February 12, 2016: Salford Lung Study
Salford Lung Study: Lessons Learned
Kourtney Davis, PhD, Head of Real-World Data and Analytics at GSK
Sue Collier, MBChB, Head of Medical Operations for the Salford Lung Study, GSK
Salford Lung Study; COPD; PCT; pRCT; EHRs; United Kingdom; Hawthorne effect
- The Salford Lung Study is a phase 3 pragmatic randomized controlled trial conducted in a typical setting. It evaluates the benefit–risk profile of a combination medication for chronic obstructive pulmonary disease (COPD).
- Pragmatic characteristics of the Salford Lung Study include use of a linked electronic health record (EHR) system, enrollment of a generalizable proportion of the eligible population, and minimal disruption to everyday clinical care.
- The study employs a geographic extension to ensure sufficient numbers of participants: patients, general practitioners, community pharmacies, and study sites.
- One lesson from the Salford Lung Study is that EHR data are of variable quality, so it’s important to start early to evaluate the data; validation and augmented data collection might be needed. Another lesson is the need for ongoing training and support for those investigators with little research experience.
A key challenge of this pragmatic study was recognizing that the data collected from EHRs are different from data in a traditional RCT.
In a study with a variety of teams participating (university staff, contractors, pharmaceutical company staff), the professional cultures may not always mesh seamlessly. The study team solved that by together developing a way of working, defining what their values are, and how they would be accountable.
The companion observational cohort study, called CHESS, is evaluating a challenge to the interpretation of Salford Lung Study results—the Hawthorne effect, where people improve or modify their behavior in response to being studied. The companion study asks: Does increased awareness by participating providers lead to increased attention to patients with COPD during the study period? To what extent has usual care in Salford been influenced by conducting the study?
Pragmatic trials are not meant to be a replacement for traditional RCTs—they are complementary. But the kind of data and evidence will be different, so trialists need to decide which type will be more relevant to everyday practice.
For More Information
More information on the Salford Lung Study is in the free online publication available via PubMed: http://1.usa.gov/1Q5rkU6.
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