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ISRCTN
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ISRCTN85619876
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ClinicalTrials.gov identifier
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Public title
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A multi-centre randomised controlled trial assessing the costs and benefits of using structured information and analysis of women's preferences in the management of menorrhagia
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 93/18/12
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Study hypothesis
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Each of the medical and surgical therapies available for the treatment of menorrhagia has different outcomes, risks and benefits. Women are likely to have different attitudes towards the trade-offs that present themselves when choosing a treatment. It is important, therefore, that women's preferences are taken into account when treatment decisions are being made. However, in order to share in decision making, women need structured and full information on menorrhagia and its treatment.
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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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Urological and genital diseases: Menstrual disorders
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Participants - inclusion criteria
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Women with menorrhagia
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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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01/10/1995
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Anticipated end date
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31/08/2000
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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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200
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Interventions
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Randomised controlled trial. This study is made up of two phases. Phase I will involve developing structured information on menorrhagia in the form of a booklet and a video, together with an interview protocol to be used to assess women's preferences regarding the treatment of the condition. In Phase II, 600 women with menorrhagia referred to one of five hospitals will be randomised to standard management or to a new management strategy involving the provision of structured information and the assessment of preferences using the package developed in Phase I. Women will be followed-up over 2 years to assess the effectiveness and cost-effectiveness of the new management strategy. The extensive data collected in Phase II of the study will facilitate secondary analyses that will provide information to improve the effectiveness and cost-effectiveness of the management of menorrhagia.
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Primary outcome measure(s)
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Women will be followed-up over 2 years to assess the effectiveness and cost-effectiveness of the new management strategy. The primary outcome was health status, measured using the 36-item short-form general health survey (SF-36) instrument.
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Secondary outcome measure(s)
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Secondary outcomes included women's treatment preferences, treatments undergone and satisfaction. In the economic analyses, health outcomes were measured in terms of quality-adjusted life-years (QALYs) based on women's responses to the EQ-5D (EuroQol-5 dimensions) instrument.
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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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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12633525
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Contact name
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Mr
Andrew
Kennedy
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Address
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Council on Health Research for Development
11 Rue de Cornavin
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City/town
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Geneva
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Zip/Postcode
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CH-1201
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Country
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Switzerland
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Tel
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+41 591 8900
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Fax
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+41 591 8910
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Email
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kennedy@cohred.org
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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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