The study was a prospective cohort study that included a cohort of patients with new-onset PMR and a comparison cohort of non-PMR patients with various conditions mimicking PMR. Study subjects were recruited from 21 community-based and academic rheumatology clinics in 10 European countries and the USA. Inclusion criteria for PMR patients were age 50 years or older, new-onset bilateral shoulder pain and no corticosteroid treatment (for any condition) within 12 weeks before study entry, fulfilling all the inclusion and exclusion criteria defined by our previous report and in accordance with the judgement of the participating investigator that the patient had PMR.18 (
link) Every effort was made to choose patients across the spectrum of disease severity. Corticosteroid treatment for PMR patients was initiated according to a predefined treatment protocol starting with 15 mg a day oral prednisone for weeks 1 and 2, 12.5 mg a day for weeks 3 and 4, 10 mg a day for weeks 6–11, 10 mg/7.5 mg every other day for weeks 12–15, 7.5 mg a day for weeks 16–25 and tapering according to treatment response from week 26 onwards. The gold standard for the pre-steroid diagnosis of PMR was established as above at presentation and when the diagnosis was maintained without an alternative diagnosis at week 26 of follow-up.
The non-PMR comparison cohort included conditions representative of the types that need to be distinguished from PMR, in both primary and secondary care. Inclusion criteria for the non-PMR comparison cohort were age 50 years or older, new-onset bilateral shoulder pain and a diagnosis of either inflammatory or non-inflammatory conditions, including new-onset RA, connective tissue diseases, various shoulder conditions (eg, bilateral rotator cuff syndrome and/or adhesive capsulitis, rotator cuff tear, glenohumeral osteoarthritis), fibromyalgia, generalised osteoarthritis and others. Patients known to have the condition for more than 12 weeks before the baseline evaluation (except fibromyalgia and chronic pain) were not eligible for inclusion. PMR patients with clinical suspicion of giant cell arteritis were included as part of the comparison cohort because these patients required different corticosteroid doses. Patients in the comparison cohort were included on the basis of clinician diagnosis and not on formal criteria. No guidelines were provided for treatment of the conditions in the comparison cohort.
Ethics board approval was obtained at all participating institutions before initiation of the study, and all participants gave written informed consent before enrollment.
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