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 ⓪①②③④⑤⑥
⑦⑧⑨⑩ No energy
3. Stiffness
No stiffness ⓪①②③④⑤⑥⑦⑧
⑨⑩ Severe stiffness
4. Sleep
Awoke rested ⓪①②③④⑤⑥⑦⑧⑨
⑩ Awoke very tired
5. Depression
No depression ⓪
①②③④⑤⑥⑦⑧⑨⑩ Very depressed
6. Memory Problems
Good memory ⓪①②③④⑤⑥⑦
⑧⑨⑩ Very poor memory
7. Anxiety
Not anxious ⓪①
②③④⑤⑥⑦⑧⑨⑩ Very anxious
8. Tenderness to Touch
No tenderness ⓪①②③④⑤⑥⑦⑧⑨
⑩ Very tender
9. Balance Problems
No imbalance ⓪①②③④⑤⑥
⑦⑧⑨⑩ Severe imbalance
10.Sensitivity (Sensitivity includes loud noises, bright lights, odors and cold)
No sensitivity ⓪①②③④⑤⑥⑦
⑧⑨⑩ 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.
~ • ~ • ~ • ~ • ~ • ~
"Adversity is only an
obstacle if we fail to see opportunity." Celeste Cooper, RN
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.
All
answers and blogs are based on the author's opinions and writing and are not
meant to replace medical advice.