A new year, another investigation

The January edition of the journal is out today, which feels strange considering Christmas hasn’t even happened yet (but is definitely coming). In an era of evidence-based medicine, scientific misconduct remains a real threat to medical research. John Carlisle, one of the editors of this journal, has developed an analytical method in order to determine whether baseline data is truly random in what is now known as the Carlisle Method. The new year brings another potential case of data fabrication. This was triggered by the submission of a suspect article to another journal, and when the data from this and other manuscripts by the same author were examined closely, there was evidence of non-random sampling. In other words, that the data was not random in its distribution in 31 trials published by Yujhi Saitoh. The majority of these papers were about neuromuscular monitoring, and they were broadly spread around the anaesthetic journals worldwide. Seven of these were published in the Canadian Journal of Anesthesia, six in the British Journal of Anaesthesia, four in the European Journal of Anaesthesiology, three in Anesthesia and Analgesia, three in Anaesthesia, three in the Journal of Anesthesia, two in Acta Anaesthesiologica Scandinavica, two in the Journal of Clinical Anaesthesia, and one in the Fukushima Journal of Medical Sciences.

This is clearly very concerning, and we await the findings from the investigation that is ongoing by the Japanese Society of Anaesthesia. However, we can’t only look backwards at studies that are already published – we also need to look very closely at what is submitted to journals in all different specialties in the future. To that end, at Anaesthesia, we have decided to screen all randomised controlled trials submitted to the journal from 2016 using the Carlisle Method. We believe we are the first journal to do this. Any that fall foul due to suspicious data that are not consistent with random sampling will be rejected and the authors informed of the reason for rejection. We hope to persuade all the other anaesthetic journals to follow suit soon, and will look to involve other specialties and organisations over the coming years.

We are seeing more and more ‘disposable’ single-use devices in our practice. These include laryngoscopes, bougies, and now even fibreoptic scopes. While there are clear advantages in terms of infection control, there remains concern about comparable efficacy, design, cost and the ‘green’ effect of throwing away so much plastic and other materials. With this in mind, it is very tempting to re-use these single-use devices in the same patient repeatedly, both on the same day and perhaps even on subsequent days, especially in the case of fibreoptic scopes. Surely if they are going back into the same patient then that can’t do any harm? Wrong – a study published in this month’s edition of the journal showed that 16 out of 20 bronchoscopes cleaned then kept after use were contaminated after 48 hours. There is a very clear clinical lesson here – single-use means exactly that, and you can’t re-use them later even in the same patient. This will have significant implications for many hospitals I suspect.

This is a welcome update on consent for anaesthesia in this month’s journal, and this a ‘must read’ for every anaesthetist. The twelve key tenets include intuitive as well extremely thoughtful recommendations. Full consent should be obtained as early in the patient pathway as possible (not in the anaesthetic room), and the information provided should be tailored to each patient, with adequate time allowed for patient questions. Documentation should be made of the consent obtained although specific consent forms are not required. The fluid nature of consent means it is an ongoing process and should be confirmed at each interventional stage. If a patient lacks capacity, the reasons should be documented, efforts should be made to reverse or reduce temporary incapacity, and if this is unachievable we should always act in the patient’s best interest. Seeking a lasting power of attorney (LPA), valid advanced decisions, a validly appointed health and welfare LPA or a court-appointed deputy are legally binding. A knowledge of the existing frameworks regarding consent in patients aged 17 or younger is recommended. Finally, when training in practical procedures is undertaken, maximising benefit whilst minimising risk to the patient is important and alternative means of training, such as virtual models or manikins should be considered. These guidelines are clear and thorough and will be the mainstay of clinical practice for years to come.

Finally for now, we have published a comparison of the adjustable pressure-limiting valves in two well-known anaesthetic machines. The manufacturer of the APL that was shown to be ‘unusual’ in its performance has also commented on the study, and an accompanying editorial has put this into perspective. The clinical lesson here is know the machine you are using and read the instructions for use. Admittedly, so many of us don’t, and if you read this article you will see how important it is to know the difference between different designs of APLs and how they function in practice, especially for paediatric use. My final comment is, why are different APLs produced and why aren’t clinicians telling manufacturers what they want and being involved in the design of new equipment? It seems nonsensical to me that there should be such a difference, with such important implications, in APLs on different common anaesthetic machines. Should we accept this from a safety perspective?

Andrew Klein


Understanding Uncertainty

How good are you at understanding chance, risk, uncertainty and probability? The UK referendum on whether to leave or remain in the European Union has brought statistics, risk and uncertainty back into our everyday language. We have (re) learnt that statistics without context can be misleading, tolerance of an acceptable risk is opinion–based, and that both financial markets and individuals struggle to deal with uncertainty. This is emphasised in an excellent article, which makes the point that 50% of anaesthetists are actually worse than average at understanding risk. Anaesthesia has made a point of providing easy-to-understand, concise, educational articles in the last year, our statistically speaking series, and this will continue into next year. We plan to publish a series called ‘methodological madness’, in which we invite readers to write in and ask our statistical guru (Dr Choi from Hong Kong email: msmethodmatters@gmail.com) about what authors have got up to when designing their methods for studies. The main message is, we all need to understand more about statistics, probabilities and risks.

Airway management is the prime professional skill of the anaesthetist; research into this topic is widespread, and Anaesthesia receives many such submissions. In a study from Switzerland, Kleine-Brueggeney and colleagues compared the performance of the Bonfils™ and SensaScope™ rigid fibreoptic scopes in 200 patients with a simulated difficult airway. They note in their introduction that rigid scopes such as the two studied are relatively underused in anaesthesia despite being favoured in otolaryngology and respiratory medicine.  The authors simulated a difficult airway by applying a cervical collar to each patient such that mouth opening was limited to a mean of 23 mm. The patients were randomly allocated into two groups; the primary outcome of the study was overall success of intubation. In this, the overall success rates were high for both devices (88% for the Bonfils and 89% for the SensaScope (p = 0.83), although median intubation times were a little shorter with the SensaScope (34 vs. 45  seconds).

In an accompanying editorial, Ward and Irwin explore the ethical implications of airway research where the normal airways of routine patients are rendered ‘difficult’ for the purpose of evaluating the performance of new devices (or those using them). Notwithstanding the fact that there are many reasons for an airway being ‘difficult’, and the difficulty created by the methods commonly used in the research context may not reproduce all of them, there are also important questions to consider about the nature of risk and benefit in such studies.

As Ward and Irwin note, patients taking part in such studies do not themselves benefit from such participation; instead, the data may contribute to the common good of future patients in general. In this context, the possible harms implied by the intervention are thrown into sharper focus. The members of research ethics committees may lack the specialist knowledge of anaesthesia devices to allow them to make a fully informed judgement about the balance of benefits and harms. Here, the anaesthetist’s first duty is the responsibility of a physician to a patient, not a researcher to data. An innovative Consensus on Airway Research Ethics is proposed, and I have also added a note advising anyone conducting airway device evaluation studies that manuscripts will need to comply with the recommendations in the Consensus if they wish to be considered for publication in Anaesthesia.

Also on the theme of airway management, this report from the Netherlands details the development of an audit tool to identify prospectively all peri-operative adverse events during airway management over an 8 week period. Data were collected daily by  questionnaires from, and interviews with, anaesthesia trainees and anaesthetic department staff members. A total of 168 airway-related events were reported out of 2803 patients undergoing general anaesthesia. The incidence of severe airway management-related events was 24/2803 (0.86%). There were 12 (0.42%) unanticipated ICU admissions and two patients (0.07%) required a surgical airway. There was one (0.04%) death, one ‘cannot intubate cannot oxygenate’ (0.04%), one pulmonary aspiration of gastric contents (0.04%) and eight (0.29%) severe desaturations (defined as an oxygen saturation less than 50%). Whilst this survey is restricted to one hospital, the authors suggest that the methodology they used could easily be followed by others within their own departments of anaesthesia.

Finally, this being December and Christmas being just around the corner, we have published our first-ever Christmas special in the journal, CRAC-ON, as in why don’t you just CRAC ON and give the anaesthetic! CRAC ON stands for complete relinquishing of anaesthetic conscientiousness, optimisation and nuance. This special article is meant to be light-hearted and satirical, and I really enjoyed reading it. It is included as an extra article, and the rest of the journal contains as many serious articles as normal. I hope you enjoy it too, and would be interested in receiving your feedback. CRAC ON and have a good Christmas!

Andrew Klein