Contact information
Type
Scientific
Primary contact
Mr Andrew Kennedy
ORCID ID
Contact details
Council on Health Research for Development
11 Rue de Cornavin
Geneva
CH-1201
Switzerland
+41 591 8900
kennedy@cohred.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 93/18/12
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Urological and genital diseases: Menstrual disorders
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
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.
Overall trial start date
01/10/1995
Overall trial end date
31/08/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women with menorrhagia
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
200
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/10/1995
Recruitment end date
31/08/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Council on Health Research for Development
Geneva
CH-1201
Switzerland
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2003 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/12633525
Publication citations
-
HTA monograph
Kennedy AD, Sculpher MJ, Coulter A, Dwyer N, Rees M, Horsley S, Cowley D, Kidson C, Kirwin C, Naish C, Bidgood K, Cullimore J, Kerr-Wilson R, Abrams KR, Stirrat G, A multicentre randomised controlled trial assessing the costs and benefits of using structured information and analysis of women's preferences in the management of menorrhagia., Health Technol Assess, 2003, 7, 8, 1-76.