Peter O'Donovan, MBBCh, FRCOG

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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.)

 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 use of systematic reviews to identify and       synthesize evidence

development by a multi-professional group including all disciplines relevant to 	the clinical topic

explicit links between the scientific evidence and the guideline's recommendations


 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 

 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 

, 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 

, 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" 

.
 
 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 

. 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.

Articles

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.

S.I.G.N. for Hysteroscopic Surgery

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       "It's nice to be here in Stockholm, Sweden, and it's great to be with       

.       We're here are at the European Society for Gynecological Endoscopy, one of       the biggest meetings in the world for gynecologists who have an interest       in endoscopic surgery. We're taking a few minutes out from a crowded       meeting schedule with two distinguished doctors to talk in a little bit       more detail about some of the exciting and emerging aspects of what's new       here at the conference, particularly in the areas of endometrial ablation.       Our special guests who are with us today are also here to talk about       what's new in the treatment of menorrhagia. I like to introduce first, Dr.       Jay Cooper, who's a Clinical Assistant Professor in Obstetrics and       Gynecology, working at the University of Arizona. He has a private       practice in Phoenix at the Women's Health Research, and Jay has a       distinguished record in assessing and evaluating new areas for endometrial       ablative technology. Leading the discussion is my good friend and       colleague, Dr. Peter O'Donovan, from England. Peter works in Bradford, in       the north of England, and Peter's got wide experience, particularly in       endometrial resection and hysteroscopic surgery. Peter, what have you seen       at the conference that you think is interesting enough to find out a bit       more about?"
       
       

       "The conference so far has been very interesting. The focus on this       morning's conversation was David Redwine's presentation on the use of       evidence-based medicine in the management of patients with their problems.       In particular, he really gave a good overview on the role of trials to       assess the response to the management of patients with endometriosis.       However, I think the most exciting event I attended was the symposium we       just had on the management of women with abnormally heavy periods. I feel       that this area was particularly interesting because it was concerned with       very exciting new developments in conservative surgery, particularly with       respect to conserving the uterus and shifting a lot of the surgery to an       office-based setting. I wonder if Dr. Jay Cooper would like to comment on       his views as to whether he feels this area of practice will grow in the       future, and particularly, locally?"
       
       

 "I       think so. I think endometrial ablation is a concept that will grow       significantly over the ensuing five or ten years, particularly now that       there are newer technologies-we call them global, or less complicated,       ablation technologies. Until now physicians thought that a patient's       endometrial ablation required a rather skillful physician who was able to       arrive at this level of skill only after many years of experience.       Consequently, there are a limited number of physicians who will invest       that time and effort to arrive at that skill level so they'll be able to       provide for their patients this method of endometrial ablation, which is       an excellent alternative to hysterectomy for women who have a problem with       excessive or heavy menstrual bleeding."
       
       

       "I endorse what Jay says. In particular, I actually train juniors in       these hysteroscopic surgery skills, and I had a discussion with Jay at a       previous meeting we attended in Miami this year, the World Congress on       Alternatives to Hysterectomy. I can remember our conversation was very       much along the lines that having trained doctors in hysteroscopic       techniques does require a certain level of skill to actually perform an       endometrial resection. And certainly, I actually had about twenty patients       which I had to do under supervision before I was reasonably confident in       the technique. I think with the new procedures, particularly in respect to       the microwave ablations and alternatives, it does seem to be a lesser       level of skill dependence. I wonder if Jay would like to comment on this       because I know he's been involved in training, particularly in the United       States."
       
       

 "I've       been involved with training, but as a criminal investigator in the United       States. The way technology receives approval from our governing agency,       the Food and Drug Administration, is by conducting what's called a       'randomized perspective clinical trial,' and what we do there is we       compare the new technology to the known technology. The known technology,       of course, is traditional resection ablation, and the new technologies are       these alternatives-global ablation, MEA technology, or what have you.       There is no doubt that in training physicians, the ease in which you're       able to impart this knowledge or learning curve is so much simpler with       the newer technologies than it has been for traditional resection       ablation. You feel so much more comfortable as the training physician to       hand this off, and you feel comfortable allowing the junior physician to       take on this surgery and to not expect significant trepidation-'oh my God,       what might happen!?-or maybe just a case or two, after which the physician       is now able to be rather expert doing the procedure. So I think there's no       doubt that this is going to significantly impact the penetration of these       technologies into the marketplace."
       
       

       "Having listened to the seminar during the last hour or so concerning       a comparative trial of, for example, what I think is the gold       standard-endometrial ablation versus microwave ablation-the results from       the Aberdeen study where they actually looked at 260 patients come to       mind. The actual findings, particularly at twelve months, were       particularly satisfying. I must admit that I am a great believer in       actually measuring things against the gold standards, and currently the       gold standard is endometrial ablation. I wonder, would Ellis make any       comment possibly on any particular safety aspects one would consider       forming when actually doing office-based ablative procedures, or so-called       office-based procedures in the U.S., but in many ways outpatient       procedures in the U.K.? Can you make any comment on any particular aspects       that you focus on?"
       
       

 "I       think it's a very important area. I think the real answer for the surgical       treatment for menorrhagia will be the procedure that we can perform in the       office setting. It's good for the patient, it avoids general anesthetic,       and it's good for the physician because it means they can give the best       care to their patients in the convenience of their offices. If you do it,       I think it's essential that you are very happy about the technique, and       you have plenty of experience doing the technique under general anesthesia       in an operating theater environment. I think that it's clear that one must       have basic resuscitation facilities available, and it's also clear that       some patients will not be suitable for an office-based procedure.       Certainly, once we take the new technology-which when used in the office       setting increases the resource and the coming of that, the newer       procedures such as microwave endometrial ablation-as surgeons get more       experienced with them, then they're much more comfortable doing them in an       office setting. Some of the big centers are now doing more than 50% of       their treatments in the office setting, and I think that's going to       continue to improve and ultimately give women more of a choice about how       they want to treat their menorrhagia."
       
       

       "The only comment I'd make is that the actual studies that are being       done in the field of microwave ablation, certainly the company would need       to report it by the way they approach this problem similarly. There are       fourteen different pro-ablative procedures on the market, and I feel that       any technique that needs to be widely introduced first needs to be       assessed very carefully in terms of long term follow-up. Also, randomized       control trials are a very good standard. I would endorse that every       particular point needs to be assessed, and we need to assess all       three."
       
       

 "I       would agree 100%. I think that everyone's-patient, insurance company,       government-goal is to bring down costs. Certainly, whatever technology we       are offering our patients, if it can be offered in a lower cost setting       and in a setting that causes less anxiety, i.e. an office setting or an       ambulatory surgical facility. That's clearly where we want to be going.       More importantly, are putting the cart before the horse? We must be sure       that the technology in question is safe and advocatus, and the only way to       make that determination is with a randomized clinical trial. That's why       all the records have been done at Aberdeen, because it is the closest to       what is required by the Food and Drug Administration in the United States,       in the form of comparing the gold standard endometrial ablation technology       to a new technology, that being MEA."
       
       

       "I think certainly the forthcoming clinical trials which are about to       start in five states in the U.S. will be gathering the data for submission       to the FDA so that marketing can begin. I think those trial sites, which       have been chosen, will give us some very good data in terms of actually       demonstrating that, yes, we can use data in the population that we want to       serve. Far too many women are having, in my view, unnecessary       hysterectomies. What is your view of the way that gynecologists can reduce       the numbers of women who are undergoing hysterectomy?"
       
       

 "I       think that we are seeing an evolution here. The Internet and all other       kinds of media are reaching our patient population, and that's       dramatically changing their abilities to come to their own decisions. In       many cases it happens even before they reach the physician's office,       whereas years ago, women would come to me and say, 'what do you think of       this?' In many cases they now come to me and ask me what I think about it,       but they'll say, 'what physician should I go to to have this done?'       They're already beginning to appreciate that the physician's office is not       necessarily the only place to come for information about healthcare needs.       So I think that will be one significant way that the pendulum will swing.       I think the newer physician will be more comfortable and the younger       physician will be more comfortable with sharing knowledge with patients       and allowing them to make informed choices. I have always found that the       more information that I can import to the patient, the better off I am.       When a patient makes an informed choice rather than me dictating that she       should choose this or that, I feel so much more comfortable because she's       now aware of the benefits and risks. And if there is a down side, she's       chosen that-I haven't chosen it for her. So I think you will see this       happening, and I think the unquestioned lowering of the risk-reward ratio       with these new ablation technologies will move women in this direction.       Traditional resection ablation is a wonderful procedure, but it       traditionally requires general anesthesia and significant potential       complications. With the newer technologies, we can lower those risks,       minimize those complications, and by doing so, allow more women to opt for       this trust."
       
       

       "I think on that positive note of empowerment, we should bring this       discussion to an end. We've been having a chat at the European Society of       Gynecological Endoscopy meeting here in Stockholm with Dr. Jay Cooper and       Dr. Peter O'Donovan. I think we've reached a consensus that 

       is about empowerment of choice for physicians and for patients. Thank you       very much, and I look forward to writing the Hospital Cuttings in future       editions."

OBGYN.net Conference CoverageFrom the 5th Meeting of the European Society of Gynecologic Endoscopy- Stockholm, Sweden - June, 1999

Gyne Endoscopy

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Gyne Endoscopy Video

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       "We're here today at the AAGL in Las Vegas, and we're having a       tremendous conference. There's an awful lot going on, a lot of great       scientific sessions, some interesting exhibits, and to mull over what's       happening, I'd like to introduce Dr. Peter O'Donovan who's a gynecologist       from Bradford in England. Peter, what's struck you about this conference       so far?"
             
             

       "I've found that today, in particular, I was struck by the early       morning sessions. There were some superb sessions, mainly on new product       development in relation to office based procedures. However, yesterday I       attended the pre-conference workshops, and there was some very nice       presentations. One in particular was very well received by Franklin Loffer,       when he overviewed all the currently available ablative procedures on the       market. I must say, Frank gave a very elegant presentation. What struck me       was the number of products now on the market that are increasingly used in       the office setting for our U.S. viewers."
             
             

       "How many products are on the market at the moment?"
             
             

       "At the last count, there were approximately fifteen. Those products       are going, I would say, almost by the day. However, at the leading edge of       product development, one could say, those products with the largest number       core group syndrome still consist of microwave and also the ThermaChoice       System."
             
             

       "I think that's very interesting. All gynecologists are really       struggling to find out what is going to be the best sort of treatment. I       think one of the other issues which is very difficult to grapple with,       Peter, is with filming this interview in the exhibition booth - there are       so many different sorts of endoscopy companies here, and what's happening       in hysteroscopes and laparoscopes. What should we be getting excited       about?"
             
             

       "I've actually just completed a talk at one of the stands, and what       struck me, Ellis, is that the scopes are going smaller, and the technology       is fast moving in terms of fiberoptic technology. I've just visited a       stand whereby the scope size, by that I mean the lens size, is 2-mm. And       believe it or not, that consists of a fiberoptic system that's also       autoclavable. This is a…"
             
             

       "You mean a 2-mm system - it's barely conceivable."
             
             

       "Not only that Ellis, not only are there advantages in lens       technology but camera technology is moving very quickly as well. When I       actually woke up - I'm slightly jet lagged - at three o'clock this morning       I turned on the television in my room, and there I saw a number of       companies that are exhibiting their products. There are a number of       companies and one of them is called Storz who are producing a smart system       within their three-chip camera system. It gets rid of what we call the       "chicken wire" appearance, and the illustrations they showed       were quite interesting. The image quality two years ago would have been       questionable, the image quality is very hard to distinguish between       fiberoptic now and raw lens."
             
             

       "Right, that's terrific. We've touched on the new ways of treating       menorrhagia, and we've touched on the changes in scope technology. What       are the other key clinical messages that you've heard from the scientific       presentations that you as a gynecologist are going to be taking away to       change your everyday clinical practice?"
             
             

       "I think having been on the Prize Committee for the Golden       Hysteroscope Award, and what struck me from some of the presentations,       particularly there was one from, I think, UCLA whereby some of the       instrumentation now is not being used in a focused way for one purpose.       They're used in a multi-usage way so an endoscope can now be used not only       for a laparoscopy but it can double up as a hysteroscope or a cystoscope,       which is a new concept. In many ways this may be a win-win situation.       Obviously, meetings like this one need commercial sponsors but these       instruments are likely to be more readily useable in the office setting.       More importantly, in terms of sterilization, we're going from a soaking       technique to actually autoclavebility for the fiberoptics."
             
             

       "Right, I think that's tremendously exciting. I'm grateful to Peter       for taking a few minutes out of his busy schedule to share his thoughts       with us about the exciting developments here at AAGL. As I leave you, I       look forward to seeing you in a couple of weeks time when we have another       exciting meeting coming up in London. It's an international meeting on       recent advances in gynecological surgery, and we're looking forward to       giving you some great up-to-the-minute, topical breaking stories of what's       new in gynecological surgery. Thanks very much."
             
             

OBGYN.net Conference CoverageFrom American Association of Gynecological LaparoscopistsLas Vegas, Nevada, November, 1999

Author | Peter O'Donovan, MBBCh, FRCOG

Articles

S.I.G.N. for Hysteroscopic Surgery

Gyne Endoscopy

Gyne Endoscopy Video

The Workshops at AAGL '99