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.
ABSTRACT
OBJECTIVE: to gain insight into the experiences and perspectives of pregnant women diagnosed antenatally with fetal lower urinary tract obstruction (LUTO) participating in an interventional fetal medicine randomised controlled trial (RCT). DESIGN: a qualitative study using semi-structured interviews. Interviews were analysed using Riessman's narrative analysis. SETTING: fetal medicine clinics within the United Kingdom National Health Service (NHS). PARTICIPANTS: five pregnant women who were recruited as part of an RCT and two additional women who were recruited after the trial was terminated before completion. FINDINGS: three themes were identified and form the basis of this article: the use of technology in pregnancy, the loss of a normal pregnancy, and decision making in uncertainty. IMPLICATIONS AND CONCLUSIONS: undertaking qualitative research within an RCT can illuminate the experience of the condition being studied. Women's experience of a pregnancy where LUTO was diagnosed in the fetus entailed an emotional journey following the visualisation of the abnormality through the use of routine ultrasound screening. Women tried to make sense of the diagnosis in order to make the best, albeit less than ideal, decisions for themselves, their baby, and their family. Midwives are in a good position to support women through the emotional distress of diagnosis and to help them negotiate the uncertain terrain in which they make decisions.
