Health-Related Quality of Life Impairment Among Patients with Severe Chronic Rhinosinusitis with Nasal Polyps in the SINUS-24 Trial.

Purpose: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2 inflammatory disease with a high symptom burden. Data are lacking on the comparative health status of patients with CRSwNP. This analysis compared baseline physical and mental health-related quality of life (HRQoL) and overall health status of patients with severe CRSwNP enrolled in a Phase 3 clinical trial with general population norms and with other chronic diseases. Methods: In this post hoc cross-sectional analysis of baseline data from the SINUS-24 study (NCT02912468), HRQoL was measured using the 36-item Short Form (SF-36) questionnaire and general health status was measured using the EuroQol-5 Dimension visual analog scale (EQ-VAS). Analyses included the intention-to-treat (ITT) population and subgroups defined by prior sinonasal surgery, systemic corticosteroid use, and coexisting asthma or non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD). Scores were compared with published values for population norms (50 for SF-36 physical component summary (PCS) and mental component summary (MCS), 70.4-83.3 for EQ-VAS) and for rheumatoid arthritis, type 2 diabetes, and asthma. Results: In the ITT population (n=276), mean SF-36 physical component summary (PCS), SF-36 mental component summary (MCS), and EQ-VAS scores were below general population norms (46.4, 48.6, and 66.0, respectively). Mean SF-36 PCS and EQ-VAS scores were below population norms across all subgroups; mean SF-36 MCS scores were below the population norm in all subgroups except no prior surgery. SF-36 PCS and MCS scores from SINUS-24 were generally similar to other chronic diseases, except SF-36 PCS which was lower in rheumatoid arthritis. EQ-VAS scores in SINUS-24 were lower than in other chronic diseases. HRQoL scores weakly correlated with objective measures of disease severity. Conclusion: In patients with severe CRSwNP, including those with coexisting asthma/NSAID-ERD, HRQoL was worse than population norms and as burdensome as diseases such as type 2 diabetes, asthma, and rheumatoid arthritis.

Rhinosinusitis symptoms, smoking and COPD: Prevalence and associations.

OBJECTIVE (S): To estimate the prevalence and associations among rhinosinusitis symptoms, smoking and chronic obstructive pulmonary disease (COPD). DESIGN: Cross-sectional study. SETTING: Population-based. PARTICIPANTS: All adults aged 40 years or more living in the selected households in the city of Florianópolis (Florianópolis, Santa Catarina, Brazil). MAIN OUTCOME MEASURES: Assessment instruments comprised household interviews, anthropometric measurements and spirometry. Rhinosinusitis symptoms were based on the responses to the 22-item Sinonasal Outcome Test (SNOT-22) questionnaire; smoking status was defined by the criteria of the CDC, and the functional diagnosis of COPD was done by spirometry. RESULTS: The prevalence (n = 1056) of rhinosinusitis symptoms, smoking and COPD was 14.7%, 17.9% and 8.7%, respectively. Multivariate analysis showed that, with the exception of COPD, all other clinical variables (smoking, previous diagnosis of rhinitis, previous diagnosis of gastritis/ulcer/gastroesophageal reflux, and symptoms of depression) remained associated with higher prevalence of rhinosinusitis symptoms. CONCLUSIONS: Rhinosinusitis symptoms were common both in smokers and in patients with COPD. However, only tobacco was significantly associated with rhinosinusitis symptoms and can act as a cofounder in the association between COPD and rhinosinusitis symptoms.

SNOT-22: adaptação cultural e propriedades psicométricas para a língua portuguesa falada no Brasil / SNOT-22: psychometric properties and cross-cultural adaptation into the portuguese language spoken in Brazil

A rinossinusite apresenta alta prevalência, gera gastos vultosos e o seu impacto vem sendo demonstrado por questionários genéricos de qualidade de vida. Todavia, instrumentos genéricos podem não detectar efeito de intervenções e tratamentos. O SNOT-22 figura entre os principais instrumentos doença-específico na avaliação da qualidade de vida dos pacientes com rinossinusite. Contudo, não existe versão validada deste questionário no Brasil. OBJETIVO: Adaptar culturalmente para o português falado no Brasil o SNOT-22 e avaliar suas propriedades psicométricas. MÉTODO: A versão em português foi desenvolvida obedecendo robusta metodologia preconizada pela literatura e incluiu 1) Preparação 2) Tradução para o português por três médicos, independentemente 3) Conciliação para versão única em português 4) Retradução 5) Comparação da retradução com a versão original 6) Avaliação pela autora do SNOT-22 da retradução 7) Revisão da versão em português por especialistas 8) Desdobramentos cognitivos 9) Versão final. A segunda fase: estudo prospectivo que verificou as propriedades psicométricas por meio da consistência interna e confiabilidade teste-reteste. RESULTADOS: A adaptação cultural do instrumento apresentou compreensão, aceitabilidade e propriedades psicométricas adequadas. CONCLUSÃO: Conduzimos a adaptação cultural do SNOT-22 para o português falado no Brasil, produzindo um instrumento de grande importância clínica e para estudos científicos.

Rhinosinusitis is a highly prevalent disease and a major cause of high medical costs. It has been proven to have an impact on the quality of life through generic health-related quality of life assessments. However, generic instruments may not be able to factor in the effects of interventions and treatments. SNOT-22 is a major disease-specific instrument to assess quality of life for patients with rhinosinusitis. Nevertheless, there is still no validated SNOT-22 version in our country. OBJECTIVE: Cross-cultural adaptation of the SNOT-22 into Brazilian Portuguese and assessment of its psychometric properties. METHOD: The Brazilian version of the SNOT-22 was developed according to international guidelines and was broken down into nine stages: 1) Preparation 2) Translation 3) Reconciliation 4) Back-translation 5) Comparison 6) Evaluation by the author of the SNOT-22 7) Revision by committee of experts 8) Cognitive debriefing 9) Final version. Second phase: prospective study consisting of a verification of the psychometric properties, by analyzing internal consistency and test-retest reliability. RESULTS: Cultural adaptation showed adequate understanding, acceptability and psychometric properties. CONCLUSION: We followed the recommended steps for the cultural adaptation of the SNOT-22 into Portuguese language, producing a tool for the assessment of patients with sinonasal disorders of clinical importance and for scientific studies.

SNOT-22: psychometric properties and cross-cultural adaptation into the Portuguese language spoken in Brazil.

UNLABELLED: Rhinosinusitis is a highly prevalent disease and a major cause of high medical costs. It has been proven to have an impact on the quality of life through generic health-related quality of life assessments. However, generic instruments may not be able to factor in the effects of interventions and treatments. SNOT-22 is a major disease-specific instrument to assess quality of life for patients with rhinosinusitis. Nevertheless, there is still no validated SNOT-22 version in our country. OBJECTIVE: Cross-cultural adaptation of the SNOT-22 into Brazilian Portuguese and assessment of its psychometric properties. METHOD: The Brazilian version of the SNOT-22 was developed according to international guidelines and was broken down into nine stages: 1) Preparation 2) Translation 3) Reconciliation 4) Back-translation 5) Comparison 6) Evaluation by the author of the SNOT-22 7) Revision by committee of experts 8) Cognitive debriefing 9) Final version. Second phase: prospective study consisting of a verification of the psychometric properties, by analyzing internal consistency and test-retest reliability. RESULTS: Cultural adaptation showed adequate understanding, acceptability and psychometric properties. CONCLUSION: We followed the recommended steps for the cultural adaptation of the SNOT-22 into Portuguese language, producing a tool for the assessment of patients with sinonasal disorders of clinical importance and for scientific studies.