Ricardo M Fernandes1,2, Maria Gabriela Andrade2, Carolina Constant1,3, Duarte Malveiro4, Manuel Magalhães5,6, Daisy Abreu2, Inês Azevedo5,7, Eduarda Sousa4, Rizério Salgado8, Teresa Bandeira1,9. 1. Department of Paediatrics, Hospital de Santa Maria, Centro Académico de Medicina de Lisboa, Lisboa, Portugal. 2. Clinical Pharmacology Unit, Instituto de Medicina Molecular, Faculty of Medicine, University of Lisbon, Lisboa, Portugal. 3. Department of Paediatrics, Unidade de Torres Vedras, Centro Hospitalar do Oeste, Torres Vedras, Portugal. 4. Department of Paediatrics, Centro Hospitalar Lisboa Ocidental, Lisboa, Portugal. 5. Department of Paediatrics, Faculty of Medicine, University of Porto, Porto, Portugal. 6. CINTESIS-Center for Research in Health Technologies and Information Systems, Porto, Portugal. 7. EPI Unit, Institute of Public Health, University of Porto, Porto, Portugal. 8. Unidade de Saúde Familiar S. Julião, Centro de Saúde de Oeiras, Oeiras, Portugal. 9. Clínica Universitária de Pediatria, Faculty of Medicine, University of Lisbon, Portugal.
Abstract
BACKGROUND: Two key limitations hamper intervention research in bronchiolitis: the absence of a clear definition of disease, and the heterogeneous choice of outcome measures in current clinical trials. We assessed how paediatricians and general practitioners (GPs) perceived definition and clinically important outcomes in bronchiolitis. METHODS: A nationwide online survey (ABBA study) was conducted through the Portuguese Society of Paediatrics and GPs' mailing lists. We assessed agreement with statements on bronchiolitis definition, and participants were asked to score the relative importance of several outcomes. Principal component analysis (PCA) explored dimensions underlying disease definition. Outcomes were ranked by mean score and proportion given highest score. RESULTS: We included 514 paediatricians and 165 GPs (overall 59% were board-certified). Most paediatricians (76.5%) agreed with a definition based on coryza, wheezing and/or crackles/rales, compared to 38.1% GPs (P < 0.001). Less than 5% physicians agreed with a definition commonly used in clinical trials (<12 months, first episode of wheeze). We retained three dimensions on PCA: one based on coryza, rales/crepitations and no sudden onset; another on number of episodes and age; and a third on wheeze. Dimensions varied by physician specialization and training (P < 0.01). Hospital admission and respiratory distress were top rated outcomes by both groups of physicians. CONCLUSIONS: Physician definitions of bronchiolitis have considerable variability and often mismatch those of clinical trials. Rating of important outcomes was consistent. Our results highlight the need for a robust standardized definition of acute bronchiolitis in infants and support the development of a core outcome set for future clinical trials. Pediatr Pulmonol. 2016;51:724-732.
BACKGROUND: Two key limitations hamper intervention research in bronchiolitis: the absence of a clear definition of disease, and the heterogeneous choice of outcome measures in current clinical trials. We assessed how paediatricians and general practitioners (GPs) perceived definition and clinically important outcomes in bronchiolitis. METHODS: A nationwide online survey (ABBA study) was conducted through the Portuguese Society of Paediatrics and GPs' mailing lists. We assessed agreement with statements on bronchiolitis definition, and participants were asked to score the relative importance of several outcomes. Principal component analysis (PCA) explored dimensions underlying disease definition. Outcomes were ranked by mean score and proportion given highest score. RESULTS: We included 514 paediatricians and 165 GPs (overall 59% were board-certified). Most paediatricians (76.5%) agreed with a definition based on coryza, wheezing and/or crackles/rales, compared to 38.1% GPs (P < 0.001). Less than 5% physicians agreed with a definition commonly used in clinical trials (<12 months, first episode of wheeze). We retained three dimensions on PCA: one based on coryza, rales/crepitations and no sudden onset; another on number of episodes and age; and a third on wheeze. Dimensions varied by physician specialization and training (P < 0.01). Hospital admission and respiratory distress were top rated outcomes by both groups of physicians. CONCLUSIONS: Physician definitions of bronchiolitis have considerable variability and often mismatch those of clinical trials. Rating of important outcomes was consistent. Our results highlight the need for a robust standardized definition of acute bronchiolitis in infants and support the development of a core outcome set for future clinical trials. Pediatr Pulmonol. 2016;51:724-732.
Authors: Clare van Miert; Ricardo M Fernandes; Helen Eccleson; Emma Bedson; Steven Lane; Matthew Peak; Kent Thorburn; Vanessa Compton; Kerry Woolfall; David Lacy; Paula Williamson; Paul S McNamara Journal: Trials Date: 2018-11-14 Impact factor: 2.279