Title: Reducing perioperative risk in chronic obstructive pulmonary disease - A feasibility study
Funder: Department of Health and Social Care

Abstract: Aims The aim is to collect feasibility data that will support a full funding application for a multi-centre randomised controlled trial which would ask the question: Does pre-operative pulmonary rehabilitation reduces postoperative complications in patients with chronic obstructive pulmonary disease (COPD)?" Background In the UK COPD affects over 3.7 million people and is Britain s 5th biggest killer (30,000 deaths/year). Patients with COPD have a 35% increased risk of postoperative complications (specifically respiratory and cardiac complications, sepsis, re-operation, and renal insufficiency) and 29% increased risk of death. Thus COPD represents a high risk surgical population that would benefit from interventions that may make surgery safer. One treatment that may make surgery safer is pulmonary rehabilitation. Pulmonary rehabilitation is a programme of physical activity and education for people with COPD. It improves exercise capacity and quality of life (NNT=2). Its effects on quality of life are so powerful that it is one of the few treatments with a negative cost per quality adjusted life year (QALY). Pulmonary rehabilitation decreases hospital admissions (NNT=3-4) and mortality following COPD exacerbations (NNT=6). We therefore hypothesise that pulmonary rehabilitation, delivered to patients with COPD prior to surgery will reduce post-operative complications and will facilitate patients returning to normal every day activities more quickly. So far, there have been no RCTs that have tested this. There is limited evidence in a handful of studies, mostly performed in cardiac and thoracic surgical patients that suggests that pre-operative pulmonary rehabilitation may be beneficial, however all studies are limited by small numbers and are thus inconclusive. The National Emphysema Treatment Trial compared lung volume reduction surgery with medical treatment for emphysema, and in that study all 1218 patients received pulmonary rehabilitation prior to recruitment. The study confirmed beneficial effects of pulmonary rehabilitation similar to that observed for the standard treatment of COPD, but was not designed to infer how pulmonary rehabilitation influences surgical outcome. Currently only 13 out of the 224 pulmonary rehabilitation programmes in England and Wales offer pulmonary rehabilitation to pre-operative patients, hence the need for a trial. Taking the available evidence from COPD treatment and the limited evidence from surgical programmes, there is a now strong need to perform a definitive RCT. This study is timely, as there has been recent emphasis in using the preoperative period as an opportunity to improve patient's health status, and thus more surgical acceptance of such strategies than ever before. As pulmonary rehabilitation is widely available and standardised, if an RCT were successful, then implementation would be relatively straightforward potentially giving great benefit to a large number of patients. Methods The overall aim is to test feasibility of running a randomised study over multiple sitescomparing pulmonary rehabilitation with standard treatment in 72 patients, and to determine the best primary and secondary outcome measures associated with the intervention (pulmonary rehabilitation) and following surgery. Qualitative studies will investigate barriers to pulmonary rehabilitation. Collaborative Group This programme of research will be led by Dr Kyle Pattinson (PI) and co-ordinated from Oxford. Clinical trials support will be coordinated by the Oxford Respiratory Trials Unit. The main collaborating university is Newcastle University. Benefits to patients and NHS By repurposing an already widely existing and well established treatment, patients with COPD undergoing surgery may benefit with fewer postoperative complications, improved quality of life and quicker return to normal. If successful, the treatment will also lead to better use of hospital resources, as a shorter hospital stay will free up beds for other patients. If the main trial is successful, implementation across the NHS could give clinical benefits to patients quickly, as pulmonary rehabilitation programmes are already widespread."

Lay abstract: COPD is Chronic Obstructive Pulmonary Disease, a condition in which lung damage leads to shortness of breath and increased risk of chest infections. In the UK, COPD affects nearly 4 million people and is Britain s 5th biggest killer (30,000 deaths/year). Following surgery, people with COPD have 35% more complications and a 29% greater chance of dying, this is particularly due to chest infections, wound infections and heart attack. Therefore there is an urgent need to make surgery safer. Pulmonary rehabilitation is a programme of activity and education for people with COPD. It helps make people fitter, more active and less breathless. Pulmonary rehabilitation following flare-ups reduces re-hospitalisation by over 50%. If pulmonary rehabilitation could be used to prevent complications following surgery, it would have powerful benefits for both the individual and the NHS. It could happen whilst waiting for surgery. Although pulmonary rehabilitation may reduce complications of surgery, there are no conclusive studies. Currently only 13 out of 224 pulmonary rehabilitation programmes in England and Wales accept patients about to undergo surgery. This feasibility study will help us design a full scale national trial. We will recruit people with COPD scheduled for major surgery. Participants will be randomly allocated to receive either a tailored course of pulmonary rehabilitation or receive normal treatment before surgery. This would happen during the normal waiting list time so surgery would not be delayed. We will find out the best measurements to collect, to help properly design the main trial. Potential benefits include fewer complications after surgery, improved quality of life and quicker return to normal. This will also lead to better use of hospital resources, and considerable cost savings for the NHS. Implementation across the NHS could help many patients in a short time frame, as pulmonary rehabilitation programmes are already widespread.

Research activity codes: 6.7 PHYSICAL
Health categories: RESPIRATORY