Turning the Page for Fibromyalgia: Revised 2010 American College of Rheumatology Diagnostic Criteria

In a move welcomed by many patients with fibromyalgia and the physicians and other clinicians who treat them, the American College of Rheumatology (ACR) last year published revised diagnostic criteria for fibromyalgia (http:// hcp.lv/jhvEGw) that are suitable for use in both primary and specialty care and are designed to take into account the varied presentation of this disease without relying solely on the narrow set of symptoms outlined in the original criteria released in 1990 (http://hcp.lv/jR58GR). That’s right: the familiar tender point exam is history (or at least removed from its place of primacy). The new criteria combine both pain and somatic presentation and ask about the most common symptoms of fatigue, cognitive disturbances (aka “fibro fog”), and sleep disturbance. “The new criteria reflect what the illness was to people instead of being peripheral to it. Tender points never bothered patients and had no real impact on outcomes,” says lead author Fred Wolfe, MD, director of the National Data Bank for Rheumatic Diseases in Wichita, KS (http://hcp.lv/kyU2ah).

The new criteria rely on two tools that, according to the authors, “best defined fibromyalgia and its symptom spectrum”: the widespread pain index (WPI), which captures pain symptoms at 19 anatomical sites and is the major legacy of the 1990 criteria, and the symptom severity (SS) scale, which identifies an extensive inventory of somatic complaints and symptoms ranging from irritable bowel syndrome to changes in hearing or taste, capturing the heterogeneity and overwhelming myriad of symptoms that fibromyalgia patients report. Under the revised criteria, patients’ symptoms must be present for at least three months. The new criteria also assess the severity of the “big three” non-pain symptoms: cognitive disturbance, waking unrefreshed, and fatigue. The thresholds for a positive fibromyalgia screen are a WPI score of 7 or higher plus an SS score of 5 or greater. An SS score of 9 or greater combined with a WPI score of 3-6 is also a positive screen. By focusing more on the totality of symptoms commonly experienced by patients and incorporating non-painfocused symptoms, the new criteria help to better capture the continuum of fibromyalgia patients. “The 1990 criteria only focused on pain, and fibromyalgia is much more than pain. Memory problems and fatigue are a significant part of the illness and the original diagnostic criteria didn’t give it much weight,” notes Daniel Clauw, MD, professor of medicine, anesthesiology, and psychiatry at the University of Michigan in Ann Arbor.

“After seeing many of these patients and listening to their stories, you come to realize that there is a lot more going on with these patients than just pain. The symptom severity score takes into account the fatigue, fibro fog, irritable bowel syndrome, mood disturbance,” and other factors, says Shay Stanford, MD, assistant professor in the department of family medicine, who sees fibromyalgia patients exclusively with the Women’s Health Research Program at the University of Cincinnati. Stanford says that most of her patients can cope with the pain associated with fibromyalgia, but find the fatigue or cognitive dysfunction the most impairing.

Eliminating gender bias in fibromyalgia

Another reason that the revised criteria are being welcomed by the fibromyalgia community is that “the 1990 criteria unknowingly turned fibromyalgia into an exclusively female disease,” says Clauw. “We didn’t know in 1990 that no men would have enough tenderpoints to meet the criteria.” Based on the prevalence of widespread chronic pain in the population, fibromyalgia would be expected to occur in two-thirds women and one-third men, yet that was not borne out in practice. Thus, under the old criteria, many male patients are not getting diagnosed and appropriately treated.

The rigidity of the tenderpoint criteria left many patients, not just men, in diagnostic limbo. “About 8% of the population throughout the world has chronic widespread pain,” notes Don Goldenberg, MD, chief rheumatologist at Newtown Wellesley Hospital and professor of medicine at Tufts University School of Medicine in Boston (http://hcp. lv/kzi8mM). Goldenberg served on both the 1990 and 2010 fibromyalgia criteria review committees. “But using the 1990 ACR fibromyalgia criteria, with 11 of 18 tender points, it drops to 3%.What about the other 5%? We’re talking million and millions of people.” Goldenberg suspects that with widespread adoption of the new criteria, the prevalence of fibromyalgia might increase. Stanford agrees, and thinks that “we’re probably missing a lot of people because they just aren’t as tender and didn’t meet the tender point criteria.”

By accommodating a continuum of symptoms, the new criteria better captures the flaring course of fibromyalgia; roughly 1 in 4 patients with a fibromyalgia diagnosis in the 2010 criteria study did not meet the 1990 definition. Wolfe has consistently seen this pattern throughout earlier research, as well. “Fibromyalgia is close to the 95% percentile of all symptoms in the world. There is a world between the 0 and 94% percentile that is also important. So for example, patients who have pain and distress from rheumatoid arthritis might have a flare-up of fibromyalgia-like symptoms. The severity of symptoms in fibromyalgia is more clinically relevant than whether or not someone met the diagnostic cutoff. We do not see healthy, happy people in subspecialty practices,” he says.

Misconceptions about the new criteria

One of the chief criticisms of the revised diagnostic approach has come from physicians and others who (mistakenly, it turns out) have interpreted the new criteria and its shift in focus from the tender point exam as downplaying the value of the physical exam. However, paramount to good pain management, the physical exam remains as important as ever in fibromyalgia. “We’re still saying patients need to be examined. How do you determine if someone has a musculoskeletal disorder versus soft-tissue pain without touching them? What we’re actually saying is that having 11 of 18 tender points is not necessary to make an accurate diagnosis of fibromyalgia,” says Goldenberg. The exclusion of major depressive disorder from the ACR 2010 criteria is another point of controversy. However, the authors said that the high rate of depression across all chronic illnesses, including chronic pain and rheumatic diseases, made it of little value as a diagnostic marker. “The use of depression did not improve the accuracy of the classification of fibromyalgia,” says Wolfe.

Exclusion of depression from the diagnostic criteria does not imply irrelevance to the clinical picture for fibromyalgia; depression is listed in the 41 potential somatic complaints. “Depression and fibromyalgia is a chicken-egg scenario. We don’t know if depression is the result of fibromyalgia or if you cannot have fibromyalgia without depression,” says Wolfe. The psychiatric community generally supports the exclusion of depression from fibromyalgia diagnostic criteria. “We don’t want to just make a diagnosis, but an accurate one. Including depression would not help us diagnose fibromyalgia better,” says Rakesh Jain MD, MPH, practicing psychiatrist and clinical researcher from Lake Jackson, TX.

Room for fibromyalgia nonbelievers in the 2010 criteria

By moving away from a strict “yes/no” diagnostic approach to fibromyalgia, the 2010 ACR criteria are thus equally accessible to fibromyalgia naysayers as well as clinicians who see it as a legitimate diagnosis. Wolfe, who includes himself in the naysayer group, viewing fibromyalgia not as a disorder, but at the extreme end of symptom continuum, sees this broad approach as one of the biggest advantages of the revised criteria. “For clinicians who do not want to be part of the political and social baggage of fibromyalgia, the new criteria provide tools for identifying patients with extreme levels of fatigue, sleep disturbance, and bodily pain. These patients can be identified and treated without the clinician having to sign-on as a full-time believer in fibromyalgia,” he says.

Applying the new criteria to practice

Goldenberg says the new criteria “are good screening tools to pick out people with chronic widespread pain similar to screening for depression in the office.” Both he and Clauw advocate that the new fibromyalgia criteria be used as a screening tool first. “We often don’t pick up on fibromyalgia because one year Mrs. Jones is coming in with low back pain, the next year it’s migraine headache,” notes Clauw. “Patients often are only seeking medical attention for the most severe pain. If we don’t fully question them, we may miss the complete picture.”

He advises physicians to “think of the new fibromyalgia criteria as similar to the Patient Health Questionnaire (PHQ-9) for depression screening for primary care.” Similar to depression, fibromyalgia is so commonly seen that patients are often not referred for care to subspecialists. Clauw admits that many rheumatologists’ reticence toward managing fibromyalgia long-term is due in part to the treatment program for the condition; they don’t have anything to offer that primary care physicians couldn’t likewise offer. Goldenberg says, “The 2010 criteria are really more for primary care than rheumatology. Hopefully, they’ll sooner be able to make a diagnosis and more confidently make the diagnosis, without the burden of having to do a tender point exam.” Until they become more familiar with the revised fibromyalgia diagnostic criteria, Goldenberg recommends that primary care physicians either perform additional lab testing on patients who have a positive screen based on the WPI and SS score or consider a referral to rheumatology.

In addition to the clinician-rated version, a patient self-reported version is now available for the 2010 fibromyalgia diagnostic criteria. (http:// hcp.lv/jWZvRm) The self-reported amended criteria remove the requirement that the physician assess the degree of general somatic complaints. Instead, a fibromyalgia score consists of the sum of the WPI score and severity of fatigue, cognitive disturbance, and waking unrefreshed. Fibromyalgia scores of 13 or higher on the patient-self report qualify as a positive screen. “Patients can fill out the self-report criteria in the waiting room. There’s no reason to have physicians administering questionnaires,” says Clauw. Wolfe adds certain caveats about the criteria: “I believe patients give us the most information. However the criteria are not patient criteria. The last thing I want is a doctor handing them a sheet and saying someone has fibromyalgia.”

Another difference between the two sets of criteria is that while the 1990 version implied that clinicians should rule out or exclude other causes of chronic widespread pain before making a diagnosis of fibromyalgia, the 2010 criteria make this explicit. When Goldenberg teaches other physicians, he tells them that the differential for fibromyalgia includes excluding rheumatoid arthritis, lupus, polymyalgia rheumatica, and neuropathies. He still palpates a few tender points to identify the generalized hyperalgesia when he is doing a joint musculoskeletal exam to rule out rheumatic conditions. “Keep the lab testing simple and avoid a fishing expedition since many rheumatologic screening tests have false positives,” he says.

For many patients, the tender point exam met the need for a definitive test that made a fibromyalgia diagnosis easier to accept. Stanford says that her patients sometimes struggle with the simplicity of the revised criteria. She says “They’ll say, ‘That’s it? You don’t have to do a blood test?’ Or worse, they’ll ask about cerebral spinal fluid testing.” Stanford says that when she explains the new criteria to her patients, “I tell them how it overlaps with the tenderpoint exam 80% to 90%. I communicate the symptom severity scale to each patient because it gives them that sense of where their disease is at.”

Another advantage of the new criteria is that the WPI and SS scale make longitudinal follow-up easier for fibromyalgia. “By using items, we gave clinicians hints as to what’s the best way to use this for followup. We want to really know whether patients are getting better or not and to have a set of questions you ask them,” says Wolfe.

While the diagnostic criteria have changed, the fibromyalgia treatment remains the same: a multidisciplinary approach with patient education, aerobic exercise, cognitive behavioral therapy, and pharmacotherapy with centrally acting agents like tricyclics, serotoninnorepinephrine, or antiepileptics. Despite their common use, opioids are ill-advised for fibromyalgia patients. “For patients screening positive for fibromyalgia, please don’t put them on opioids. It’s the worst thing for them,” says Clauw. “Fibromyalgia innately has hyperalgesia and gastrointestinal issues. Superimpose opioid-related hyperalgesia and other side effects, and we create patients no one wants to take care of.”

The revised fibromyalgia criteria “are simple criteria, but not necessarily easy,” says Wolfe. “They’re easier than tender points, but there is a real necessity to talk to the patient. Fibromyalgia is not a clear, distinct disorder but a long gray line. And so if you having a little trouble deciding, that’s okay because that reflects the real world.”

Heather Haley is a freelance writer from Cincinnati, OH, who writes about continuing education, pain, and other topics. Follow her on Twitter @ haleywriting.