We are seeking guidance on the ethical issues surrounding drug/medicine use evaluation (DUE or MUE) audit cycles, particularly with respect to the publication of findings but also perhaps with regard to the conduct of these audits in general.
DUE is a quality improvement activity that involves data collection and evaluation (usually by audit), followed by ‘action’ or intervention and a repeat or ‘follow-up’ audit to monitor changes in practice. DUE methodology was used for a recent national quality improvement activity overseen across approximately 60 hospitals by an independent organisation funded by the government to promote quality use of medicines. Participating hospital ‘project teams’ were asked to identify a predefined number of patients from their surgical lists for the baseline audit, obtain consent from the patient for inclusion (‘if required by local authorities’), conduct a brief postoperative patient interview regarding pain management and, after discharge, retrospectively collect pain management data from the medical record .
Data were submitted to the national project team for collation and assessment, with individual and combined results fed back to hospitals. An educational intervention was then conducted at each site, attempting to address medical, nursing and pharmacy issues, and utilising a number of tools, including one-on-one ‘academic detailing’, presentations and posters. A follow-up audit (same as the baseline) was then conducted at each institution.
A manuscript was submitted to our journal describing the conduct and outcome of the project in two hospitals, and comparing these with each other and with the national results. The hospitals were not specifically identified but were labelled A and B, although one could be assumed to have been the primary institution of the authors and the other probably one of two smaller institutions in the same area health network. The methods stated that formal patient consent was not required for the inpatient interview component because the questions asked fell within routine postoperative care. Institutional Ethics Committee approval appears not to have been sought for any aspect of the project in either of the hospitals concerned although the overall project appears to have been conducted with the approval of various state health bodies and presumably individual hospital administrations, although this is not clear.
The manuscript was rejected on a number of grounds, mainly relating to questions of methodology and partly related to the question of publishing a small subset of a much larger set of data (also to be published eventually according to the website of the national project). The submission did, however, raise other ethical questions that remain a matter of some debate among the editors concerned, and we seek the help of COPE in addressing these since it appears this sort of situation is likely to come up again with increasing regularity. Our first question relates to the study subjects study. In the submitted paper, the assumption appeared to be that the patients were the subjects and their ‘recruitment’ was discussed. However, we feel that the subjects of the investigation were the staff of the participating hospitals since it was their drug prescription administration and documentation behaviour that was being examined before and after a behavioural intervention.
Our second question regards the nature of the project. Is it a quality assurance/improvement activity that does not require ethics approval for its conduct and/or publication of results? Or is it actually a research study examining the behavioural effect of an educational intervention on hospital staff, and as such does require ethics committee consideration, approval and possibly individual participant (staff) consent?
This case prompted a discussion on the differences between a study and an audit. Most agreed that if there is an intervention, then it is a study, but it was pointed out that there are regional differences, and different countries have different policies on what type of studies need ethics approval. The Helsinki declaration discusses “human subjects” and so does not make a distinction between patients and staff. The advice from the Forum was for the journal to develop their own policy on this issue and to perhaps commission an ethical debate around the subject for publication in their journal. The Forum also reiterated the fact that even if a study has ethics approval, the editor does not have to publish it if s/he is unhappy about any of the aspects of the study.
COPE suggested we develop internal policies regarding situations like these, and this was discussed at our subsequent editorial board meeting. The Committee's advice was found to be very helpful by the board, and in particular the agreement with our assessment that the staff, not the patients, were the subjects of this particular “experiment”, and some discussion occurred surrounding this and other cases discussed at the COPE Forum meeting involving conflict of interest issues (new ICMJE guidelines) and Clinical Trial Registration.
Notices regarding conflict of interest and trial registration are being considered for inclusion in our instructions for authors and also for a new set of editorial guidelines.
The more difficult ethical question is yet to be fully resolved. However, we will continue to deal with such cases on a case by case basis and hopefully reach consensus among the editors.