{"id":2983,"date":"2024-09-24T13:51:57","date_gmt":"2024-09-24T13:51:57","guid":{"rendered":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/?p=2983"},"modified":"2024-10-21T15:27:35","modified_gmt":"2024-10-21T15:27:35","slug":"rapid-set-up-of-obstetric-bleeding-study-lessons-from-the-obs-uk","status":"publish","type":"post","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/rapid-set-up-of-obstetric-bleeding-study-lessons-from-the-obs-uk\/","title":{"rendered":"Rapid Set Up of Obstetric Bleeding Study: Lessons from the OBS UK"},"content":{"rendered":"<h2 style=\"font-weight: 400\"><strong>A Unique Trial Set Up Journey \u2013 <\/strong><strong>Obstetric Bleeding Study UK (<\/strong><strong>OBS UK)<\/strong><\/h2>\n<p style=\"font-weight: 400\">OBS UK (<a href=\"https:\/\/www.obsuk.org\/\">OBSUK Study<\/a>) is a National Institute for Health and Care Research (NIHR) funded stepped wedge cluster randomised controlled trial of a complex intervention for postpartum haemorrhage. It is being fully coordinated by the CTR\u2019s Population Health and Social Care Division. The primary outcome is the proportion of women receiving allogenic red blood cell transfusion for postpartum haemorrhage. OBS UK is a large study comprising three sub studies at set up (now has five sub studies) \u2013 a process evaluation, an economic analysis and psychological component. The main study aims to captures data from approximately 189,000 women and birthing people without the requirement of individual level consent and has the appropriate regulatory approvals from the different nations in the UK in place. Individual consent for standard care, implementation and OBS UK post-partum haemorrhage\u00a0 care will not be sought because the change in management will be delivered at a maternity unit level and therefore to everyone giving birth at that site. Aggregate primary outcome data will be reported by sites for all women and birthing people.<\/p>\n<p><span class=\"embed-youtube\" style=\"text-align:center; display: block;\"><iframe loading=\"lazy\" class=\"youtube-player\" width=\"640\" height=\"360\" src=\"https:\/\/www.youtube.com\/embed\/jTzts_vPNpA?version=3&#038;rel=1&#038;showsearch=0&#038;showinfo=1&#038;iv_load_policy=1&#038;fs=1&#038;hl=en-GB&#038;autohide=2&#038;wmode=transparent\" allowfullscreen=\"true\" style=\"border:0;\" sandbox=\"allow-scripts allow-same-origin allow-popups allow-presentation allow-popups-to-escape-sandbox\"><\/iframe><\/span><\/p>\n<p style=\"font-weight: 400\">I joined the study team formally on the 1<sup>st<\/sup> May 2023 as the Trial Manager, although I had attended some of the study management group meetings prior to this date, I would certainly recommend this prior to formally starting work on a study as it gave me a huge amount of insight into the study and the researchers involved. The study management group was and is very friendly and supportive. In particular the two Chief Investigators and CTR Study Lead are very hands on, helpful and always willing to answer questions. This was particularly important as the trial required a rapid set up.<\/p>\n<p style=\"font-weight: 400\">For example, when one site was struggling with the reimbursement plan for research nurse funding due to the financial restrictions in place for the site the team were able to find a solution and the site were able to join the study.<\/p>\n<p style=\"font-weight: 400\">The first stop go criteria was to have 30 site contracts signed by the 1<sup>st<\/sup> February 2024, so a nine month set up period, there isn\u2019t an internal pilot. This was a rather daunting task as due to the nature of the design of the study all the sites needed to start data collection together on the 1<sup>st<\/sup> February and 30 sites were required to ensure the study had the statistical power to report the outcomes.<\/p>\n<p style=\"font-weight: 400\">In addition to this, as the main study is UK wide we needed to ensure we had sites from England, Scotland and Northern Ireland. Wales was excluded as the maternity units in Wales were already following the OBS care bundle but 4 sites in Wales did undertake the process evaluation sub study. The inclusion criteria for the sites meant they were in general not the very large research active sites which perhaps was an additional challenge.<\/p>\n<p style=\"font-weight: 400\">One of the Chief Investigators had already identified and communicated with potential sites and Principal Investigators. This in my opinion was invaluable in achieving the goal of setting the sites up. Early in May 2023 we met with the interested sites and asked them to return a site assessment form, \u00a0we could only have a maximum of 36 sites in the study. Initially these forms were slow to return but they then flooded in and we ended up having to choose 36 sites, the rest who met the inclusion criteria were reserve sites. Right from the start it was made very clear that if they wanted to be in the study they had to be set up and ready to start on the 1<sup>st<\/sup> February 2024, all sites also needed to be ready to start data collection on day 1 too. This was a message that was repeated and repeated throughout the set period.<\/p>\n<h2 style=\"font-weight: 400\"><strong>Approvals<\/strong><\/h2>\n<p style=\"font-weight: 400\">We applied for ethics approval but also had to apply for Confidentiality Advisory Group (CAG) approval to link and access electric health records in England without consent under section 251 of the NHS Act 2006 and Public Benefit and Privacy Panel for Health (PBPP) approval in Scotland to retrieve routinely collected data, from NHS databases, to provide trial outcome data and collect data without consent. As the application for CAG approval is submitted alongside the ethics application we made the decision to apply for CAG approval and then move onto applying for PBPP approval for the Scottish sites. Northern Ireland do not have the equivalent of CAG or PBPP so we spent a lot of time working with the one site there to ensure they could be included and ultimately came up with a solution.<\/p>\n<h2 style=\"font-weight: 400\"><strong>Site set up<\/strong><\/h2>\n<p style=\"font-weight: 400\">Once we had ethics and CAG approval we made sure all the sites had the full Local Information Pack (i.e. all the documents required to complete local R&amp;D review of the site\u2019s capacity and capability to take part in the trial). \u00a0We were in constant communication with them to ensure they had all the relevant documentation and information to get to the point where contracts could be signed. A large excel spreadsheet was created in Teams to track the progress of each site and Sponsor, who were well aware of the tight timeframe ensured contracts were signed rapidly when they were returned by the sites.<\/p>\n<p style=\"font-weight: 400\">Although we didn\u2019t have PBPP approval when we had CAG approval, we began setting the Scottish sites up and updated them on the progress of the PBPP application.<\/p>\n<p style=\"font-weight: 400\">Site induction visits were carried out on Teams with multiple sites attending the same site induction visit.<\/p>\n<h2 style=\"font-weight: 400\"><strong>Success<\/strong><\/h2>\n<p style=\"font-weight: 400\">Ultimately, we ended up with 32 signed contracts by the 1<sup>st<\/sup> February and met the stop go criteria. It was a very steep learning curve with regards to CAG and PBPP and a huge amount of work from the whole team.<\/p>\n<h2 style=\"font-weight: 400\"><strong>Conclusion<\/strong><\/h2>\n<p style=\"font-weight: 400\">On reflection, I believe all the following helped in a rapid set up:<\/p>\n<ol>\n<li>Team work.<\/li>\n<li>Early communication with sites and the timelines made explicitly clear.<\/li>\n<li>Good communication with everyone!<\/li>\n<li>Early involvement of chief investigators, principal investigators and CTR study lead as appropriate if issues are discovered during the site set up period.<\/li>\n<li>Organisation is essential to ensure progress of each site is tracked.<\/li>\n<li>A supportive team and a sense of humour!<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"A Unique Trial Set Up Journey \u2013 Obstetric Bleeding Study UK (OBS UK) OBS UK (OBSUK Study) is a National Institute for Health and Care Research (NIHR) funded stepped wedge [&hellip;]","protected":false},"author":7107,"featured_media":2984,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[7],"tags":[],"class_list":["post-2983","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-events"],"jetpack_publicize_connections":[],"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p7dIou-M7","jetpack-related-posts":[{"id":2381,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/stillbirths-in-nigeria\/","url_meta":{"origin":2983,"position":0},"title":"Stillbirths in Nigeria","author":"Rebecca Milton","date":"October 4, 2022","format":false,"excerpt":"Background Stillbirth is defined by the World Health Organisation as \u2018a baby born with no signs of life at or after 28 weeks' gestation\u2019 and are reported as one of the most neglected tragedies in global health today. Each year almost 2m stillbirths occur, the majority occurring in low- and\u2026","rel":"","context":"In &quot;Events&quot;","block_context":{"text":"Events","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/events\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/10\/Animation-Timline-Rebecca-Milton-Blog.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/10\/Animation-Timline-Rebecca-Milton-Blog.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/10\/Animation-Timline-Rebecca-Milton-Blog.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/10\/Animation-Timline-Rebecca-Milton-Blog.png?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":2998,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/pool-study-wins-royal-college-of-midwives-excellence-in-midwifery-for-research-award-2024\/","url_meta":{"origin":2983,"position":1},"title":"POOL Study Wins Royal College of Midwives Excellence in Midwifery for Research Award 2024","author":"Rebecca Cannings-John","date":"October 22, 2024","format":false,"excerpt":"The Royal College of Midwives (RCM) announced in October 2024 that the POOL study had won the award for Excellence in Midwifery for Research 2024. Background Since 2007 NICE have recommended that women without complications should have the option to use a birth pool during labour for pain relief. Among\u2026","rel":"","context":"In &quot;Events&quot;","block_context":{"text":"Events","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/events\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/10\/POOL-Study-Team-scaled.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/10\/POOL-Study-Team-scaled.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/10\/POOL-Study-Team-scaled.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/10\/POOL-Study-Team-scaled.jpg?resize=700%2C400&ssl=1 2x, 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NMAHP use their clinical expertise to inform optimal trial processes extending\u2026","rel":"","context":"In &quot;Events&quot;","block_context":{"text":"Events","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/events\/"},"img":{"alt_text":"Photo of the Centre for Trials Research Nurses, Midwives, and Allied Health Professionals Group (Left to Right: Vicky Shepherd, Jane Davies, Alison Johnson, Gladys Makuta, Hayley Prout, Monica Busse, Nicola Ivins, Ffion Davies).","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/11\/CTR-NMAHP-Group-photo-09.11.2022-scaled.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/11\/CTR-NMAHP-Group-photo-09.11.2022-scaled.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/11\/CTR-NMAHP-Group-photo-09.11.2022-scaled.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/11\/CTR-NMAHP-Group-photo-09.11.2022-scaled.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/11\/CTR-NMAHP-Group-photo-09.11.2022-scaled.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/11\/CTR-NMAHP-Group-photo-09.11.2022-scaled.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":1210,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/flight-study-milestones-researching-immune-thrombocytopenia-itp\/","url_meta":{"origin":2983,"position":5},"title":"FLIGHT Study Milestones: Researching Immune Thrombocytopenia (ITP)","author":"Julie Pell","date":"November 22, 2018","format":false,"excerpt":"FLIGHT is a\u00a0multicentre randomised trial of First Line treatment pathways for newly diagnosed Immune Thrombocytopenia: Standard steroid treatment versus combined steroid and mycophenolate.\u00a0 Funded by the National Institute for Health Research (NIHR). 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