Patient-reported outcome measures in severe asthma: an expert consensus.

OBJECTIVE: The study aimed to reach a consensus on the most relevant patient-reported outcomes (PROs), the corresponding measures (PROMs), and measurement frequency during severe asthma patient follow-up. METHODS: Two Delphi rounds were conducted. The questionnaire was developed based on a systematic literature review, a focus group with patients, and a nominal group with experts. It assessed PROs' relevance and the appropriateness (A) and feasibility (F) of PROMs using a Likert scale (1=totally agree; 9=totally disagree). The consensus was established when ≥75% of participants agreed (1-3) or disagreed (7-9). RESULTS: Sixty-three professionals (25 hospital pharmacists, 14 allergists, 13 pulmonologists, and 11 nurses) and 5 patients answered the Delphi questionnaire. A consensus was reached on all PROs regarding their relevance. Experts agreed on the use of ACT (A:95.24%; F:95.24%), mini AQLQ (A:93.65; F:79.37%), mMRC dyspnea scale (A:85.71%; F:85.71%), TAI (A:92.06%; F:85.71%), MMAS (A:75.40%; F:82%), and the dispensing register (A:96.83%; F:92.06%). Also considered suitable were: SNOT-22 (A:90.48%; F:73.80%), PSQI (A:82.54; F:63.90%), HADS (A:82.54; F:64%), WPAI (A:77.78%; F:49.20%), TSQM-9 (A:79.37; F:70.50%) and knowledge of asthma questionnaire (A:77%; F:68.80%); however, their use in clinical practice was considered unfeasible. Panelists also agreed on the appropriateness of EQ-5D, which was finally included despite being considered unfeasible (A: 84.13%; F:67.20%) in clinical practice. Agreement was reached on using ACT, TAI, mMRC, and a dispensing register every three months; mini-AQLQ and MMAS every six months; and EQ-5D every twelve months. CONCLUSION: This consensus paves the way toward patient-centered care, promoting the development of strategies supporting routine assessment of PROs in severe asthma management.

Diagnostic validity of specific immunoglobulin E levels to alpha-gal in alpha-gal syndrome: a cross-sectional analysis.

BACKGROUND: The diagnosis of Alpha-gal Syndrome (AGS) is based on the presence of symptoms after being exposed to potential sources of alpha-gal together with values ​​of specific IgE (sIgE) to alpha-gal ≥ 0.1 kUA/L or ≥ 0.35 kUA/L. The aim of this study was to evaluate the diagnostic validity of sIgE levels to alpha-gal ≥ 0.1 kUA/L for identifying AGS. METHODS: This was a cross-sectional analysis of adult patients with available data on sIgE levels to alpha-gal, classified into two groups according to the presence (Group 1) or absence (Group 2) of symptoms after being exposed to potential sources of alpha-gal. Values of sIgE to alpha-gal ≥ 0.1 kUA/l were considered a positive result. A descriptive analysis of internal and external validity parameters was performed in the entire population and adjusted by sex. RESULTS: The study included 33 individuals in Group 1 and 65 in Group 2, with a mean age of around 47 years. The analysis of internal validity parameters revealed a high sensitivity, specificity, and positive probability ratio, with higher sensitivity in men and higher specificity in women. The analysis of external validity parameters showed a high negative predictive value and global value in all populations and both sexes. However, the positive predictive value was relatively high in men, but low in women. CONCLUSIONS: Our results suggest that sIgE levels ≥ 0.1 kUA/L may be a useful tool for the diagnosis of AGS, although other factors and diagnostic techniques should also be considered.

Phase I study of subcutaneous allergen immunotherapy with Dermatophagoides pteronyssinus in patients with allergic rhinoconjunctivitis with or without asthma.

AIM: A double-blind placebo-controlled study was conducted according to EMA guidelines, to evaluate safety, tolerability and short-term treatment effects of three updosing regimens of Dermatophagoides pteronyssinus subcutaneous allergen immunotherapy. PATIENTS & METHODS: Forty-eight patients were randomized to groups: A (six weekly doses), B (eight weekly doses) or C (eight doses, two clustered doses over 3 weeks).  RESULTS: The most frequent adverse events were local reactions. No serious adverse events were found. Severe systemic reactions were reported more frequently in Group C. Decreased cutaneous responses and increased specific IgGs were shown in all active groups, even within the short-term. CONCLUSION:  Dermatophagoides pteronyssinus subcutaneous allergen immunotherapy in depot presentation exhibited good safety and tolerability. Group A seemed to show the best profile for further clinical development.