Assessment of Patients with Fibromyalgia Syndrome
Abstract
Objectives: The purpose of this review is to describe the current state of consensus on the key clinical domains which constitute fibromyalgia syndrome [FMS], from both the clinician and patient perspective, and the outcome measures being used or in development to assess these domains in clinical research.Results: In a series of Delphi exercises and patient focus groups, both clinicians and patients concurred that key domains which constitute the experience of FMS and should be assessed in clinical research include pain, fatigue, sleep disturbance, multidimensional function, health-related quality of life, mood disturbance, and problems with cognition. In addition, clinicians are concerned about assessing treatment side effects and patients feel that stiffness should be assessed. Most of these domains, save dyscognition and stiffness, are currently being assessed with a variety of outcome measures in clinical trials. The performance quality of these instruments is reviewed. Areas in which further research and development is needed and, to a certain extent, underway to improve the assessment of these domains is described. Other areas of methodologic research include the establishment of “minimal clinically important difference” thresholds for outcome measures and the development of a composite responder index for FMS.Conclusions: The field of outcome assessment of FMS is maturing rapidly, both as a result of increased awareness of the importance of the clinical problem as well as the emergence of new effective therapies. Developments in this field are reviewed, including the determination and prioritization of key domains that constitute the syndrome and the performance characteristics of outcome measures for those domains.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The SF-36 aggregate score has previously been used as the primary outcome in a comparable trial in adults due to well-known psychometric problems with the existing physical component score (PCS) and based on the rationale that these three subscales have shown to be key domains affected in this patient group.
“This score has previously been used as the primary outcome in a comparable trial in adults39 due to well-known psychometric problems with the existing physical component score (PCS)73 and based on the rationale that these three subscales have shown to be key domains affected in this patient group.74”
Cites
An inventory for measuring depression
BECK, A. T. (1961) · Archives of General Psychiatry · doi:10.1001/archpsyc.1961.01710120031004 · Cited by 38,032 · see citing works
(1992) · PubMed · Cited by 33,716 · see citing works
The MOS 36-ltem Short-Form Health Survey (SF-36): I. Conceptual Framework and Item Selection
Ware, J. E., & Sherbourne, C. D. (1992) · Medical Care · doi:10.1097/00005650-199206000-00002 · Cited by 30,033 · see citing works
(1998) · The Journal of Clinical Psychiatry · Cited by 19,139 · see citing works
An inventory for measuring clinical anxiety: Psychometric properties.
Beck, A. T., Epstein, N., Brown, G., & Steer, R. A. (1988) · Journal of Consulting and Clinical Psychology · doi:10.1037/0022-006x.56.6.893 · Cited by 14,407 · see citing works
The american college of rheumatology 1990 criteria for the classification of fibromyalgia
Wolfe, F., Smythe, H. A., Yunus, M. B., Bennett, R. M., Bombardier, C., Goldenberg, D. L., Tugwell, P., Campbell, S. M., Abeles, M., Clark, P., et al. (1990) · Arthritis & Rheumatism · doi:10.1002/art.1780330203 · Cited by 9,563 · see citing works
The McGill Pain Questionnaire: Major properties and scoring methods
Melzack, R. (1975) · Pain · doi:10.1016/0304-3959(75)90044-5 · Cited by 6,873 · see citing works
Krupp, L. B. (1989) · Archives of Neurology · doi:10.1001/archneur.1989.00520460115022 · Cited by 6,172 · see citing works
Farrar, J. T., Young, J. P., LaMoreaux, L., Werth, J. L., & Poole, M. R. (2001) · Pain · doi:10.1016/s0304-3959(01)00349-9 · Cited by 5,808 · see citing works
The short-form McGill pain questionnaire
Melzack, R. (1987) · Pain · doi:10.1016/0304-3959(87)91074-8 · Cited by 4,368 · see citing works
Smets, E. M. A., Garssen, B., Bonke, B., & de Haes, J. C. J. M. (1995) · Journal of Psychosomatic Research · doi:10.1016/0022-3999(94)00125-o · Cited by 3,622 · see citing works
Core outcome domains for chronic pain clinical trials: IMMPACT recommendations
Turk, D. C., Dworkin, R. H., Allen, R. R., Bellamy, N., Brandenburg, N., Carr, D. B., Cleeland, C., Dionne, R., Farrar, J. T., Galer, B. S., et al. (2003) · Pain · doi:10.1016/j.pain.2003.08.001 · Cited by 3,510 · cited 1× · see citing works
“There has been a recent example of this type of collaborative endeavor among pain researchers and representatives of the Food and Drug Administration to establish guidelines for outcome measure development in chronic pain research (6,7).”
BackgroundThe MOS Short-form General Health Survey: Reliability and Validity in a Patient Population
Stewart, A. L., Hays, R. D., & Ware, J. E. (1988) · Medical Care · doi:10.1097/00005650-198807000-00007 · Cited by 3,339 · see citing works
Group Techniques for Program Planning: A Guide to Nominal Group and Delphi Processes
(1976) · The Journal of Applied Behavioral Science · doi:10.1177/002188637601200414 · Cited by 2,811 · see citing works
(1991) · PubMed · Cited by 1,837 · see citing works
(2003) · Health and Quality of Life Outcomes · doi:10.1186/1477-7525-1-79 · Cited by 1,506 · see citing works
ICF linking rules: an update based on lessons learned
Cieza, A., Geyh, S., Chatterji, S., Kostanjsek, N. F. I., Üstün, B., & Stucki, G. (2005) · Journal of Rehabilitation Medicine · doi:10.1080/16501970510040263 · Cited by 1,307 · see citing works
A scale for the estimation of sleep problems in clinical research
Jenkins, C. D., Stanton, B.-A., Niemcryk, S. J., & Rose, R. M. (1988) · Journal of Clinical Epidemiology · doi:10.1016/0895-4356(88)90138-2 · Cited by 1,216 · see citing works
The Arizona Sexual Experience Scale (ASEX): Reliability and Validity
A. McGahuey, A. J. G. (2000) · Journal of Sex & Marital Therapy · doi:10.1080/009262300278623 · Cited by 1,155 · see citing works
Defining the clinically important difference in pain outcome measures
Farrar, J. T., Portenoy, R. K., Berlin, J. A., Kinman, J. L., & Strom, B. L. (2000) · Pain · doi:10.1016/s0304-3959(00)00339-0 · Cited by 1,071 · see citing works
Delphi: A reevaluation of research and theory
Rowe, G., Wright, G., & Bolger, F. (1991) · Technological Forecasting and Social Change · doi:10.1016/0040-1625(91)90039-i · Cited by 733 · see citing works
Crofford, L. J., Rowbotham, M. C., Mease, P. J., Russell, I. J., Dworkin, R. H., Corbin, A. E., Young, J. P., LaMoreaux, L., Martin, S. A., Sharma, U., et al. (2005) · Arthritis & Rheumatism · doi:10.1002/art.20983 · Cited by 651 · see citing works
Self-citationArnold, L. M., Lu, Y., Crofford, L. J., Wohlreich, M., Detke, M. J., Iyengar, S., & Goldstein, D. J. (2004) · Arthritis & Rheumatism · doi:10.1002/art.20485 · Cited by 624 · see citing works
Mease, P. J. (2005) · PubMed · Cited by 528 · see citing works
Self-citationArnold, L. M., Rosen, A., Pritchett, Y. L., D'Souza, D. N., Goldstein, D. J., Iyengar, S., & Wernicke, J. F. (2005) · Pain · doi:10.1016/j.pain.2005.06.031 · Cited by 471 · see citing works
Correlates of Fatigue in Older Adults with Rheumatoid Arthritis
Belza, B. L., Henke, C. J., Yelin, E. H., Epstein, W. V., & Gilliss, C. L. (1993) · Nursing Research · doi:10.1097/00006199-199303000-00006 · Cited by 434 · see citing works
Developing patient-reported outcome measures for pain clinical trials: IMMPACT recommendations
Turk, D. C., Dworkin, R. H., Burke, L. B., Gershon, R. C., Rothman, M. L., Scott, J., Allen, R. R., Atkinson, H. J., Chandler, J., Cleeland, C. S., et al. (2006) · Pain · doi:10.1016/j.pain.2006.09.028 · Cited by 301 · see citing works
Holman, A. J., & Myers, R. R. (2005) · Arthritis & Rheumatism · doi:10.1002/art.21191 · Cited by 289 · see citing works
Efficacy of milnacipran in patients with fibromyalgia.
Gendreau, R. M., Thorn, M. D., Gendreau, J., Kranzler, J., Ribeiro, S. C. M., Gracely, R. H., Williams, D. A., Mease, P. J., McLean, S. A., & Clauw, D. J. (2005) · PubMed · Cited by 237 · see citing works
Self-citationOkifuji, A., Turk, D., Sinclair, J. D., Starz, T. W., & Da, M. (1997) · PubMed · Cited by 220 · see citing works
Development and validation of a multiple ability self-report questionnaire
Seidenberg, M., Haltiner, A. M., Taylor, M. A., Hermann, B., & Wyler, A. R. (1994) · Journal of Clinical and Experimental Neuropsychology · doi:10.1080/01688639408402620 · Cited by 208 · see citing works
Evoked pain measures in fibromyalgia
Gracely, R. H., Grant, M. A. B., & Giesecke, T. (2003) · Best Practice & Research Clinical Rheumatology · doi:10.1016/s1521-6942(03)00036-6 · Cited by 204 · see citing works
ICF Core Sets for chronic widespread pain
Cieza, A., Stucki, G., Weigl, M. B., Kullmann, L., Stoll, T. M., Kamen, L. B., Kostanjsek, N. F. I., & Walsh, N. E. (2004) · Journal of Rehabilitation Medicine · doi:10.1080/16501960410016046 · Cited by 166 · see citing works
Measuring clinical pain in chronic widespread pain: selected methodological issues
Gendreau, M., Hufford, M. R., & Stone, A. A. (2003) · Best Practice & Research Clinical Rheumatology · doi:10.1016/s1521-6942(03)00031-7 · Cited by 138 · see citing works
Longterm Effects of Fibromyalgia on Everyday Life: A Study of 56 Patients
Henriksson, C. M. (1994) · Scandinavian Journal of Rheumatology · doi:10.3109/03009749409102133 · Cited by 117 · see citing works
Responsiveness of fibromyalgia clinical trial outcome measures.
Dunkl, P. R., Taylor, A. G., Mcconnell, G. G., Alfano, A. P., & Conaway, M. R. (2000) · PubMed · Cited by 111 · see citing works
Cognitive dysfunction in fibromyalgia and chronic fatigue syndrome: New trends and future directions
Glass, J. M. (2006) · Current Rheumatology Reports · doi:10.1007/s11926-006-0036-0 · Cited by 104 · see citing works
Neumann, L., Berzak, A., & Buskila, D. (2000) · Seminars in Arthritis and Rheumatism · doi:10.1053/sarh.2000.7171 · Cited by 84 · see citing works
Martínez‐Lavín, M., López, S., Medina, M., & Nava, A. (2003) · Seminars in Arthritis and Rheumatism · doi:10.1053/sarh.2003.50017 · Cited by 77 · see citing works
Defining response to disease modifying antirheumatic drugs in patients with rheumatoid arthritis.
Hider, S., Bruce, I. N., Silman, A. J., & Symmons, D. P. M. (2005) · PubMed · Cited by 75 · see citing works
Development of preliminary criteria for response to treatment in fibromyalgia syndrome.
Simms, R. W., Dt, F., & Goldenberg, D. L. (1991) · PubMed · Cited by 61 · see citing works
Pain and fatigue in patients with rheumatic disorders
Mengshoel, A. M., & Førre, Ø. T. (1993) · Clinical Rheumatology · doi:10.1007/bf02231782 · Cited by 56 · see citing works
Psychological evaluation of patients diagnosed with fibromyalgia syndrome: a comprehensive approach
Turk, D. C., Monarch, E. S., & Williams, A. D. (2002) · Rheumatic Disease Clinics of North America · doi:10.1016/s0889-857x(01)00003-5 · Cited by 36 · see citing works
Littlejohn, G. O. (1995) · Rheumatic Disease Clinics of North America · doi:10.1016/s0889-857x(21)00451-8 · Cited by 24 · see citing works
Flagged first, then by citations
1 of the 45 references couldn’t be matched to a known paper.
Cited by
Sorted by citations
Minimal Clinically Important Difference in the Fibromyalgia Impact Questionnaire
BENNETT, R. M., BUSHMAKIN, A. G., CAPPELLERI, J. C., ZLATEVA, G., & SADOSKY, A. B. (2009) · The Journal of Rheumatology · doi:10.3899/jrheum.081090 · Cited by 407 · see citing works
Mease, P. J., Clauw, D. J., Gendreau, R. M., Rao, S. G., Kranzler, J., CHEN, W., & Palmer, R. H. (2009) · The Journal of Rheumatology · doi:10.3899/jrheum.080734 · Cited by 248 · see citing works
Self-citationIncidence and predictors of secondary fibromyalgia in an early arthritis cohort
Lee, Y., Lü, B., Boire, G., Haraoui, B. P., Hitchon, C. A., Pope, J. E., Thorne, C., Keystone, E. C., Solomon, D. H., & Bykerk, V. P. (2012) · Annals of the Rheumatic Diseases · doi:10.1136/annrheumdis-2012-201506 · Cited by 100 · see citing works
Cognitive–behavioural group treatment for a range of functional somatic syndromes: Randomised trial
Schröder, A., Rehfeld, E., Ørnbøl, E., Sharpe, M., Licht, R. W., & Fink, P. (2012) · British Journal of Psychiatry · doi:10.1192/bjp.bp.111.098681 · Cited by 95 · see citing works
Moldofsky, H., HARRIS, H. W., Archambault, W. T., KWONG, T., & Lederman, S. M. (2011) · The Journal of Rheumatology · doi:10.3899/jrheum.110194 · Cited by 93 · see citing works
Branco, J., Zachrisson, O., Perrot, S., & Mainguy, Y. (2010) · The Journal of Rheumatology · doi:10.3899/jrheum.090884 · Cited by 81 · see citing works
CHOY, E. H., ARNOLD, L. M., CLAUW, D. J., CROFFORD, L. J., GLASS, J. M., SIMON, L. S., MARTIN, S. A., STRAND, C. V., WILLIAMS, D. A., & MEASE, P. J. (2009) · The Journal of Rheumatology · doi:10.3899/jrheum.090368 · Cited by 76 · see citing works
Self-citationBurden of Illness and Treatment Patterns for Patients with Fibromyalgia
Robinson, R. L., Kroenke, K., Mease, P. J., Williams, D. A., Chen, Y., D’Souza, D. N., Wohlreich, M. M., & McCarberg, B. H. (2012) · Pain Medicine · doi:10.1111/j.1526-4637.2012.01475.x · Cited by 69 · see citing works
Self-citationAcupuncture for Fibromyalgia in Primary Care: A Randomised Controlled Trial
Vas, J., Santos-Rey, K., Navarro-Pablo, R., Modesto, M., Aguilar, I., Campos, M. Á., Aguilar-Velasco, J. F., Romero, M., Párraga, P., Hervás, V., et al. (2016) · Acupuncture in Medicine · doi:10.1136/acupmed-2015-010950 · Cited by 69 · see citing works
Mease, P. J., Clauw, D. J., Christensen, R., Crofford, L. J., Gendreau, R. M., Martin, S. A., Simon, L. S., Strand, V., Williams, D. A., Arnold, L. M., et al. (2011) · The Journal of Rheumatology · doi:10.3899/jrheum.110277 · Cited by 66 · see citing works
Self-citationRobinson, R. L., Kroenke, K., Williams, D. A., Mease, P. J., Chen, Y., Faries, D. E., Peng, X., Hann, D. M., Wohlreich, M. M., & McCarberg, B. H. (2013) · Pain Medicine · doi:10.1111/pme.12168 · Cited by 45 · see citing works
Self-citationShould Rheumatologists Retain Ownership of Fibromyalgia?
Shir, Y., & Fitzcharles, M. (2009) · The Journal of Rheumatology · doi:10.3899/jrheum.081073 · Cited by 41 · see citing works
Xiao, Y., He, W., & Russell, I. J. (2011) · The Journal of Rheumatology · doi:10.3899/jrheum.101104 · Cited by 37 · see citing works
Kesiktaş, F. N., Karagülle, Z., Erdoğan, N., Yazıcıoğlu, K., Yılmaz, H. G., & Paker, N. (2011) · Journal of Back and Musculoskeletal Rehabilitation · doi:10.3233/bmr-2011-0276 · Cited by 29 · see citing works
Kallesøe, K. H., Schröder, A., Wicksell, R. K., Fink, P., Ørnbøl, E., & Rask, C. U. (2016) · BMJ Open · doi:10.1136/bmjopen-2016-012743 · Cited by 23 · see citing works
Möller, M. C., Berginström, N., Ghafouri, B., Holmqvist, A., Löfgren, M., Nordin, L. E., & Stålnacke, B. (2023) · BMJ Open · doi:10.1136/bmjopen-2022-068011 · Cited by 11 · see citing works
Maher, C., & Gaffiero, D. (2025) · Psychology and Health · doi:10.1080/08870446.2025.2474013 · Cited by 4 · see citing works
Pentoxifylline's Theoretical Efficacy in the Treatment of Fibromyalgia Syndrome
Khalil, R. B. (2012) · Pain Medicine · doi:10.1111/j.1526-4637.2012.01381.x · Cited by 3 · see citing works
Career lifetime advances in rheumatology
Scott, D. L. (2010) · Clinical Medicine · doi:10.7861/clinmedicine.10-2-156
rani, S. R., Ahmed, H., Khan, S., & Amir, M. (2024) · Allied Medical Research Journal · doi:10.59564/amrj/02.02/006
- Authors
- Mease, P. J.
- Venue
- Journal of Musculoskeletal Pain
- Publisher
- Informa UK Limited
- Published
- 2008-01
- Volume
- 16
- Issue
- 1-2
- Pages
- 75-83
- ISSN
- 1058-2452 (ISSN-L)
- 1540-7012
- OpenAlex
- W2017565051
- Cited by
- 20
- References
- 45
- Citations by year
- 2025: 1 · 2024: 1 · 2023: 1 · 2016: 2 · 2013: 1 · 2012: 4
- FWCI
- 2.34
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Musculoskeletal Pain (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cell Biology › Myofascial pain diagnosis and treatment
- Keywords
- fibromyalgia, outcome measures, pain, fatigue, sleep disorders, health-related quality of life, mood disturbance, cognitive impairment, joint stiffness, treatment side effects, minimal clinically important difference, Delphi consensus, patient perspectives
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review