A multi-centre study on quality of life and absenteeism in patients with CRS referred for endoscopic surgery

Aims: This study summarises the health-related quality of life (HRQOL) scores and absenteeism caused by sinus problems in patients awaiting surgery with the diagnoses recurrent acute rhinosinusitis (RARS), chronic rhinosinusitis with nasal polyps (CRS+NP) or CRS without nasal polyps (CRS-NP), in a prospective multi-centre study. Methodology: Two hundred and seven patients with RARS, CRS+NP or CRS-NP were enrolled. EP3OS definitions of CRS and NP were used. The patients completed the 22 Sinonasal Outcome Test (SNOT-22), the short-form 36-item questionnaire (SF-36), the Hospital Anxiety and Depression Scale (HAD) and a total Visual Analogue Scale (VAS) regarding rhinosinusitis symptoms. Results: SNOT-22 and VAS scores indicated severe disease. Comparison of the HRQOL scores in the three rhinosinusitis subgroups showed statistical differences in nine of the SNOT-22 items and in the SF-36 subscale of bodily pain. Mean scores of SF-36 were significantly lower than that of the normal Swedish population. According to the HAD scores, 28% of the patients had probable or possible anxiety or depression disorder. Fifty-seven percent of the patients reported absenteeism from work due to sinus problems. Conclusions: RARS, CRS+NP and CRS-NP significantly decrease HRQOL. Some statistically significant differences in HRQOL were found between the three rhinosinusitis subgroups. Absenteeism due to chronic sinus conditions is considerable

Minimal clinically important difference for asthma endpoints: an expert consensus report

Minimal clinically important difference (MCID) can be defined as the smallest change or difference in an outcome measure that is perceived as beneficial and would lead to a change in the patient's medical management.The aim of the current expert consensus report is to provide a "state-of-the-art" review of the currently available literature evidence about MCID for end-points to monitor asthma control, in order to facilitate optimal disease management and identify unmet needs in the field to guide future research.A series of MCID cut-offs are currently available in literature and validated among populations of asthmatic patients, with most of the evidence focusing on outcomes as patient reported outcomes, lung function and exercise tolerance. On the contrary, only scant and partial data are available for inflammatory biomarkers. These clearly represent the most interesting target for future development in diagnosis and clinical management of asthma, particularly in view of the several biologic drugs in the pipeline, for which regulatory agencies will soon require personalised proof of efficacy and treatment response predictors

Recommendations for assessing Patient-Reported Outcomes and Health-Related quality of life in clinical trials on allergy: a GA(2)LEN taskforce position paper

The aim of this Global Allergy and Asthma European Network (GA(2)LEN) consensus report is to provide recommendations for patient-reported outcomes (PROs) evaluation in clinical trials for allergic diseases, which constitute a global health problem in terms of physical, psychological economic and social impact. During the last 40 years, PROs have gained large consideration and use in the scientific community, to gain a better understanding of patients' subjective assessment with respect to elements concerning their health condition. They include all health-related reports coming from the patient, without involvement or interpretation by physician or others. PROs assessment should be performed by validated tools (disease-specific tools when available or generic ones) selected taking into account the aim of the study, the expected intervention effects and the determinant and confounding factors or patient-related factors which could influence PROs. Moreover, each tool should be used exclusively in the patient population following the authors' indications without modification and performing a cross-cultural validation if the tool must be used in a language that differs from the original. The result analysis also suggests that the relevance of PROs results in any interventional study should include a pre-post assessment providing information concerning statistical differences within or among groups, rates of response for the PROs and a minimal important difference for the population. The report underlines the importance of further investigation on some topics, such as the quality assessment of existing PROs tools, the definition of inclusion and exclusion criteria and a more extensive evaluation of the correlation between PROs, besides health-related quality of life, and clinical data

Mid‐Holocene site formation, diagenesis and human activity at the foothills of Serra da Estrela (Portugal)

UIDB/00749/2020 UIDP/00749/2020The Neolithic occupation of Penedo dos Mouros in the foothills of Serra da Estrela, Portugalʼs highest mountain, dates to the 5th to 4th millennia cal B.C. The siteʼs faunal assemblage is extremely rare in the regional prehistoric archaeological record, due to the acidity of the granitic geology. This underlines Penedo dos Mouros importance as a reference site for understanding early pastoralism in the region. Due to the insufficient survival of bone collagen for radiocarbon dating and the homogeneity of the stratigraphy, where most visible contacts are due to postdepositional processes, we chose micromorphology to address the reasons behind the bone preservation and to assess the stratigraphic integrity of the prehistoric deposit. Reworking of eroding saprolitic soils was a major factor in the sediment accumulation, with remains of short human occupation events. Possible evidence for clearance fires linked to the first occurrences of pastoralism practised in the region, creating open spaces for grazing, was identified. Post‐depositional carbonate cementation derived from ashes, identifiable at the microscopic scale, enabled bone preservation. Carbonate and spodic‐like features document water saturation once the sedimentation ceased. This sedimentary dynamic has broader geomorphological implications, such as an inferred post‐Neolithic incision of the stream valley adjacent to the site.publishersversionpublishe

A survey of clinical features of allergic rhinitis in adults

Background: Allergic rhinitis (AR) has high prevalence and substantial socio-economic burden. Material/Methods: The study included 35 Italian Centers recruiting an overall number of 3383 adult patients with rhinitis (48% males, 52% females, mean age 29.1, range 18–45 years). For each patient, the attending physician had to fill in a standardized questionnaire, covering, in particular, some issues such as the ARIA classification of allergic rhinitis (AR), the results of skin prick test (SPT), the kind of treatment, the response to treatment, and the satisfaction with treatment. Results: Out of the 3383 patients with rhinitis, 2788 (82.4%) had AR: 311 (11.5%) had a mild intermittent, 229 (8.8%) a mild persistent, 636 (23.5%) a moderate-severe intermittent, and 1518 (56.1%) a moderate-severe persistent form. The most frequently used drugs were oral antihistamines (77.1%) and topical corticosteroids (60.8%). The response to treatment was judged as excellent in 12.2%, good in 41.3%, fair in 31.2%, poor in 14.5%, and very bad in 0.8% of subjects. The rate of treatment dissatisfaction was significantly higher in patients with moderate-to-severe AR than in patients with mild AR (p<0.0001). Indication to allergen immunotherapy (AIT) was significantly more frequent (p<0.01) in patients with severe AR than with mild AR. . Conclusions: These fndings confirm the appropriateness of ARIA guidelines in classifying the AR patients and the association of severe symptoms with unsuccessful drug treatment. The optimal targeting of patients to be treated with AIT needs to be reassessed

Patients with Asthma and Comorbid Allergic Rhinitis: Is Optimal Quality of Life Achievable in Real Life?

Asthma trials suggest that patients reaching total disease control have an optimal Health Related Quality of Life (HRQoL). Moreover, rhinitis is present in almost 80% of asthmatics and impacts asthma control and patient HRQoL. We explored whether optimal HRQoL was reachable in a real-life setting, and evaluated the disease and patient related patterns associated to optimal HRQoL achievement. = 7.617; p<0.006).Approximately one third of the patients in our survey were found to have an optimal HRQoL. While unsatisfactory disease control was the primary reason why the remainder failed to attain optimal HRQoL, it is clear that illness perception and mood also played parts. Therefore, therapeutic plans should be directed not only toward achieving the best possible clinical control of asthma and comorbid rhinitis, but also to incorporating individualized elements according to patient-related characteristics

Urticaria : recommendations from the Italian Society of Allergology, Asthma and Clinical Immunology and the Italian Society of Allergological, Occupational and Environmental Dermatology

Background: Urticaria is a disorder affecting skin and mucosal tissues characterized by the occurrence of wheals, angioedema or both, the latter defining the urticaria-angioedema syndrome. It is estimated that 12-22% of the general population has suffered at least one subtype of urticaria during life, but only a small percentage (estimated at 7.6-16%) has acute urticaria, because it is usually self-limited and resolves spontaneously without requiring medical attention. This makes likely that its incidence is underestimated. The epidemiological data currently available on chronic urticaria in many cases are deeply discordant and not univocal, but a recent Italian study, based on the consultation of a national registry, reports a prevalence of chronic spontaneous urticaria of 0.02% to 0.4% and an incidence of 0.1-1.5 cases/1000 inhabitants/year. Methods: We reviewed the recent international guidelines about urticaria and we described a methodologic approach based on classification, pathophysiology, impact on quality of life, diagnosis and prognosis, differential diagnosis and management of all the types of urticaria. Conclusions: The aim of the present document from the Italian Society of Allergology, Asthma and Clinical Immunology (SIAAIC) and the Italian Society of Allergological, Occupational and Environmental Dermatology (SIDAPA) is to provide updated information to all physicians involved in diagnosis and management of urticaria and angioedema