Preventing Recurrence of Endometriosis
Elaine Denny, Professor of Health Sociology
The PRE-EMPT (Preventing Recurrence of Endometriosis by Means of long acting Protestogen Therapy) trial is a multi-centre, randomised controlled trial (RCT) that aims to evaluate the clinical and cost effectiveness of the long acting progestogens DMPA and LNG IUS system in the prevention of the recurrence of endometriosis. In enhancing the delivery and interpretation of the trial, a qualitative study has been integrated into the design.
Aim of research
The objective of the study is to explore those issues the participants of the trial will identify as important in relation to their treatment and its impact on their lives. The study will be carried out in three stages: during the piloting stage of the trial, one year into the trial and three years into the trial.
Prof Elaine Denny and her research team will initially investigate the factors which motivate women to consent or refuse randomisation, and assess how acceptable the four treatment options are to them within the trial (no treatment, LNG IUS, DMPA and COCP). The second and third stage of the study is an in-depth exploration of women's subjective experience of receiving treatment.
This investigation will lead to an increased understanding of the quality of life issues for women with endometriosis.
During the piloting stage of the trial, focus group discussions will take place at the Centre for Health and Social Care Research at Birmingham City University and/or Birmingham Women's Hospital. Women who do not wish to participate in a focus group discussion will have the option to take part in an individual interview (using the same interview schedule). A purposive recruitment strategy will be used and data will be analysed using content analysis.
For the second and third part of the study, Prof Elaine Denny and her research team are planning to carry out individual interviews with a small purposeful sample of women taking part in the different arms of the trial, one and three years into the trial. Around 10 women from each arm of the trial will be interviewed but, depending on the properties of the data, it is likely that recruitment will continue until the point of theoretical saturation is reached and until no new themes will be emerging from the data.
Progress and findings
This research is still in progress.
Outputs and more information
The results of PRE-EMPT will be published in the HTA monograph series. In addition, the research team will be submitting to high impact international journals and presenting at local, national and international gynaecological meetings and conferences. The team will also be working very closely with Endometriosis UK on developing lay summaries of the trial together with clear and detailed information on what the results mean for individual women.
This project aims to increase understanding of the quality of life issues for women with endometriosis.