Cough
Conditions
Keywords
patient-reported outcomes, cough, control, questionnaire
Brief summary
Chronic cough (\>8 weeks in duration) affects 5-12% of the global population, and is associated with considerable health status impairment and comorbidities. Currently, there are validated severity and impact outcome measures whilst objective measures with cough frequency monitoring is not available in routine clinical practice. Unlike other chronic respiratory diseases, namely asthma, there are no validated dedicated tools to assess the control of cough as a disease. This study aims to develop a validated patient-focused tool to assess the control of cough, which may be useful to evaluate the benefit and value of treatments in both clinical and research settings.
Detailed description
This study will involve 3 phases: * Phase 1: Literature review. Review of currently available validated tools to assess control in respiratory diseases. * Phase 2: Development of Cough Control Questionnaire (CCQ). Patient focus groups will aid development of a conceptual framework of cough control and ensure content validity through qualitative research methods including thematic analysis. Expert panel review of cough control framework will also be undertaken. CCQ item development will be grounded in patient focus groups and expert review findings, and reviewed through cognitive debrief with patients. * Phase 3: Validation of CCQ. Prospective consecutive patients with chronic cough will complete CCQ, cough severity assessments and health status assessments. Patients will be invited to undergo objective cough frequency monitoring and cough challenge testing.
Interventions
OTHERQuestionnaires
Completion of new questionnaire in addition to other patient reported outcome measures that measure cough severity and cough-related quality of life.
Semi-structured focus group interviews for patients with refractory chronic cough
OTHERObjective cough measures
Cough monitoring and cough sensitivity testing.
Sponsors
King's College Hospital NHS Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients aged 18 and over with acute and chronic cough (including refractory chronic cough and unexplained chronic cough) and able to read and write in English. A smaller number (n =20) of healthy volunteers will also be included with no evidence of significant respiratory disease.
Exclusion criteria
* Current smokers (or smoking within the last 12 months), respiratory tract infection within the last 4 weeks, use of angiotensin converting enzyme inhibitors (ACEi), and pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A questionnaire to assess cough control | 2 weeks | The primary aim of the study is to develop and validate a cough control questionnaire which accurately reflects the nature of cough control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cough severity | 2 weeks | Assessed using dedicated patient reported outcome measures. Correlations with CCQ will be assessed. |
| Cough-related quality of life and health status | 2 weeks | Assessed using dedicated patient reported outcome measures. Correlations with CCQ will be assessed. |
| Cough frequency | 2 weeks | Cough frequency (Coughs/24 hours) will be assessed at visits using cough monitors and correlations with CCQ will be assessed. |
| Cough reflex testing | 2 weeks | Capsaicin concentration for C2 and C5 (to elicit 2, and 5 coughs respectively) will be assessed in a subset of patients. Correlations with CCQ will be assessed. |
Countries
United Kingdom
Outcome results
None listed