Related article, page 424
The International Ovarian Tumor Analysis (IOTA) Group and their Simple Rules are well known to those health care providers who follow the ongoing attempt to use transvaginal ultrasound to better triage adnexal masses. In this issue of the journal, in the article entitled, “Predicting the risk of malignancy in adnexal masses based on the Simple Rules from the International Ovarian Tumor Analysis group,” Timmerman et al show that quantifying a risk of malignancy based on these Simple Rules will perform well both in oncology centers and other centers. Thus, they conclude that, “patients with a high risk may benefit from surgery by a gynecological oncologist, while patients with a lower risk may be managed locally.”
Additionally, the authors are concerned about the, “absence of an estimated risk of malignancy.” I agree somewhat but as a clinician, I am more interested in 3 possible “buckets” of triage for masses that are asymptomatic. These 3 categories include: (1) no surgery for masses that are self-limited or have no malignant potential so that there is no justification at all for surgery–I would concede that follow-up scan for resolution or stability may be necessary in some cases, while other cases may require none; (2) surgery for evolving symptoms, increasing size, or development (rarely) of acute torsion, all of which can certainly be accomplished by the general gynecologist or what these authors call “locally”; and (3) when surgery is being performed for concern of potential malignancy then, in my opinion, it should be performed by a gynecologic oncologist. Abundant studies show that when ovarian cancer is handled primarily by a gynecologic oncologist, the survival and prognosis is improved.
The authors acknowledge that a limitation of this current paper is that it was performed only on patients who did in fact get operated on, which they state was needed as a gold standard. In their cohort 2.6% were functional cysts, 17.4% endometriomas, 10.6% dermoids, and 5.9% simple cysts. The problem in real-world clinical practice is first to determine which patients will get surgery vs expectant management with variable follow-up, and second, if surgery is performed, which will go to gynecologic oncology and which to a generalist.
I do believe that these rules, if applied to the practice of ultrasound, will certainly improve the “yield” of surgical procedures. When applied prospectively in oncology centers, there were 2.3 surgeries for each malignancy. In all other centers, there were 5.9 surgeries for each malignancy. In the United States, there are 200,000 surgeries for adnexal masses yielding 22,000 cancers for a yield of 9.1 surgeries per malignancy. Why is the US rate so high? Is it inferior ultrasound ability or equipment? Is the ultrasound training inadequate? Is it fear of medical legal liability? Perhaps some degree of all of the above is the case.
Still, Simple Rules have some limitations, not in what they have reported but in any attempt to promulgate widespread implementation into the United States. First, one must adhere to strict definitions of “M” and “B” features. Previously, “simple” cyst and “unilocular” cyst in the United States were interchangeable. This is not true with Simple Rules. Also papillary projections that are small (<3 mm) or few (<4 in number) were considered “mural nodules” by many imagers in the United States and have led to prompt removal. This is not the case in Simple Rules .
I believe that not all masses will ever be triaged by one methodology such as Simple Rules . Many cases, when classic in their appearance, such as simple cysts, hemorrhagic corpora lutea, endometriomas, dermoids, and ovarian fibromas lend themselves to definitive diagnosis by pattern recognition, although the confidence of this may vary depending on the experience and expertise as well as the equipment of the examiner. Many masses that seem almost obvious in their malignancy because of features such as ascites, clearly metastatic lesions, larger solid areas, and abundant vascularity can be directly referred to gynecologic oncology. Yet when neither of these categories seems to fit, that is the initial examiner believes that it is “indeterminate,” subsequent evaluation may well depend on local expertise and availability of resources. Referral to an expert for consultative ultrasound similar to what is often done in difficult obstetrical cases is appropriate and should be encouraged. For years as a teacher, I have often opined that the mark of a good physician is knowing when to ask for help. For some, magnetic resonance imaging may be appropriate, while Food and Drug Administration-approved tumor markers such as Risk of Malignancy Algorithm or OVA-1 for preoperative help in triage may be utilized by other clinicians.
I acknowledge that, as we seem to be entering an era in medicine in general where algorithms and clinical pathways are replacing experience, judgment, and individualization, a system such as Simple Rules seems to be the wave of the future. Certainly, validated systems, carefully followed, have some advantages and disadvantages. Currently, in many areas including ultrasound, health care providers are using experience, judgment, and individualization but some are doing a very poor job. Adherence to standardization will improve those cases but they will also diminish the value of the expert in recognizing the unusual case or outlier. Adherence to protocols narrows the bandwidth in that it brings the bottom up but it brings the top down. More people get better care. The only ones who suffer are the outliers–yet many people seeking help from the medical system do so for fear of being an outlier. As clinicians, we have all heard the patient who, when quoted the chance of something as 1 in whatever, 1 in 100, 1 in 1000, always responds, “I am always that 1.”
Do not misunderstand me. Widespread strict use of Simple Rules in this country would improve patient care. However, even more important would be to improve the quality of ultrasound performed and this requires a commitment by the powers that be, which I assume, in this case, is the residency review committee, to mandate enough time and importance of ultrasound training of residents to ensure a higher level of competence than what exists now. Then, whether we speak of pattern recognition or application of a system such as Simple Rules , the ability to do so will be enhanced. I have spent my academic career in writing and lecturing just trying to do that. However, it requires a systemwide mandate from governing bodies such as the American Board of Obstetrics and Gynecology and the Residency Review Committee to allow for widespread adoption.
In summary, the authors state that the primary aim of the IOTA studies is to develop and validate methods for making correct diagnoses of adnexal tumors prior to surgery. I would modify this somewhat. My concern about proper diagnosis is to diminish the amount of surgery for what is often benign or even functional enlargement and thus avoid any surgery and its associated myriad of risks as well as costs both direct and indirect. Concurrently, not nearly enough women with ovarian cancer are operated on primarily by gynecologic oncologists. We need a better system to improve this.