Consensus on ethics in airway research – a reply

Abstract

We welcome Cook et al.'s editorial 1, since further academic discussion regarding the ethics and conduct of airway research can only be productive. Unfortunately, the authors seem to have misunderstood the purpose of our editorial 2 and the scope of the CARE guidelines proposed therein. Our intention was to describe some of the ethical issues surrounding patient recruitment and airway interventions involving patients (as opposed to manikin-based studies) and to provide a basic framework to researchers and institutional review boards by which patient risk and morbidity could potentially be reduced. The CARE guidelines are not an all-encompassing mandatory protocol, and were not proposed as such. They are designed to provide guidance and to promote informed discussion between researchers and institutional review boards in the field of airway research. In the following reply, we hope to address a few more of Cook et al. incorrect assertions (to address them all is beyond the scope of this letter). Our editorial does not promote patient studies over manikin/simulation-based studies; rather it provides a balanced view as to the potential advantages and disadvantages of each in the context of airway management research. As a course director and instructor on several simulation-based courses (PW) and a senior journal editor and experienced researcher who has personally simulated difficult airways for the purposes of clinical research (MI), we are both aware of the merits and applicability of manikins and simulation, and acknowledged this in our editorial. Cook et al. claim that manikin studies represent a relatively small proportion of airway studies. In fact, when we undertook a full and meticulous literature search of ‘airway management’, the 3500 studies identified in 2016, for example, include absolutely anything related to airway management and, therefore, represents a misleading denominator which is unrepresentative of the type of research that we have alluded to in our editorial. Of these 3500 studies, we identified 63 studies using manikins for airway management in the context of research on airway devices and techniques, and approximately 40 comparable non-manikin studies (see Online Supporting Information, Appendix 1). Compared with other research areas within anaesthesia, there is a greater proportion of manikin studies within airway management, as we correctly asserted. Cook et al. contend that airway research does not merit specific guidance above other areas of anaesthesia clinical practice e.g. cardiovascular, regional, TIVA, etc., suggesting that the proposed CARE guideline is superfluous. They then proceed to support the Difficult Airway Society's establishment of a working party to explore ethics in airway research, suggesting that this area does actually require further clarification and guidance, contradicting their previous statement. Often when there is an ethical issue raised by a reviewer/editor about a submitted manuscript, it is rarely due to lack of guidance. Excellent guidance on research ethics and methodology already exists, and our editorial highlights the need for researchers to employ good research practices and reinforces their obligation to follow research ethics committee requirements (including fully informing patients of the risks involved), and the need for transparency with research and development departments (who may lack the necessary expertise) on what constitutes standard care and how the researchers’ protocol differs from it. Our CARE guideline provides an additional framework to underpin this process. Cook et al. criticise the CARE guideline's recommendations about including only ASA 1 and 2 patients, limiting tracheal intubation attempts, and restricting airway management to experienced practitioners, citing a lack of generalisability and the risk of potentiating irrelevant research. In our guideline, each of these recommendations was carefully constructed and, in each case, accompanied by a caveat specifically addressing the concerns raised by Cook et al. These recommendations were included in our guideline to ensure that researchers and institutional review boards have a basic structure (that promotes patient safety) to refer to when designing or reviewing a study protocol. They are not ‘rules’, as Cook et al. incorrectly infer. For example, the guideline does not preclude ASA 3 and 4 patients being studied, rather it suggests that researchers should consider the additional risks, justify them carefully, and convey them clearly to the institutional review board before including them for study. In fact, patients who are ASA 3 and 4, by definition, have significant comorbidities but not necessarily anything unique about their airway. With less physiological reserve, it makes sense not to include them in airway research trials unless absolutely necessary. The CARE guideline, therefore, serves as a useful reminder of good research practice and methodology. Finally, Cook et al. discuss the definition of ‘consensus’. Our editorial received similar feedback from Dr. Grocott 3 and on social media, which we have already specifically addressed in Anaesthesia 4. Nevertheless, this is an opportunity to reiterate the points we expressed. Consensus is a generally accepted opinion or decision among a group of people, with no criterion as to the number that should represent the group. It is also a matter of debate as to whether it is actually the best way to make decisions 5 and the more people involved in this process the less useful it is 6. While we identified a need for and then wrote these guidelines, members of the Anaesthesia editorial board and an external expert in the field also reviewed them. There is certainly no false or implicit implication of a broader consensus than this and we still feel that these provide a useful framework for clinicians interested in airway research. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

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