Drug Hypersensitivity Quality of Life Questionnaire: validation procedures and first results of the Portuguese version

Background: Hypersensitivity reactions to drugs are unpredictable and can be very complex and severe, even life threatening. Assess its impact on patient’s health related quality of life (HRQoL) is crucial. The Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q) is the only validated disease-specific HRQoL questionnaire. We aimed to translate and cross-cultural validate the DrHy-Q to the Portuguese population. It was also our purpose to determine the impact of drug hypersensitivity on patients’ HRQoL. Methods: The translation and cross-cultural adaptation of the DrHy-Q to Portuguese was performed according to standards. Reliability of the DrHy-Q Portuguese version was assessed in terms of internal consistency and test–retest reliability. Structural validity, divergent validity (with a generic health related QoLQ-PGWBI) and discriminant validity were also evaluated. Forty patients accepted to participate in the validation phase. The Portuguese version of the DrHy-Q was applied to 260 consecutively adult patients, studied in our Department for suspected drug hypersensitivity. Results: The Portuguese DrHy-Q showed adequate internal consistency (Cronbach’s ¿ = 0.938), good test–retest reliability [ICC = 0.713 (95% CI 0.488–0.850] and one-dimensional structure. No significant correlation was found between the DrHy-Q and the PGWBI total scores (r = - 0.010, p = 0.957). Two hundred of patients completed the study: 78.5% female; mean age = 44 ± 15 years. Mean DrHy-Q score was 36.8 ± 12.6. Two clinical factors significantly predict DrHy-Q total score: clinical manifestations and number of suspected drugs. Patients with anaphylaxis (ß = 11.005; 95% CI 5.523; 16.487), urticaria/angioedema (ß = 7.770; 95% CI 2.600; 12.940) and other manifestations (ß = 7.948; 95% CI 1.933; 13.962) are more likely to have higher DrHy-Q total score than patients with maculopapular exanthema. Patients with = 2 suspected drugs are also more likely to have worse QoL (ß = 7.927; 95% CI 3.687; 12.166). Conclusion: The Portuguese version of DrHy-Q revealed adequate validity and reliability, indicating that it is appropriate to assess the impact of drug hypersensitivity on patients’ HRQoL, providing data for a better comprehension and management of our patients. Moreover, our results highlight that the severity of the drug hypersensitivity reaction and the number of suspected drugs have impact on patient’s DrHy-QoL

the portuguese version of rhinitis and asthma patient s perspective rapp validation and assessment

Abstract Background Allergic rhinitis (AR) and asthma are two common chronic diseases that often coexist. There is a need for a validated tool to evaluate HRQoL of Portuguese speakers with asthma and/or rhinitis patients in clinical practice. Objectives To adapt and validate RhinAsthma Patient Perspective (RAPP) in Portuguese. Methods The RAPP questionnaire was translated into Portuguese. Asthmatics with comorbidities and rhinitis attending the allergy department of Coimbra University Hospital were asked to complete the Portuguese translation of RAPP, in addition to the SF-12, ACT, and a Symptomatologic VAS twice, with a 4-week interval between visits. During Visit 2, a Global Rating Scale (GRS) was completed to assess any change in health status. Scale dimensions, internal consistency and convergent validity, reliability, discriminant ability and responsiveness to change, as well as Minimal Clinical Difference were assessed. Results Factor and confirmatory analysis confirm the unidimensional structure of the questionnaire. Internal consistency has been shown to be satisfactory (0.82 visit 1 and 0.86 at visit 2). The tool is able to discriminate between patients on the basis of asthma severity, asthma control level, and rhinitis severity; convergent validity showed a significant correlation with SF-2 Physical component (r = −0.46 and 0.42, p at Visits 1 and 2). An ICC of 0.97 and a CCC = 0.94 indicate that the tool is highly reliable. Responsiveness was shown in detecting a significant association with GRS changes (r = 0.41, p Conclusions The Portuguese version of RAPP has been demonstrated to have good measurement properties and sensitivity to health changes, which will provide a valid, reliable and standardized HRQoL measurement in patients with asthma and comorbid allergic rhinitis in clinical practice

Patients and doctors group meetings: an innovative way to explore severe asthma backstage

Severe asthma patients' life is heavily influenced by the disease, which has impact on personal and professional choic-es or general lifestyle. Despite the available tools to help physicians investigating the patient-reported outcomes there is a need for a more standardised and structured approach to include the evaluation of quality of life together with the emotions of patients into the routine clinical interaction. We hereby report the use of an active listening and insight approach to understand the emotions of patients with severe asthma through dedicated in-person meetings involving a group of patients with their doctors, caregivers and an external moderator. The initiative "Patients insight meeting" was organized within 17 specialist referral centres for severe asthma in Italy in 2019 and involved 149 patients. Insights related to 4 different items were collected and a task force composed by the external moderators produced a general report including the suggestions from the participating centres. This experience of group-meetings involving both patients and doctors together represents an innovative way to investigate real life experience and the emotions of asthmatic patients, highlighting unmet needs related to patient's experience of his/her disease that need to be included in severe asthmatics' management strategy

Liposomes: a new non-pharmacological therapy concept for seasonal-allergic-rhinoconjunctivitis

Mucosal barrier disorders play an important role in the pathomechanism of the allergic disease. A new approach for their treatment uses liposomes, which consist of phospholipids that make up 75% of the protective nasal surfactant layer. Our aim was to investigate the efficacy of liposomal-based therapy, as a comprehensive treatment alternative to guideline cromoglycate-based therapy, in the treatment of seasonal allergic rhinoconjunctivitis (SAR). We compared nasal and conjunctival symptom reduction with LipoNasal n nasal spray used as monotherapy (LNM), or LipoNasal n nasal spray and Tears Again eye spray combination therapy (LTC), against standard cromoglycate combination therapy (CGC). This prospective, controlled, open observational study was conducted monocentrically. According to their symptoms and preferences 72 patients with SAR were distributed in three equal groups. The study comprised two visits at an interval of 7 days. The efficacy was examined by daily documenting nasal and conjunctival symptom scores. The Nasal-Spray-Sensory-Scale and the Eye-Drops/Spray-Sensory-Scale were used to investigate the tolerability. Quality of life (QoL) was evaluated, using the RHINASTHMA QoL German adapted version. LNM achieved significant improvement in nasal (p < 0.001) and conjunctival symptoms (p = 0.050). The symptom reduction using CGC was equally significant. LTC led to significant nasal symptom relief (p = 0.045). QoL did not improve significantly in all groups (p > 0.05). The tolerability of all treatments was good and no adverse reactions were observed. In all treatment groups the improvement of the nasal and conjunctival symptom scores exceeds the minimal clinically important difference (MCID). The results demonstrate good tolerability and efficacy of non-pharmaceutical liposomal-based treatment (LipoNasal n and Tears Again), given as monotherapy or combination therapy, for nasal and conjunctival symptoms caused by SAR. This study indicates that liposomal-based treatment for SAR may be a comparable alternative to cromoglycate therapy. Further studies are needed to verify these findings

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

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

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

Impact of children's respiratory allergies on caregivers.

Background. Despite the great attention that has been paid to HRQoL in children with respiratory allergy, few studies have addressed this aspect in relation to caregivers. The aim of our study was to evaluate the impact of childhood respiratory allergies on caregivers by means of a new method. Methods. 119 parents of children suffering from allergies (75 suffering from asthma and 44 suffering from rhinitis) were recruited from three Italian Allergy Units. Parents were asked to complete the Disease Impact On Caregiver (DIOC), a new non disease specific questionnaire, validated on the Italian population. The questionnaire consists of 31 items grouped in four factors (Performance, Personal gratification, Psychophysical endurance, Socio-emotional domain) and covers the life aspects that could be affected by the assistance duties towards an ill family member. Results. Child's asthma resulted to have a worse impact on many aspects of a parents' life than rhinitis. Differences resulted to be statistically significant in 19 aspects out of the 31 assessed. The worse impact of asthma versus rhinitis was confirmed in the following domains: Performance (24.0±18.2 vs 11.5±17.8), Personal gratification (26.3±20.5 vs 12.1±16.5) and Psychophysical endurance (35.0±24.8 vs 18.8±21.7). In the Socio-emotional domain no difference emerged. Conclusions. Compared to parents of rhinitics, parents of asthmatic children appear to be more compromised in their resistance to stress, mood, emotional stability, amount of spare time and leisure activities. Our results suggest the need of giving the due attention to these problems both in clinical practice and in research, in order to avoid possible interferences of the caregiver's distress in the optimization of treatment outcome