Responsiveness and meaningful thresholds of PROMIS pain interference, fatigue, and physical function forms in adults with idiopathic inflammatory myopathies: Report from the OMERACT Myositis Working Group.

BACKGROUND: A series of qualitative studies conducted by the OMERACT Myositis Working Group identified pain interference, fatigue, and physical function as highly important life impact domains for adults with idiopathic inflammatory myositis (IIM). In this study, our goal was to assess the responsiveness and minimal important difference of PROMIS pain interference (6a), fatigue (7a), and physical function (8b). METHODS: Adults with IIM from USA, Netherlands, Korea, Sweden, and Australia with two "clinical" visits were enrolled in this prospective study. Anchor questions on a Likert scale were collected at baseline, and manual muscle testing (MMT), physician and patient reported global disease activity, and PROMIS instruments were collected at both visits. Responsiveness was assessed with i) ANOVA, ii) paired t-test, effect size and standardized response mean, and iii) Pearson correlation. Minimal important difference (MID), minimal important change (MIC) and minimal detectable change (MDC) values were calculated. RESULTS: 114 patients with IIM (median age 60, 60 % female) completed both visits. Changes in PROMIS instruments were significantly different among anchor categories. Patients who reported improvement had a significant improvement in their PROMIS scores with at least medium effect size, while patients who reported worsening and stability did not show a significant change with weak effect size. PROMIS instruments had weak to moderate correlations with MMT, patient and physician global disease activity. MID was approximately 2-3 points for Pain Interference and 3-4 points for Fatigue and Physical Function forms based on the method used. MIC was approximately 4-5 for improvement of all the instruments, while MDC was 1.7-2 points for Pain Interference and Physical Function and 3.2-3.9 for Fatigue. CONCLUSION: This study provides evidence towards the responsiveness of the PROMIS instruments in a large international prospective cohort of adults with IIM supporting their use as PROMs in adult myositis.

Predictive value of maternal serum and vaginal interleukin-6 levels in preterm labor.

OBJECTIVE: The aim of the current study was to evaluate the predictive value of maternal serum and vaginal interleukin 6 (IL-6) levels for preterm delivery before 37 gestational weeks in patients with preterm labor and to determine the probable relationship between IL-6 concentrations and delivery interval. METHODS: In this prospective study, maternal serum and vaginal IL-6 levels were measured in 40 patients with the diagnosis of preterm labor between the 28th and 36th gestational weeks (study group) and in 20 pregnant women between the same gestational weeks attending the antenatal clinic with no complaints (control group). The gestational age at the time of admission and delivery, as well as the delivery interval, were evaluated and compared with the concentration of IL-6 on admission. RESULTS: There were no significant relationships between maternal serum concentrations of IL-6 and preterm delivery. Vaginal IL-6 levels were significantly higher in the study group as compared with the control group (P < .001). The optimal cut-off value for vaginal IL-6 (172 pg/mL) gave a sensitivity level of 73.9% (95% confidence interval [CI], 67-82%) at a specificity of 100% (95% CI, 91-100%) with positive and negative predictive values of 94.1% and 83.7%, respectively. In the study group, the interval from collection to delivery was significantly shortened when the maternal vaginal IL-6 levels increased. CONCLUSION: The ease of measurement, feasibility, cost-effectiveness, and success of identifying pregnancies at risk for preterm labor with vaginal IL-6 make this a useful biochemical marker for preterm labor and delivery.