Jennifer Kettle1, Chris Deery2, Robert Bolt2, Diana Papaioannou3, Zoe Marshman2. 1. School of Clinical Dentistry, University of Sheffield, 19 Claremont Crescent, Sheffield, S10 2TA, UK. j.e.kettle@sheffield.ac.uk. 2. School of Clinical Dentistry, University of Sheffield, 19 Claremont Crescent, Sheffield, S10 2TA, UK. 3. School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
Abstract
BACKGROUND: The 'Melatonin for Anxiety prior to General anaesthesia In Children' (MAGIC) trial was designed to compare midazolam and melatonin as pre-medications for anxious children (aged five to fourteen), undergoing day-case surgical procedures under general anaesthesia. Low recruitment is a challenge for many trials, particularly paediatric trials and those in 'emergency' settings. A qualitative study as part of MAGIC aimed to gather stakeholder perspectives on barriers and enablers to recruitment. METHODS:Sixteen stakeholders from six sites participated in semi-structured interviews about their experiences of setting up the MAGIC trial and recruiting patients as part of the internal pilot. Data was analysed using framework analysis. RESULTS: Participants identified barriers and enablers to recruitment. Barriers and enablers related to the study, participants, the population of anxious children, practitioners, collaboration with other health professionals, ethics, specific settings and the context of surgical day units and the wider health system. Attempting to recruit anxious children from a surgical day unit is particularly challenging for several reasons. Issues include the practicalities of dealing with a child experiencing anxiety for parents/guardians; professional unwillingness to make things more difficult for families and clinicians and nurses valuing predictability within a busy and time-sensitive setting. CONCLUSIONS: Multi-site RCTs face recruitment barriers relating to study-wide and site-specific factors. There are multiple barriers to recruiting anxious children due to undergo day-case surgery. Barriers across domains can interrelate and reinforce each other, reflecting challenges relating to populations and settings. For example, in the case of anxious children, parents and other health professionals are concerned about exacerbating children's anxiety prior to surgery. They may look for ways to keep things predictable and avoid the uncertainty of an RCT. Pre-trial engagement work could help address concerns among collaborating health professionals. Using rapid ethnography during set-up or an internal pilot to focus on how the protocol will be or has been operationalised in practice may help identify issues. Allowing time to reflect on the findings of internal pilots and implement necessary changes could facilitate higher recruitment during the main phase of a trial. TRIAL REGISTRATION: NIHR Trial Registration Number: ISRCTN18296119 . Registered on October 01, 2019.
RCT Entities:
BACKGROUND: The 'Melatonin for Anxiety prior to General anaesthesia In Children' (MAGIC) trial was designed to compare midazolam and melatonin as pre-medications for anxiouschildren (aged five to fourteen), undergoing day-case surgical procedures under general anaesthesia. Low recruitment is a challenge for many trials, particularly paediatric trials and those in 'emergency' settings. A qualitative study as part of MAGIC aimed to gather stakeholder perspectives on barriers and enablers to recruitment. METHODS: Sixteen stakeholders from six sites participated in semi-structured interviews about their experiences of setting up the MAGIC trial and recruiting patients as part of the internal pilot. Data was analysed using framework analysis. RESULTS:Participants identified barriers and enablers to recruitment. Barriers and enablers related to the study, participants, the population of anxiouschildren, practitioners, collaboration with other health professionals, ethics, specific settings and the context of surgical day units and the wider health system. Attempting to recruit anxiouschildren from a surgical day unit is particularly challenging for several reasons. Issues include the practicalities of dealing with a child experiencing anxiety for parents/guardians; professional unwillingness to make things more difficult for families and clinicians and nurses valuing predictability within a busy and time-sensitive setting. CONCLUSIONS: Multi-site RCTs face recruitment barriers relating to study-wide and site-specific factors. There are multiple barriers to recruiting anxiouschildren due to undergo day-case surgery. Barriers across domains can interrelate and reinforce each other, reflecting challenges relating to populations and settings. For example, in the case of anxiouschildren, parents and other health professionals are concerned about exacerbating children's anxiety prior to surgery. They may look for ways to keep things predictable and avoid the uncertainty of an RCT. Pre-trial engagement work could help address concerns among collaborating health professionals. Using rapid ethnography during set-up or an internal pilot to focus on how the protocol will be or has been operationalised in practice may help identify issues. Allowing time to reflect on the findings of internal pilots and implement necessary changes could facilitate higher recruitment during the main phase of a trial. TRIAL REGISTRATION: NIHR Trial Registration Number: ISRCTN18296119 . Registered on October 01, 2019.
Authors: Benjamin Kasenda; Erik von Elm; John You; Anette Blümle; Yuki Tomonaga; Ramon Saccilotto; Alain Amstutz; Theresa Bengough; Joerg J Meerpohl; Mihaela Stegert; Kari A O Tikkinen; Ignacio Neumann; Alonso Carrasco-Labra; Markus Faulhaber; Sohail M Mulla; Dominik Mertz; Elie A Akl; Dirk Bassler; Jason W Busse; Ignacio Ferreira-González; Francois Lamontagne; Alain Nordmann; Viktoria Gloy; Heike Raatz; Lorenzo Moja; Rachel Rosenthal; Shanil Ebrahim; Stefan Schandelmaier; Sun Xin; Per O Vandvik; Bradley C Johnston; Martin A Walter; Bernard Burnand; Matthias Schwenkglenks; Lars G Hemkens; Heiner C Bucher; Gordon H Guyatt; Matthias Briel Journal: JAMA Date: 2014-03-12 Impact factor: 56.272
Authors: Zoe Marshman; Jennifer E Kettle; Richard D Holmes; Kathryn B Cunningham; Ruth Freeman; Barry J Gibson; Elaine McColl; Anne Maguire; Gail V A Douglas; Janet E Clarkson; Nicola P T Innes Journal: BMC Oral Health Date: 2020-03-04 Impact factor: 2.757