Prednisolone

PMR patients were evaluated at baseline, and at 1, 4, 12 and 26 weeks. At each follow-up visit, clinical evaluation included response to corticosteroid therapy and opinion on the emergence of alternative diagnoses. Patients not considered as having PMR at any time were evaluated and treated according to accepted clinical practice. They were excluded from the PMR cohort and included in the non-PMR comparison cohort. Patients in the comparison cohort were evaluated at baseline and at 26 weeks.
Data were collected using standardised data collection forms and questionnaires translated into national languages. Data collection included the candidate inclusion/exclusion criteria items for classification of PMR, physical examination and assessment of corticosteroid response. Criteria items were age 50 years or older, symptom duration 2 weeks or more, bilateral shoulder and/or pelvic girdle aching, recent weight loss greater than 2 kg, duration of morning stiffness more than 45 min, elevated ESR, elevated CRP and rapid response of symptoms to corticosteroids (>75% global response within 1 week to prednisolone/prednisone 15–20 mg a day). Pain was assessed using a horizontal 100 mm visual analogue scale (VAS) in four separate locations (shoulder, pelvic, neck and overall) with zero indicating no pain and 100 indicating worst pain. Morning stiffness (in the past 24 h) was assessed in minutes; functional status and quality of life were assessed by the modified health assessment questionnaire (MHAQ) and short form 36. A 100-mm VAS was also used for recording global wellbeing measures (patient and physician global) and fatigue. Physical examination included the presence or absence of tenderness, pain on movement and limitation of the shoulders and hips. Aspects of corticosteroid therapy including dose, therapeutic response and change in dose and therapy discontinuation were documented.
Data regarding laboratory measures (including ESR, CRP, rheumatoid factor (RF) and anticitrullinated protein antibody (ACPA)) were obtained from clinically ordered tests performed at each study centre. As the laboratory assays used at each centre varied, test results were classified as normal/abnormal using the reference ranges from each centre (see supplementary appendix table S1, available online only). Both PMR and non-PMR subjects underwent ultrasound evaluation of shoulders and hips at baseline and at 26 weeks. Evaluations were made according to EULAR guidelines28 (link) to assess for features previously reported to be associated with PMR, including bicipital tenosynovitis, subacromial and subdeltoid bursitis, trochanteric bursitis and glenohumeral and hip effusion. A rheumatologist or radiologist experienced in musculoskeletal ultrasound performed the ultrasound examination using linear probes with the frequency range 6–10 MHz for shoulders and linear or curved array probes with the frequency range 5–8 MHz for hips.

In all centres, patients undergoing FMT treatment were registered prospectively. Data about IBD outcome and long-term follow-up were in part collected retrospectively (Supplemental Figure 1).
Data collection was performed by each centre using files of the FMT services and hospital records for the patients. If possible, patients were contacted directly. The following baseline characteristics were collected: age, gender, and the use of PPIs. The following data about the CDI were collected: number of episodes; diagnostics by polymerase chain reaction or toxin enzyme immunoassay; and information about previous treatment with metronidazole, vancomycin, fidaxomicin, or bezlotoxumab. Severe CDI was defined as leukocytes ⩾15 × 10⁹/L and/or a 50% increase in creatinine at baseline.^{17 (link)} FMT data included the pre-treatment regimen (antibiotics, bowel lavage), total number of FMTs needed per patient, the route of administration of FMT, and the total amount of faeces (grams) used for preparation of the suspensions or capsules that were administered per patient. Data about clinical recurrence and microbiological testing for CDI after FMT were collected at 8–12 weeks after FMT. Long-term follow-up data of CDI recurrence were included if available.
For IBD, information was collected about the diagnosis according to the Montreal classification and the disease duration. Previous and current IBD medication at the moment of FMT and the use of immunosuppressive medication (including corticosteroids and budesonide, immunomodulators and biologicals) was assessed. Both at baseline and 8 weeks after FMT, the presence of an IBD flare was based on information from the treating physician and/or endoscopic scores. In case of a concomitant flare, remission-induction therapy was defined as the use of prednisolone or budesonide at the moment of FMT, or recently initiated antitumor necrosis factor (TNF) treatment (⩽2 months before FMT). Also haemoglobin (mmol/l) and C-reactive protein (mg/l) in the blood and the calprotectin (µg/g) in the faeces were collected at baseline and after 8 weeks.
The long-term follow-up period per patient was calculated from the date of FMT up to 31 December 2020. Long-term follow-up data included information about possibly occurring events and if yes, the number of days after FMT it occurred. Possible occurring events, collected via patient recall or from hospital records, were as follows: a recurrence of CDI, the development of an IBD flare, general infection and antibiotic use, hospital admission, colectomy, and occurrence of death.