Database-derived measures of asthma control was predictive of asthma treatment response and future asthma exacerbation. This study validates the usage of database records for future studies investigating the efficacy of treatments and predicting risk for future asthma.
Singapore 7th September 2018
Randomised control trials (RCTs) have been the study design of choice for evaluating the efficacy of new treatments and therapies. Yet, therapies found to be efficacious in randomised trials are not always found to be so in routine clinical practice.1 This is because RCTs tend to use selected populations and minimise real-life factors such as sub optimal adherence.2 Observational studies using patient records from clinical practices offer a complementary source of evidence by looking at the real-life effectiveness of specific therapies. However, there remain concerns regarding the validity and reliability of observational research.3-5
For this reason, Colice and fellow authors recently published a new study, in the Journal of Pragmatic and Observational Research, highlighting the responsiveness of asthma database outcomes to evaluate the effectiveness of real-life asthma treatment and to estimate the association between outcomes and future risk of exacerbation6. The authors conducted this research using data from the Optimum Patient Care Research Database (OPCRD; http://opcrd.co.uk/), a comprehensive research database containing anonymised, routinely recorded clinical data from over 5.5 million patients and over 650 primary care practices across the UK.7
The authors found that following asthma treatment with inhaled corticosteroid (ICS), the recorded number of patients who had uncontrolled asthma and the average number of asthma exacerbation episodes decreased. Patients who were recorded as having uncontrolled asthma in the year before initiating ICS were also at higher risk of developing subsequent asthma exacerbations, in agreement with a previous study.8
The results of this study confirm the validity of database recorded measures of asthma control to evaluate real-life effectiveness of asthma therapies as well as to predict future asthma outcomes. This supports the use of observational database studies to complement results of RCTs in investigating the effectiveness of novel asthma therapies. “This exciting study validates the use of composite endpoints of risk domain asthma control, overall asthma control and acute respiratory events to future database studies” said Professor David Price, co-author and Chair of Primary Care Respiratory Medicine at the University of Aberdeen, Aberdeen, UK and Director of the Observational and Pragmatic Research Institute, Singapore.
As the number of practices in the UK joining OPCRD grows, so will the wealth of available information to support observational studies. This will be invaluable in enabling large population-based studies to identify different asthma phenotypes and for the future development of personalised medicine.
OPRI (www.opri.sg) aims to improve disease management and patient outcomes by undertaking the highest quality observational and pragmatic clinical research in real-life factors that influence outcomes and real-life effectiveness, both in terms of disease management and pharmacological interventions. By collaborating with clinical, academic and industry partners, OPRI drives a vision for the inclusion of real-life research into all aspects of medical research. Professor David Price has been a world leader in respiratory real-life research for over 20 years.
If you would like to schedule an interview with Professor David Price, please fill out the contact form on http://opri.sg/contact-us/
- Price D, Brusselle G, Roche N, Freeman D, Chisholm A. Real-world research and its importance in respiratory medicine. Breathe (Sheff). 2015;11(1):26-38.
- Roche N, Reddel H, Martin R, et al. Quality standards for real-world research. Focus on observational database studies of comparative effectiveness. Annals of the American Thoracic Society. 2014;11 Suppl 2:S99-104.
- Concato J, Horwitz RI. Beyond randomised versus observational studies. Lancet (London, England). 2004;363(9422):1660-1661.
- Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. The New England journal of medicine. 2000;342(25):1887-1892.
- Rawlins M. De testimonio: on the evidence for decisions about the use of therapeutic interventions. Lancet (London, England). 2008;372(9656):2152-2161.
- Colice G, Chisholm A, Dima A, et al. Performance of database-derived severe exacerbations and asthma control measures in asthma: responsiveness and predictive utility in a UK primary care database with linked questionnaire data” accepted for publication in the journal Pragmatic and Observational Research (In Press). 2018.
- OPCRD. The Optimum Patient Care Research Database (OPCRD). https://opcrd.co.uk/. Accessed: June 2018.
- Miller MK, Lee JH, Miller DP, Wenzel SE. Recent asthma exacerbations: a key predictor of future exacerbations. Respiratory medicine. 2007;101(3):481-489.