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Journal
of Musculoskeletal Pain, Vol. 11, No. 4, pp.xiii-xv
Preface: Back to the Future
This entire special issue of the Journal of Musculoskeletal Pain [JMP] is
devoted to presentation of what will likely to be called the Canadian
Consensus Document on Fibromyalgia Syndrome [FMS] (1).
The
document encompasses a very broad scope, involving a clinical case
definition,diagnosis, and management of FMS. In addition, the importance of
research findings within the FMS construct has prompted the inclusion of a
section regarding what is known about the pathogenesis of FMS.
The
history of the development of this document, which was supported by Health
Canada, is
outlined in a companion editorial (2) by its physician editors and the lay
group coordinator of the project.
The clinical case definition proposed by the Expert Consensus Panel (1)
chosen by Health Canada is based on the reasonable judgment of Panel
members who have considerable experience with FMS in academic and community
environments. In the same way that the Delphi of the 1990 ACR Criteria
study were properly entrusted to know the disorder based on their extensive
clinical experience, so the Panel members, in their composite wisdom, were
considered to perceive what was likely to prove to be useful in the community.
This undertaking can be viewed as a the next step in a long-term plan.
Since the development of the American College of Rheumatology [ACR] 1990
classification Criteria for the Fibromyalgia Syndrome (3), it has been
clear that eventually it would be necessary to determine what to include in
a clinical case definition for use in community medicine. The ACR Criteria
were developed to guide the uniform selection of FMS patients for entry
into research studies. The ACR Criteria have made it possible for a reader
of FMS research to have confidence that studies done separately in Wichita,
Peoria, Boston, Portland, and San Antonio were evaluating comparable
patients. The same applies to studies performed in Europe and Asia that
have espoused the ACR Criteria. On the other hand, there has been no
certainty that the 1990 ACR Criteria would properly identify all of the
affected individuals in a community clinic while properly excluding those
who should not be given this diagnosis.
The 1990 ACR Criteria utilized statistical analysis to establish a somewhat
arbitrary cut in the number [at least 11 affected of 18 anatomically-named]
of body sites, called tender points [TePs], that were unusually sensitive
to deep digital palpation pressure and were required for a patient to enter
a FMS research study. That was a reasonable approach to standardizing
enrollment in pivotal research about a Delphi-defined disorder. On the
other hand, some (4) have argued that it is improper to use the 1990 ACR
criteria for diagnosis in community medical practice. Of course, physicians
in clinical practice have applied the 1990 ACR criteria diagnostically
because body pain is such a major clinical problem and there is nothing
more precise than the 1990 ACR Criteria for identifying patients with FMS.
Nothing comparable has been created and or validated for use in community
medicine. Frankly, the only reason anyone really cares what physicians
diagnose in the confines of their practices is that the diagnosis of FMS
can then take on legal [compensation] implications for which someone has to
pay. Another view, with similar implications, holds that management
strategies [often expensive ones] found to work for FMS should be made
available to community patients with ten or less TePs, especially if they
have typical FMS associated symptoms, such as chronic insomnia, prolonged
morning stiffness, or irritable bowel syndrome.
The development of the Canadian Clinical Case Definition for FMS can be
viewed as the first concerted effort to correct this deficit. It is hoped
that the process of validation will eventually benefit both the
practitioners and their patients.
The clinical case definition proposed in the Canadian Consensus Document
(1) contains elements very similar to those proposed by Yunus and coworkers
in 1989 (5), hence the title of the Preface, "Back to the
Future." While new, this approach to the diagnosis and management of
FMS uses what has been learned about FMS since 1990 and addresses
previously expressed
concerns. Thus, clinicians have recognized that patients who met the 1990
ACR Criteria for Classification of FMS can also exhibit a variety of
clinical manifestations other than body pain and tenderness, such as
insomnia, cognitive complaints, headaches, morning stiffness, and affective
symptoms. Those concerns have also been the basis for many of the
pharmaceutical based studies involving FMS patients. The main objective of
the Canadian Consensus Document (1) is to enhance the ability of Canadian
community physicians to recognize and treat FMS in their practices and to
be more aware of its many clinical manifestations, including pain, and
beyond. The extent to which its influence extends beyond Canada is yet to
be seen.
This document addresses previous concerns and presents a clinical case
definition that the international scientific community can refine as needed
and then should attempt to validate. To facilitate that process, the JMP
editorial staff have contacted two well-respected epidemiologists, with
established track records in studying FMS. Each was asked to apply
established epidemiological and statistical methods in the design of a
study to validate a clinical case definition for use in community medicine.
The Research Ideas section of this volume provides three short manuscripts.
The first (6) is a summary of the challenge given to the epidemiologists.
That is followed by outlines from each of the experts (7,8) indicating what
needs to be done and how it could be accomplished using the Canadian
Consensus Document (1) as a resource. These efforts will help to resolve
conceptual, legal, and other disputes that have arisen from the clinical
application of the 1990 ACR Criteria Research Definition for FMS.
The panel had no illusion that everyone in the field would be completely
satisfied with the document as it now stands. The proposed Canadian
Clinical Case Definition must be submitted to further research scrutiny in
the relevant settings. The definitive study will be expensive. It must be
carefully planned by those with much experience in this process. It will
require international cooperation between interested parties from a variety
of disciplines and holding different views. The main requirements for
professional participation in the proposed study should be a willingness to
contribute selflessly to the effort and a commitment to accept the
scientific outcome. Strong advocacy will be needed to develop an airtight
protocol and to secure adequate funding to do the job right. It is expected
that there will be honest disagreements that must be amicably negotiated,
but cynical detractors and bodacious naysayers must be ignored. The readers
of JMP are invited to voice opinions in the form of Letters to the Editor.
I. Jon Russell, MD, PhD
The Editor
REFERENCES
1. Jain AK, Carruthers BM, van de Sande MI, Barron SR, Donaldson CCS, Dunne
JV, Gingrich E, Heffez DS, Leung FY-K, Malone DJ, Romano TJ, Russell 11,
Saul D, Seibel DG: Fibromyalgia syndrome: Canadian clinical working case
definition, diagnostic and treatment protocols-a consensus document. J
Musculoske Pain 11(4):3-107,2003.
2. Jain AK, Carruthers BM, van de Sande MI: Introduction: Canadian
Consensus Document on Fibromyalgia Syndrome. J Musculoske Pain 11 (4): 1-2,
2003.
3. Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL,
Tugwell P, Campbell SM, Abeles M, Clark P, Fam AG, Farber SJ, Fiechtner JJ,
Franklin CM, Gatter RA, Hamaty D, Lessard J, Lichtbroun AS, Masi AT, McCain
GA, Reynolds WI, Romano TJ, Russell U, Sheon RP: The American College of
Rheumatology 1990 Criteria for the Classification of Fibromyalgia.
Arthritis Rheum 33: 160-172, 1990.
4. Wolfe F: Stop using the American College of Rheumatology Criteria in the
clinic. J Rheumatol 30(8): 1671-1672,2003.
5. Yunus MB, Masi AT, Aldag JC: Preliminary criteria for primary
fibromyalgia syndrome (PFS): Multivariate analysis of a consecutive series
of PFS, other pain patients, and normal subjects. Clin Exp Rheumatol
7:63-69,1989.
6. Russell U: Proposed study to develop and validate a clinical case
definition for the fibromyalgia syndrome applicable to the community
practice setting. J Musculoske Pain 11(4):109-111,2003.
7. White KP: Developing and validating a clinical case definition for the
fibromyalgia syndrome for use in clinical practice. J Musculoske Pain
11(4):117-118,2003.
8. Raphael KG: Proposed methods for validation of a clinical case
definition of the fibromyalgia syndrome. J Musculoske Pain
11(4):113-115,2003.
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