Questioning approaches to consent in time critical obstetric trials: findings from a mixed-methods study
Objective Trial legislation enables research to be conducted without prior consent (RWPC) in emergency situations, yet this approach has rarely been used in time-critical obstetric trials. This study explored views and experiences of antenatal recruitment and consent and RWPC in an emergency intrapa...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2024-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/2/e081874.full |
| _version_ | 1797271599758442496 |
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| author | Kerry Woolfall Carrol Gamble Elizabeth Deja Andrew Weeks Tina Lavender Gillian Gyte Shireen Meher Charlotte Van Netten |
| author_facet | Kerry Woolfall Carrol Gamble Elizabeth Deja Andrew Weeks Tina Lavender Gillian Gyte Shireen Meher Charlotte Van Netten |
| author_sort | Kerry Woolfall |
| collection | DOAJ |
| description | Objective Trial legislation enables research to be conducted without prior consent (RWPC) in emergency situations, yet this approach has rarely been used in time-critical obstetric trials. This study explored views and experiences of antenatal recruitment and consent and RWPC in an emergency intrapartum randomised clinical trial.Design Embedded, mixed-methods study within a trial, involving questionnaires, recorded recruitment discussions, interviews and focus groups in the first 13 months of trial recruitment (December 2020–January 2022).Setting COPE is a double-blind randomised controlled trial, comparing the effectiveness of carboprost or oxytocin as first-line treatment of postpartum haemorrhage.Participants Two hundred and eighty-six people (190 women/96 birth partners), linked to 198/380 (52%) COPE recruits participated in the embedded study. Of these, 272 completed a questionnaire (178 women/94 birth partners), 22 were interviewed (19 women/3 birth partners) and 16 consent discussions with 12 women were recorded. Twenty-seven staff took part in three focus groups and nine staff were interviewed.Results Participants recommended that information about the study should be more accessible antenatally for those who wish to be informed. Most women and staff did not think it would be appropriate to seek consent during pregnancy or early labour as it may cause ‘unnecessary panic’ and lead to research waste, as most women would not become eligible. There was support for the use of RWPC as COPE interventions are used in standard clinical practice and viewed as low risk. Women who were approached about the trial while having a postpartum haemorrhage also supported RWPC as they could not recall research discussions.Conclusions Findings support the use of RWPC for time-critical interventions, and raise questions about the appropriateness of other commonly used consent pathways, including antenatal consent and verbal assent. |
| first_indexed | 2024-03-07T14:08:50Z |
| format | Article |
| id | doaj.art-7c2b46551004462db40cf03c61f0cebd |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-07T14:08:50Z |
| publishDate | 2024-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-7c2b46551004462db40cf03c61f0cebd2024-03-06T18:20:08ZengBMJ Publishing GroupBMJ Open2044-60552024-02-0114210.1136/bmjopen-2023-081874Questioning approaches to consent in time critical obstetric trials: findings from a mixed-methods studyKerry Woolfall0Carrol Gamble1Elizabeth Deja2Andrew Weeks3Tina Lavender4Gillian Gyte5Shireen Meher6Charlotte Van Netten7Department of Public Health, Policy and Systems, University of Liverpool, Liverpool, UKHealth Data Science, University of Liverpool, Liverpool, UKDepartment of Public Health, Policy and Systems, University of Liverpool, Liverpool, UKDepartment of Women`s and Children`s Health, University of Liverpool, Liverpool, UKDepartment of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UKNational Childbirth Trust, London, UKBirmingham Women`s Hospital, Birmingham, UKLiverpool Clinical Trials Centre, University of Liverpool, Liverpool, UKObjective Trial legislation enables research to be conducted without prior consent (RWPC) in emergency situations, yet this approach has rarely been used in time-critical obstetric trials. This study explored views and experiences of antenatal recruitment and consent and RWPC in an emergency intrapartum randomised clinical trial.Design Embedded, mixed-methods study within a trial, involving questionnaires, recorded recruitment discussions, interviews and focus groups in the first 13 months of trial recruitment (December 2020–January 2022).Setting COPE is a double-blind randomised controlled trial, comparing the effectiveness of carboprost or oxytocin as first-line treatment of postpartum haemorrhage.Participants Two hundred and eighty-six people (190 women/96 birth partners), linked to 198/380 (52%) COPE recruits participated in the embedded study. Of these, 272 completed a questionnaire (178 women/94 birth partners), 22 were interviewed (19 women/3 birth partners) and 16 consent discussions with 12 women were recorded. Twenty-seven staff took part in three focus groups and nine staff were interviewed.Results Participants recommended that information about the study should be more accessible antenatally for those who wish to be informed. Most women and staff did not think it would be appropriate to seek consent during pregnancy or early labour as it may cause ‘unnecessary panic’ and lead to research waste, as most women would not become eligible. There was support for the use of RWPC as COPE interventions are used in standard clinical practice and viewed as low risk. Women who were approached about the trial while having a postpartum haemorrhage also supported RWPC as they could not recall research discussions.Conclusions Findings support the use of RWPC for time-critical interventions, and raise questions about the appropriateness of other commonly used consent pathways, including antenatal consent and verbal assent.https://bmjopen.bmj.com/content/14/2/e081874.full |
| spellingShingle | Kerry Woolfall Carrol Gamble Elizabeth Deja Andrew Weeks Tina Lavender Gillian Gyte Shireen Meher Charlotte Van Netten Questioning approaches to consent in time critical obstetric trials: findings from a mixed-methods study BMJ Open |
| title | Questioning approaches to consent in time critical obstetric trials: findings from a mixed-methods study |
| title_full | Questioning approaches to consent in time critical obstetric trials: findings from a mixed-methods study |
| title_fullStr | Questioning approaches to consent in time critical obstetric trials: findings from a mixed-methods study |
| title_full_unstemmed | Questioning approaches to consent in time critical obstetric trials: findings from a mixed-methods study |
| title_short | Questioning approaches to consent in time critical obstetric trials: findings from a mixed-methods study |
| title_sort | questioning approaches to consent in time critical obstetric trials findings from a mixed methods study |
| url | https://bmjopen.bmj.com/content/14/2/e081874.full |
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