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.