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156 A service evaluation of the exercise facilities at a new CF centre
Posters / Journal of Cystic Fibrosis 15 (2016) S51–S120
described activities. There were no adverse events reported as a result of physiotherapy prescribing and all PPs rated their practice as ‘very safe’. Service remodelling was described as a result of prescribing practice – half of PPs were prescribing in inhalation test dosing clinics and reported ‘improved speed of access to inhaled drugs’ and ‘less reliance on doctors who are not familiar with CF drugs – a safer service’. Conclusion: The 2015 review of PPs in the UK has revealed an unsurprising trend towards the prescription of inhalation therapies, describes an extended role which is reported as ‘very safe’ and is resulting in service remodelling. Longitudinal data on patient outcome and experience of PPs is required to further understand the benefit of this role. 156 A service evaluation of the exercise facilities at a new CF centre F. Haynes1 , L. Durkin2 , E. Douglas2 , S. Millward1 , T. Hughes1 , M. Cook1 . 1 Nottingham University Hospitals, Wolfson CF Centre, Nottingham, United Kingdom; 2 University of Nottingham, Physiotherapy & Health Sciences, Nottingham, United Kingdom Objectives: The Wolfson Centre at Nottingham University Hospitals is a new regional centre that had input from CF patients in the development of the exercise facilities. Exploring patient’s opinions on current services is becoming increasingly important in the NHS and is crucial in the future development of new services. This service evaluation aimed to explore patient satisfaction and their use of the exercise facilities now that the centre is open. Methods: A questionnaire was designed and distributed as an exit questionnaire by clinicians at the centre between October and November 2014. Fourteen questionnaires were completed by inpatients at the centre. Descriptive statistics were used to evaluate the data. Results: All patients (n = 14) that completed the questionnaire exercised during admission to the centre. The majority of participants (n = 12) reported that they were “very satisfied” with the centre and the remaining respondents (n = 2) reported that they were “satisfied”. Open questions highlighted areas where satisfaction could be further improved, such as increasing the access to facilities out of normal working hours and to the variety of equipment and services offered. Conclusion: All patients (n = 14) that completed the questionnaire exercised during admission to the centre. The majority of participants (n = 12) reported that they were “very satisfied” with the centre and the remaining respondents (n = 2) reported that they were “satisfied”. Open questions highlighted areas where satisfaction could be further improved, such as increasing the access to facilities out of normal working hours and to the variety of equipment and services offered. 157 Staff shuttle walk challenge
S91
results will help patients put their own test results into perspective and allay some of the anxiety surrounding exercise assessment. The project has been a fun team building exercise and has also inspired some members of the team to improve their fitness levels. It may be necessary to offer annual exercise testing to staff in the future.
8. Gastroenterology/Liver Disease/Endocrinology 158 Background incidence of liver function test (LFT) abnormalities in patients (pts) with cystic fibrosis (CF) V. Seliger1 , L. Bessonova1 , N. Volkova1 , C. Simard1 , S. Tian1 . 1 Vertex Pharmaceuticals Incorporated, Boston, United States Objectives: LFT abnormalities are frequently observed in pts with CF, although supporting prospective epidemiological data are limited. We evaluated background incidence of LFT elevations across placebo arms of Vertex-sponsored CF clinical trials. Methods: Analyses included pts aged ≥6 years with CF randomized to placebo across 8 completed trials of novel CFTR modulator therapies, with ≥8 weeks of follow-up. LFTs of interest (measured every 2–8 weeks) included alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), total bilirubin (BIL), and alkaline phosphatase (ALP). Incidence rates (IRs) and proportions were assessed. Potentially clinically significant (PCS) LFT elevations were defined as ALT/AST/GGT >3× upper limit of normal (ULN) or BIL/ALP >2×ULN. Analyses were stratified by baseline ALT/AST. Results: Of 645 pts on placebo, 506 (78%) had normal baseline ALT/AST. Of those 506, 263 (52%) had at least one elevation above the ULN over an average of 5.6 months of follow-up (IR 15.5 per 100 person-months) and 42 (8%) had elevations considered PCS (IR 1.6 per 100 personmonths). Of 139 pts with a baseline ALT/AST abnormality, 32 (23%) had PCS elevations during follow-up (IR 4.6 per 100 person-months). Conclusion: LFT elevations were common in pts with CF and normal baseline ALT/AST and some were PCS. Pts with baseline ALT/AST abnormalities had more frequent PCS elevations. IRs of LFT elevations among placebo-treated pts in trials with close LFT monitoring were higher than previously reported. The true incidence may be underestimated due to strict trial exclusion criteria. Acknowledgement: Sponsored by Vertex Pharmaceuticals Incorporated (“Vertex”) 159 Evaluation of fibrosis and inflammation parameters of the liver in patients with diagnosed cystic fibrosis
S. Millward1 , F. Haynes1 , T. Hughes1 , J. Dewar1 . 1 Nottingham University Hospitals, Wolfson CF Centre, Nottingham, United Kingdom
S. Wiecek1 , H. Wos1 , B. Kordys-Darmolinska1 , U. GrzybowskaChlebowczyk1 . 1 Medical University of Silesia, Department of Paediatrics, Katowice, Poland
Objectives: Exercise testing is an integral part of the management of people with CF and has been used to predict prognosis, evaluate therapeutic interventions, monitor disease progression and is part of the annual assessment. There are many different types of exercise tests available but the modified shuttle walk test (MSWT) is frequently selected. Patients are often apprehensive about undergoing exercise testing and this is compounded by the assumption made by many patients that those not affected by CF would be able to complete the exercise test. Therefore we decided to put the staff at the Wolfson CF centre to the test and demonstrate to patients that this is not the case! Method: 28 staff members (20 female, 8 male, age range 23–67 years) volunteered to take part in the modified shuttle walk test over a period of 3 months. Standard protocol for the MSWT was adhered to during the testing. Results: The results ranged from 66 to 150 shuttles (average 111.4). Only 5 (18%) members of the staff completed the test in full, 4 of these being male members of staff. Conclusion: The results from the staff modified shuttle walk challenge will be shared with the patients and will demonstrate that only a minority (18%) of staff actually completed the test. We hope that our
Objectives: Liver lesions in the course of cystic fibrosis are a group of complex interactions of the processes of fibrosis, inflammation, remodelling, apoptosis and cholestasis. The aim of the study was to evaluate selected parameters of the liver fibrosis and inflammation in patients with cystic fibrosis. Methods: 33 patients were evaluated, aged from 13 months to 17 years, with cystic fibrosis. Activity of aminotransferases, alkaline phosphatase, gamma glutamyltranspeptidase, concentration of albumin, bilirubin, alfa-macroglobulin, A1 apolipoprotein and haptoglobulin in the blood were evaluated. Index Fibrotest and Actitest were calculated on the basis of these parameters. Results: Increased activity of AlAT was observed in 3/33 patients (10%) and GTP in 3/33 (10%) children too. Elevated concentration of alfa2macroglobulin was until in 22/33 children, its correlated with abnormal result of Fibrotest Index (F1-F2) in 5 patients. All children with abnormal Fibrotest Index had increased concentration of alfa2-macroglobulin in the blood. Increased concentration of A1 Apolipoprotein in the blood was found in 7 children, this parameters correlated with abnormal results of Fibrotest and Actitest Index only in 2 patients. Increased concentration of haptoglobulin in the blood was observed only in 4/33
described activities. There were no adverse events reported as a result of physiotherapy prescribing and all PPs rated their practice as ‘very safe’. Service remodelling was described as a result of prescribing practice – half of PPs were prescribing in inhalation test dosing clinics and reported ‘improved speed of access to inhaled drugs’ and ‘less reliance on doctors who are not familiar with CF drugs – a safer service’. Conclusion: The 2015 review of PPs in the UK has revealed an unsurprising trend towards the prescription of inhalation therapies, describes an extended role which is reported as ‘very safe’ and is resulting in service remodelling. Longitudinal data on patient outcome and experience of PPs is required to further understand the benefit of this role. 156 A service evaluation of the exercise facilities at a new CF centre F. Haynes1 , L. Durkin2 , E. Douglas2 , S. Millward1 , T. Hughes1 , M. Cook1 . 1 Nottingham University Hospitals, Wolfson CF Centre, Nottingham, United Kingdom; 2 University of Nottingham, Physiotherapy & Health Sciences, Nottingham, United Kingdom Objectives: The Wolfson Centre at Nottingham University Hospitals is a new regional centre that had input from CF patients in the development of the exercise facilities. Exploring patient’s opinions on current services is becoming increasingly important in the NHS and is crucial in the future development of new services. This service evaluation aimed to explore patient satisfaction and their use of the exercise facilities now that the centre is open. Methods: A questionnaire was designed and distributed as an exit questionnaire by clinicians at the centre between October and November 2014. Fourteen questionnaires were completed by inpatients at the centre. Descriptive statistics were used to evaluate the data. Results: All patients (n = 14) that completed the questionnaire exercised during admission to the centre. The majority of participants (n = 12) reported that they were “very satisfied” with the centre and the remaining respondents (n = 2) reported that they were “satisfied”. Open questions highlighted areas where satisfaction could be further improved, such as increasing the access to facilities out of normal working hours and to the variety of equipment and services offered. Conclusion: All patients (n = 14) that completed the questionnaire exercised during admission to the centre. The majority of participants (n = 12) reported that they were “very satisfied” with the centre and the remaining respondents (n = 2) reported that they were “satisfied”. Open questions highlighted areas where satisfaction could be further improved, such as increasing the access to facilities out of normal working hours and to the variety of equipment and services offered. 157 Staff shuttle walk challenge
S91
results will help patients put their own test results into perspective and allay some of the anxiety surrounding exercise assessment. The project has been a fun team building exercise and has also inspired some members of the team to improve their fitness levels. It may be necessary to offer annual exercise testing to staff in the future.
8. Gastroenterology/Liver Disease/Endocrinology 158 Background incidence of liver function test (LFT) abnormalities in patients (pts) with cystic fibrosis (CF) V. Seliger1 , L. Bessonova1 , N. Volkova1 , C. Simard1 , S. Tian1 . 1 Vertex Pharmaceuticals Incorporated, Boston, United States Objectives: LFT abnormalities are frequently observed in pts with CF, although supporting prospective epidemiological data are limited. We evaluated background incidence of LFT elevations across placebo arms of Vertex-sponsored CF clinical trials. Methods: Analyses included pts aged ≥6 years with CF randomized to placebo across 8 completed trials of novel CFTR modulator therapies, with ≥8 weeks of follow-up. LFTs of interest (measured every 2–8 weeks) included alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), total bilirubin (BIL), and alkaline phosphatase (ALP). Incidence rates (IRs) and proportions were assessed. Potentially clinically significant (PCS) LFT elevations were defined as ALT/AST/GGT >3× upper limit of normal (ULN) or BIL/ALP >2×ULN. Analyses were stratified by baseline ALT/AST. Results: Of 645 pts on placebo, 506 (78%) had normal baseline ALT/AST. Of those 506, 263 (52%) had at least one elevation above the ULN over an average of 5.6 months of follow-up (IR 15.5 per 100 person-months) and 42 (8%) had elevations considered PCS (IR 1.6 per 100 personmonths). Of 139 pts with a baseline ALT/AST abnormality, 32 (23%) had PCS elevations during follow-up (IR 4.6 per 100 person-months). Conclusion: LFT elevations were common in pts with CF and normal baseline ALT/AST and some were PCS. Pts with baseline ALT/AST abnormalities had more frequent PCS elevations. IRs of LFT elevations among placebo-treated pts in trials with close LFT monitoring were higher than previously reported. The true incidence may be underestimated due to strict trial exclusion criteria. Acknowledgement: Sponsored by Vertex Pharmaceuticals Incorporated (“Vertex”) 159 Evaluation of fibrosis and inflammation parameters of the liver in patients with diagnosed cystic fibrosis
S. Millward1 , F. Haynes1 , T. Hughes1 , J. Dewar1 . 1 Nottingham University Hospitals, Wolfson CF Centre, Nottingham, United Kingdom
S. Wiecek1 , H. Wos1 , B. Kordys-Darmolinska1 , U. GrzybowskaChlebowczyk1 . 1 Medical University of Silesia, Department of Paediatrics, Katowice, Poland
Objectives: Exercise testing is an integral part of the management of people with CF and has been used to predict prognosis, evaluate therapeutic interventions, monitor disease progression and is part of the annual assessment. There are many different types of exercise tests available but the modified shuttle walk test (MSWT) is frequently selected. Patients are often apprehensive about undergoing exercise testing and this is compounded by the assumption made by many patients that those not affected by CF would be able to complete the exercise test. Therefore we decided to put the staff at the Wolfson CF centre to the test and demonstrate to patients that this is not the case! Method: 28 staff members (20 female, 8 male, age range 23–67 years) volunteered to take part in the modified shuttle walk test over a period of 3 months. Standard protocol for the MSWT was adhered to during the testing. Results: The results ranged from 66 to 150 shuttles (average 111.4). Only 5 (18%) members of the staff completed the test in full, 4 of these being male members of staff. Conclusion: The results from the staff modified shuttle walk challenge will be shared with the patients and will demonstrate that only a minority (18%) of staff actually completed the test. We hope that our
Objectives: Liver lesions in the course of cystic fibrosis are a group of complex interactions of the processes of fibrosis, inflammation, remodelling, apoptosis and cholestasis. The aim of the study was to evaluate selected parameters of the liver fibrosis and inflammation in patients with cystic fibrosis. Methods: 33 patients were evaluated, aged from 13 months to 17 years, with cystic fibrosis. Activity of aminotransferases, alkaline phosphatase, gamma glutamyltranspeptidase, concentration of albumin, bilirubin, alfa-macroglobulin, A1 apolipoprotein and haptoglobulin in the blood were evaluated. Index Fibrotest and Actitest were calculated on the basis of these parameters. Results: Increased activity of AlAT was observed in 3/33 patients (10%) and GTP in 3/33 (10%) children too. Elevated concentration of alfa2macroglobulin was until in 22/33 children, its correlated with abnormal result of Fibrotest Index (F1-F2) in 5 patients. All children with abnormal Fibrotest Index had increased concentration of alfa2-macroglobulin in the blood. Increased concentration of A1 Apolipoprotein in the blood was found in 7 children, this parameters correlated with abnormal results of Fibrotest and Actitest Index only in 2 patients. Increased concentration of haptoglobulin in the blood was observed only in 4/33