Hey! American College of Rheumatology, What’s the Deal? by Celeste Cooper

I have concerns regarding the response I received from the American College of Rheumatology (ACR) regarding fibromyalgia diagnostics. You can read my inquiry letter here and the ACR response to that letter here. Could it be the ACR is distancing itself from the fibromyalgia the controversy? 

My concerns as follows:

• Some studies show immune dysfunction in fibromyalgia, so could fibromyalgia be treated by immunologists in the future?
• Studies show the brain of the fibromyalgia patient is structurally affected, so should neurologists study and treat fibromyalgia?
• Other research suggests fibromyalgia is indeed an autoimmune disease similar to lupus (SLE). If this is the case, knowing a hallmark symptom is indeed overwhelming muscle and soft tissue pain and anomalies, shouldn't it stay right where it is—under the umbrella of rheumatology?
• What kind of research can we expect in the future, and investigated by whom?
• If the ACR will not endorse any criteria, who will?
• Don't clinicians currently look to the ACR for guidance, as they would look to the American College of Neurology for diagnostic criteria for MS?
• Can we expect consistency if so many are being misdiagnosed with fibromyalgia as we are seeing with the Wolfe, et al criteria? How will a tainted study participant pool yield accurate results?
• Exactly who should be responsible for amending and updating the criteria for diagnosing fibromyalgia to reflect research findings moving forward?

Can we expect research funded by outside sources to be based solely on their intent to prove their product to boost their bottom line? Are we to be okay with having half the participant pool misdiagnosed with fibromyalgia when they actually have a mental health disorder? See the following excerpt from a blog I posted in April 2013, Fibromyalgianess is ALL in Our Head? My Correspondence with DrFrederick Wolfe.

Celeste Cooper (Me): I also have grave concerns over the non-specific disease related symptoms being seen as somatic complaints, in the [Preliminary Proposed Diagnostic Criteria for Fibromyalgia] PPDCFM when they can be linked to specific comorbid disorders and treated appropriately. Marla Silverman and I co-wrote an ADVOCACY PIECE over a year ago regarding our concerns for CFS/ME and FM in the new DSM-5, and now our concerns are born out. I fear it is because the PPDCFM specifically identifies somatic complaints associated with FM without tying them to the comorbid disorders other than IBS and hypothyroidism and that 40% of FM patients (as you report) fall into this DSM-5. This is significant.

 Dr Wolfe’s email response: I don't share that concern or agree with you. However, the physician can certainly chose to exclude symptoms of known diseases if she chooses. That's why we ask physicians to analyze the symptoms and make a judgment.

I am surprised that Arthritis Care and Research would allow the ACR to be named in titles if they indeed want to distance themselves from any criteria, ie. New American College of Rheumatology Criteria for Fibromyalgia: A Twenty-Year Journey by Frederick Wolfe, published in Arthritis Care and Research, May, 2010. This is just one of many examples. Folks are referring to these unapproved criteria as the new ACR criteria in their papers.

Is It Just Me?

Is it just me, or does the ACR letter seem ambiguous? Following are excerpts that factored into my conclusion.

… the ACR did provide provisional endorsement of the 2010 FM diagnostic criteria authored by Dr. Wolfe, et al… but the criteria were not yet validated in an external dataset so full endorsement could not yet be given… Once this external validation work has been done, investigators can then come back to the ACR for consideration for full approval.  

… the ACR has since 2010 established a policy that it will no longer endorse diagnostic criteria. …we recognize that there will be exceptions to any standard criteria that are developed.  Because our endorsement of diagnostic criteria may imply that this is not the case, the ACR has chosen not to endorse newly developed or validated diagnostic criteria now or in the future. [So why are the suggesting that once it is validated by an outside source, it is to be resubmitted for consideration of full approval. CC]

You can read the full letter here.

And what about the Bennett, et. al criteria? No mention, even though it was published in the September, 2014 Arthritis Care and Research?

By the Seat of Their Pants—Post Exfacto

I believe the ACR is flying by the seat of their pants on this one, post exfacto (after the fact). The Wolfe criteria have been criticized for the same reasons I am concerned. The criteria under-performs and identifies patients with FM at a much greater rate than the 1990 criteria. It doesn't take a rocket scientist to figure out this is because they are diagnosing fibromyalgia in patients with somatic symptoms disorder (pdf here). 

A direct quote from the DSM-5:

 "...while medically unexplained symptoms were a key feature for many of the disorders in DSM-IV, an SSD diagnosis does not require that the somatic symptoms are medically unexplained."

Is it starting to make sense as to why some physicians now see fibromyalgianess as a label for psychosomatic illness? 

What can we do?

• Talk to your physician about what criteria he or she used to make your diagnosis.
• Make your providers aware of the stance the ACR has taken.
• Educate your provider on the Bennett Alternative Criteria. (See my blog, which was over-viewed by Dr. Bennett. http://fmcfstriggerpoints.blogspot.com/2014/09/the-2013-alternative-criteria-dr-robert.html#.VAS01fldU6w
• Share this blog with your doctor or his/her nurse. Ask about their opinion and write about it. We all need to hear encouraging words. I am thankful to say, there are those who strongly disagree that fibromyalgia is a psychosomatic illness.
• Write to the American College of Rheumatology, here and to the editor of Arthritis Care and Research, here. 
• Support the researchers with your gratitude for what they do. (You can usually find an email address for the lead investigator in the abstract on PubMed, here. 
• Use the helpful links on my website, here.

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Update 2015

"Adversity is only an obstacle if we fail to see opportunity."  

Celeste Cooper, RN

Author—Patient—Health Central Chronic Pain Pro —Advocate

New Website

Celeste’s Website: http://CelesteCooper.com

Learn more about what you can do to help your body function to its potential in the books you can find here on Celeste's  blog. Subscribe to posts by using the information in the upper right hand corner or use the share buttons to share with others.

All answers and blogs are based on the author's opinions and writing and are not meant to replace medical advice.  

”FIBROMYALGIANESS”—Patient Harm: The Facts and the Effects of Fibromyalgia Diagnostic Criteria by Celeste Cooper

Someone recently shared a comment made by her physician at Duke University that horrified me. I was appalled that a physician would make such a statement, so I want to share my reaction with you. It goes like this…

Duke University physician reportedly said:

"You do know that fibromyalgia is just a word we use 

to talk about psycho-somatic pain, don't you?"

Could it be she read “The American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia and Measurement of Symptom Severity”? (Wolfe, 2014). In a letter to follow this blog, I will be looking into whether or not the American College of Rheumatology has approved the 2010 criteria. It appears they consider comorbid conditions of migraine and IBS (here) that are not considered in the Wolfe criteria as follows:”

“Of the binary variables, irritable bowel syndrome, abdominal pain, and headache had variable importance. However, they added no power to correct classification and we did not include them in the diagnostic criteria.” (Page 208, Wolfe, et al., 2010).

Could it be this Duke University physician is unaware of what others in the field have to say? See “ACR 2010 criteria for fibromyalgia critiqued by: Mary Ann Moon, Family Practice News Digital Network, here. 

Could it be that she did not see Dr. Sean Mackey’s lecture at Stanford University that I believe supports key elements in the 2013 Alternative Diagnostic Criteria? You can view it here.

This attitude toward fibromyalgia must be stopped in its tracks if we are to maintain forward momentum. There is a great deal of empirical evidence showing FM is biological. Yet, despite repeated research that the brain of the FM patient does not respond to painful stimulus in a normal way, (not only the emotional center, but also the center in the brain that specifically interprets pain), many practitioners, even those from Duke University, are ignorant. The 2010 Preliminary Proposed Diagnostic Criteria modified in 2011 set forth by Dr. Frederick Wolfe are endangering the many strides taken to understand fibromyalgia over the past 100+ years.

“[Fibromyalgia] has been known to exist for more than a hundred years. Symptoms of what we know today as FM were first described in the seventeen hundreds, and the disorder was first observed and documented by British surgeon William Balfour in 1816. In 1904 the same collection of symptoms was recognized by another British fibromyalgia pioneer, Sir William Gowers, who described chronic soft tissue syndromes as fibromyositis.” (Excerpt Integrative Therapies for Fibromyalgia, Chronic Fatigue Syndrome, and Myofascial Pain: The Mind-Body Connection.)

http://www.dsm5.org/

We also have the new Diagnostic and Statistical Manual of Mental Disorders (DSM-5) from the American Psychiatric Association's (APA) to thank for what Dr. Wolfe calls FIBROMYALGIANESS. Marly Silverman and I wrote about, and predicted, this two years ago in a piece on the prospects of the DSM-5.     

I have been in collaboration with well-respected fibromyalgia expert Dr. Robert Bennett, and have written a blog explaining his well-researched diagnostic criteria, which DOES consider all aspects of fibromyalgia. He and his colleagues report their findings without bias. I hope you will read that blog here. Pay close attention to the example of the 2013 Alternate Fibromyalgia Criteria (2013 Alt FM Criteria) and the proven tools such as the Fibromyalgia Impact Questionnaire (see: http://fiqrinfo.ipage.com/). Following is an excerpt from that blog with my comments.

*1. “Fibromyalgia patients have a continuum of symptoms; a diagnosis based on a strict numerical cutoff is subject to error.” In other words, a physician or nurse practitioner should not be limited by a subjective questionnaire. They should rely on their abilities to physically assess a patient with hands-on exam to assess physical complaints, take a patient history, order and interpret test results, complete a physical exam, and apply their diagnostic skills. No practitioner should limit the scope of their abilities. Without these expert assessments, we would not know that the tender point count has not stringently met the 1990 ACR criteria.

*2. “The presence of another pain disorder or related symptoms does not rule out a diagnosis of fibromyalgia.” We know from the literature that fibromyalgia can and often does coexist with certain other disorders, such as those defined by the CDC. Dr. Wolfe's modification of his 2010 criteria suggests in point three under the description of the criteria above in order to diagnose fibromyalgia, “the patient does not have a disorder that would otherwise sufficiently explain the pain.

* 3. “A careful clinical evaluation is always required in order to identify any condition that could fully account for the patient’s symptoms and/or contribute to the severity of the symptoms.” A clinical evaluation includes the parameters mentioned above in *1. The Bennett investigators conclude that a patient’s symptoms should be investigated seriously and not be dismissed as poly-symptom somatic complaints as suggested by the Wolfe team of investigators. This is important because many of the symptoms fibromyalgia patients experience can be attributed to other treatable conditions that affects patient outcome.

I had to respond to the likes of the Duke University doctor, because she is not alone thanks to the likes of Dr. Wolfe who uses unapproved APA tools and handpicked databases for his research. I am not a scientist, nor a statistician, however I did conduct a study while in college, and I can tell you that doing an unbiased literature review is research 101. Choosing only literature that fits your hypothesis is flawed. Oddly enough, or not so oddly enough, I recently saw an article in a Physicians online journal “Healthcare Professionals Network” here that suggested Dr. Bennett endorsed the 2010 Wolfe Criteria carte blanche. In fact, the Bennett Alternative Criteria published in the September issue of Arthritis Care and Research, (Bennett, et al. 2014), includes a comparative analysis. Yet, this reporter made no mention that the 2013 Alternate Criteria outperformed the Wolfe, et al 2010 modified criteria in key areas. This partiality makes his report nothing short of propaganda.

Remember, if your physician is not helping you feel better physically, mentally, and emotionally, they have issues, not you! If they are not conducting a physical exam and considering common comorbid conditions to fibromyalgia, they are negligent. If you are harmed by their disregard for your complaints or inconsiderate statements, report them. (See the links on my website here.) Next time, record your visit. Plenty of chronically ill patients need to have counseling for dealing with their symptoms, but to need it because of a doctor that took an oath to do no harm is unacceptable.

postea: added after original blog post:

To whom it may concern—American College of Rheumatology… Criteria for Diagnosing Fibromyalgia, by Celeste Cooper

http://fmcfstriggerpoints.blogspot.com/2014/11/to-whom-it-may-concernamerican-college.html#.VFpus_nF86w

Resources:

Albrecht PJ, Hou Q, Argoff CE, Storey JR, Wymer JP, Rice FL. Excessive Peptidergic Sensory Innervation of Cutaneous Arteriole-Venule Shunts (AVS) in the Palmar Glabrous Skin of Fibromyalgia Patients: Implications for Widespread Deep Tissue Pain and Fatigue. Pain Med. 2013 May 20. doi: 10.1111/pme.12139. [Epub ahead of print]

Behm FG, Gavin IM, Karpenko O, Lindgren V, Gaitonde S, Gashkoff PA, Gillis BS. Unique immunologic patterns in fibromyalgia. BMC Clin Pathol. 2012 Dec 17;12(1):25. doi: 10.1186/1472-6890-12-25.

http://www.biomedcentral.com/1472-6890/12/25

Bennett RM. Opinion on preliminary guidelines for the clinical diagnostic criteria for fibromyalgia Practical Pain Management, July/August, 2010, Volume 10 (6) pages 76-79. 

Bennett R, Friend R, Marcus D, Bernstein C, Han BK, Yachoui R, Deodar A, Kaell A, Bonafede P, Chino A, Jones K. Criteria for the diagnosis of fibromyalgia: Validation of the modified 2010 preliminary ACR criteria and the development of alternative criteria. Arthritis Care Res (Hoboken). 2014 Feb 4. doi: 10.1002/acr.22301. [Epub ahead of print]

Buskila, D, Neumann, L, Alhoashle, A, and Abu-Shakra, M. “Fibromyalgia syndrome in men,” Seminars in Arthritis and Rheumatism 30, no. 1 (2000): 47–51.

Caro XJ, Winter EF. Evidence of abnormal epidermal nerve fiber density in fibromyalgia: Clinical and immunologic implications. Arthritis Rheumatol. 2014 Apr 9. doi: 10.1002/art.38662. [Epub ahead of print]

Castro-Sánchez AM, Matarán-Peñarrocha GA, López-Rodríguez MM, Lara-Palomo IC, Arendt-Nielsen L, Fernández-de-las-Peñas C. Gender differences in pain severity, disability, depression, and widespread pressure pain sensitivity in patients with fibromyalgia syndrome without comorbid conditions. Pain Med. 2012 Dec;13(12):1639-47. doi: 10.1111/j.1526-4637.2012.01523.x. Epub 2012 Nov 21.

Cook D. B., Lange G., Ciccone D. S., Liu W. C., Steffener J., and Natelson B. H. Functional imaging of pain in patients with primary fibromyalgia, Journal of Rheumatology, 31, no. 2 (2004): 364–78.

Cooper, C and Miller, J. (2010). Integrative Therapies for Fibromyalgia, Chronic Fatigue Syndrome and Myofascial Pain: The Mind-Body Connection. Healing Arts Press: Vermont

Craggs JG, Staud R, Robinson ME, Perlstein WM, Price DD.Effective connectivity among brain regions associated with slow temporal summation of C-fiber-evoked pain in fibromyalgia patients and healthy controls. J Pain. 2012 Apr;13(4):390-400.

Flodin P1, Martinsen S, Löfgren M, Bileviciute-Ljungar I, Kosek E, Fransson P. Fibromyalgia Is Associated with Decreased Connectivity Between Pain- and Sensorimotor Brain Areas. Brain Connect. 2014 Aug 7. [Epub ahead of print]

Gonzalez B, Baptista TM, Branco JC, Ferreira AS.Fibromyalgia: antecedent life events, disability, and causal attribution. Psychol Health Med. 2013 Jan 17. [Epub ahead of print]

Kosmidis ML1, Koutsogeorgopoulou L1, Alexopoulos H1, Mamali I1, Vlachoyiannopoulos PG1, Voulgarelis M1, Moutsopoulos HM1, Tzioufas AG1, Dalakas MC2. Reduction of Intraepidermal Nerve Fiber Density (IENFD) in the skin biopsies of patients with fibromyalgia: A controlled study.

Light KC, White AT, Tadler S, Iacob E, Light AR. Genetics and Gene Expression Involving Stress and Distress Pathways in Fibromyalgia with and without Comorbid Chronic Fatigue Syndrome.  Pain Res Treat. 2012;2012:427869. Epub 2011 Sep 29.

Staud R, Craggs JG, Perlstein WM, Robinson ME, and. Price DD, “Brain activity associated with slow temporal summation of C-fiber evoked pain in fibromyalgia patients and healthy controls,” European Journal of Pain (March 2008).

Dr. Sean Mackey, assistant professor of anesthesia at the Stanford University Medical Center, “An Update on Fibromyalgia.” https://www.youtube.com/watch?v=jtc2JARVpPw&feature=em-subs_digest-vrecs  (accessed 10-30-2014).

Mary Ann Moon, “ACR 2010 criteria for fibromyalgia critiqued.” Family Practice News Digital Network.http://www.familypracticenews.com/news/journals/single-article/acr-2010-criteria-for-fibromyalgia-critiqued/31131c4db6bf3642dd8748c0ad23f08b.html (accessed, 10-29-2014).

Frederick Wolfe. Fibromyalgianess. Arthritis Care and Research. DOI: 10.1002/art.24553 Article first published online: 28 MAY 2009. http://onlinelibrary.wiley.com/doi/10.1002/art.24553/full

Fibromyalgia: an INTERVIEW with Dr Frederick Wolfe, University of Kansas School of Medicine. Medical Net News. 

Frederick Wolfe, Daniel J. Clauw, Mary-Ann Fitzcharles,  Don L. Goldenberg, Robert S. Katz, Philip  Mease, Anthony S. Russell, I. Jon Russell, John  B. Winfiled, and Muhammad B. Yunus. The American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia and Measurement of Symptom Severity. Arthritis Care & Research, Vol. 62, No. 5, May 2010, pp 600–610. DOI 10.1002/acr.20140

Wolfe F, Brähler E, Hinz A, Häuser W. Arthritis Care Res (Hoboken).Fibromyalgia prevalence, somatic symptom reporting, and the dimensionality of polysymptomatic distress: Results from a survey of the general population. 2013 Feb 19. doi: 10.1002/acr.21931. [Epub ahead of print]

Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Häuser W, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB. Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. J Rheumatol. 2011 Jun;38(6):1113-22. doi: 10.3899/jrheum.100594. Epub 2011 Feb 1.

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Update as of April 2015

"Adversity is only an obstacle if we fail to see opportunity."  

Celeste Cooper, RN

Author—Patient—Health Central Chronic Pain Pro —Advocate

New Website

Celeste’s Website: http://CelesteCooper.com

Learn more about what you can do to help your body function to its potential in the books you can find here on Celeste's  blog. Subscribe to posts by using the information in the upper right hand corner or use the share buttons to share with others.

Costs Associated with Fibromyalgia: What’s Up with That? by Celeste Cooper

"When I was young I thought that money was the most important thing in life; 

now that I am old I know that it is."

~Oscar Wilde

How one answers the question, "What are the Costs Associated to FM?" depends on who you ask. Treating fibromyalgia is a costly business because often times it takes years for the right diagnosis. Patients will return for medical care until they get the answers they need. Why does it take so long to be diagnosed? Many care providers are unaware of other conditions that co-occur more frequently with fibromyalgia, and therefore, those conditions go unnoticed and untreated and the patient experiences unnecessary pain and fatigue from a wound up brain trying to process many messages at once.

Side Note: We need consistent diagnostic criteria such as that I reported on in my blog, The 2013 Alternative Criteria Dr. Robert Bennett, et al. – Interpretation for patients and providers by Celeste Cooper, here. Also shared on ProHealth here.

Ask the patient about the cost of having fibromyalgia. Most of the therapies found to be helpful, warm water therapy, acupuncture, acupressure, myofascial release, massage therapy, therapeutic trigger point massage therapy (for comorbid myofascial pain syndrome), T'ai Chi, Yoga, and other complimentary and alternative therapies are not covered by insurance, and if they are, they are capped. This means that most of the treatments suggested will never happen unless the patient has an endless supply of money.

Take a look at the latest Pain Action Alliance to Implementa National Strategy  policy brief NEVER ONLY OPIOIDS: The Imperative for Early Integration of Non-pharmacological Approaches and Practitioners in the Treatment of Patients with Pain accessible from my website here. 

We know that fibromyalgia patients need ongoing care, particularly since we have other painful comorbid conditions. The alternative diagnostic criteria by Bennett, et al, are comprehensive and can easily guide the diagnostician to the right conclusion (see side note above). If we can get integrative therapies moved to mainstream medicine, the overall cost to everyone will go down and the patient will have a better outcome.

You can also find my answer here  to What are the monetary costs associated with fibromyalgia? Don’t miss the hundreds of other questions answered by Celeste and others on Sharecare.com here.

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"Adversity is only an obstacle if we fail to see opportunity."  

Celeste Cooper, RN

Author, patient/ advocate, fibromyalgia health expert

Website: http://www.TheseThree.com

All answers and blogs are based on the author's opinions and writing and are not meant to replace medical advice.  

The 2013 Alternative Criteria Dr. Robert Bennett, et al. – Interpretation for patients and providers by Celeste Cooper

In an effort to raise awareness for chronic pain awareness, and as fibromyalgia expert at Sharecare, I felt the best way to honor September would be share what I have learned about the newest diagnostic criteria. I think it is important for you to know why I believe this criterion is the most comprehensive and easiest to use.

Backdrop/Foreword

Those of you who follow me know of my concerns and my correspondence with the editor of Arthritis Care and Research and the National Institute of Health regarding the preliminary (Wolfe, et al., 2010) and modified criteria (Wolfe, et al., 2011).

My biggest concern is the criteria’ (Wolfe, 2010, 2011) states that fibromyalgia patients complain of “non-specific disease related symptoms” despite literature suggesting otherwise. Comorbid conditions can and do exist, and as pointed out in the "Alternative Criteria" (Bennett, 2013) having a painful comorbid disorder does not exclude fibromyalgia. In the case of symptoms compatible with myofascial pain syndrome, patients will be denied helpful treatments for this peripheral pain disorder that can keep the fibro brain in wind-up. Ignoring that periodic limb movement, and bruxism have a central component and peripheral component is neglectful. The list goes on. You can review more here. When our symptoms are described as “non-specific disease related symptoms,” we are at risk for being diagnosed with a somatic symptom disorder (SSD), a psychiatric diagnosis once called hypochondria. You can learn more about this in the article Marla Silverman and I co-wrote “Who is the WHO and Why Does It Matter to You? here. 

Dr. Wolfe stated in an interview that up to 40% of FM patients (significant) could fall into the DSM-5 diagnostic manual for psychiatrists. I am unsure what criteria he was using when he came to this conclusion. This is concerning for several reasons, the patient will not get the appropriate treatment (making them seem difficult to treat), insurance carriers could deny coverage for certain tests or impose limitations, and data collection that relies on diagnostic codes will be greatly skewed and could affect research results and funding.

While the 1990 American College ofRheumatology criteria  helped Identify some patients with fibromyalgia, it was never intended to become the diagnostic tool it became. Once it was put through the rigorous trials of clinical use, we found that not all patients had 11 of 18 tender points and tender points can be located in different areas, they are wide-spread. Since 1990, research has advanced and we know that even though tenderness and a proper physical exam are still important, there is a great deal more to diagnosing fibromyalgia.

It’s exciting that physicians, researchers, and other advocates are taking a closer look. I have corresponded with Dr. Frederick Wolfe, Dr. I Jon Russell, and Dr. Robert Bennett over the past several years. My own literature review for our book “Integrative Therapies for Fibromyalgia, ChronicFatigue Syndrome, and Myofascial Pain: The Mind-Body Connection (co-author Jeffrey Miller, PhD), has had an impact on my perceptions of how fibromyalgia should be diagnosed and treated, and I have bias towards the 2013 Bennett, et al. criteria.

Introduction

Objectives of the “Alternate Criteria for Diagnosing Fibromyalgia,” research led by Robert Bennett, MD and the resulting paper, fresh off the press in the September issue of Arthritis Care and Research, include evaluation and comparison of the “modified preliminary diagnostic criteria” (Wolfe et al., 2011) and the 1990 criteria. The alternative diagnostic criteria (Bennett, et al. 2013) has been scientifically evaluated and compared to the “modified preliminary diagnostic criteria” (Wolfe et al., 2011) for accuracy and usefulness in a clinical setting.

From here on:

• Bennett criteria will be referred to as 2013AltCr

• Wolfe criteria will be referred to as the 2011ModCr

• 1990 ACR criteria will be referred to as 1990Cr. (You can review the criteria on my website here.) 

Keep in mind that Dr. Bennett and Dr. Wolfe are the lead investigators, but they did not function alone. All investigators should be recognized for their hard work.

I am not a statistician, but I do like to read expert’s conclusions. I have made every effort to interpret the information here correctly and appreciate Dr. Bennett’s help. If you are not a research buff, then I suggest you fast forward to “The Bennett, et al. Alternative Criteria (2013AltCr ) in Action.” You will find examples there.

THE BENNETT, et al. STUDY  – 2013AltCr

A total of 321 patients aged 18 years and older were evaluated. Of these 135 participants were diagnosed with FM using the ACR 1990 criteria, and the other 186 participants had 16 other common chronic pain problems. The study included 242 females and 79 males. “Major depressive disorder (MDD) was based on DSM-IV. All other diagnoses were based on published guidelines."

This study included a cross section of chronic pain disorders, varied geographical locations, and a sampling of clinicians.

Questionnaires

Data was collected using five standard sets of questions:

1.  Demographics
2.  The 2011 Modified Criteria for FM (2011ModCr) – Wolfe et al. study
3.  The Symptom Impact Questionnaire (SIQR)
4.  The Short Form 36 (SF-36)
5. A 28 anatomical location inventory 

(1) Demographics considered age, gender, educational level, work status, marital status, number of years with chronic pain, and other chronic pain disorders.

(2) 2011ModCr - The Wolfe, et al. Study – A patient satisfies the Wolfe, et al. 2010 criteria, which was modified in 2011, if the following 3 conditions are met: 

1. Widespread Pain Index ≥ 7 and Symptom Severity Score ≥ 5 or Widespread Pain Index between 3–6 and Symptom Severity Score ≥ 9.
2. Symptoms have been present at a similar level for at least 3 months.
3. The patient does not have a disorder that would otherwise sufficiently explain the pain. (more about this later).

Widespread Pain Index (WPI ): The number of 19 areas in which the patient had pain over the last week. 

1. Jaw, Lt.	8. Shoulder girdle, Lt.	14. Upper Back
2. Jaw, Rt.	9. Shoulder girdle, Rt.	15. Lower Back
3. Neck	10. Chest	16. Upper Leg, Lt.
4. Upper Arm, Lt.	11. Abdomen	17. Upper Leg, Rt
5. Upper Arm, Rt.	12. Hip (buttock, trochanter), Lt.	18. Lower Leg, Lt.
6. Lower Arm, Lt.	13. Hip (buttock, trochanter), Rt.	19. Lower Leg, Rt.
7. Lower Arm, Rt.

WPI  = (0-19)

Symptom Severity Score (0-12): The Symptom Severity Score (SSS) is the sum of the severity of the 3 symptoms (fatigue, waking unrefreshed, and cognitive difficulties) over the past week. (0-9), plus the sum of the number of the following symptoms occurring during the previous 6 months: headaches, pain or cramps in lower abdomen, and depression (0–3).

Severity Score:
0 = No problem;
1 = Slight or mild problems; generally mild or intermittent
2 = Moderate; considerable problems; often present and/or at a moderate level
3 = Severe; pervasive [all encompassing], continuous, life-disturbing problems

Symptom:
1) fatigue   (0-3) 2) waking unrefreshed (0-3) 3) cognitive symptoms (0-3)
1) headaches (0-1)
2) pain or cramps in lower abdomen (0-1)
3) depression (0-1)
    

SSS = (0-12)

The data resulting from the Bennett study (2013AltCr) suggests the 2011ModCr widespread pain index (WPI) excluding the symptom severity score was more accurate than a combining the WPI and the SSS. 

(3) Symptom Impact Questionnaire (SIQR) (Bennett, et al. 2013AltCr). I encourage you to look at the FIQR. You can find a calculator and print a copy for your provider, here. http://www.fiqr.info/

Note: The SIQR was based on questions pertaining to the last seven days and was used to gather data. The SIQR is identical to the fibromyalgia impact questions (FIQR) with the exception that the word FM was excluded in the three domains, 1) function, 2) impact, and 3) intensity of symptoms so the same tool could be used to assess patients with non-FM disorders.

(4) The Short Form Health Survey 36 (SF-36). 

The Short Form (36) Health Survey is a patient-reported survey of patient health. The SF-36 is a measure of health status and an abbreviated variant of it, the SF-6D, is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The original SF-36 came out from the Medical Outcome Study, done by the RAND Corporation. Since then a group of researchers from the original study released a commercial version of SF-36 while the original SF-36 is available in public domain license free from RAND. Wikipedia - http://en.wikipedia.org/wiki/SF-36 

2013AltCr were developed from the same data set using research analysis. 

(5) Pain location inventory (PLI) – Assesses 28 locations and includes:

1. Number of pain locations (0-28). Pain without physical assessment.
2. Intensity of pain at 28 locations using the 0 – 10 scale “no pain” and “extremely painful.”

And

1. Number of tender locations (0-28). Tenderness on palpation.
2. Intensity of tenderness when touched or pressed using the 0 – 10 scale, "no tenderness” to “extremely tender." 

The Bennett, et al. Alternative Criteria (2013AltCr ) in Action.

Following is an example of how the alternative criteria questionnaire can be used to assist in the diagnose fibromyalgia. It is presented as an example so you can see how it works.

Pain location inventory (PLI) - 28 areas

Directions: Select from the 28 locations where you have experienced persistent pain during the past 7 days. Your score will be between 0 and 28.

For the example the locations are highlighted.

1.  Neck	8.  Right knee	15. Left hand	22. Right arm
2.  Left upper back	9.  Left jaw	16. Right ankle	23. Left hip
3.  Right wrist	10. Left lower back	17. Front of chest	24. Right foot
4.  Left thigh	11. Right hand	18. Left shoulder	25. Right upper back
5.  Right jaw	12. Left knee	19. Right hip	26. Left arm
6.  Right lower back	13. Mid- upper back	20. Left ankle	27 Right thigh
7.  Left wrist	14. Right shoulder	21. Mid- lower back	28. Left foot

Example:

Add the total of highlighted symptoms.

PLI Total + __20__ (0 – 28)

10-item SIQR symptoms:

Directions: For each of the following 10 questions, check the one box ( for the ease of this example a circle is highlighted) that best indicates the intensity of the following common symptoms over the last 7 days. 

1. Pain                                    

    No pain            ⓪①②③④⑤⑥⑦⑧⑨⑩   Unbearable pain

2. Energy
    Lots of energy   ⓪①②③④⑤⑥⑦⑧⑨⑩   No energy

3. Stiffness
    No stiffness       ⓪①②③④⑤⑥⑦⑧⑨⑩    Severe stiffness

4. Sleep
    Awoke rested   ⓪①②③④⑤⑥⑦⑧⑨⑩    Awoke very tired

5. Depression
    No depression   ⓪①②③④⑤⑥⑦⑧⑨⑩    Very depressed

6. Memory Problems
    Good memory   ⓪①②③④⑤⑥⑦⑧⑨⑩    Very poor memory

7. Anxiety
    Not anxious       ⓪①②③④⑤⑥⑦⑧⑨⑩    Very anxious

8. Tenderness to Touch
    No tenderness   ⓪①②③④⑤⑥⑦⑧⑨⑩    Very tender

9. Balance Problems
    No imbalance    ⓪①②③④⑤⑥⑦⑧⑨⑩    Severe imbalance

10.Sensitivity (Sensitivity includes loud noises, bright lights, odors and cold)
    No sensitivity    ⓪①②③④⑤⑥⑦⑧⑨⑩    Extreme sensitivity

Total the score by adding the degree of severity 0 – 10 for each symptom (0-100) and divide the sum by 2 to obtain the SIQR symptom score.

Example: = 70 (out of 100 possible) divided by 2 = 35

SIQR __35__

Note: By adding the SIQR to the score PLI, it increased the specificity of the 2013AltCr from

72% to 80% and yielded a correct classification of 80%.

A patient fulfilling the following guidelines has a high likelihood of having FM:*

1. The symptoms and pain locations have been persistent for at least the last 3 months

            Example Yes

2. Pain location score is ≥ 17

            Example 20

3. SIQR symptom score is ≥ 21

            Example 35

Example meets criteria for fibromyalgia diagnosis.

A comparison of the 2011ModCr with the ACR 1990Cr provided:

• Diagnostic sensitivity = 83%
• Specificity = 67%
• Correct classification = 74%.

2013AltCr were derived from the 10-item symptom score from the SIQR symptoms

and the 28 PLI as shown in the example:

• Diagnostic sensitivity = 81%
• Specificity = 80%
• Correct classification = 80%.

Conclusion:

Comparing the 2011ModCr to the 2013AltCr we don’t see much difference in sensitivity, a hearty improvement in specificity, and a moderate improvement in classifying fibromyalgia correctly. Overall, the subjective questionnaire part of the 2013AltCr outperforms the 2011ModCr and as you can see if you applied it to yourself, it is easy to use.

It is important to remember, as pointed out in the article:

*1. “Fibromyalgia patients have a continuum of symptoms; a diagnosis based on a strict numerical cutoff is subject to error.” [In other words, a physician or nurse practitioner should not be limited by a subjective questionnaire. They should rely on their abilities to physically assess a patient with hands-on exam to assess physical complaints, take a patient history, order and interpret test results, complete a physical exam, and apply their diagnostic skills. No practitioner should limit the scope of their abilities. Without these expert assessments, we would not know that the tender point count has not stringently meet the 1990Cr.]

*2. “The presence of another pain disorder or related symptoms does not rule out a diagnosis of fibromyalgia.” [We know from the literature that fibromyalgia can and often does coexist with certain other disorders, such as those defined by the CDC. The 2011ModCr suggests in point three under the description of the criteria above in order to diagnose fibromyalgia, “the patient does not have a disorder that would otherwise sufficiently explain the pain.” ]

* 3. “A careful clinical evaluation is always required in order to identify any condition that could fully account for the patient’s symptoms and/or contribute to the severity of the symptoms.” [A clinical evaluation includes the parameters mentioned above in *1. The Bennett investigators conclude that a patient’s symptoms should be investigated seriously and not be dismissed as poly-symptom somatic complaints as suggested by the Wolfe team of investigators. This is important because many of the symptoms fibromyalgia patients experience can be attributed to other treatable conditions that affects patient outcome.]

Notes:

The 2013AltCr (Bennett, et al.) considers three diagnostically useful symptoms that were not identified in the 2011ModCr (Wolfe, et al.): stiffness, tenderness to touch and environmental sensitivity. The AltCr identified more patients with FM than did the 1990Cr, yet it identified closer to the 1990Cr than the 2011ModCr. I suspect that is because both the 1990Cr and 2013AltCr both require a physical assessment for tenderness. Tenderness cannot be assessed without applying a certain amount of pressure to the patient, not to mention that a skilled examiner can only assess rebound tenderness, non-verbal clues, such as wincing or guarding, and other symptoms that are important to assess, such as listening for hyperactive or diminished bowel sounds. These things are considered objective data, findings by the examiner. The 2013AltCr includes a scientifically evaluated questionnaire to aid in a diagnosis, yet does not insinuate that it alone is sufficient.

The demographics of 2013AltCr were “fairly typical of chronic pain patients.” However, the investigators found a prevalence of males at 34% vs the 31% identified in the ModCr. The AltCr found that females and males had similar PLI scores, but differed on the calculated sum of pain and tenderness and males reported less pain and tenderness intensity. This is important because research has shown that males with FM report their symptoms differently, and this could provide “a potentially useful discriminatory variable in fibromyalgia questionnaires.”

The investigators discussed the importance of understanding that most FM patients also have another chronic pain disorder. The 1990Cr suggests ONLY 13% DO NOT. Therefore, it is not necessary to “exclude” other pain disorders (point 3 of the 2011ModCr); to the contrary, they should be included. 

"Fibromyalgia is NOT a diagnosis of exclusion."

Also of importance is that “the presence of a non-FM related pain disorder increased the total SIQR score by approximately ten percent; however having a related medical disorder did not significantly affect the total SIQR score. Recognizing this will help the physician and nurse practitioner give the patient the best care possible, and hopefully reduce to stigma associated with FM.

Resources:

Bennett R, Friend R, Marcus D, Bernstein C, Han BK, Yachoui R, Deodar A, Kaell A, Bonafede P, Chino A, Jones K. Criteria for the diagnosis of fibromyalgia: Validation of the modified 2010 preliminary ACR criteria and the development of alternative criteria. Arthritis Care Res (Hoboken). 2014 Feb 4. doi: 10.1002/acr.22301. [Epub ahead of print]

Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB: The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken) 62(5):600-10, 2010 May.

Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Häuser W, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB: Fibromyalgia Criteria and Severity Scales for Clinical and Epidemiological Studies: A Modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. J Rheumatol 38;1113-1122, 2011.

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"Adversity is only an obstacle if we fail to see opportunity."  Celeste Cooper, RN

Author, patient/ advocate, fibromyalgia health expert 

Books:

Read about Celeste and access to her books at Author Central here

Broken Body, Wounded Spirit: Balancing the See Saw of Chronic Pain [Four book series]

Integrative Therapies for Fibromyalgia, Chronic Fatigue Syndrome, and Myofascial Pain 

Advocacy: 

Fibromyalgia expert on Sharecare, here. 

Participant in the Pain Acition Alliance to Implement a National Strategy, here.

Website: http://www.TheseThree.com

All answers and blogs are based on the author's opinions and writing and are not meant to replace medical advice.