Measuring and reporting quality of life outcomes in clinical trials in cystic fibrosis: a critical review
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Review
Measuring and reporting quality of life outcomes in clinical trials in cystic fibrosis: a critical review Janice Abbott* and Anna Hart Address: Faculty of Health, University of Central Lancashire, Preston, PR1 2HE, UK Email: Janice Abbott* - [email protected]; Anna Hart - [email protected] * Corresponding author
Published: 24 March 2005 Health and Quality of Life Outcomes 2005, 3:19
doi:10.1186/1477-7525-3-19
Received: 10 March 2005 Accepted: 24 March 2005
This article is available from: http://www.hqlo.com/content/3/1/19 © 2005 Abbott and Hart; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract Good quality clinical trials are essential to inform the best cystic fibrosis (CF) management and care, by determining and comparing the effectiveness of new and existing therapies and drug delivery systems. The formal inclusion of quality of life (QoL) as an outcome measure in CF clinical trials is becoming more common. Both an appropriate QoL measure and sound methodology are required in order to draw valid inferences about treatments and QoL. A review was undertaken of randomised controlled trials in cystic fibrosis where QoL was measured. EMBASE, MEDLINE and ISI Web of Science were searched to locate all full papers in the English language reporting randomised controlled trials in cystic fibrosis, published between January 1991 and December 2004. All Cochrane reviews published before December 2004 were hand searched. Papers were included if the authors had reported that they had measured QoL or well being in the trial. 16 trials were identified. The interventions investigated were: antibiotics (4); home versus hospital administration of antibiotics (1); steroids (1); mucolytic therapies (6); exercise (3) and pancreatic enzymes (1). Not one trial evaluated in this review provided conclusive results concerning QoL. This review highlights many of the pitfalls of QoL measurement in CF clinical trials and provides constructive information concerning the design and reporting of trials measuring QoL.
Review Cystic fibrosis and its management Cystic fibrosis (CF) is a life threatening, recessively inherited disease caused by defects in a single gene on chromosome 7 [1,2]. The faulty gene causes an increased production of thickened secretions in most organs of the body. In the respiratory tract this impairs the clearance of micoorganisms resulting in recurrent infections, inflammation, lung damage and eventually death from respiratory failure. In the pancreas, the pancreatic exocrine cells become blocked, leading to the failure of the pancreas to produce digestive enzymes causing the maldigestion and malabsorption of nutrients. Current median survival is
more than 30 years [3,4], and half of children born in the 1990's are expected to survive t
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