Measuring Clinical Severity in Infants with Bronchiolitis

Van Miert, Clare
Measuring Clinical Severity in Infants with Bronchiolitis. PhD thesis, University of Liverpool.

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Bronchiolitis is a viral lower respiratory tract infection of infancy and a major cause of infant morbidity. Respiratory syncytial virus is the most common cause of bronchiolitis. The majority of infants infected with bronchiolitis will have mild symptoms, lasting up to five days with the infant being successfully managed at home. However, up to 3% of all infants will be admitted to hospital for supportive therapy, such as oxygen and/ or fluids. A small proportion of these hospitalised infants (10%) will rapidly deteriorate further and require critical care admission for either invasive or non-invasive ventilation. Many clinical trials have been undertaken to evaluate a number of pharmaceutical interventions used to treat bronchiolitis. However, no treatment intervention has been proven to be effective. A large proportion of these clinical trials used clinical severity scores as an outcome measure. These clinical severity scores had not undergone any rigorous development and validation as recommended by the Food and Drug Agency (FDA) when developing an outcome measure for clinical trials. This thesis sets out the psychometric methods used to develop and validate the Liverpool Infant Bronchiolitis Severity Score – Proxy Reported Outcome Measure (LIBSS-PRO). The premise of the LIBSS-PRO is two-fold. Firstly, the LIBSS-PRO has been primarily developed for use in daily clinical management to identify infant improvement or deterioration. This will contribute to the standardisation of patient care and facilitate clinical decision making. Secondly, by fulfilling the FDA criteria as an outcome measure the LIBSS-PRO will improve the quality of future clinical trials of treatment interventions for bronchiolitis. The study was divided into three phases over three bronchiolitis seasons. The first phase was concerned with the development of the LIBSS-PRO. Items were identified from the literature and through stakeholder group workshops. A conceptual framework of bronchiolitis severity was developed. Consensus methods were used to identify which items were considered the most important and to develop criteria for mild, moderate and severe bronchiolitis. The second phase determined the content validity of the LIBSS-PRO. The LIBSS-PRO was evaluated by a range of health care professionals working in a variety of clinical environments by applying the score to eligible infants. Cognitive interviewing of health care professionals was used to assess comprehension and interpretation of each section of the LIBSS-PRO. Finally, in phase three, clinical field testing was undertaken in a variety of clinical locations by health care professionals to establish construct and criterion validity and reliability of the LIBSS-PRO. Responsiveness to change and cross cultural validation will be assessed in future clinical trials.

Item Type: Thesis (PhD)
Additional Information: Date: 2015-06 (completed)
Subjects: ?? RJ101 ??
Depositing User: Symplectic Admin
Date Deposited: 15 Jan 2016 15:43
Last Modified: 17 Dec 2022 01:18
DOI: 10.17638/02037906