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Posted: April 14, 2010
It's been 20 years since the American College of Rheumatology (ACR) published the criteria for the classification of fibromyalgia. This criteria requires pain in all four quadrants of the body for at least three months AND moderate pain sensitivity at a minimum of 11 of the 18 predetermined tender points.
As with any diagnostic criteria, especially those that cannot be based on a blood marker or similar test, there were problems with implementing the 1990 criteria. The authors of the new preliminary criteria, headed up by Frederick Wolfe, M.D., of Wichita, KS, contend:1
- Tender point counts are rarely performed in primary care where most fibromyalgia diagnoses occur. Doctors have not been trained on how to perform the tender point exam and some simply refuse to do so.
- Outside of research, practitioners in the clinical setting often diagnose fibromyalgia based on symptoms rather than tender point counts. So why not standardize the diagnostic process so all doctors can use the same procedures.
- The prior focus on tender point counts obscured the importance of other common symptoms, such as fatigue, sleep, and cognitive difficulties.
Twenty years experience with any set of diagnostic criteria is bound to illuminate its shortcomings. Research has shown that there is a serious gender bias in how the 1990 criteria are used, making it much harder for men to receive this diagnosis and the available treatments.2 The tender point criteria also did a poor job of measuring symptom severity or charting the effectiveness of new treatments. Although the new diagnostic criteria do away with the tender point concept and take into consideration the more common symptoms of fibromyalgia, it remains unknown whether primary care physicians will find them any easier. The new ACR diagnostic criteria for fibromyalgia should still be viewed as preliminary. However, patients should be aware of what Wolfe and the ACR committee are proposing.
For starters, Wolfe's editorial published online along with the new criteria in Arthritis Care and Research, makes two unflattering statements about fibromyalgia:
- "The ACR diagnostic criteria should not be seen as an endorsement of the legitimacy and existence of fibromyalgia-the criteria are neutral on that point."3 He goes on to indicate that the "fibromyalgia wars" over whether fibro is a real condition, or just the end of the spectrum showing how some people poorly respond to distress (it's what Wolfe refers to as "fibromyalgianess"), remain unresolved.4
- "... one can now study fibromyalgia and fibromyalgianess without the requirement for belief in its existence." Does this mean that Wolfe and other non-believers will enter the research field of fibromyalgia? Time will tell. With the new criteria that is virtually a symptom checklist, Wolfe adds, "... it is now possible to study widespread pain, fibromyalgia, fibromyalgianess-indeed the whole spectrum of illness related symptoms, simply and inexpensively in survey research." But this form of "study" is not likely to lead to biomarkers or effective new therapies, which is what fibromyalgia patients need the most.
The study paper for developing the new ACR diagnostic criteria for fibromyalgia was only based on 829 fibro patients (75 percent meeting the tender point criteria) and 829 control subjects with other non-inflammatory rheumatic disorders (e.g., osteoarthritis, degenerative neck and back conditions, regional pain syndromes, etc.). For the purposes of developing new criteria, this is a relatively small group of study subjects and could be why the authors refer to them as "preliminary."
The new criteria appear in a one-page symptom checklist format that will hopefully be more suitable for use in the primary-care setting. A tender point evaluation is no longer required although a full physical exam is still recommended along with other diagnostic tests to identify causes for the patients' symptoms besides fibromyalgia. In place of the tender point count, patients (or their physician) may endorse 19 body regions in which pain has been experienced during the past week. This number is referred to as the Widespread Pain Index (WPI) and it is one of the two required scores needed for a doctor to make a diagnosis of fibromyalgia.
The second part of the score required to assess the diagnosis of fibromyalgia involves the evaluation of a person's symptoms. The end result is a Symptom Severity score or SS score. The diagnosis is based on evaluating both the WPI score and the SS score. Overall, it takes into consideration the widespread nature of your pain and your other bothersome symptoms.
The greatest problem with the new criteria is that the authors do not state how severe the pain must be in order to check "yes" for that area. What if the pain is just a dull ache or intermittent? The criteria do not specify the intensity or quantity of pain that one must have in a given area over the past week to merit a "yes" answer. Quantifying the symptoms for the SS score is even more vague. In fact, the carefully selected non-fibromyalgia control patients scored an average of 3 on a scale of 0 to 12, which is not far from the SS score requirements for fibro.
On the downside, is it possible these new criteria may greatly increase the number of patients diagnosed with fibro by diluting what is called "fibromyalgia." Quite possibly, people with chronic, painful illnesses that do not involve widespread pain will meet the new diagnostic criteria.
Now that we've introduced you to the new preliminary criteria, we invite you to see how you measure up to this new grading system in the following survey. The survey is open to everyone. You do not have to have fibromyalgia to take the survey and learn about the new criteria. This does not take the place of a professional diagnosis, but will give you an idea of what is being proposed.
As you are taking the survey, consider that your current medications may be greatly helping you or you may be experiencing a good week, which in the end could classify some fibromyalgia patients as not having the illness. One of the purposes of this new criteria is for healthcare providers to be able to chart your progress. Although you are asked about your symptoms for the past week, it is assumed that they have persisted for at least three consecutive months in order to meet the criteria. You will be offered an opportunity to comment at the end of the survey. We invite you to let us know what you think.
- Wolfe F, et al. Arthritis Care Res DOI 10.1002/acr.20140 [Epub ahead of print] February 23, 2010.
- Katz JD, et al. Gender Med 7:19-27, 2010.
- Wolfe F. Arthritis Care Res DOI 10.1002/acr.20156 [Epub ahead of print] February 23, 2010.
- Wolfe F. Arthritis Rheum 61:715-6, 2009.
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