Evaluating the Efficacy and Safety of Modified Qing-Zao-Jiu-Fei Decoction on Pneumoconiosis Patients

The 6MWT, developed by Balke in 1963, is one of the tests widely used to assess functional exercise capacity evaluated by measuring the distance walked during 6 min. The test is easy to administer and is better tolerated and more reflective of the activities of daily living than other walk tests. Most activities of daily life usually are performed at a submaximal level of exertion, so the 6MWT seems to better reflect the functional exercise level for daily physical activities. Accordingly, the 6MWT would be a good estimation tool for objective health and assessment in pneumoconiosis and the test will be carried out according to the standards of the American Thoracic Society . The 6MWT will be conducted by trained investigators or research assistants.

SGRQ is a disease-specific instrument designed for, and commonly applied in, patients with chronic obstructive lung disease (COPD). The SGRQ has three components: (1) Symptom, measuring respiratory symptoms; (2) Activity, measuring impairment of mobility or physical activity, and (3) Impact, measuring the psychosocial impact of disease. It has a Chinese version validated in Hong Kong (the SGRQ-HK), which has been applied in two Hong Kong studies of pneumoconiosis.

PSQI measures the quality and pattern of sleep in older adult by measuring seven domains in 19 questions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication and daytime dysfunction over the last month. The scoring is 0-3 on a Likert scale.

The HADS, developed by Zigmond and Snaith in 1983, is a 14-item self assessment questionnaire commonly used to measure the severity of anxiety and depression in individuals undergoing medical care. It is now widely used in clinical and research settings. Many studies conducted around the world have confirmed its validity in community and primary care medical practice. HADS is often used to evaluate the mental health of patients with physical or chronic illnesses. The HADS questionnaire has 7 questions for anxiety and 7 questions for depression, with a scale of 0-3. Higher scores indicate higher levels of anxiety or depression.

The CAT is a tool used to assess the severity of symptoms in patients with COPD, it can also be used in patients with pneumoconiosis. It consists of eight questions to assess the severity of symptoms and effects of COPD in daily life. These questions relate to dyspnoea, cough, sputum retention, chest pain, sleep quality, energy levels, mobility and anxiety. Each problem is rated on a scale of 0 to 5, the higher the score the more severe the symptoms.

Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse".