Luers, ethics, research and service evaluation: more than just the sharp end

Research is part of the scientific method: “the term research designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships)” 1. Research governance is quite correctly designed to protect the individual patient or subject on whom it is being performed, although the complexity of the regulatory framework is one of a number of deterrents to clinical anaesthetic research 2. In the UK, scientific data may also be collected through the processes of clinical audit or service evaluation, which have considerably simpler governance processes. The UK system requires that a study must be designated either as research or as audit/service evaluation, although things are not always so black-and-white. Dr Cook recently described a desirable structured approach for the introduction of non-Luer neuraxial equipment, going from test bench to manikin to formal clinical research 3. Although this might be an aspiration for the future, for instance as laid out with reference to airway equipment in the ADEPT guidelines 4, it is not current practice. In the absence of the earlier pre-clinical stages, the assessment of non-Luer equipment had to start with clinical practice. Two clinical evaluations of non-Luer spinal needles have recently been performed in England, published in Anaesthesia in November 2012 and in this issue 5, 6. These were prompted by the issuing of a Patient Safety Alert by the National Patient Safety Agency (NPSA, its responsibilities now taken over by the NHS Commissioning Board) requiring NHS organisations to introduce spinal devices that would not cross-connect to intravenous (Luer) devices and vice versa 7. The evaluations were considered by us and by the regulatory bodies including the NPSA as service evaluation 5, 6, but by Cook in the accompanying editorial in this issue, as research 8. Two years ago the Editors-in-Chief of this journal and Anesthesia & Analgesia considered their differing approaches to the distinctions between research and audit, based almost completely on the different national remits of the Institutional Review Board and the Research Ethics Committee 1, 9. The US approach is intrinsically more sensible: all investigations are considered by the relevant committee, which can then decide in a consistent fashion what the ethical issues are 1. The role of a journal when presented with a manuscript should be to act as an ethical filter, not the arbiter of ethical probity. Shafer's approach 1 lacks logic with respect to publication intent, however: the same human investigation performed as an audit has different ethical standards and review depending on whether the aim is dissemination of results inside the institution or externally. ‘Intent’ seems to be a very soft area for arbitrating these issues, but this is important according to the guidance from the National Research Ethics Service (NRES) 10. According to this, our evaluation could be considered to fit within ‘research’: “The primary aim of research is to derive generalizable new knowledge,… research is to find out what you should be doing.” “Quantitative research – may involve evaluating or comparing interventions, particularly new ones….usually involves collecting data that are additional to those for routine care but may include data collected routinely.” On the other hand, this phrase for clinical audit also applies: “designed and conducted to produce information to inform delivery of best care.” The concept of investigative research implies control over the process, but in the clinical arena change may happen without our involvement. Manufacturers make constant alterations to the equipment that we use. These may be considered to be functional improvements, or involve manufacturing process changes to reduce production costs, increase efficiency, etc. We are not formally told about most of them; patients may therefore be exposed to risk without our (or their) knowledge. An interesting instance occurred during the Welsh National Single-use Instrument Surveillance Programme process for monitoring disposable tonsillectomy equipment 11. During this, the incidence of complaints about two items of equipment spiked temporarily. This was identified as a change in component manufacture that had not been notified to the purchasing authority. Individual clinicians, if presented with such a problem in the absence of the monitoring programme, might well have complained about the equipment ‘on the spot’ but not carried it any further – reports to the Medicines and Healthcare products Regulatory Agency constitute a tiny fraction of our daily difficulties with devices. But there are times when we are aware and involved in change. In recent years in my hospital, we have been required to evaluate alternative equipment because of issues including cost (spinal needles), change to single-use devices (supraglottic airways) and safety legislation (sheathed-needle intravenous cannulae). These have been done as service evaluation, without the consent of patients. The alternative to participation in these evaluations would have been to have no influence in the process, with likely detriment to patients in the long run. With regard to the non-Luer spinal equipment process, the first proposal for data collection was to establish the rate of technical problems and conversion to general anaesthesia during spinal anaesthesia for caesarean section, initially during current practice with Luer equipment and subsequently after the introduction of non-Luer devices, on behalf of the Obstetric Anaesthetists’ Association (OAA) 12, 13. Differing views on whether this was research or service evaluation were obtained by informal enquiries to journal editors and other experts. We approached the NRES to help judge the question. They advised us to approach our Local Research Ethics Committee (LREC); the latter accepted this as service evaluation. Once this judgement is made, the process diverges from research and therefore no further scrutiny of the ethical issues can be made by the LREC 9. We returned to the LREC when the clinical evaluations of spinal equipment were proposed 5, and the advice was reconfirmed. Although the devices were an untried entity for us, our view was that this was an alteration to familiar equipment used during the routine process of spinal anaesthesia, rather than being a novelty. The management of the evaluation process was similar to the informal evaluations of Luer spinal needles mentioned above. We were also swayed by advice from Alun Tomkinson, the surgeon and project lead for the Single-use Instrument Surveillance Programme, who suggested that, if major problems occurred after the introduction of non-Luer neuraxial devices, there would not be questions about whether evaluations should have been research or audit, but rather ‘Why did you not monitor and evaluate this change?’ (Tomkinson A, personal communication). It is possible that, if these evaluations had been structured as research with full informed consent, they would never have been completed. As Cook states, opinions about our approach will vary. For the future, where should we look? The National Assembly for Wales's Health and Social Care Committee has agreed to undertake work on access to medical technologies in Wales including appraisal processes for new technologies 14, which seems to me to be how a national health service should work. If Government does not take the lead, it may fall on the profession and the manufacturers to introduce appraisal 15, although the identification of funding remains problematic. The worst aspect of this debate concerning ethics and publication is that, to use Cook's words, “it remains generally accepted that clinicians may ‘trial’ or simply ‘use’ new CE marked devices without explicit patient consent, but only provided no data is collected for publication: i.e. that no effort is made to evaluate the device formally and disseminate the results to a wider audience for general benefit.” The complexities of research governance promote unstructured and unpublicised experimentation by clinicians in this way rather than encouraging the sharing of concerns (and plaudits). It is to the benefit of the community as a whole, including medical professionals, patients and the equipment manufacturers, if knowledge is shared. I represent the OAA on the Data Intelligence Group of the Safe Anaesthesia Liaison Group and the External Reference Group for Safer Neuraxial Devices of the NHS Commissioning Board. I was appointed as an Editor of Anaesthesia soon after our paper on needle evaluations was submitted for potential publication in Anaesthesia 5 and the manuscript was therefore sent for further external review. The views expressed in this editorial are personal and support from the above organisations should not be imputed. No external funding declared.