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.

Pattern of ventilation during manual hyperinflation performed by physiotherapists.

Summary The aim of this prospective observational study was to document patterns of ventilation during manual hyperinflation by physiotherapists. Manual hyperinflation with a Mapleson-F system was performed on the same patients on two consecutive days. Patterns of ventilation were recorded using a heated pneumotachometer, pressure transducer and custom designed data acquisition and analysis systems. The mean (SE) results were: inspiratory time 1.45 (0.10) s; volume delivered 1.23 (0.07) l; peak inspiratory and expiratory flow rate 1.51 (0.06) l.s(-1) and 3.26 (0.30) l.s(-1), respectively and I : E flow rate ratio 0.63 (0.05). All the physiotherapists achieved an increase in volume which was delivered within a safe and effective pressure range and without cardiovascular compromise. Most (26 out of 34 sessions) performed the technique in the way recommended for enhancing secretion clearance. This is the first study to document comprehensively the pattern of ventilation during manual hyperinflation and provides the basis for further clinical trials evaluating its effectiveness for secretion clearance and volume restoration.