The challenges of keeping clinicians unaware of their participation in a national, cluster-randomised, implementation trial.

Show simple item record Kuo, Jex Woodall, Sonja Harding, Jane Crowther, Caroline Alsweiler, Jane
dc.coverage.spatial England 2022-07-26T03:34:20Z 2022-07-26T03:34:20Z 2022-05-30
dc.identifier.citation (2022). BMC Medical Ethics, 23(1), 55-.
dc.identifier.issn 1472-6939
dc.description.abstract <h4>Background</h4>Implementation of recommendations from clinical practice guidelines is essential for evidence based clinical practice. However, the most effective methods of implementation are unclear. We conducted a national, cluster-randomised, blinded implementation trial to determine if midwife or doctor local implementation leaders are more effective in implementing a guideline for use of oral dextrose gel to treat hypoglycaemic babies on postnatal wards. To prevent any conscious or unconscious performance bias both the doctor and midwife local implementation leaders were kept unaware of the trial. This paper reports the ethical dilemmas and practical challenges of ensuring clinicians remained unaware of their involvement in an implementation trial.<h4>Methods</h4>We sought approval from the National Health and Disability Ethics committee to keep clinicians unaware of the trial by waiving the standard requirement for locality approval usually required for each district health board. The ethics committee did not approve a waiver of consent but advised that we approach the chief executive of each district health board to ask for provisional locality approval. Ultimately it was necessary to seek ethics approval for three separate study designs to keep clinicians unaware of the trial.<h4>Results</h4>The median (IQR) time for chief executive approval was 16 (6-40) days and for locality approval was 57 (39-84) days. We completed 21 different locality approval forms for 27 hospitals.<h4>Conclusions</h4>Keeping clinicians unaware of their involvement in a national implementation cluster-randomised trial is feasible. However, despite a national ethics committee, significant logistical challenges were time consuming and delayed trial completion. Co-ordination of the locality approval process would help facilitate multi-centre trials.
dc.format.medium Electronic
dc.language eng
dc.publisher Springer Nature
dc.relation.ispartofseries BMC medical ethics
dc.rights Items in ResearchSpace are protected by copyright, with all rights reserved, unless otherwise indicated. Previously published items are made available in accordance with the copyright policy of the publisher.
dc.subject Ethics
dc.subject Hypoglycaemia
dc.subject Locality approval
dc.subject Newborn
dc.subject Patient Safety
dc.subject Clinical Research
dc.subject Clinical Trials and Supportive Activities
dc.subject 2201 Applied Ethics
dc.title The challenges of keeping clinicians unaware of their participation in a national, cluster-randomised, implementation trial.
dc.type Journal Article
dc.identifier.doi 10.1186/s12910-022-00794-9
pubs.issue 1
pubs.begin-page 55
pubs.volume 23 2022-06-07T01:43:34Z
dc.rights.holder Copyright: The author en
dc.identifier.pmid 35637453 (pubmed)
pubs.publication-status Published
dc.rights.accessrights en
pubs.subtype Journal Article
pubs.elements-id 905738 Liggins Institute Medical and Health Sciences School of Medicine Paediatrics Child & Youth Hlth LiFePATH
dc.identifier.eissn 1472-6939
dc.identifier.pii 10.1186/s12910-022-00794-9
pubs.number 55
pubs.record-created-at-source-date 2022-06-07 2022-12

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