2012
DOI: 10.1016/j.midw.2011.08.006
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Deciding to join a perinatal randomised controlled trial: Experiences and views of pregnant women enroled in the Magpie Trial

Abstract: ObjectiveTo provide insight into pregnant women's experiences of participating in a large multicentre randomised trial. DesignQualitative semi-structured interviews. SettingSix UK maternity units. ParticipantsWomen recruited to the Magpie Trial. The Magpie Trial was a trial of prophylactic anticonvulsants for women with severe pre-eclampsia. Measurements FindingsA number of major but related themes emerged regarding influences on the women's decision-making: unpredictability of pre-eclampsia; quality of inform… Show more

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Cited by 47 publications
(85 citation statements)
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“…However, Blockchain is certainly not a “one size fits all” solution to the problem of a low enrolment rate. Indeed, there are many other parameters that interfere with the enrolment, which fall beyond the scope of transparency, user control and reliability that Blockchain technology helps to achieve: age, sex, cultural background, socio-economic factors, lack of educational materials 15 , readability and length of consent 16– 18 , limited awareness about clinical research 19 or patient-physician relationship 20 and momentum of consent request 21 . Besides, the scope of our method did not address the question of consent collected in singular situations, such as intensive care, unconscious patients or psychiatric pathologies.…”
Section: Discussionmentioning
confidence: 99%
“…However, Blockchain is certainly not a “one size fits all” solution to the problem of a low enrolment rate. Indeed, there are many other parameters that interfere with the enrolment, which fall beyond the scope of transparency, user control and reliability that Blockchain technology helps to achieve: age, sex, cultural background, socio-economic factors, lack of educational materials 15 , readability and length of consent 16– 18 , limited awareness about clinical research 19 or patient-physician relationship 20 and momentum of consent request 21 . Besides, the scope of our method did not address the question of consent collected in singular situations, such as intensive care, unconscious patients or psychiatric pathologies.…”
Section: Discussionmentioning
confidence: 99%
“…In the Magpie trial some women relied on the confidence they had in the recruiting clinician, trusting that he or she would not expose them or their babies to anything risky (19). In another study, parents explained how they put themselves in the hands of the medical staff (20).…”
Section: Accepted Articlementioning
confidence: 99%
“…Indeed, a number of parents in this study said that they would have liked information about the RCT earlier in their pregnancy, such as during antenatal classes. Parents in the Magpie trial (19), and in other studies exploring parental consent (1,12,24), also said that they preferred to receive information about relevant research trials during pregnancy. This strategy is in accordance with the recommendations of the Association for Improvements in the Maternity Services (25) and the more recent Royal College of Obstetricians and Gynaecologists guidelines (26).…”
Section: Accepted Articlementioning
confidence: 99%
“…Similarly, a wider study of parents of new born babies being recruited to a range of trials, found their competence was lowest in emergency situations (Mason & Allmark, 2000). Smyth, Jacoby, and Elbourne (2012) explored views of participants in a RCT of a drug for the life-threatening condition pre-eclampsia. They identified issues related to the timing of information and consent, the quality of consent materials and professional influences on participation.…”
Section: Literature Regarding Informed Consent and The Context Of Thementioning
confidence: 99%
“…They identified issues related to the timing of information and consent, the quality of consent materials and professional influences on participation. They suggest that despite the researchers' best efforts, some participants had not fully comprehended what was being asked of them at the time of giving consent, due to the stressful circumstances in which they were informed about the study (Smyth et al, 2012) Individual and demographic characteristics of potential participants are important, in particular, levels of education may affect ability to use information (Flory & Emanuel, 2004;Joffe et al, 2001). However, there is also evidence that consent processes can be adapted to meet the needs of vulnerable groups and individuals (Carpenter et al, 2000;David, Edwards, & Alldred, 2001).…”
Section: Literature Regarding Informed Consent and The Context Of Thementioning
confidence: 99%