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

Elaine Denny; Annalise Weckesser; Georgina Jones; Stavroula Bibila; Jane Daniels; Siladitya Bhattacharya; PRE-EMPT team

doi:10.1186/s40814-018-0358-5

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

Elaine Denny (Corresponding Author), Annalise Weckesser, Georgina Jones, Stavroula Bibila, Jane Daniels, Siladitya Bhattacharya, PRE-EMPT team

Applied Health Sciences

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	168
Journal	Pilot & Feasibility Studies
Volume	4
DOIs	https://doi.org/10.1186/s40814-018-0358-5
Publication status	Published - 5 Nov 2018

Bibliographical note

Due 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.

Keywords

endometriosis
treatment
experiences
qualitative research
trial recruitment

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Women’s experiences of medical treatment for endometriosis and its impact on PRE-EMPT trial participation
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Cite this

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title = "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 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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author = "Elaine Denny and Annalise Weckesser and Georgina Jones and Stavroula Bibila and Jane Daniels and Siladitya Bhattacharya and {PRE-EMPT team}",

note = "Due 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. ",

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AU - Denny, Elaine

AU - Weckesser, Annalise

AU - Jones, Georgina

AU - Bibila, Stavroula

AU - Daniels, Jane

AU - Bhattacharya, Siladitya

AU - PRE-EMPT team

N1 - Due 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.

PY - 2018/11/5

Y1 - 2018/11/5

N2 - 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.

AB - 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.

KW - endometriosis

KW - treatment

KW - experiences

KW - qualitative research

KW - trial recruitment

U2 - 10.1186/s40814-018-0358-5

DO - 10.1186/s40814-018-0358-5

M3 - Article

C2 - 30410786

SN - 2055-5784

VL - 4

JO - Pilot & Feasibility Studies

JF - Pilot & Feasibility Studies

M1 - 168

ER -

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

Abstract

Bibliographical note

Keywords

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