Background: Endometriosis is a common cause of chronic pelvic pain which can relapse after surgery, yet little research has been conducted on women's experience of medical treatments for prevention of recurrence and the influence of this on participation in clinical trials.
Methods: This study explored women's past experiences with medical treatments for endometriosis symptoms and the impact this has on their motivation to enter the pilot phase of a post-conservative surgery clinical trial, PRE-EMPT: Preventing Recurrence of Endometriosis by Means of long acting Progestogen Therapy. Qualitative methodology was adopted, involving semi-structured interviews in three UK cities, and one focus group was used to collect data from women with a diagnosis of endometriosis participating in the PRE-EMPT trial.
Results: Ten women were interviewed individually and four took part in the focus group discussion. Women's willingness to enter the PRE-EMPT trial was bound up with their previous experiences, present situation and future expectations of medication, as well as the control offered by flexible randomisation which allows the option to reject a particular treatment post-surgery.
Conclusion: Women were strongly influenced by previous experience and personal circumstances in their decision to enter the PRE-EMPT trial. This decision was facilitated by the ability to 'opt out' of the treatment arm(s) they found unacceptable. This element of choice offered patients a sense of control in the randomisation process and has important implications for clinical trial design and recruitment.
Trial registration: ISRCTN97865475. EUDRACT number 2013-001984-21.
Bibliographical noteDue to the sensitive nature of the data generated and the possibility of identification of individuals, datasets are not generally available. The anonymised datasets used and/or analysed during the current qualitative study are available from the corresponding author on reasonable request.
This study formed part of the HTA Project: 11/114/01 - PRE-EMPT: Preventing Recurrence of Endometriosis by Means of long acting Progestogen Therapy.
- qualitative research
- trial recruitment