Two companion papers from a single author, a paediatric surgeon working in a secondary/tertiary unit, were received. He had performed the same minor operation on 420 babies and 60 children over two years. His paper purported to report safety and efficacy. From the hanging committee’s own knowledge, and after checking with a surgical board member, a paediatric surgeon might be expected to do four or five such procedures in a year in an average practice, but there were over 200 in the report. Paediatricians regard the procedure as unnecessary. All paediatric textbooks agree. Apparently, some paediatric surgeons overseas, parent support groups, and speech therapists are quite keen on it. There is no good evidence base on which to decide who is right. The concerns were: 1. As there was no known indication for the treatment, should it have been part of a randomised controlled trial? 2. Ethics committee approval was not sought. 3. The stated indications for surgery were highly subjective and, in any case, mostly regarded by paediatricians as representing normal and transient physiological or behavioural events. 4. There were no statements made about mode of referral, and these surely could not have been made by local paediatricians. 5. Many infants were not anaesthetised, although the author claimed it caused no distress. The papers were rejected, and the author was informed of the anxieties. What should be done now?
_ In the absence of an evidence base relating to the procedure’s indications any trial should have a control arm and be approved by the institution’s research ethics committee. _ The papers were submitted as cases series, where there had been a range of preoperative symptoms and no standardised pre or postoperative assessment reported. It was unclear whether the procedures were carried out in private or public practice. Did the papers represent a research study? _ In similar previous cases, investigators had to go back to the theatre records, patient notes, and original statistical analysis. It is sometimes difficult to draw a line between where clinical innovation ends and experimentation begins. _ The editor should seek clarification from the author, advising him that he would raise his concerns with the institution where the surgeon was based/operations being carried out, over the failure to obtain ethical committee approval for an unusual procedure. _ If patient safety is an issue there is a statutory duty on the chief executive of the hospital to ensure this.
The editor wrote to the author’s institution, informing the author about this course of action. The author had requested a copy of the letter and also the COPE minute on the case. The chief executive of the institution agreed to fully investigate the case. The medical director convened a Trust committee/panel, which concluded that the doctor’s activities did not count as research and gave the procedure a clean bill of health. The panel felt that the work submitted to the journal was a case series. The editor was not informed of the membership of the inquiry. He felt that the committee of inquiry appeared to have not taken external advice on the procedure under scrutiny. Patients had been referred from a substantial group of non-clinicians, a normal practice in this field, but there is some disquiet in local medical circles that this procedure is being carried out in such volume.