Chronic obstructive pulmonary disease (COPD): The impact of a telemetric COPD monitoring service

The time until first hospital admission with a primary diagnosis of an exacerbation of COPD up to one year post-randomisation.

An exacerbation is a sustained worsening of the patient's symptoms from his or her usual stable state that is beyond normal day-to-day variations, and is acute in onset. Commonly reported symptoms are worsening breathlessness, cough, increased sputum production and change in sputum colour. The change in these symptoms often necessitates a change in medication.

An exacerbation is defined as being the 'primary diagnosis' if the presenting symptoms are consistent with, and the patient is treated for an acute exacerbation of COPD, and if no other disease was treated as a priority.

1. Exacerbations and admissions
1.1. The time until first hospital admission with a primary diagnosis of an exacerbation of COPD or all-cause deaths up to one year post-randomisation
1.2. The difference in mean number of bed-days for emergency admissions with a primary diagnosis of COPD during one calendar year
1.3. The number of hospital admissions with a primary diagnosis of COPD during one calendar year
1.4. The number and duration of admissions in which COPD is listed in the discharge letter as a factor in the admission (i.e., not necessarily the primary diagnosis) during one calendar year
1.5. The number of exacerbations (defined as a sustained worsening of the patient's symptoms necessitating a change in medication) during one calendar year
1.6. Proportion of deaths at one year. Cause of death will be taken from the primary and/or secondary care clinical records.

2. Quality of life
2.1. St George's Respiratory Questionnaire (SGRQ) at one year. The SGRQ is a validated and widely used instrument which measures health impairment (symptoms, activities and impacts) in patients with COPD on a scale: 100 (greatest impairment) to 0, is responsive to change, with a minimum important difference (MID) of 4.
2.2. Proportion of patients with an improvement of 4 or more units in the SGRQ at one year.

3. Anxiety and depression
3.1. Hospital Anxiety and Depression Scale (HADS) at one year. The HADS is a validated questionnaire with independent scales for anxiety and for depression (scores >=11 indicate significant anxiety [or depression]; scores <=7 are normal)

4. Patient knowledge and self-efficacy
4.1. Self-Efficacy for Managing Chronic Disease 6-item scale (SECD6) at one year. The SECD6 assesses confidence in ability to self-manage symptoms and impact on life on a scale of 1 (low self-efficacy) to 10 (high). It has been used in a range of long-term conditions.
4.2. Lung Information Needs Questionnaire (LINQ) at one year. The LINQ measures the information needs of people with COPD on a scale of 0 (low needs) to 25 (high). Scores correlate with the healthcare services accessed.

5. Engagement with process
5.1. Medication Adherence Report Scale (MARS) at one year. MARS-5 is a 5-item reduction of the validated MARS scale which has good reliability and validity in populations with respiratory conditions, and other chronic diseases. It assesses adherence to medication on a 5-point scale: higher scores indicating higher levels of adherence.
5.2. Compliance with monitoring and self-management will be assessed using the electronic record of symptoms and the action taken (or not) during one calendar year

6. Cost-effectiveness
6.1. Cost per Quality Adjusted Life-Years (QALYs) at one year. QALYs are derived from responses to the Euroqol EQ-5D.
6.2. Use of healthcare resources during one calendar year will be extracted from the patients' primary and secondary care records."