Abstract
Pseudomonas aeruginosa status influences cystic fibrosis (CF) clinical management but no ‘gold standard’ definition exists. The Leeds criteria are commonly used but may lack sensitivity for chronic P. aeruginosa. We compared clinicians’ decision with the Leeds criteria in three adult CF centres. Two independent prospective datasets (Sheffield dataset, n = 185 adults; ACtiF pilot dataset, n = 62 adults from two different centres) were analysed. Clinicians involved in deciding P. aeruginosa status were blinded to the study objectives. Clinicians considered more adults with CF to have chronic P. aeruginosa infection compared to the Leeds criteria. This was more so for the Sheffield dataset (106/185, 57.3% with clinicians’ decision vs. 80/185, 43.2% with the Leeds criteria; kappa coefficient between these two methods 0.72) compared to the ACtiF pilot dataset (34/62, 54.8% with clinicians’ decision vs. 30/62, 48.4% with the Leeds criteria; kappa coefficient between these two methods 0.82). However, clinicians across different centres were relatively consistent once age and severity of lung disease, as indicated by the type of respiratory samples provided, were taken into account. Agreement in P. aeruginosa status was similar for both datasets among adults who predominantly provided sputum samples (kappa coefficient 0.78) or adults > 25 years old (kappa coefficient 0.82). Across three different centres, clinicians did not always agree with the Leeds criteria and tended to consider the Leeds criteria to lack sensitivity. Where disagreement occurred, clinicians tended to diagnose chronic P. aeruginosa infection because other relevant information was considered. These results suggest that a better definition for chronic P. aeruginosa might be developed by using consensus methods to move beyond a definition wholly dependent on standard microbiological results.
Highlights
Cystic fibrosis (CF), an autosomal recessive genetic condition, affects around 10,000 people in the UK [1]
P. aeruginosa status and management decisions related to P. aeruginosa status are often decided by clinicians in routine clinical practice, this is the first study that formally evaluates clinicians’ diagnosis of P. aeruginosa status among adults with CF
This study demonstrated that clinicians diagnosed chronic P. aeruginosa when the Leeds criteria did not, partly because clinicians placed less importance on negative cough swabs, and, in the face of negative cough swabs, integrated other relevant information to decide on P. aeruginosa status
Summary
Cystic fibrosis (CF), an autosomal recessive genetic condition, affects around 10,000 people in the UK [1]. It is a multisystem condition; lungs (resulting in recurrent infections and respiratory failure) and the gastrointestinal tract (resulting in malabsorption of fat and poor growth) are the two main affected organs. P. aeruginosa infection is associated with increased risk of pulmonary exacerbations and accelerated lung function decline [3]. Eradication therapy mitigates lung function decline and delays onset of chronic infection [4], while longterm inhaled antibiotics reduce the risk of exacerbation and improves lung function in those with chronic P. aeruginosa infection [5].
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