Background and aims
This study has two main aims: (1) To explore the overlap between classification criteria in patients with Chronic Widespread Pain (CWP) and (2) To explore the use of the Patient Generated Index (PGI) as a quality of life (QoL) measure in this patient group.
Patients with Widespread Pain (ICD-11: pain in four or more out of five bodily regions, i.e. the four quadrants and axially) in a tertiary pain outpatient clinic were assessed according to classification criteria for Fibromyalgia [FM, American College of Rheumatology (ACR) criteria of 1990, 2010, 2011 and 2016], Chronic Fatigue Syndrome [CFS, Fukuda, Canada and International Consensus Criteria (ICC)] and Bodily Distress Syndrome (BDS). Furthermore, patients completed the PGI to assess QoL, and electronic questionnaires including demographic variables and standardised patient-reported outcome measures (PROMs).
All patients (n=33) fulfilled the criteria for musculoskeletal type single-organ BDS, 81.8% met the 2016 modified criteria for FM, 30.3% met the Canada criteria for CFS and 24.2% met the criteria for multi-organ type BDS. There was substantial agreement between the 2016 and the 2011 and 2010 criteria sets for FM compared to the 1990 criteria (κ=0.766 and 0.673 compared to 0.279). Patients generally scored low on the PGI, indicating poor QoL (mean PGI 28.9, SD 19.8, range 0–100).
Our findings support the use of the term musculoskeletal type single-organ BDS to describe patients with CWP and the 2016 revision of the FM criteria. The PGI provides useful clinical information which is not captured by standardised PROMs.
The terminology of CWP has become less ambiguous as the new ICD-11 is closely related to the generalised pain criterion of the modified 2016 FM definition. Studies based on the 1990 classification criteria for FM should not be directly compared to studies based on later criteria set. The PGI may be a supplement to other measurements to portray patients’ individual concerns in patients with complex symptom disorders.
Research funding: The study was funded by the Norwegian Directorate of Health.
Conflict of interest: The authors declare that they have no competing interests.
Informed consent: Patients signed an informed consent form prior to being included in the study.
Ethical approval: The study was approved by the Norwegian Regional Ethics Committee (2016/1127-1). The study is registered in clinicaltrials.gov: NCT03413501.
LPG made substantial contribution to conception of the study. HTM and LPG made substantial contributions to design. All authors made substantial contributions to acquisition of data and revisions of the manuscript. HTM performed the analyses of the study and drafted the manuscript, with major contributions from all authors. All authors read and approved the final manuscript.
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