Design, synthesis, and public understanding and involvement in randomised trials
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Introduction The initial aim of my PhD was to assess if amniotic membrane sweeping, a common intervention in maternity care, is a safe and effective way of preventing a formal induction of labour1 in pregnant women at or near term2. However, with the arrival of a novel coronavirus (SARS-CoV-2) and the immediate and profound changes it brought to clinical practice and the conduct of clinical research, the intended pathway of my PhD research altered significantly. Therefore, my thesis comprises two sections. Section one focuses on membrane sweeping to prevent a formal induction of labour. Section two of the thesis focuses on The People’s Trial. The aim of The People’s Trial is to support the public understanding and knowledge of randomised trials, to understand why they matter and be better equipped to think critically about health claims by becoming involved in each step of the clinical trial process. The People’s Trial also potentially supports researchers in learning how best to involve and engage the public in trials. Methods This thesis includes four papers. The first paper (Chapter 2 published), a Cochrane systematic review and meta-analysis was undertaken to assess the effects and safety of amniotic membrane sweeping for induction of labour in women at or near term. The findings of this review directly informed The MILO Study, presented in paper two (Chapter 3 published). The MILO Study is a Feasibility study protocol of a pragmatic, randomised controlled pilot trial, to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. Paper three (Chapter 4, submitted for review), describes the process of The People’s Trial, an online parallel group, randomised controlled trial, including aims, design, conduct and dissemination. Paper four (Chapter 5, submitted for review), reports the design, conduct and findings of the randomised controlled trial designed by the public, which we called The Reading Trial. Results The Cochrane systematic review and meta-analysis found that when comparing membrane sweeping with no treatment/sham, women randomised to membrane sweeping may be more likely to experience a spontaneous onset of labour and less likely to experience an induction of labour; however, overall, the evidence was of low certainty. The review identified the need for further robust research to assess the optimal gestation to receive a membrane sweep and whether having more than one sweep would be beneficial. It further highlighted the need to explore women’s views of membrane sweeping. The MILO study, a feasibility study, includes a pilot randomised trial, a health economic analysis, a qualitative study and a Study Within A Trial (SWAT). The MILO study was due to commence recruitment in March 2020, with ethical approval, study documentation, site procedures, clinicians and research midwives in position to support the study conduct. The MILO Study is now due to commence recruitment in February 2021, dependent on clinical circumstances and COVID-19. The remainder of the PhD focuses on, The People’s Trial, a novel, online randomised trial designed by the public for the public. Over 3000 members of the public, from 72 countries, participated in The People’s Trial, engaging in all aspects of the trial design, from choosing the trial question, to trial conduct, analysis and dissemination. We report the processes of The People’s Trial in seven phases, mimicking the steps of a randomised trial, In December 2019, 991 participants took part in a trial designed by the public, called The Reading Trial. The trial aimed to answer a question identified and prioritised by the public ‘Does reading a book in bed make a difference to sleep in comparison to not reading a book in bed?’ The Reading Trial found that, 56/369 (42%) of people in the intervention group felt their sleep improved, compared to 112/405 (28%) of those in the control group, a difference of 14%. Conclusion My PhD supports the development of four papers, which individually and collectively provide an original contribution to knowledge. The outputs from this body of work include: A multi-site feasibility study, informed by a Cochrane systematic review, which is designed and ready to commence recruitment in 2021. The findings of the MILO study, including the views of women and clinicians, will inform the optimal design of a future definitive randomised trial to examine the effectiveness including optimal timing and frequency of membrane sweeping to prevent post-term pregnancy. The People’s Trial, a novel, online trial that has successfully involved over 3000 members of the public in the design, conduct, and dissemination of a randomised trial. This demonstrates public appetite to engage with, and learn about randomised trials, to understand why they matter, and to be better equipped to think critically about health claims.
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