Background/Purpose: Patients with rheumatoid arthritis (RA) who are included in clinical trials generally are selected for measures indicating high disease activity, such as more than 6 swollen and/or tender joints and/or erythrocyte sedimentation rate (ESR) greater than 28. These inclusion criteria enhance the possibility of documenting responses to therapy. Patient questionnaire scores are correlated significantly with joint counts and to a lesser (but nonetheless significant) extent with ESR and other laboratory acute phase reactants. However, observations in clinical care suggest that scores on a multidimensional health assessment questionnaire (MDHAQ) generally are higher in patients who have distress, such as fibromyalgia or depression etc., than in patients with RA, unless the RA patients also have secondary distress. We therefore analyzed formally scores on an MDHAQ in patients with FM vs RA seen in routine care.

Methods: All patients with all diagnoses seen at one academic rheumatology center complete a multidimensional health assessment questionnaire (MDHAQ) at all visits in the waiting area, before seeing the rheumatologist in routine care. The MDHAQ includes 0-10 scores for physical function (FN), 0-10 pain (PN) visual analog scale (VAS), 0-10 patient global estimate (PATGL) VAS, compiled into a 0-30 RAPID3, as well as a 0-10 fatigue VAS, 0-48 RADAI self-report joint count, 0-60 symptom checklist, and demographic data. Mean levels of measures were compared in patients with RA or FM, analyzed using t tests.

Results: Patients with FM had higher scores for all MDHAQ scales studied, including FN, pain, PATGL, fatigue, RADAI, and symptom checklist (Table) (p<0.001). For example, RAPID3 scores were 11.4 for RA vs 17.8 for FM (p<0.001) (Table).

Conclusion:  Evidence that patients who have FM have higher MDHAQ scores may initially appear to compromise the possible value of self-report questionnaire data in RA. However, the data may be informative in clinical research and clincial care in at least 2 ways: 1. It may be desirable to exclude patients from clinical trials who might have self-report scores that are extremely high, e.g., pain VAS >8/10, symptom checklist >24/60 of 60, as these patients are unlikely to respond to therapy, whether they have primary or secondary FM while meeting criteria for another rheumatic disease. 2. In routine care, high MDHAQ self-report scores may provide clues to identify patients who have primary or secondary FM, which is seen in 15-30% of patients with RA, SLE, or other rheumatic diagnoses. High self-report scores in FM may prove informative in rheumatology toward better interpretation of clinical researchand improved patient care.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/patients-with-fibromyalgia-in-general-have-higher-self-report-questionnaire-scores-than-patients-with-rheumatoid-arthritis-implications-for-clinical-trials-and-clinical-research/