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ISRCTN
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ISRCTN82765705
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ClinicalTrials.gov identifier
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Public title
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What is the cost-effectiveness of endoscopy undertaken by nurses? A Multi-Institution NUrse Endoscopy Trial (MINuET)
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Scientific title
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Acronym
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MINuET
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Serial number at source
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HTA 97/37/09
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Study hypothesis
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The project will evaluate the acceptability, effectiveness, outcome and cost of upper and lower gastrointestinal endoscopy undertaken by nurses in hospital. We plan to compare:
1. The acceptability to patients of these procedures when undertaken by nurses or doctors
2. The quality of the process of these procedures when undertaken by nurses or doctors
3. The outcome for, and value to, patients of these procedures when undertaken by nurses or doctors
4. The resources consumed by the NHS and patients through these procedures when undertaken by nurses or doctors.
We also plan to develop an economic model to predict the effect of nurse endoscopies on the labour market and training requirements for clinical nurse specialists.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Digestive system diseases
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Participants - inclusion criteria
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Patients undergoing upper and lower gastrointestinal (GI) endoscopy.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/09/2001
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Anticipated end date
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31/10/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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1888
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Interventions
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Endoscopy undertaken by nurses versus doctors
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Primary outcome measure(s)
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1. Acceptability and anxiety scores, completeness of examination, incidence of technical complications, recording of clinical findings, and need for further investigation or procedure.
2. Incidence of clinical complications, quality of life (generic and disease-specific) measured pre-procedure and at one and 12 months post-procedure.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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HTA monograph on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids= 17018229
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Contact name
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Prof
John
Williams
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Address
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University of Wales Swansea
Singleton Park
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City/town
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Swansea
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Zip/Postcode
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SA2 8PP
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Country
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United Kingdom
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Tel
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+44 (0)1792 513402
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Fax
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+44 (0)1792 513430
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Email
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j.g.williams@swan.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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17/01/2008
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Date ISRCTN assigned
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25/04/2003
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