Primarne mjere ishoda
1. Lung clearance index [0 months]
Lung clearance index will be measured using the multiple breath inert gas washout (MBW) test. MBW testing measures the functional residual capacity (FRC) and the efficiency with which gas mixes in the lungs. The non-uniformity of ventilation distribution across the lung is often referred to as ventilation inhomogeneity (VI).
Measurement of lung clearance index in this study will be performed using the Nitrogen Washout, EXHALYZER D, Ecomedics system. Tests will be performed in triplicate and a minimum of 2 tests with coefficient of variation (CV) <5% will be required in order to ensure reliable test.
2. Spirometry [0 months]
Spirometry will be performed according to the American Thoracic Society/European Respiratory Society guidelines (Miller et al, 2005). All spirometry manoeuvres will be performed in sitting position whilst wearing nose clips. At least three acceptable manoeuvres will be performed for each time point and the results will meet within-test and between-test criteria for acceptability. A maximum of six manoeuvres will be performed at any time point.
The following parameters will be recorded as part of the spirometry assessment:
FEV1 - Forced expiratory volume in one second (L)
FVC - Forced vital capacity (L)
FEV1/FVC (ratio)
FEF25-75 - Forced expiratory flow between 25 and 75% of forced vital capacity (FVC) (L / sec).
Time the participant last administered bronchodilator will be recorded
3. St Georges Respiratory Questionnaire (SGRQ) [0 months]
Is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease and has been validated for use in non-cystic fibrosis bronchiectasis (Wilson et al, 1997). It contains 50 items in two parts. Part 1 the symptoms component is concerned with frequency and severity of symptoms (8 items); Part 2 relates to activities that cause or are limited by breathlessness (16 items) and impact components (26 items) (social functioning, psychological disturbances resulting from airways disease). Part 1 contains several scales and Part 2 has dichotomous (true/false) response except the last question which is a 4-point Likert scale. It takes about 10 minutes to complete the questionnaire. The total score ranges from 0-100, with a higher score indicating a poorer health related quality of life. It assesses the impact of symptoms over the preceding four weeks.
4. Quality of Life-Bronchiectasis (QOL-B) Questionnaire [0 months]
The Quality of Life-Bronchiectasis (QOL-B) questionnaire is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with non-cystic fibrosis bronchiectasis. It contains 37 items assessed across eight domains: respiratory symptoms; physical functioning; role; emotional functioning; social functioning; vitality; health perceptions; and, treatment burden. The responses are given in the form of a 4-point Likert scale (except 1 question about sputum colour, which has 6 answer options) with a recall period of 'the last week' (except for the treatment burden and sputum colour questions, which do not specify a recall period). It will take approximately 10-15 minutes to complete this questionnaire. For the outcome, each dimension will be scored separately on a scale of 0 to 100. The questionnaire has demonstrated excellent internal consistency and 2-week test-retest reliability for each scale (Quittner et al, 2014).
5. EuroQol 5 Dimension (EQ-5D) [0 months]
EQ-5D is applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. EQ-5D is primarily designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics and face-to-face interviews. It is cognitively simple, taking only a few minutes to complete.
The EQ-5D essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
6. Sputum analysis [0 months]
A spontaneous sputum sample will be collected at each study visit. Where necessary participants will be instructed to perform cycles of two to three forced expiratory techniques (huffs) followed by coughing to enhance expectoration. All sputum expectorated will be collected in a labelled sterile transparent container and immediately frozen at -80°C until shipment to central lab (Queen's University Belfast).
The first priority for sputum processing will be to conduct molecular analysis for sputum microbiology. In addition, where volume allows, processing for sputum inflammatory markers will also be conducted. Where possible a proportion of the sample will be stored at -80oC for future analysis.
7. Blood analysis [0 months]
In total approximately 20mls of blood will be collected from each participant by venepuncture at each visit in accordance with local laboratory procedures in order to analyse white cell count and C-Reactive protein with a 10ml aliquot stored as plasma for inflammatory marker analysis (including but not limited to fibrinogen, TNF alpha, interleukin 6).
8. Lung clearance index [4 months]
Lung clearance index will be measured using the multiple breath inert gas washout (MBW) test. MBW testing measures the functional residual capacity (FRC) and the efficiency with which gas mixes in the lungs. The non-uniformity of ventilation distribution across the lung is often referred to as ventilation inhomogeneity (VI).
Measurement of lung clearance index in this study will be performed using the Nitrogen Washout, EXHALYZER D, Ecomedics system. Tests will be performed in triplicate and a minimum of 2 tests with coefficient of variation (CV) <5% will be required in order to ensure reliable test.
9. Spirometry [4 months]
Spirometry will be performed according to the American Thoracic Society/European Respiratory Society guidelines (Miller et al, 2005). All spirometry manoeuvres will be performed in sitting position whilst wearing nose clips. At least three acceptable manoeuvres will be performed for each time point and the results will meet within-test and between-test criteria for acceptability. A maximum of six manoeuvres will be performed at any time point.
The following parameters will be recorded as part of the spirometry assessment:
FEV1 - Forced expiratory volume in one second (L)
FVC - Forced vital capacity (L)
FEV1/FVC (ratio)
FEF25-75 - Forced expiratory flow between 25 and 75% of forced vital capacity (FVC) (L / sec).
Time the participant last administered bronchodilator will be recorded
10. St Georges Respiratory Questionnaire (SGRQ) [4 months]
Is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease and has been validated for use in non-cystic fibrosis bronchiectasis (Wilson et al, 1997). It contains 50 items in two parts. Part 1 the symptoms component is concerned with frequency and severity of symptoms (8 items); Part 2 relates to activities that cause or are limited by breathlessness (16 items) and impact components (26 items) (social functioning, psychological disturbances resulting from airways disease). Part 1 contains several scales and Part 2 has dichotomous (true/false) response except the last question which is a 4-point Likert scale. It takes about 10 minutes to complete the questionnaire. The total score ranges from 0-100, with a higher score indicating a poorer health related quality of life. It assesses the impact of symptoms over the preceding four weeks.
11. Quality of Life-Bronchiectasis (QOL-B) Questionnaire [4 months]
The Quality of Life-Bronchiectasis (QOL-B) questionnaire is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with non-cystic fibrosis bronchiectasis. It contains 37 items assessed across eight domains: respiratory symptoms; physical functioning; role; emotional functioning; social functioning; vitality; health perceptions; and, treatment burden. The responses are given in the form of a 4-point Likert scale (except 1 question about sputum colour, which has 6 answer options) with a recall period of 'the last week' (except for the treatment burden and sputum colour questions, which do not specify a recall period). It will take approximately 10-15 minutes to complete this questionnaire. For the outcome, each dimension will be scored separately on a scale of 0 to 100. The questionnaire has demonstrated excellent internal consistency and 2-week test-retest reliability for each scale (Quittner et al, 2014).
12. EuroQol 5 Dimension (EQ-5D) [4 months]
EQ-5D is applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. EQ-5D is primarily designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics and face-to-face interviews. It is cognitively simple, taking only a few minutes to complete.
The EQ-5D essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
13. Sputum analysis [4 months]
A spontaneous sputum sample will be collected at each study visit. Where necessary participants will be instructed to perform cycles of two to three forced expiratory techniques (huffs) followed by coughing to enhance expectoration. All sputum expectorated will be collected in a labelled sterile transparent container and immediately frozen at -80°C until shipment to central lab (Queen's University Belfast).
The first priority for sputum processing will be to conduct molecular analysis for sputum microbiology. In addition, where volume allows, processing for sputum inflammatory markers will also be conducted. Where possible a proportion of the sample will be stored at -80oC for future analysis.
14. Blood analysis [4 months]
In total approximately 20mls of blood will be collected from each participant by venepuncture at each visit in accordance with local laboratory procedures in order to analyse white cell count and C-Reactive protein with a 10ml aliquot stored as plasma for inflammatory marker analysis (including but not limited to fibrinogen, TNF alpha, interleukin 6).
15. Lung clearance index [8 months]
Lung clearance index will be measured using the multiple breath inert gas washout (MBW) test. MBW testing measures the functional residual capacity (FRC) and the efficiency with which gas mixes in the lungs. The non-uniformity of ventilation distribution across the lung is often referred to as ventilation inhomogeneity (VI).
Measurement of lung clearance index in this study will be performed using the Nitrogen Washout, EXHALYZER D, Ecomedics system. Tests will be performed in triplicate and a minimum of 2 tests with coefficient of variation (CV) <5% will be required in order to ensure reliable test.
16. Spirometry [8 months]
Spirometry will be performed according to the American Thoracic Society/European Respiratory Society guidelines (Miller et al, 2005). All spirometry manoeuvres will be performed in sitting position whilst wearing nose clips. At least three acceptable manoeuvres will be performed for each time point and the results will meet within-test and between-test criteria for acceptability. A maximum of six manoeuvres will be performed at any time point.
The following parameters will be recorded as part of the spirometry assessment:
FEV1 - Forced expiratory volume in one second (L)
FVC - Forced vital capacity (L)
FEV1/FVC (ratio)
FEF25-75 - Forced expiratory flow between 25 and 75% of forced vital capacity (FVC) (L / sec).
Time the participant last administered bronchodilator will be recorded
17. St Georges Respiratory Questionnaire (SGRQ) [8 months]
Is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease and has been validated for use in non-cystic fibrosis bronchiectasis (Wilson et al, 1997). It contains 50 items in two parts. Part 1 the symptoms component is concerned with frequency and severity of symptoms (8 items); Part 2 relates to activities that cause or are limited by breathlessness (16 items) and impact components (26 items) (social functioning, psychological disturbances resulting from airways disease). Part 1 contains several scales and Part 2 has dichotomous (true/false) response except the last question which is a 4-point Likert scale. It takes about 10 minutes to complete the questionnaire. The total score ranges from 0-100, with a higher score indicating a poorer health related quality of life. It assesses the impact of symptoms over the preceding four weeks.
18. Quality of Life-Bronchiectasis (QOL-B) Questionnaire [8 months]
The Quality of Life-Bronchiectasis (QOL-B) questionnaire is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with non-cystic fibrosis bronchiectasis. It contains 37 items assessed across eight domains: respiratory symptoms; physical functioning; role; emotional functioning; social functioning; vitality; health perceptions; and, treatment burden. The responses are given in the form of a 4-point Likert scale (except 1 question about sputum colour, which has 6 answer options) with a recall period of 'the last week' (except for the treatment burden and sputum colour questions, which do not specify a recall period). It will take approximately 10-15 minutes to complete this questionnaire. For the outcome, each dimension will be scored separately on a scale of 0 to 100. The questionnaire has demonstrated excellent internal consistency and 2-week test-retest reliability for each scale (Quittner et al, 2014).
19. EuroQol 5 Dimension (EQ-5D) [8 months]
EQ-5D is applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. EQ-5D is primarily designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics and face-to-face interviews. It is cognitively simple, taking only a few minutes to complete.
The EQ-5D essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
20. Sputum analysis [8 months]
A spontaneous sputum sample will be collected at each study visit. Where necessary participants will be instructed to perform cycles of two to three forced expiratory techniques (huffs) followed by coughing to enhance expectoration. All sputum expectorated will be collected in a labelled sterile transparent container and immediately frozen at -80°C until shipment to central lab (Queen's University Belfast).
The first priority for sputum processing will be to conduct molecular analysis for sputum microbiology. In addition, where volume allows, processing for sputum inflammatory markers will also be conducted. Where possible a proportion of the sample will be stored at -80oC for future analysis.
21. Blood analysis [8 months]
In total approximately 20mls of blood will be collected from each participant by venepuncture at each visit in accordance with local laboratory procedures in order to analyse white cell count and C-Reactive protein with a 10ml aliquot stored as plasma for inflammatory marker analysis (including but not limited to fibrinogen, TNF alpha, interleukin 6).
22. Lung clearance index [12 months]
Lung clearance index will be measured using the multiple breath inert gas washout (MBW) test. MBW testing measures the functional residual capacity (FRC) and the efficiency with which gas mixes in the lungs. The non-uniformity of ventilation distribution across the lung is often referred to as ventilation inhomogeneity (VI).
Measurement of lung clearance index in this study will be performed using the Nitrogen Washout, EXHALYZER D, Ecomedics system. Tests will be performed in triplicate and a minimum of 2 tests with coefficient of variation (CV) <5% will be required in order to ensure reliable test.
23. Spirometry [12 months]
Spirometry will be performed according to the American Thoracic Society/European Respiratory Society guidelines (Miller et al, 2005). All spirometry manoeuvres will be performed in sitting position whilst wearing nose clips. At least three acceptable manoeuvres will be performed for each time point and the results will meet within-test and between-test criteria for acceptability. A maximum of six manoeuvres will be performed at any time point.
The following parameters will be recorded as part of the spirometry assessment:
FEV1 - Forced expiratory volume in one second (L)
FVC - Forced vital capacity (L)
FEV1/FVC (ratio)
FEF25-75 - Forced expiratory flow between 25 and 75% of forced vital capacity (FVC) (L / sec).
Time the participant last administered bronchodilator will be recorded
24. St Georges Respiratory Questionnaire (SGRQ) [12 months]
Is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease and has been validated for use in non-cystic fibrosis bronchiectasis (Wilson et al, 1997). It contains 50 items in two parts. Part 1 the symptoms component is concerned with frequency and severity of symptoms (8 items); Part 2 relates to activities that cause or are limited by breathlessness (16 items) and impact components (26 items) (social functioning, psychological disturbances resulting from airways disease). Part 1 contains several scales and Part 2 has dichotomous (true/false) response except the last question which is a 4-point Likert scale. It takes about 10 minutes to complete the questionnaire. The total score ranges from 0-100, with a higher score indicating a poorer health related quality of life. It assesses the impact of symptoms over the preceding four weeks.
25. Quality of Life-Bronchiectasis (QOL-B) Questionnaire [12 months]
The Quality of Life-Bronchiectasis (QOL-B) questionnaire is a self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with non-cystic fibrosis bronchiectasis. It contains 37 items assessed across eight domains: respiratory symptoms; physical functioning; role; emotional functioning; social functioning; vitality; health perceptions; and, treatment burden. The responses are given in the form of a 4-point Likert scale (except 1 question about sputum colour, which has 6 answer options) with a recall period of 'the last week' (except for the treatment burden and sputum colour questions, which do not specify a recall period). It will take approximately 10-15 minutes to complete this questionnaire. For the outcome, each dimension will be scored separately on a scale of 0 to 100. The questionnaire has demonstrated excellent internal consistency and 2-week test-retest reliability for each scale (Quittner et al, 2014).
26. EuroQol 5 Dimension (EQ-5D) [12 months]
EQ-5D is applicable to a wide range of health conditions and treatments. It provides a simple descriptive profile and a single index value for health status. EQ-5D is primarily designed for self-completion by respondents and is ideally suited for use in postal surveys, in clinics and face-to-face interviews. It is cognitively simple, taking only a few minutes to complete.
The EQ-5D essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
27. Sputum analysis [12 months]
A spontaneous sputum sample will be collected at each study visit. Where necessary participants will be instructed to perform cycles of two to three forced expiratory techniques (huffs) followed by coughing to enhance expectoration. All sputum expectorated will be collected in a labelled sterile transparent container and immediately frozen at -80°C until shipment to central lab (Queen's University Belfast).
The first priority for sputum processing will be to conduct molecular analysis for sputum microbiology. In addition, where volume allows, processing for sputum inflammatory markers will also be conducted. Where possible a proportion of the sample will be stored at -80oC for future analysis.
28. Blood analysis [12 months]
In total approximately 20mls of blood will be collected from each participant by venepuncture at each visit in accordance with local laboratory procedures in order to analyse white cell count and C-Reactive protein with a 10ml aliquot stored as plasma for inflammatory marker analysis (including but not limited to fibrinogen, TNF alpha, interleukin 6).
