Extrait

Background and study aims This study is designed to identify people who may have a lung disease called chronic obstructive pulmonary disease (COPD). COPD affects 5-10% of people worldwide, is rising in prevalence, and is a leading cause of death. In the UK it costs the NHS over £800 million per year. There is however much uncertainty about the natural history of COPD, how to approach early identification of patients, and what treatments are effective in early disease. There is significant under diagnosis of COPD patients and this represents a group of people who could benefit from treatment by their GP. There is increasing interest in finding these patients but no evidence as to which approach to case finding would be most effective or cost-effective. The aims of the study are to determine whether targeted case finding is more effective and cost-effective than current practice, to find out the relative effectiveness and cost-effectiveness of two alternative methods of targeted case finding, and to obtain patients’ views about the process. Who can participate? Potential participants will be identified through GP practice registers and anyone who is potentially eligible will be screened by the GP before being invited to take part. Patients must be aged between 40 and 79 years with no clinical diagnosis of COPD. What does the study involve? Participating practices will be randomly allocated to either the targeted group or the routine care group. Patients in the routine care group will not have to do anything. There will be no changes to their care. Patients in the targeted group will fill out a questionnaire either at home or at the surgery (once) and if they say they have respiratory symptoms in the questionnaire they will have a one-time simple lung function test. This lung function test will take about half an hour and will be at their local or nearby surgery. It will require patients to take a standard dose of a salbutamol inhaler prior to taking the test. A few additional questions on their health and personal information will be requested at this point. For all participants, further medical information at the start and end of the study will be sought from their GP, which will be anonymous until they provide consent. Finally, about 80 of the study patients will be invited to be interviewed, either in their own home or in the surgery as preferred. The aim of this is to explore participants' perceptions and understanding of the case finding process and its consequences, any barriers to attendance and participation, and for those who attend the lung function test, what their perceptions are of being either “disease free” or labelled with a new disease. Patients who have lung function test results which indicate that they may have COPD will be referred back to their GP for management. They will also have the chance to take part in another linked study. Further information from GP records on how they are being managed will also be collected 1 year after their diagnosis. What are the possible benefits and risks of participating? The benefits of participating will include additional monitoring of their health status and the possibility of earlier treatment for COPD identified through the study. Patients may also have the chance to take part in a linked study which will provide them with more detailed and more regular monitoring and health assessment. There are no risks from the methods involved. The lung function test may detect previously undiagnosed COPD that requires treatment. With the patients’ agreement, we will pass these details onto their GP for further consideration. Where is the study run from? University of Birmingham (UK). When is the study starting and how long is it expected to run for? The study started in August 2012 and end in April 2015. Who is funding the study? National Institute of Health Research (NIHR) (UK). Who is the main contact? Dr Joanne O’Beirne-Elliman [email protected]

Critère d'inclusion

• Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Liens

• ictrp
• isrctn