Willingness of postmenopausal women to participate in a study involving local vaginal oestrogen treatment as an adjunct to pelvic organ prolapse surgery: a qualitative study.
Oestrogen
Postmenopausal women
Qualitative design
Journal
International urogynecology journal
ISSN: 1433-3023
Titre abrégé: Int Urogynecol J
Pays: England
ID NLM: 101567041
Informations de publication
Date de publication:
Feb 2021
Feb 2021
Historique:
received:
09
05
2020
accepted:
28
07
2020
pubmed:
26
8
2020
medline:
3
7
2021
entrez:
26
8
2020
Statut:
ppublish
Résumé
Pelvic organ prolapse (POP) negatively affects many women's quality of life. The ability to develop improved therapeutic approaches for POP patients is hampered by low patient recruitment and retention rates in clinical trials. Our objective was to explore the motivational factors and barriers to recruitment and participation in clinical trials among postmenopausal women with POP who are intending to have surgical management. Qualitative study based on in-depth face-to-face interviews with postmenopausal women attending urogynaecology clinics in the UK intending to have surgical management for pelvic organ prolapse. These women were eligible to participate in the on-going clinical trial on the use of local vaginal oestrogen as an adjunct to surgical treatment. Twenty-two postmenopausal women aged 52-76 years were interviewed. Interviews were analysed using thematic analysis method. Many women participated because of altruistic motivations; however, we found that clarity of information provided, timing of approach and acceptability of study design played a pivotal role in women. Of the women who declined participation, the following themes emerged: uncertainty of the investigational product, fear of experimentation, logistical concerns and regret that their condition was trivialised at an early stage. We have gained a valuable insight into women's views and experience in the decision making process. Understanding the elements that will enhance trial participation such as clarity of information provided, balance between professional guidance whilst maintaining equipoise, easy access to trial teams and timing of approach will ultimately enable us to improve our recruitment to clinical trials.
Sections du résumé
BACKGROUND
BACKGROUND
Pelvic organ prolapse (POP) negatively affects many women's quality of life. The ability to develop improved therapeutic approaches for POP patients is hampered by low patient recruitment and retention rates in clinical trials.
OBJECTIVE
OBJECTIVE
Our objective was to explore the motivational factors and barriers to recruitment and participation in clinical trials among postmenopausal women with POP who are intending to have surgical management.
DESIGN
METHODS
Qualitative study based on in-depth face-to-face interviews with postmenopausal women attending urogynaecology clinics in the UK intending to have surgical management for pelvic organ prolapse. These women were eligible to participate in the on-going clinical trial on the use of local vaginal oestrogen as an adjunct to surgical treatment. Twenty-two postmenopausal women aged 52-76 years were interviewed. Interviews were analysed using thematic analysis method.
RESULTS
RESULTS
Many women participated because of altruistic motivations; however, we found that clarity of information provided, timing of approach and acceptability of study design played a pivotal role in women. Of the women who declined participation, the following themes emerged: uncertainty of the investigational product, fear of experimentation, logistical concerns and regret that their condition was trivialised at an early stage.
CONCLUSION
CONCLUSIONS
We have gained a valuable insight into women's views and experience in the decision making process. Understanding the elements that will enhance trial participation such as clarity of information provided, balance between professional guidance whilst maintaining equipoise, easy access to trial teams and timing of approach will ultimately enable us to improve our recruitment to clinical trials.
Identifiants
pubmed: 32839831
doi: 10.1007/s00192-020-04480-5
pii: 10.1007/s00192-020-04480-5
pmc: PMC7838130
doi:
Substances chimiques
Estrogens
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
413-421Subventions
Organisme : Research for Patient Benefit Programme
ID : PB-PG-0213-30126
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