Development and validation of a questionnaire for the assessment of the knowledge, management and reporting ADR in paediatrics by healthcare teams (QUESA-P)

Abstract

Objective We aimed to develop and validate a new instrument called Questionnaire for the assessment of the knowledge, management and reporting ADR in Paediatrics by Healthcare teams (QUESA-P). Design This is a cross-sectional study. Settings and participants Teams of healthcare professionals (HCP) that lead with pharmacological therapy in Paediatrician's sector (Paediatric-HCP) in seven public hospitals in Brazil. Outcome An assessment of the knowledge and current management of ADR in Paediatric-HCP. Methods We developed and validated QUESA-P, using a standardised procedure which included item development and psychometric prevalidation using Cronbach's Alpha, item-total correlation and test-retest validity for internal consistency and reliability. External criterion was used as criterion validation (the instrument was applied to the focus group expert vs focus group team of Paediatric-HCP in hospitals). The focus group of experts who participated in psychometrics was asked to respond to the QUESA-P twice in order to assess test-retest reliability. The content validity of the initial questionnaire was assessed by the Delphi method and pilot test. Subsequently, we made minor revisions and finalized the QUESA-P Results Selection of domains and facets were based on literature review made in duplicate by authors. Content validity was done by trial of different examiners (panellists, n=16), conducting analysis through Delphi method (three rounds). The QUESA-P was constructed with three domains. The intraclass correlations (0.80) and the Cronbach's alpha coefficient (0.82), indicated adequate test-retest reliability and internal consistency for each domain. The application of the QUESA to 61 Paediatric-HCP in hospital resulted in lower mean score of 42.1 ± 3.4 in all domains when compared with expert teams (n= 46) 48.2 ± 3.7 (p <0.001) indicating that the instrument is valid to discriminate QUESA experts and Paediatric-HCP. Conclusion The selected domains can be used to check weaknesses in the identification, management and reporting of suspected ADR by Paediatric-HCP in Brazil.