Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland Mail Centre, PO BOX 92019, Auckland, New Zealand.
Faculty of Science, University of Auckland, Auckland, New Zealand.
BMC Med Ethics. 2022 May 30;23(1):55. doi: 10.1186/s12910-022-00794-9.
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.
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.
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.
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.
实施临床实践指南的建议对于基于证据的临床实践至关重要。然而，最有效的实施方法尚不清楚。我们进行了一项全国性、集群随机、盲法实施试验，以确定助产士或医生作为当地实施领导者，在产后病房中使用口服葡萄糖凝胶治疗低血糖婴儿方面，是否更能有效地实施指南。为了防止任何有意识或无意识的表现偏见，医生和助产士当地实施领导者都不知道试验的存在。本文报告了确保临床医生不知道他们参与实施试验的伦理困境和实际挑战。
我们寻求国家卫生和残疾伦理委员会的批准，通过放弃通常每个地区卫生局都需要的地方批准的标准要求，使临床医生不知道试验。伦理委员会没有批准同意豁免，但建议我们与每个地区卫生局的首席执行官联系，要求临时地方批准。最终，有必要为三种不同的研究设计寻求伦理批准，以使临床医生不知道试验的存在。
首席执行官批准的中位数（IQR）时间为 16（6-40）天，地方批准的中位数（IQR）时间为 57（39-84）天。我们为 27 家医院完成了 21 份不同的地方批准表。
使临床医生不知道他们参与全国性实施集群随机试验是可行的。然而，尽管有国家伦理委员会，但大量的后勤挑战耗时且延迟了试验完成。协调地方批准程序将有助于促进多中心试验。
