P216 Recruiting COPD inpatients to clinical research: recent experience from interventional and observational studies

Abstract

Background: Despite currently available treatment, 13.9% of patientsadmitted to hospital for exacerbations of chronic obstructivepulmonary disease (COPD) die within 3 months, and fewer thanhalf survive 5 years. Most of the cost of COPD to the UK healthservice, which approaches 1bn/year, is associated with the treatmentof exacerbations. There is clearly a need to improve outcomesof patients admitted to hospital for exacerbations, and yet relativelyfew research studies attempt to recruit patients specifically duringthis phase of their illness. Methods: During 2010e2011, two studies were conducted withinour institution recruiting patients hospitalised for COPD exacerbations.One was an observational study with relatively broad entrycriteria; the other was a randomised, controlled, interventional trialwith more stringent entry criteria (ISRCTN66148745). We analysedthe screening logs to identify eligibility rates and potential barriersto recruitment, and to provide a guide for researchers on the feasibilityof proposed studies in similar populations elsewhere. Results: In the 12-month period commencing March 2010, 172patients were screened for entry to the observational study. In theperiod January to June 2011, a further 72 patients, not included inthe first study, were screened for entry into the clinical trial.Significant exclusion criteria for each study protocol for were identified;for comparison, these are represented across organ systems(Abstract P216 table 1). 29% of those screened for the observationalstudy were eligible for inclusion and 11% for the clinical trial. Theclinical trial identified more renal and metabolic conditions,reflecting their particular relevance to experimental drug administration.The observational study identified more physical factors,such as frailty, which may limit patients' ability to engage withobservational research tasks. (Table presented) Conclusion: Patients hospitalised for COPD exacerbations are heterogeneousand have significant and diverse co-morbidities which maylimit their eligibility for research studies. In view of this, broad entrycriteria are necessary to ensure that studies in this population arefeasible. With careful design, such studies will be pivotal in drivingimproved treatment and outcomes among these patients who,despite their poor prognosis, presently receive disproportionatelylittle research attention.