If we consider how the management of our patient's medical problems has changed throughout the years, it is easy to despair at the well-meaning intentions of our predecessors. Though we still cannot be complacent about many of the current treatment options for patients, a new era of evidence based practice as opposed to the intuitive based practice of former times has evolved. Evidence based practice is not a panacea, but it can provide us with an insight into the advantages and disadvantages of existing therapies, and expose their weaknesses thus encouraging further research.
If we consider how the management of our patient's medical problems has changed throughout the years, it is easy to despair at the well-meaning intentions of our predecessors.
Though we still cannot be complacent about many of the current treatment options for patients, a new era of evidence based practice as opposed to the intuitive based practice of former times has evolved. Evidence based practice is not a panacea, but it can provide us with an insight into the advantages and disadvantages of existing therapies, and expose their weaknesses thus encouraging further research.
Recognizing the limitations of many aspects of current practice, the Scottish Intercollegiate Guidelines Network (S.I.G.N.)1 was formed in 1993. Its objective is to improve the effectiveness and efficiency of clinical care for patients in Scotland by developing, publishing and disseminating guidelines that identify and promote good clinical practice.
S.I.G.N. is a network of clinicians and healthcare professionals including representatives of all the UK Royal Medical Colleges as well as nursing, pharmacy, dentistry and professions allied to medicine. Patients' views are represented on S.I.G.N. through the Scottish Association of Health Councils. S.I.G.N. works closely with other national groups and government agencies working in the National Health Service in Scotland.
The S.I.G.N. Secretariat is based at the Royal College of Physicians of Edinburgh and selects guideline topics on the basis of the burden of disease, evidence of variation in practice and the potential to improve outcome. Over 40 guidelines have been published or are in development, covering areas as diverse as the interventions for dementia, to the management of a sore throat.
S.I.G.N. methodology for developing guidelines was outlined in its Criteria for Appraisal published in 1995. Key elements include
The evidence-based national recommendations, published by S.I.G.N., are translated by local practitioners into protocols which reflect particular local circumstances and style of practice. The development process for each guideline includes a national workshop at which the draft guideline is presented and discussed. To ensure the continued validity of the recommendations, each guideline is periodically reviewed and updated if necessary to reflect new scientific evidence.
It is important to note that one of the strengths of organizations like S.I.G.N., and the Cochrane Collaboration's 2 recommendations is that they have sufficient quality published data in the form of randomized controlled trials to provide mainly grade "A" recommendations for practice. This has been accomplished by years of clinical research work by individual doctors.
In gynaecology, and specifically in the treatment of menorrhagia, one of the paradoxes has been that it was not until modern surgical alternatives were evaluated, in for example, the MISTLETOE study 3, that a proper critical reappraisal for our existing methods of treatment (both medical and surgical) occurred.
The introduction of alternative surgical techniques for the treatment of menorrhagia represents an ideal example of the shift in our professional attitudes to the evaluation of treatments for our patients, occurring as it did at the watershed of our former intuitive based practice in the pre-1980's.
According to Garry 4, the story of endometrial ablation to date has had 5 phases. The first phase was following the pioneering work of Milton Goldrath in 1981, using endometrial laser ablation, other progressive surgeons also developed the technique with good results. Publications flourished, but the data was generally of poor quality, due to small numbers of patients, lack of long term follow up, and lack of attention to rigorous scientific methods. In the second phase, adventurous gynaecologists could envisage the potential for this new procedure, often with excessive enthusiasm but varying degrees of skill, spurred on by the preliminary data of the pioneers. As a result the third phase was characterized by disillusionment- complications were reported and long term results were not as good as had been predicted, due in some degree to the poor quality of study design utilized by many of the earlier researchers. The fourth phase was (and still is) the refinement of techniques to improve outcomes and minimize complications, with the organization of rigorous large scale randomized controlled trials in order to properly evaluate the role for endometrial ablation in the treatment of menorrhagia. The wealth of data obtained has ensured the place of endometrial ablation in the gynaecologist's surgical repertoire, and endometrial ablation has now been described as "one of the most carefully evaluated of surgical procedures" 4.
We are now also in the fifth phase, which is the appraisal of the newer methods of endometrial ablation. These 2nd generation techniques must give equal results to the existing methods of endometrial ablation, but have the advantages of being easier to perform, with less complications- not an easy challenge 5. Whilst these are still being evaluated, we can build on the work performed by our colleagues in the fourth phase by formulating evidence based guidelines, such as the S.I.G.N. Hysteroscopic Surgery to promote safe, effective treatments for our patients.
1. Hysteroscopic Surgery: Scottish Intercollegiate Guidelines Network, Royal College of Physicians, Edinburgh. April 1999 http://www.show.scot.nhs.uk/sign/home.htm
2. Lethaby, A., Shepherd, S., Cooke, I., Farquhar, C. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Menstrual Disorders & Subfertility Group, 1999
3. Overton C, Hargreaves J, Maresh M. A national survey of the complications of endometrial destruction for menstrual disorders: the MISTLETOE study. Br J Obstet Gynaecol, 1997; 104: 1351-9.
4. Garry R. Endometrial ablation and resection: validation of a new surgical concept. Br J Obstet Gynaecol, 1997; 104: 1329-31.
5. Hodgson DA, Feldberg I, Sharp N, Cronin N, Evans M, Hirschowitz L. Microwave endometrial ablation: development, clinical trials and outcomes at three years. Br J Obstet Gynaecol, 1999; 106: 684-94.