Information for patients

1)     What is the PACE study about?

PACE is a study to see if a quick and safe finger prick blood test, measuring C-reactive protein (CRP) levels, can help guide better antibiotic use in patients suffering from an acute exacerbation of their Chronic Obstructive Pulmonary Disease (COPD). People with COPD often experience attacks or periods when their illness gets worse (sometimes referred to as acute exacerbations). Acute exacerbations can be triggered by many things, including infections, and are sometimes treated with antibiotics. But many patients with an exacerbation will not benefit from antibiotics, and taking antibiotics can sometimes result in side effects or cause the bugs that are normally present in our bodies to become resistant to antibiotics.

2)     What does it involve?

  1. If you are experiencing an acute exacerbation of your COPD and you visit your GP surgery you will be asked to provide consent to say that you are happy to take part
  2. Your doctor will examine you as usual and the doctor or nurse will then take more information,sputum and throat swab samples from you. You will be asked to complete two short questionnaires.
  3. You will be allocated by chance to either have the finger prick test or be treated as you normally would have been outside of this study
  4. If you are allocated to have the finger prick test, your GP or nurse will conduct a finger prick blood test to help your doctor decide if you would benefit from antibiotics for your acute exacerbation.
  5. At week 1 and 2 you will be phoned by a researcher from Cardiff University to ask you some questions about how you are feeling
  6. You will be asked to come back in to the GP surgery 4 weeks after your initial consultation when you consented and you will be asked more questions about how you feel.
  7. At 6 Months you will be contacted by the study team to ask you to complete 2 short postal questionnaires asking about your COPD symptoms and general health.
  8. We will be contacting a small number of people in each area about 4 to 6 weeks after your initial consultation to ask if you would like to take part in an informal telephone interview to tell us what you thought of the test and what it was like to take part in the study. The interview will be audio-recorded. Only the research team will have access to this recording, and your doctor will not be told what answers you give in the interview.

3)     Important information

All information you give to us will be kept confidential and all ethical and legal procedures will be stictly adhered to. Your sputum may be stored securely for further research but no human DNA tests will be performed on the samples. You can leave the study at any time, without giving a reason. A decision to leave or not to take part, will not affect the standard of care you receive now or in the future. In case of any problems relating to taking part in the study you can always speak to your GP or the nurse.

The results from the study will be submitted to the National Institute of Health Research who are funding the study. Results will also be published in scientific journals and presented at scientific conferences. You will not be identified in any report, publication or presentation; all results will be completely anonymous.

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee to protect your safety, rights, wellbeing and dignity.

Thank you for considering taking part in the study.

PIS Version 3 - Dated: 11/06/2015