Patient-reported outcomes included n COUGH-1 and COUGH-2
| PRO name | Description | Responder definition |
| Leicester Cough Questionnaire (LCQ) | The LCQ includes 3 domains: physical, psychological and social. Domain scores (range 1–7) are the sum of individual item scores divided by the number of items in the domain; total LCQ score (range 3–21) is the sum of the 3 domain scores | Change from baseline in LCQ total score of ≥1.3 points [21] |
| Cough Severity VAS | Subjects scored cough severity from 0 to 100 using a VAS | ≥30 mm reduction in Cough Severity VAS score (data on file/manuscript in preparation) |
| Cough Severity Diary (CSD) | The CSD includes 7 items, each with scores ranging from 0 (best) to 10 (worst). The total daily CSD score is the sum of these 7 item scores. Mean total daily scores are the sum of 7 item scores divided by 7; 3 subscales (cough frequency, intensity and disruption) were derived for each day | Change from baseline in mean weekly CSD total score of ≥1.3-point reduction as the first threshold and ≥2.7-point reduction as the second threshold [12] |
| Patient Global Impression of Change Questionnaire (PGIC) | The rate of change in participants’ chronic cough compared to the start of the study will be assessed using the PGIC with response options ranging from “very much improved” to “very much worse” | N/A |
| Hull Airway Reflux Questionnaire (HARQ) | The HARQ is used to more completely characterise the patient population and consists of 14 questions with responses on a numeric scale from 0 to 5. A score of “0” means that no problems are caused by the cough symptom and “5” means severe/frequent problems | N/A |
| 12-item Short Form Survey (SF-12) | The SF-12 is a validated, 12-item questionnaire designed to assess general health-related quality of life. It is a widely used instrument that has been shown to be responsive to changes in disease severity following intervention. The SF-12 is scored such that a total score and 8 domain scores can be calculated with higher scores indicating better functioning: Physical Functioning, Role Physical, Role-Emotional, Bodily Pain, General Health, Social Functioning, Mental Health and Vitality. Data obtained from the SF-12 will be used in health economic analyses | N/A |
| EuroQoL 5 L Dimensions Questionnaire | The EQ5D-5 L is a standardised instrument for measuring generic health status used for estimating preference weights for that health status. By combining the weight with time, quality adjusted life years can be computed. The EQ5D-5 L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels and the participant will be asked to indicate their health state using a 5-level rating scale. The EQ VAS records the participant's self-rated health on a vertical VAS where the endpoints are labelled “best imaginable health state” and “worst imaginable health state”. This information can be used as a quantitative measure of health outcome as judged by the individual patient | N/A |
| Work Productivity and Activity Impairment Questionnaire (WPAI) | The impact of cough on work productivity and activity will be assessed with the WPAI questionnaire, which provides an assessment on the following: 1) absenteeism (work time missed); 2) presenteeism (impairment at work/reduced on-the-job effectiveness); 3) work productivity loss (overall work impairment/absenteeism plus presenteeism); and 4) activity impairment. The WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. Participants will be asked to indicate if they are currently employed and to respond to the following questions referring to “the past 7 days”: work hours missed due to health problems, work hours missed for other reasons, hours actually worked, the degree to which their health has affected productivity while working, and the degree to which their health affected productivity in regular unpaid activities | N/A |
PRO: patient-reported outcome; VAS: Visual Analogue Scale.