治験レーダー

Frequency of bronchiectasis exacerbations

Worsening of respiratory symptoms, as defined by the EMBARC/BRR criteria (Eur Respir J. 2017;49(6):1700051), requiring adjustments to treatment strategies.

2 years

Time to the first exacerbation

Worsening of respiratory symptoms, as defined by the EMBARC/BRR criteria (Eur Respir J. 2017;49(6):1700051), requiring adjustments to treatment strategies.

2 years

The Quality of Life Bronchiectasis Respiratory Symptom Scales (QOL-B-RSS)

The Quality-of-Life-Bronchiectasis (QoL-B) questionnaire is a disease-specific survey designed for patients with bronchiectasis. The Respiratory Symptoms scale is a component of the QoL-B questionnaire, with a scale range from 0 to 100. Higher scores on this scale signify a better health status. In bronchiectasis, the established minimal clinically important difference (MCID) is 8 points.

2 years

The Bronchiectasis Health Questionnaire (BHQ)

The BHQ is a brief, self-administered tool consisting of 10 items that assess health status over the previous 14 days. It uses 7-point Likert scales, with scores ranging from 0 to 100, where higher scores reflect better health-related quality of life (HRQoL). In bronchiectasis, the established minimal clinically important difference (MCID) is 3 points.

2 years

The Bronchiectasis Impact Measure (BIM)

The Bronchiectasis Impact Measure (BIM) is a validated patient-reported outcome measure for patients with bronchiectasis. The BIM includes eight domains (cough, sputum, breathlessness, tiredness, activity, general health, control, exacerbations) and is numbered 0-10. Higher scores on this scale signify a greater impact of these domains on daily life. In bronchiectasis, the minimal clinically important difference (MCID) for each domain as 1.5 points on a 10-point scale.

2 years

The St Georges Respiratory Questionnaire (SGRQ)

St.George Respiratory Questionnaire (SGRQ): a validated questionnaire for use in bronchiectasis population. This questionnaire is structured into 3 main components: symptoms, activity and impacts. Scale range is 0-100, where lower scores correspond to the better health status. Each questionnaire response has a unique empirically derived "weight". Each component of the questionnaire is scored separately in three steps: i. The weights for all items with a positive responses are summed. ii. The weights for missed items are deducted from the maximum possible weight for each component. The weights for all missed items are deducted from the maximum possible weight for the Total score. iii. The score is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage The Total score is calculated in similar way. In bronchiectasis, the established MCID is 4 points.

2 years

The bronchiectasis exacerbation and symptom tool (BEST)

The Bronchiectasis Exacerbation and Symptom Tool (BEST) is a validated questionnaire designed to evaluate daily symptoms in patients with bronchiectasis. It has a maximum score of 26, with higher scores reflecting a greater symptom burden. In bronchiectasis, the minimal clinically important difference (MCID) is 4 points.

2 years

Bronchiectasis Symptom VAS (BS-VAS)

The Bronchiectasis Symptom Visual Analogue Scale (BS-VAS) is a simple, patient-reported tool designed to quantify the severity of individual symptom burden in patients with bronchiectasis. It consists of 11 separate 100-mm horizontal visual analogue scales, each assessing a different core symptom: cough, sputum volume, sputum colour, sputum viscosity, dyspnoea, fatigue, wheezing, chest tightness, chest pain, exercise tolerance, and haemoptysis. Patients are instructed to mark a vertical line on each 10-mm scale to indicate symptom severity over the past 24 hours, with the left anchor (0 mm) defined as "No symptom at all" and the right anchor (10 mm) defined as "Worst imaginable". Each item is measured from 0 to 10 mm (scored 0-10 with one decimal place).

2 years

Forced expiratory volume in 1 second (FEV1)

Spirometry

2 years

Hospitalization for severe exacerbations

Admission to hospital for an exacerbation meeting the EMBARC/BRR exacerbation

2 years

All cause mortality

Survival during the study

3 years