Can Clinical, Psychological, and Cognitive Patient-Reported Outcome Measures (PROMs) Help to Discriminate Women with Fibromyalgia from Those with Other Localized/Regional Pain Conditions? A Diagnostic Accuracy Study

Overview

Journal Medicina (Kaunas)

Publisher MDPI

Specialty General Medicine

Date 2025 Feb 26

PMID 40005475

Authors

Margarita Cigaran-Mendez

Angela Tejera-Alonso

Cristina Gomez-Calero

Cesar Fernandez-de-Las-Penas

Monica Lopez-Redondo

Juan A Valera-Calero

Francisco G Fernandez-Palacios

Juan C Pacho-Hernandez

Affiliations

Soon will be listed here.

Abstract

The heterogeneous clinical manifestations of fibromyalgia syndrome have led to the revision of diagnostic criteria in the last decade. The aim of this study was to determine the capability of clinical, psychological, and cognitive patient-related outcome measures (PROMs) to differentiate women with fibromyalgia syndrome (FMS) from women with localized or regional pain conditions. A diagnostic accuracy study was conducted. Clinical (pain intensity-NPRS; related disability-FIQ), psychological (anxiety/depressive levels-HADS-A/HADS-D), and cognitive (sleep quality-PSQI; pain hypervigilance-PVAQ-9) PROMs were collected in 129 women with FMS and 65 women with localized/regional chronic pain conditions. The area under the receiver operating characteristic (ROC) curve, cut-off point, sensitivity/specificity values, and positive and negative likelihood (LR) ratios of each variable were calculated. Women with FMS showed higher levels of pain, related disability, and anxiety/depressive levels, worse sleep quality, and higher levels of hypervigilance (all, < 0.001) than women without FMS. All PROMs showed excellent discriminatory power and good sensitivity (pain intensity: ROC 0.987, sensitivity 91.5%; related disability: ROC 0.980, sensitivity 93.8%; HADS-A: ROC 0.901, sensitivity 81.4%; HADS-D: ROC 0.906, sensitivity 85.3%; PSQI: ROC 0.909, sensitivity 79.1%; PVAQ-9: ROC 0.798, sensitivity 80.6%). Specificity was extremely small for all variables (<18%) except for pain hypervigilance (specificity: 34%). Women with FMS exhibited worse clinical, psychological, and cognitive variables than women with localized/regional chronic pain. Although all PROMs had good discriminatory power, related disability and pain hypervigilance were those showing the best models. These PROMs could be combined with the American College of Rheumatology (ACR) diagnostic criteria to better discriminate between women with and without FMS. Studies investigating the relevance of combining these PROMs with the ACR diagnostic criteria in clinical settings are needed.

References

Mandrekar J . Receiver operating characteristic curve in diagnostic test assessment. J Thorac Oncol. 2010; 5(9):1315-6. DOI: 10.1097/JTO.0b013e3181ec173d. View

Esteve-Vives J, Rivera Redondo J, Isabel Salvat Salvat M, de Gracia Blanco M, Alegre de Miquel C . [Proposal for a consensus version of the Fibromyalgia Impact Questionnaire (FIQ) for the Spanish population]. Reumatol Clin. 2011; 3(1):21-4. DOI: 10.1016/S1699-258X(07)73594-5. View

Bennett R, Friend R, Jones K, Ward R, Han B, Ross R . The Revised Fibromyalgia Impact Questionnaire (FIQR): validation and psychometric properties. Arthritis Res Ther. 2009; 11(4):R120. PMC: 2745803. DOI: 10.1186/ar2783. View

Wu Y, Chang L, Lee H, Fang S, Tsai P . Sleep disturbances in fibromyalgia: A meta-analysis of case-control studies. J Psychosom Res. 2017; 96:89-97. DOI: 10.1016/j.jpsychores.2017.03.011. View

Umeda M, Corbin L, Maluf K . Pain mediates the association between physical activity and the impact of fibromyalgia on daily function. Clin Rheumatol. 2013; 34(1):143-9. DOI: 10.1007/s10067-013-2386-0. View

Wolfe F, Clauw D, Fitzcharles M, Goldenberg D, Katz R, Mease P . The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010; 62(5):600-10. DOI: 10.1002/acr.20140. View

Alonso J, Bartlett S, Rose M, Aaronson N, Chaplin J, Efficace F . The case for an international patient-reported outcomes measurement information system (PROMIS®) initiative. Health Qual Life Outcomes. 2013; 11:210. PMC: 3879205. DOI: 10.1186/1477-7525-11-210. View

Quintana J, Padierna A, Esteban C, Arostegui I, Bilbao A, Ruiz I . Evaluation of the psychometric characteristics of the Spanish version of the Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 2003; 107(3):216-21. DOI: 10.1034/j.1600-0447.2003.00062.x. View

Ferreira-Valente M, Pais-Ribeiro J, Jensen M . Validity of four pain intensity rating scales. Pain. 2011; 152(10):2399-2404. DOI: 10.1016/j.pain.2011.07.005. View

10.

McDermid A, Rollman G, McCain G . Generalized hypervigilance in fibromyalgia: evidence of perceptual amplification. Pain. 1996; 66(2-3):133-44. DOI: 10.1016/0304-3959(96)03059-x. View

11.

Parikh R, Mathai A, Parikh S, Sekhar G, Thomas R . Understanding and using sensitivity, specificity and predictive values. Indian J Ophthalmol. 2007; 56(1):45-50. PMC: 2636062. DOI: 10.4103/0301-4738.37595. View

12.

Bennett R, Jones K, Aebischer J, St John A, Friend R . Which symptoms best distinguish fibromyalgia patients from those with other chronic pain disorders?. J Eval Clin Pract. 2021; 28(2):225-234. DOI: 10.1111/jep.13615. View

13.

Le C . A solution for the most basic optimization problem associated with an ROC curve. Stat Methods Med Res. 2007; 15(6):571-84. DOI: 10.1177/0962280206070637. View

14.

Cassisi G, Sarzi-Puttini P . Consistency between the 2016 ACR criteria and a previous diagnosis or hypothesis of fibromyalgia in a specialised referral clinic. Clin Exp Rheumatol. 2023; 41(6):1283-1291. DOI: 10.55563/clinexprheumatol/mopepq. View

15.

Salaffi F, Di Carlo M, Farah S, Atzeni F, Buskila D, Ablin J . Diagnosis of fibromyalgia: comparison of the 2011/2016 ACR and AAPT criteria and validation of the modified Fibromyalgia Assessment Status. Rheumatology (Oxford). 2020; 59(10):3042-3049. DOI: 10.1093/rheumatology/keaa061. View

16.

Duleba A, Olive D . Regression analysis and multivariate analysis. Semin Reprod Endocrinol. 1996; 14(2):139-53. DOI: 10.1055/s-2007-1016322. View

17.

Mease P, Arnold L, Choy E, Clauw D, Crofford L, Glass J . Fibromyalgia syndrome module at OMERACT 9: domain construct. J Rheumatol. 2009; 36(10):2318-29. PMC: 3419373. DOI: 10.3899/jrheum.090367. View

18.

Martinez-Calderon J, Flores-Cortes M, Morales-Asencio J, Luque-Suarez A . Pain-Related Fear, Pain Intensity and Function in Individuals With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. J Pain. 2019; 20(12):1394-1415. DOI: 10.1016/j.jpain.2019.04.009. View

19.

Buysse D, Reynolds 3rd C, Monk T, BERMAN S, Kupfer D . The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989; 28(2):193-213. DOI: 10.1016/0165-1781(89)90047-4. View

20.

Herrero M, Blanch J, Peri J, de Pablo J, Pintor L, Bulbena A . A validation study of the hospital anxiety and depression scale (HADS) in a Spanish population. Gen Hosp Psychiatry. 2003; 25(4):277-83. DOI: 10.1016/s0163-8343(03)00043-4. View