A pilot trial of integrating the Patient-Reported Outcome Measurement Information System (PROMIS®) into rheumatology care.

OBJECTIVES: Utilising Patient-Reported Outcomes Measurement Information System (PROMIS®) questionnaires can enhance clinical care by measuring longitudinal changes in symptom severity as reported by the patient. The aim of this pilot study was to assess the feasibility and impact of incorporating PROMIS® questionnaires at the point-of-care in rheumatology practice. METHODS: Patients with rheumatic diseases and decrements in ≥1 PROMIS® domain (pain intensity, physical function, or sleep disturbance) were stratified by their concerning domain, then randomised to either receive an interpretation of their PROMIS® scores prior to their rheumatology appointment (Arm 1) or to usual care (Arm 2) (ClinicalTrials.gov ID: NCT05026853). The primary outcome was the documentation of PROMIS® scores in the electronic medical record (EMR). Secondary outcomes include recommendations made by physicians based on PROMIS® scores, patient-provider communication, and change in the most concerning PROMIS® domain score from baseline to 12 weeks. RESULTS: 110 patients were enrolled. 55 were randomised to receive report cards (Arm 1), of which 46 received the report card, and 55 received usual care (Arm 2). Documentation of PROMIS® scores in the EMR was 50% higher in Arm 1 (12.7% in Arm 2, p<0.0001). More recommendations were made based on PROMIS® scores for Arm 1 patients. There was no significant difference in post-visit PROMIS® score improvement between Arm 1 and Arm 2. CONCLUSIONS: Providing PROMIS® report cards to patients and healthcare providers increased score documentation in the EMR. Increased recommendations made based on PROMIS® scores in Arm 1 suggest that having a score interpretation might help direct medical decision-making.

Elevated neutrophil extracellular traps in systemic sclerosis-associated vasculopathy and suppression by a synthetic prostacyclin analog.

OBJECTIVES: Neutrophils and neutrophil extracellular traps (NETs) contribute to the vascular complications of multiple diseases, but their role in systemic sclerosis (SSc) is understudied. We sought to test the hypothesis that NETs are implicated in SSc vasculopathy and that treatment with prostacyclin analogs may ameliorate SSc vasculopathy not only through vasodilation but also by inhibiting NET release. METHODS: Blood from 125 patients with SSc (87 diffuse cutaneous SSc and 38 limited cutaneous SSc) was collected at a single academic medical center. Vascular complications such as digital ulcers, pulmonary artery hypertension, and scleroderma renal crisis were recorded. The association between circulating NETs and vascular complications was determined using in vitro and ex vivo assays. The impact of the synthetic prostacyclin analog epoprostenol on NET release was determined. RESULTS: Neutrophil activation and NET release were elevated in patients with SSc-associated vascular complications compared to matched patients without vascular complications. Neutrophil activation and NETs positively correlated with soluble E-selectin and VCAM-1, circulating markers of vascular injury. Treatment of patients with digital ischemia with a synthetic prostacyclin analog boosted neutrophil cyclic AMP, which was associated with the blunting of NET release and reduced NETs in circulation. CONCLUSION: Our study demonstrates an association between NETs and vascular complications in SSc. We also identified the potential for an additional therapeutic benefit of synthetic prostacyclin analogs, namely to reduce neutrophil hyperactivity and NET release in SSc patients.

Ciprofloxacin versus levofloxacin prophylaxis in hematopoietic stem cell transplantation: A randomized trial.

OBJECTIVES: We aimed to assess whether there is a difference between ciprofloxacin and levofloxacin as prophylaxis in hematopoietic stem cell transplant (SCT) recipients. METHODS: This is a prospective, randomized trial in patients receiving SCT at Henry Ford Health in the United States of America. We randomly assigned patients (1:1) to receive ciprofloxacin or levofloxacin. The primary outcome was incidence of bloodstream bacterial infections (BSI) up to day 60 after SCT. RESULTS: Between June 4, 2018, and May 23, 2022, we randomly assigned 308 consecutive patients to receive ciprofloxacin (154 patients) or levofloxacin (154 patients). BSI was similar in both the ciprofloxacin and levofloxacin groups (18 [11.7%] vs 18 [11.7%]). Pneumonia was more frequent in the ciprofloxacin group compared to the levofloxacin group (18 [18%] vs 7 [23%]; relative risk 2.57, 95% CI 1.11-5.98; p = 0.028). There were no differences in neutrophil engraftment, fever, Clostridium difficile infection, relapse incidence, overall survival, nonrelapse mortality, length of stay post-SCT, or intensive care unit admission. CONCLUSION: Although both prophylaxis regimens demonstrated the same efficacy in SCT recipients, levofloxacin prophylaxis led to less pneumonia in the first 60 days post-SCT. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov, NCT03850379.