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

ISRCTN	ISRCTN85619876
DOI	https://doi.org/10.1186/ISRCTN85619876
Secondary identifying numbers	HTA 93/18/12

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 08/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Andrew Kennedy
Scientific

Council on Health Research for Development
11 Rue de Cornavin
Geneva
CH-1201
Switzerland

Phone	+41 591 8900
Email	kennedy@cohred.org

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	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
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
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 study start date	01/10/1995
Completion date	31/08/2000

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	200
Key inclusion criteria	Women with menorrhagia
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/10/1995
Date of final enrolment	31/08/2000

Locations

Countries of recruitment

Switzerland
United Kingdom

Study participating centre

Council on Health Research for Development

Geneva
CH-1201
Switzerland

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	HTA monograph	01/12/2003		Yes	No

Editorial Notes

08/11/2022: Internal review.