Dataset Information

Women's views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study.

ABSTRACT:

Background

The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. In addition to standard written consent, an oral assent pathway was developed for use when birth was imminent. The aim of this study was to explore women's views and experiences of two alternative consent pathways to participate in the Cord Pilot Trial.

Methods

We conducted a qualitative study using semi-structured interviews. A total of 179 participants in the Cord Pilot Trial were sent a postal invitation to take part in interviews. Women who agreed were interviewed in person or by telephone to explore their experiences of two consent pathways for a preterm intrapartum trial. Data were analysed using inductive systematic thematic analysis.

Results

Twenty-three women who gave either written consent (n?=?18) or oral assent followed by written consent (n?=?5) to participate in the trial were interviewed. Five themes were identified: (1) understanding of the implications of randomisation, (2) importance of staff offering participation, (3) information about the trial and time to consider participation, (4) trial secondary in women's minds and (5) reasons for agreeing to take part in the trial. Experiences were similar for the two consent pathways. Women recruited by the oral assent pathway reported being given less information about the trial but felt it was sufficient to make a decision regarding participation. There were gaps in women's understanding of the trial and intervention, regardless of the consent pathway.

Conclusions

Overall, women were positive about their experiences of being invited to participate in the trial. The oral assent pathway seems an acceptable option for women if the intervention is low-risk and time is limited.

Trial registration

ISRCTN Registry, ISRCTN21456601 . Registered on 28 February 2013.

SUBMITTER: Sawyer A

PROVIDER: S-EPMC5591564 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Publications

Women's views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study.

Sawyer Alexandra A Chhoa Celine C Ayers Susan S Pushpa-Rajah Angela A Duley Lelia L

Trials 20170909 1

<h4>Background</h4>The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. In addition to standard written consent, an oral assent pathway was developed for use when birth was imminent. The aim of this study was to explore women's views and experiences of two alternative consent pathways to participate in the Cord Pilot Trial.<h4>Methods</h4>We conducted a qualitative study using semi-structured interviews. A total of 179 partic ...[more]

PMID: 28886747

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Project description:The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. Preterm birth can be rapid and unexpected, allowing little time for the usual consent process. Therefore, in addition to the usual procedure for written consent, a two-stage pathway for consent for use when birth was imminent was developed. The aims of this study were to explore clinicians' views and experiences of offering two consent pathways for recruitment to a randomised trial of timing of cord clamping at very preterm birth.This was a qualitative study using semi-structured interviews. Clinicians from eight hospitals in the UK who had been involved in offering consent to the Cord Pilot Trial were invited to take part in an interview. Clinicians were interviewed in person or by telephone. Interviews were analysed using inductive systematic thematic analysis.Seventeen clinicians who had either offered usual written consent only (n?=?6) or both the two-stage pathway (with oral assent before the birth and written consent after the birth) and usual written consent (n?=?11) were interviewed. Six themes were identified: (1) team approach to offering participation; (2) consent form as a record; (3) consent and participation as a continual process; (4) different consent pathways for different trials; (5) balance between time, information, and understanding; and (6) validity of consent. Overall, clinicians were supportive of the two-stage consent pathway. Some clinicians felt that in time-critical situations oral assent presented an advantage over the usual written consent as they provided information on a "need to know" basis. However, there was some concern about how much information should be given for oral assent, and how this is understood by women when birth is imminent.The two-stage pathway for consent developed for use in the Cord Pilot Trial when birth was imminent was acceptable to clinicians for comparable low-risk studies, although some concerns were raised about the practicalities of obtaining oral assent.ISRCTN Registry, ISRCTN21456601 . Registered on 28 February 2013.

Project description:BackgroundRaising awareness of the importance of fetal movements (FMs) and advising women on the appropriate action to take if they experience reduced FMs, is important for minimising or avoiding adverse perinatal outcomes. To gain insight and understanding of women's perspectives of assessing FMs in pregnancy, we conducted a qualitative evidence synthesis.MethodsA qualitative evidence synthesis using thematic synthesis was conducted. Studies were eligible if they included pregnant women who were at least 20 weeks gestation and reported qualitative data from women on assessing FMs in pregnancy. MEDLINE, CINAHL, EMBASE, PsycINFO and Social Science Citation Index, from inception to July 2020, were searched. The methodological quality of included studies was assessed by at least two reviewers using an Evidence for Policy and Practice Information (EPPI)-Centre quality assessment tool. Data synthesis, using the Thomas and Harden framework, involved line by line coding of extracted data, establishing descriptive themes, and determining analytical themes. Confidence in the findings was assessed using GRADE CER-Qual.ResultsNine studies, involving 2193 women, were included in the review. The methodological quality of the studies was overall generally high. The synthesis revealed three dominant themes, and seven sub-themes that reflected women's perspectives of assessing FMs in pregnancy. These were; 1) How women engage with FMs, with subthemes of informal engagement, formal engagement, and strategies to stimulate FMs; 2) ' … like a feather inside my belly' - articulating and describing FMs, with sub-themes of sensations associated with FMs and timing and frequency of FMs; and 3) FMs and help/health seeking, with sub-themes of information sources and interacting with healthcare professionals. Confidence in the findings was either high or moderate, although two findings were rated low confidence and one very low.ConclusionThis qualitative evidence synthesis reveals that women informally engage with FMs during pregnancy. Women commonly adopt strategies to stimulate FMs when concerned. The use of the internet was a common source of obtaining information regarding FMs. Women require better support when contacting healthcare professionals about FMs. As only three of the nine included studies were exclusively qualitative in design, further qualitative studies exploring women's perspective of assessing FMs in pregnancy are required.

Project description:BACKGROUND:Evidence has shown that there are several physical and mental advantages of exercise during pregnancy. Despite this, the recommendations for exercise during pregnancy are poorly fulfilled. The aim of this study was to illuminate non-exercising pregnant women's views and experiences concerning exercise before and during pregnancy. METHOD:The study had a qualitative design with an inductive approach and was analysed by content analysis. A total of 16 individual and face-to-face interviews were conducted with healthy pregnant women, mainly in the third trimester and living in Sweden. The participating women had not been exercising 3 months before pregnancy or during pregnancy. RESULTS:The main category "Insurmountable now, but possible in the future" was based on the four categories: "Lost and lack of routines", "Feelings of inadequacy", "Having a different focus" and "Need for support". The women experienced that their lack of routines was a major barrier that prevented them from exercising. Other factors that contributed were, for example, pregnancy-related problems, long working days and prioritizing family life. The women described it as difficult to combine exercise with their focus on the pregnancy and they missed continuous support from the antenatal care provider. The women expressed a need for suggestions concerning exercise during pregnancy and follow-up on previous counselling, especially when pregnancy-related issues arose. Information about easily accessible alternatives or simple home exercises was requested. They felt immobile and were not satisfied with their inactivity and tried to partly compensate with everyday activities. The women identified the postpartum period as an important possibility for becoming more active, for their own sake, but also because they wanted to become role models for their children. CONCLUSION:Continuous support during pregnancy is needed concerning exercise. Pregnancy is mostly a barrier that prevents exercise for this group of women but, at the same time, may be a motivator and a possibility for better health. As the result showed that these women were highly motivated to a life-style change post-pregnancy, it may be crucial to support previously non-exercising women postpartum.

Project description:Background Informed consent is often cited as the “cornerstone” of research ethics. Its intent is that participants enter research voluntarily, with an understanding of what their participation entails. Despite agreement on the necessity to obtain informed consent in research, opinions vary on the threshold of disclosure necessary and the best method to obtain consent. We aimed to investigate Australian researchers’ views on, and their experiences with, obtaining informed consent. Methods Semi-structured interviews were conducted with 23 researchers from NSW institutions, working in various fields of research. Interviews were analysed and coded to identify themes. Results Researchers reported that consent involved information disclosure, understanding and a voluntary decision. They emphasised the variability of consent interactions, which were dependent on potential participants’ abilities and interests, study complexity and context. All researchers reported providing written information to potential participants, yet questioned the readability and utility of this information. The majority reported using signed consent forms to ‘operationalise’ consent and reported little awareness of, and lack of support in implementing more dynamic informed consent procedures, such as verbal informed consent, that was fit for the purposes of their studies. Views on Human Research Ethics Committees (HRECs) varied. Some reported inconsistent, arduous inputs on the information form and consent process. Others expressed reliance on HRECs for guidance, viewing them as institutional safeguards. Conclusions This study highlights the importance of transparent relationships, both between researchers and participants, and between researchers and HRECs. Where the relationship with study participants was reported as more robust, researchers felt that they were better able to ensure participants made better, more informed decisions. Where the relationship with HRECs was reported as more robust, researchers were more likely to view them as institutional safeguards, rather than as bureaucratic hindrances. Conscientious and mindful researchers are paramount to ensuring the procedure accommodates individual requirements. This study advocates that when designing ethical informed consent practices, researchers should be integrated as autonomous players with a positive input on the process, rather than, in the worst case, predatory recruiters to be curtailed by information forms and oversight.

Project description:Aboriginal and Torres Strait Islander (collectively, Indigenous Australian) women experience a higher burden of cervical cancer than other women. The National Cervical Screening Program (NCSP) is failing to meet the needs of Indigenous Australian women, resulting in many women not regularly participating in cervical screening. However, one third of Indigenous Australian women do participate in cervical screening. The reasons that some women in this population commence and continue to screen remain unheard but could provide insights to support women who currently do not participate. We aimed to describe Indigenous Australian women's experiences and views of participation in cervical screening by yarning (a culturally-appropriate interview technique) with 50 Indigenous Australian women aged 25-70 years who had completed cervical screening in the past five years, recruited via Primary Health Care Centres (PHCCs) from three jurisdictions. Aboriginal or Torres Strait Islander women researchers conducted the interviews. Thematic analysis identified six themes: screening as a means of staying strong and in control; overcoming fears, shame, and negative experiences of screening; needing to talk openly about screening; the value of trusting relationships with screening providers; logistical barriers; and overcoming privacy concerns for women employed at PHCCs. Despite describing screening as shameful, invasive, and uncomfortable, women perceived it as a way of staying healthy and exerting control over their health. This ultimately supported their participation and a sense of empowerment. Women valued open discussion about screening and strong relationships with health providers. We identified logistical barriers and specific barriers faced by women employed at PHCCs. This study is strengthened by a research approach that centred Indigenous Australian women's voices. Understanding the experiences of Indigenous Australian women who participate in screening will help screening providers support women to start and continue to screen regularly. Recommendations for practice are provided.

Dataset Information

Women's views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study.

Background

Methods

Results

Conclusions

Trial registration

Publications

Women's views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study.

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