Surgery and evidence-based medicine

A new Australian registry promises to strengthen the push towards evidence-based surgery

MJA 1998; 169: 348-349

The pace of change in surgery is increasing the pressures to assess new technologies and procedures in ever-decreasing periods of time. The rush towards new techniques and technologies in surgical practice is encouraged by increased media attention, sensational reporting and ready access of patients to unrefereed Internet information. At the same time, there is increasing attention being focused on the need for evidence-based medicine in any clinical decision making. The practice of evidence-based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research.1 External clinical evidence can be ranked in a hierarchical framework with the randomised controlled trial at the top, meta-analysis or systematic reviews in the middle, and clinical experience at the bottom. From this framework of information, clinical practice guidelines are currently evolving.2 Yet the article by Solomon and McLeod in this issue of the Journal3 highlights the poor representation of randomised controlled clinical trials in the surgical literature and the consequent lack of an adequate "gold standard" by which surgeons can measure their performance and develop evidence-based management plans and treatment. The many reasons why randomised controlled clinical trials are not well conducted or pursued in surgical practice4 no doubt include the influence of the expertise and preferences of individual surgeons, poor support from competitive granting agencies and little industry support from surgical manufacturers or pharmaceutical companies when compared with the support for drug trials. Indeed, it is no coincidence that in order to attract funding many randomised controlled surgical clinical trials have needed to include a pharmaceutical agent within the study design. Furthermore, the surgical temperament does not always lead to well-developed team skills among surgeons. The ability to stage meaningful, randomised-controlled clinical trials requires recruiting support from a range of colleagues across a number of departments or hospitals and having sufficient resources to follow through not only the initial setup phase, but also collection and analysis of the data. A good example of the difficulties attending efforts to set up surgical trials was the attempt by the Royal Australasian College of Surgeons (RACS) to establish a trial to assess laparoscopic colorectal surgery for malignant disease.5 This carefully developed plan for a randomised controlled trial, with every chance of generating useful data on the success (or otherwise) of laparoscopic colorectal surgery in both malignant and benign conditions, failed to begin because Commonwealth Government funding was not provided after early encouragement had been given. Surgeons are not encouraged to give their time and effort in the pursuit of such trials when there seems little genuine support from funding bodies which should have an ongoing interest in such studies. If the purchasers of surgical services (government, insurers and patients) desire evidence-based practice, they must also be prepared to support the cost of data collection.6 Fortunately, the Commonwealth Government has recently shown some recognition of these issues by funding a three-year pilot program for the Australian Safety and Efficacy Register of New Interventional Procedures-Surgical (ASERNIP-S) through the RACS. The ASERNIP-S group was formed early in 1998 and is based in Adelaide. Its aims are to establish a mechanism for collecting data on the safety and efficacy of selected new surgical procedures and to collate and analyse this data in conjunction with other evidence available, a concept endorsed by The Lancet in 1996.7 It is hoped that ASERNIP-S will suggest which procedures are appropriate candidates for randomised controlled clinical trials and develop recommendations for the application of new procedures, indicating whether a procedure should be used with or without continuing audit, or if a more fully controlled evaluation is necessary before the procedure is generally used. One of the functions of the pilot program will be to assess the effectiveness of ASERNIP-S itself and make recommendations about the scope for developing a comprehensive audit mechanism for new surgical procedures in the Australian healthcare system. Various sources have nominated procedures for assessment by ASERNIP-S: Divisions of the RACS, credentialling committees, consumers (through the Consumer Health Forum) and the National Centre for Classification in Health. The role of ASERNIP-S will be to assist in the collection and critical analysis of the literature on selected procedures and to facilitate further evaluation of the procedure if required. So far the group has been able to consider procedures across the breadth of surgery and has been able to involve nearly all sub-specialties associated with the RACS. This may help focus surgical efforts towards conducting randomised controlled clinical trials where they are most needed, rather than where the funding can be found. The Commonwealth Government will need to support trials in those areas that clearly need more critical evaluation, but funding for such support has not yet been identified. Meanwhile, there is a large backlog of established procedures that still require critical analysis by the surgical community.8 Once this evidence is collected, analysed and made the basis of a consensus position, it will be important that surgical practice guidelines are developed. In a recent article in the Australian and New Zealand Journal of Surgery, Barraclough defended the need for practice guidelines if errors were to be eliminated and evidence-based practice was to gain a further footing in surgical care.9 The concerns regarding medicolegal implications of such practice guidelines and the cries against "cookbook surgery" seem rather hollow. Surgeons, like all healthcare workers, need to ask whether their longstanding practices, prejudices and patient wishes really reflect current best practice according to the evidence. Where the evidence remains unclear, then it behoves all in Government and the healthcare sector to pursue well-constructed studies of appropriate size likely to resolve the clinical question. The RACS has certainly made a clear commitment to this and recognises the need to redress the less-than-perfect evidence base of current surgical practice. Guy J Maddern Professor of Surgery University of Adelaide, Adelaide, SA Sackett DL, Richardson WS, Rosenberg W, Haynes RB. Evidence-based medicine: how to practice and teach EBM. New York: Churchill Livingstone, 1997. Pelly JE, Newby L, Tito F, Redman S, Adrian AM. Clinical practice guidelines before the law: sword or shield? Med J Aust 1998; 169: 330-333. Solomon MJ, McLeod RS. Surgery and the randomised controlled trial: past, present and future. Med J Aust 1998; 169: 380-383. Sondenaa K, Nesvik I, Solhaug JH, Soreide O. Randomization to surgery or observation in patients with symptomatic gallbladder stone disease. Scand J Gastroenterol 1997; 32: 611-616. Hewett P. The Australian laparoscopic assisted resection for adenocarcinoma of the colon clinical trial [abstract]. Aust N Z J Surg 1997; 66 Suppl 1: 49. Rodarte JR. Evidence-based surgery [editorial]. Mayo Clin Proc 1998; 73: 603. Horton R. Surgical research or comic opera: questions, but few answers [editorial]. Lancet 1996; 347: 984. Howes N, Chagla L, Thorpe M, McCulloch P. Surgical practice is evidence based. Br J Surg 1997; 84: 1222-1223. Barraclough B. The value of surgical practice guidelines. Aust N Z J Surg 1998; 68: 6-9.