Women’s experiences of medical treatment for endometriosis and its impact on PRE-EMPT trial participation: a qualitative study

on behalf of the PRE-EMPT team, Elaine Denny, Annalise Weckesser, Georgina Jones, Stavroula Bibila, Jane Daniels, Stavroula Bıbıla, Siladitya Bhattacharya, PRE-EMPT team
Pilot and feasibility studies · 2018 · vol. 4(1) , pp. 168 · doi:10.1186/s40814-018-0358-5 · PMID:30410786 · W2900245266
article OA: gold CC0 ⤵ 7 in-corpus citations
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Abstract

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.

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endometriosischronic_pelvic_pain

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