Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Positive Predictive Value (PPV) of the eNose for detecting confirmed BE |
PPV of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care. |
16 weeks after breath test (eNose) |
|
Primary |
Negative Predictive Value (NPV) of the eNose for detecting confirmed BE |
NPV of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care. |
16 weeks after breath test (eNose) |
|
Primary |
Sensitivity of the eNose for detecting confirmed BE |
Sensitivity of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care. |
16 weeks after breath test (eNose) |
|
Primary |
Specificity of the eNose for detecting confirmed BE |
Specificity of the eNose for detecting confirmed BE with the diagnosis made by transnasal endoscopy and upper endoscopy as the reference standard in primary care. |
16 weeks after breath test (eNose) |
|
Secondary |
Patient acceptability (discomfort and overall experience) of the eNose measured on a NPRS. |
Patient acceptability consists of two questions regarding discomfort and overall experience of the eNose. Discomfort is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'none' and 10 being 'severe'. Overall experience is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'the worst experience', 5 being 'neither pleasant nor unpleasant' and 10 being 'the best experience'. |
Directly after breath test (eNose) |
|
Secondary |
Patient acceptability (discomfort and overall experience) of uTNE measured on a NPRS. |
Patient acceptability consists of two questions regarding discomfort and overall experience of uTNE. Discomfort is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'none' and 10 being 'severe'. Overall experience is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'the worst experience', 5 being 'neither pleasant nor unpleasant' and 10 being 'the best experience'. |
Directly after uTNE |
|
Secondary |
Patient acceptability (discomfort and overall experience) of conventional endoscopy (if applicable) measured on a NPRS. |
Patient acceptability consists of two questions regarding discomfort and overall experience of conventional endoscopy. Discomfort is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'none' and 10 being 'severe'. Overall experience is measured on a Numeric Pain Rating Scale (NPRS) with 0 being 'the worst experience', 5 being 'neither pleasant nor unpleasant' and 10 being 'the best experience'. |
Directly after conventional endoscopy |
|
Secondary |
Willingness to undergo repeat eNose procedure |
Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'. |
Directly after breath test (eNose) |
|
Secondary |
Willingness to undergo repeat uTNE procedure |
Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'. |
Directly after uTNE |
|
Secondary |
Willingness to undergo repeat conventional endoscopy |
Willingness to undergo repeat procedure consists of one question with answer options 'Yes' and 'No'. |
Directly after conventional endoscopy |
|
Secondary |
Cancer worry (CWS-8) |
The Cancer Worry Scale (CWS-8) is used to measure cancer worry. Scores are ranging from 8 to 32, and higher scores indicate more cancer worry. |
At baseline, 7 days after eNose, 7 days after uTNE, 7 days after conventional endoscopy (if applicable), 30 days after eNose, 30 days after uTNE, 30 days after conventional endoscopy (if applicable), 90 days after last study procedure. |
|
Secondary |
Anxiety (STAI-6) |
The State-Trait Anxiety Inventory (STAI-6) is used to measure anxiety. Scores are ranging from 6 to 24, and higher scores indicate more anxiety. |
At baseline, 7 days after eNose, 7 days after uTNE, 7 days after conventional endoscopy (if applicable), 30 days after eNose, 30 days after uTNE, 30 days after conventional endoscopy (if applicable), 90 days after last study procedure. |
|
Secondary |
Impact of event (IES-15) |
The Impact of Event Scale (IES-15) is used to measure impact of event. Scores are ranging from 0 to 75, and higher scores indicate more impact of event. |
7 days after eNose, 7 days after uTNE, 7 days after conventional endoscopy (if applicable), 30 days after eNose, 30 days after uTNE, 30 days after conventional endoscopy (if applicable), 90 days after last study procedure. |
|
Secondary |
Rate of successful evaluation by uTNE |
The rate of successful intubation and complete evaluation will be measured. |
1 week after the last participant undergoes uTNE. |
|
Secondary |
Rate of successful evaluation by breath test (eNose) |
The rate of successful intubation and complete evaluation will be measured. |
1 week after the last participant undergoes breath test (eNose). |
|
Secondary |
Safety of uTNE based on reported Adverse Events. |
The safety will be measured based on reported Adverse Events. |
1 week after the last participant undergoes uTNE. |
|
Secondary |
Safety of eNose based on reported Adverse Events. |
The safety will be measured based on reported Adverse Events. |
1 week after the last participant undergoes breath test (eNose). |
|