Women’s experiences of medical treatment for endometriosis and its impact on PRE-EMPT trial participation: a qualitative study
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 stud...
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| Format: | Article |
| Language: | English |
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BMC
2018-11-01
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| Series: | Pilot and Feasibility Studies |
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| Online Access: | http://link.springer.com/article/10.1186/s40814-018-0358-5 |
| _version_ | 1819020702418731008 |
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| author | Elaine Denny Annalise Weckesser Georgina Jones Stavroula Bibila Jane Daniels Siladitya Bhattacharya on behalf of the PRE-EMPT team |
| author_facet | Elaine Denny Annalise Weckesser Georgina Jones Stavroula Bibila Jane Daniels Siladitya Bhattacharya on behalf of the PRE-EMPT team |
| author_sort | Elaine Denny |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-21T03:55:24Z |
| format | Article |
| id | doaj.art-cf7a17f3d8e245d7bdc3e916a683ad37 |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-12-21T03:55:24Z |
| publishDate | 2018-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-cf7a17f3d8e245d7bdc3e916a683ad372022-12-21T19:16:51ZengBMCPilot and Feasibility Studies2055-57842018-11-014111010.1186/s40814-018-0358-5Women’s experiences of medical treatment for endometriosis and its impact on PRE-EMPT trial participation: a qualitative studyElaine Denny0Annalise Weckesser1Georgina Jones2Stavroula Bibila3Jane Daniels4Siladitya Bhattacharya5on behalf of the PRE-EMPT teamCentre for Social Care, Health and Related Research, Faculty of Health, Education and Life Sciences, Birmingham City UniversityCentre for Social Care, Health and Related Research, Faculty of Health, Education and Life Sciences, Birmingham City UniversitySchool of Social Sciences, Leeds Beckett UniversityCoventry University GroupNottingham Clinical Trials Unit, Queen’s Medical CentreInstitute of Applied Health Sciences, School of MedicineAbstract 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.http://link.springer.com/article/10.1186/s40814-018-0358-5EndometriosisTreatmentExperiencesQualitative researchTrial recruitment |
| spellingShingle | Elaine Denny Annalise Weckesser Georgina Jones Stavroula Bibila Jane Daniels Siladitya Bhattacharya on behalf of the PRE-EMPT team Women’s experiences of medical treatment for endometriosis and its impact on PRE-EMPT trial participation: a qualitative study Pilot and Feasibility Studies Endometriosis Treatment Experiences Qualitative research Trial recruitment |
| title | Women’s experiences of medical treatment for endometriosis and its impact on PRE-EMPT trial participation: a qualitative study |
| title_full | Women’s experiences of medical treatment for endometriosis and its impact on PRE-EMPT trial participation: a qualitative study |
| title_fullStr | Women’s experiences of medical treatment for endometriosis and its impact on PRE-EMPT trial participation: a qualitative study |
| title_full_unstemmed | Women’s experiences of medical treatment for endometriosis and its impact on PRE-EMPT trial participation: a qualitative study |
| title_short | Women’s experiences of medical treatment for endometriosis and its impact on PRE-EMPT trial participation: a qualitative study |
| title_sort | women s experiences of medical treatment for endometriosis and its impact on pre empt trial participation a qualitative study |
| topic | Endometriosis Treatment Experiences Qualitative research Trial recruitment |
| url | http://link.springer.com/article/10.1186/s40814-018-0358-5 |
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