Women's Experiences of Participating in the Magpie Trial: A Postal Survey in the United Kingdom

Department of Public Health, University of Liverpool, Liverpool, UK.
Birth (Impact Factor: 1.26). 09/2009; 36(3):220-9. DOI: 10.1111/j.1523-536X.2009.00326.x
Source: PubMed


The Magpie Trial compared magnesium sulfate with placebo for women with preeclampsia. The objective of this study was to explore women's views and experiences of participating in the Magpie Trial in the United Kingdom.
Postal questionnaires were sent to 771 women participants in the Magpie Trial to assess long-term health of UK women and children. The questionnaire included three questions exploring women's experience of participating in the trial: (a) If time suddenly went backward, and you had to do it all over again, would you agree to participate in the Magpie Trial? (b) Please tell us if there was anything about the Magpie Trial that you think could have been done better; and (c) Please tell us if there was anything about the Magpie Trial, or your experience of joining the trial, that you think was particularly good.
Overall, 619 of the 771 women who were sent questionnaires returned them. In response to the three questions: (a) 58 percent (356) of women responded "definitely yes," 27 percent (169) "probably yes," 4 percent (23) "probably no," 5 percent (33) "definitely no," and 5 percent (34) "not sure." No clear evidence was shown of a relationship with allocated treatment, although women who responded "probably or definitely no" were more likely to have had side effects from trial treatment. (b) Although 44 percent of women stated that nothing could have been done better, free text suggestions related to content of recruitment information, and its timing, and wanting to know treatment allocation and trial results. c) Women were generally extremely positive about being followed up and receiving trial results.
Women were largely positive about participation in the trial and its follow-up, but still reported ways they believed the study could have been improved, such as more information, given earlier, which also has implications for clinical care.

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    • "Women were also asked about their experience of participating in the Magpie Trial. Responses to these questions are part of a qualitative analysis of participants' views of being in the trial, and are reported elsewhere [14]. "
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    ABSTRACT: The Magpie Trial, a randomised trial comparing magnesium sulphate with placebo for women with pre-eclampsia. This paper describes methods used for follow up in the UK, and presents additional data collected. In the UK 774 women and their 827 children were included; excluded were women discharged without a surviving child and families who opted out. General practitioners were sent a questionnaire when the child was around 18 months old. When the child was two years, or older, questionnaires asking about the health of the women and children were posted to families. A sample of families was offered a home visit, during which the child was assessed using the Bayley Scales of Infant Development. Of the women, 12 were lost to follow up and three died. Of the children, 12 were lost to follow up, 5 were excluded and 19 died. General practitioners returned 688/759 (91%) questionnaires, as did 619/759 (82%) women. Responses were largely comparable. 32 women had serious morbidity potentially related to pre-eclampsia. 30% of children were reported to have been admitted to hospital. There were no clear differences between the randomised groups in the child's behaviour, women's fertility or use of health service resources. Data presented here provide further reassurance about the longer term safety of magnesium sulphate when used for women with pre-eclampsia. Postal questionnaires in the UK to assess the longer term health and wellbeing of women and children recruited to trials are feasible, and can achieve a high response rate. Responses from families and general practitioners were comparable
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    ABSTRACT: to provide insight into pregnant women's experiences of participating in a large multi-centre randomised trial. qualitative semi-structured interviews. six UK maternity units. women recruited to the Magpie Trial. The Magpie Trial was a trial of prophylactic anticonvulsants for women with severe pre-eclampsia. MEASUREMENTS FINDINGS: a number of major but related themes emerged regarding influences on the women's decision-making: unpredictability of pre-eclampsia; quality of information received; role of others in the decision-making process; perceived personal benefit from trial participation; and perception of voluntariness of joining. the data presented give valuable insights into the women's views and experiences of decision-making. Research into many of the other elements of care given during pregnancy and childbirth is still needed, and with this need comes the ethical responsibility of researchers to ensure trials are performed in the most scientifically robust ways, which are also acceptable to women. To examine the experiences of those involved in trial participation and their views about doing so is a crucial way of advancing this. The QUOTE Study increases understanding of the experiences of women participating in a randomised controlled trial. the general implication for practice is that procedures are needed that can improve the design and conduct of randomised trials and therefore ultimately enhance the experience for future women. Recommendations include informed consent should be tailored, recognising individual differences in the desire for information. For instance the time individuals need to make consent decisions varies, as do their desires to consult with family before agreeing.
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