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Calculating the Ankylosing Spondylitis Disease Activity Score (ASDAS) in radiographic and non-radiographic axial spondyloarthritis when Patient Global Assessment (PGA) is not available
Proposal
5814
Title of Proposed Research
Calculating the Ankylosing Spondylitis Disease Activity Score (ASDAS) in radiographic and non-radiographic axial spondyloarthritis when Patient Global Assessment (PGA) is not available
Lead Researcher
Désirée van der Heijde
Affiliation
Leiden University Medical Center (LUMC)
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
26 Mar 2019
Lay Summary
This project is about patients affected with a disease called “spondyloarthritis”, an inflammatory disorder of the spine starting before the age of 45 years old. In order to decide upon treatment for these young patients, physicians often rely on measuring the inflammatory “activity” of the disease. This implies not only checking blood tests, but also asking the patients how much back pain, stiffness, and general complaints they have. There is a very specific way to combine all this information in one single number: it is the Ankylosing Spondylitis Disease Activity Score (known as ASDAS), a measure of disease activity combining data from the blood test and from patients' complaints. It is a very important instrument to help the physician decide whether patients are doing well or whether they need extra care, but unfortunately it is not always possible to calculate it. This happens because, in order to calculate the ASDAS, the physician needs to ask the patients about their perceived level of disease activity or PGA (Patient global Assessment). In other words, patients have to answer the question “On a scale from 0 to 10, how active was your spondylitis on average during the last week?”. Despite the question seeming simple, the answer is not always available: patients get tired of answering questions, or they have difficulties in declaring their judgement on the concept of disease activity, more than what could happen for the level of pain or stiffness. Instead of just accepting that this information is missing, a possibility would be to check if this information may be replaced using other methods. For example, a value derived from other patients' answers could be used - e.g information on fatigue, fatigue and discomfort in areas tender to touch or pressure, a constant value, etc. The present project aims to find the best way to replace PGA, when this is not available, in the formula for the calculation of the ASDAS. In order to do this, data from patients who have been assessed in the past, for example during previous studies or trials, will be used. These patients are normally visited very accurately and all necessary information is collected. Therefore, by exploiting information which is already available, without bothering other patients or setting up complicated studies, we could mathematically and with a precise methodology, verify whether there is an acceptable way to replace PGA in the ASDAS formula.
Study Data Provided
[{ "PostingID": 2365, "Title": "UCB-AKS001", "Description": "Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis" }]
Statistical Analysis Plan
Publication Citation
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