Background-Health related quality of life (HRQoL) measurement is important in determining the impact of disease on daily functioning and subsequently informing interventions. In cystic fibrosis (CF) generic HRQoL measures have been employed but these may not be suYciently specific. The aim of the current work was to develop and validate a disease specific HRQoL measure for adults and adolescents with cystic fibrosis. Methods-Areas of concern to adults and adolescents with CF were identified by unstructured interviews, selfadministered questionnaires, consultation with multidisciplinary specialist staV, a review of the relevant literature, and examination of other HRQoL measures. Advances in the care and treatment of cystic fibrosis (CF) have resulted in most patients surviving into adulthood.1 Despite these improvements, CF remains a progressive and ultimately fatal multisystem disease that has a heavy treatment regimen.2 Given this, a new goal for intervention in CF should be to measure and improve health related quality of life (HRQoL) in relation to medical and psychosocial interventions. The measurement of HRQoL complements clinical measures of disease status such as respiratory function tests. Once developed a questionnaire would be useful as (a) an outcome measure in clinical trials, (b) for the assessment of disease progression, and (c) for the monitoring of individual patients.To date, HRQoL in adults with CF has been measured using either generic scales 3-5 or disease specific respiratory measures.6-9 These measures were not developed for the CF population and are limited since they do not reflect areas of functioning that are particularly salient to the adult with CF. Because of this the data are likely to lack sensitivity and be problematic in their interpretation. This work aims to develop, test, and validate a disease specific measure of HRQoL for adults and adolescents with CF. The measure should include areas of functioning that are meaningful to adults with CF, be brief enough to be applied in a clinical setting (that is, completion time of about 10 minutes), be simple to administer and score (for use in clinical settings and postal surveys), and be sensitive enough to detect both changes in health within the individual and diVerences between levels of disease severity.The development, testing, and validation of the Cystic Fibrosis Quality of Life (CFQoL) questionnaire took place over four phases: (1) initial item generation and testing of a preliminary questionnaire; (2) testing and validation of a second version of the questionnaire including concurrent and discriminative validity; (3) test-retest reliability of a third and final version of the questionnaire; and (4) sensitivity testing of the final version of the questionnaire. The step by step development and validation of the CFQoL is reflected in the structure of this paper with the various methods and results sections reported in sequential order for each stage of development and testing. Thorax 2000;55:946-954 946

A mechanistic understanding of the relationship between the chemistry of drug antigen formation and immune function is lacking. Thus, mass spectrometric methods were employed to detect and fully characterize circulating antigens derived from piperacillin in patients undergoing therapy and the nature of the drug derived-epitopes on protein which can function as an antigen to stimulate T-cells. Albumin modification with piperacillin in vitro resulted in the formation of two distinct haptens, one formed directly from piperacillin and a second in which the dioxopiperazine ring had undergone hydrolysis. Modification was time- and concentration-dependent, with selective modification of Lys541 observed at low concentrations, whereas at higher concentrations up to 13/59 lysine residues were modified, four of which (Lys190, 195, 432 and 541) were detected in patients’ plasma. Piperacillin-specific T-lymphocyte responses (proliferation, cytokines and granzyme-B release) were detected ex vivo with cells from hypersensitive patients, and analysis of incubation medium showed that modification of the same lysine residues in albumin occurred in situ. The antigenicity of piperacillin-modified albumin was confirmed by stimulation of T-cells with characterized synthetic conjugates. Analysis of minimally-modified T-cell stimulatory albumin conjugates revealed peptide sequences incorporating Lys190, 432 and 541 as principal functional epitopes for T-cells. This study has characterized the multiple haptenic structures on albumin in patients, and showed that they constitute functional antigenic determinants for T-cells.

Disease severity has an impact on HRQoL in adolescents and adults with CF. Some differences emerged between males and females, with females generally reporting poorer HRQoL. Evidence indicated that males and females perceived their health status differently, with females having a more accurate perception of objective clinical health status.

The aim of the study was to investigate the reliability of a new test of soccer performance and evaluate the effect of carbohydrate (CHO) on soccer performance. Eleven university footballers were recruited and underwent 3 trials in a randomized order. Two of the trials involved ingesting a placebo beverage, and the other, a 7.5% maltodextrin solution. The protocol comprised a series of ten 6-min exercise blocks on an outdoor Astroturf pitch, separated by the performance of 2 of the 4 soccer-specific tests, making the protocol 90 min in duration. The intensity of the exercise was designed to be similar to the typical activity pattern during soccer match play. Participants performed skill tests of dribbling, agility, heading, and shooting throughout the protocol. The coefficients of variation for dribbling, agility, heading, and shooting were 2.2%, 1.2%, 7.0%, and 2.8%, respectively. The mean combined placebo scores were 42.4 +/- 2.7 s, 43.1 +/- 3.7 s, 210 +/- 34 cm, and 212 +/- 17 points for agility, dribbling, heading, and kicking, respectively. CHO ingestion led to a combined agility time of 41.5 +/- 0.8 s, for dribbling 41.7 +/- 3.5 s, 213 +/- 11 cm for heading, and 220 +/- 5 points for kicking accuracy. There was a significant improvement in performance for dribbling, agility, and shooting (p < .05) when CHO was ingested compared with placebo. In conclusion, the protocol is a reliable test of soccer performance, and ingesting CHO leads to an improvement in soccer performance.

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