics / Q000628:therapy
keywords: Electronic clinical decision support; Gastric cancer; General practice; Oesophageal cancer; Primary care