Barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings: lessons learned from a trial of melatonin versus midazolam in the premedication of anxious children (the MAGIC trial)
Background: Poor recruitment is one key reason for premature closure of randomised controlled trials. The Melatonin for Anxiety prior to General Anaesthesia In Children (MAGIC) trial was a multicentre randomised controlled trial of melatonin vs midazolam in the premedication of anxious children, bef...
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Elsevier
2025-03-01
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| Series: | BJA Open |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772609624001254 |
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| author | Marie C. Hyslop Diana E. Papaioannou Robert Bolt Matthew J. Wilson Michael Bradburn Janet Clarkson Esther Herbert Nicholas Ireland Jennifer Kettle Amanda Loban Amy C. Norrington Christopher Vernazza Christopher Deery |
| author_facet | Marie C. Hyslop Diana E. Papaioannou Robert Bolt Matthew J. Wilson Michael Bradburn Janet Clarkson Esther Herbert Nicholas Ireland Jennifer Kettle Amanda Loban Amy C. Norrington Christopher Vernazza Christopher Deery |
| author_sort | Marie C. Hyslop |
| collection | DOAJ |
| description | Background: Poor recruitment is one key reason for premature closure of randomised controlled trials. The Melatonin for Anxiety prior to General Anaesthesia In Children (MAGIC) trial was a multicentre randomised controlled trial of melatonin vs midazolam in the premedication of anxious children, before surgery. The trial ran between 2019 and 2022, closing early because of recruitment futility. This paper describes the challenges that arose during the trial and offers recommendations for the design of future perioperative trials. Methods: A case-based approach was used to identify barriers to recruitment. As part of a qualitative sub-study, semi-structured interviews with local site teams, participants, and caregivers also explored barriers and enablers to recruitment. Results: Issues encountered included time sensitivity within pressured environments; feasibility of paediatric assent; research pharmacy availability; variation in anaesthetist equipoise; multifactorial decision-making issues in premedication selection; and the Associate Principal Investigator scheme being unable to support trials within anaesthetic trainee rotations. Future paediatric perioperative medicine trials could consider funding for research pharmacy outside of working hours; conducting risk assessments for study drugs to be held on theatre admission units; and a tailored design of site feasibility assessments to help address variation in practice. Challenges remain for the feasibility of including anaesthetic trainees within the Associate Principal Investigator scheme structure. Conclusions: There are significant challenges to recruitment for paediatric clinical trials in anaesthesia and perioperative medicine. The MAGIC trial highlighted variations within anaesthetic practice at individual, local, and regional levels. Lessons learned from the MAGIC trial identifies specific barriers to paediatric trial enrolment, offer solutions and discusses ongoing challenges. Clinical trial registration: ISRCTN registry: ISRCTN18296119. |
| format | Article |
| id | doaj-art-324c10fa69c84b5db94aeb9001625344 |
| institution | Kabale University |
| issn | 2772-6096 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | BJA Open |
| spelling | doaj-art-324c10fa69c84b5db94aeb90016253442025-02-06T05:13:05ZengElsevierBJA Open2772-60962025-03-0113100375Barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings: lessons learned from a trial of melatonin versus midazolam in the premedication of anxious children (the MAGIC trial)Marie C. Hyslop0Diana E. Papaioannou1Robert Bolt2Matthew J. Wilson3Michael Bradburn4Janet Clarkson5Esther Herbert6Nicholas Ireland7Jennifer Kettle8Amanda Loban9Amy C. Norrington10Christopher Vernazza11Christopher Deery12Sheffield Clinical Trials Research Unit, SCHARR, University of Sheffield, Sheffield, UK; Corresponding author.Sheffield Clinical Trials Research Unit, SCHARR, University of Sheffield, Sheffield, UKSchool of Clinical Dentistry, University of Sheffield, Sheffield, UKSheffield Centre for Health & Related Research (SCHARR), University of Sheffield, Sheffield, UKSheffield Clinical Trials Research Unit, SCHARR, University of Sheffield, Sheffield, UKDundee Dental Hospital and School, University of Dundee, Dundee, UKSheffield Clinical Trials Research Unit, SCHARR, University of Sheffield, Sheffield, UKNewcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UKSchool of Clinical Dentistry, University of Sheffield, Sheffield, UKSheffield Clinical Trials Research Unit, SCHARR, University of Sheffield, Sheffield, UKSouth Tees Hospitals NHS Foundation Trust, Middlesbrough, UKSchool of Dental Sciences, Newcastle University, Newcastle upon Tyne, UKSchool of Clinical Dentistry, University of Sheffield, Sheffield, UKBackground: Poor recruitment is one key reason for premature closure of randomised controlled trials. The Melatonin for Anxiety prior to General Anaesthesia In Children (MAGIC) trial was a multicentre randomised controlled trial of melatonin vs midazolam in the premedication of anxious children, before surgery. The trial ran between 2019 and 2022, closing early because of recruitment futility. This paper describes the challenges that arose during the trial and offers recommendations for the design of future perioperative trials. Methods: A case-based approach was used to identify barriers to recruitment. As part of a qualitative sub-study, semi-structured interviews with local site teams, participants, and caregivers also explored barriers and enablers to recruitment. Results: Issues encountered included time sensitivity within pressured environments; feasibility of paediatric assent; research pharmacy availability; variation in anaesthetist equipoise; multifactorial decision-making issues in premedication selection; and the Associate Principal Investigator scheme being unable to support trials within anaesthetic trainee rotations. Future paediatric perioperative medicine trials could consider funding for research pharmacy outside of working hours; conducting risk assessments for study drugs to be held on theatre admission units; and a tailored design of site feasibility assessments to help address variation in practice. Challenges remain for the feasibility of including anaesthetic trainees within the Associate Principal Investigator scheme structure. Conclusions: There are significant challenges to recruitment for paediatric clinical trials in anaesthesia and perioperative medicine. The MAGIC trial highlighted variations within anaesthetic practice at individual, local, and regional levels. Lessons learned from the MAGIC trial identifies specific barriers to paediatric trial enrolment, offer solutions and discusses ongoing challenges. Clinical trial registration: ISRCTN registry: ISRCTN18296119.http://www.sciencedirect.com/science/article/pii/S2772609624001254early termination of clinical trialsgeneral anaesthesiapaediatric anxietyperioperative carepoor recruitmentreasons for recruitment failure |
| spellingShingle | Marie C. Hyslop Diana E. Papaioannou Robert Bolt Matthew J. Wilson Michael Bradburn Janet Clarkson Esther Herbert Nicholas Ireland Jennifer Kettle Amanda Loban Amy C. Norrington Christopher Vernazza Christopher Deery Barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings: lessons learned from a trial of melatonin versus midazolam in the premedication of anxious children (the MAGIC trial) BJA Open early termination of clinical trials general anaesthesia paediatric anxiety perioperative care poor recruitment reasons for recruitment failure |
| title | Barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings: lessons learned from a trial of melatonin versus midazolam in the premedication of anxious children (the MAGIC trial) |
| title_full | Barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings: lessons learned from a trial of melatonin versus midazolam in the premedication of anxious children (the MAGIC trial) |
| title_fullStr | Barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings: lessons learned from a trial of melatonin versus midazolam in the premedication of anxious children (the MAGIC trial) |
| title_full_unstemmed | Barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings: lessons learned from a trial of melatonin versus midazolam in the premedication of anxious children (the MAGIC trial) |
| title_short | Barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings: lessons learned from a trial of melatonin versus midazolam in the premedication of anxious children (the MAGIC trial) |
| title_sort | barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings lessons learned from a trial of melatonin versus midazolam in the premedication of anxious children the magic trial |
| topic | early termination of clinical trials general anaesthesia paediatric anxiety perioperative care poor recruitment reasons for recruitment failure |
| url | http://www.sciencedirect.com/science/article/pii/S2772609624001254 |
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