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 |
| Protocol serial number | HTA 93/18/12 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
Scientific
Council on Health Research for Development
11 Rue de Cornavin
Geneva
CH-1201
Switzerland
| Phone | +41 591 8900 |
|---|---|
| kennedy@cohred.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/08/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- Switzerland
Study participating centre
Council on Health Research for Development
Geneva
CH-1201
Switzerland
CH-1201
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
