OA trials need PROMs for flares that extend beyond pain criteria
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Wide variation exists in the definitions of osteoarthritis flare currently in rheumatology trials, which negate the value of direct comparison between trials and impede interpretation of evidence, according to recent findings.
In a systematic literature review, researchers queried the Medline and PsychINFO databases for publications up using the search terms “osteoarthritis,” “knee,” “hip” and “flare.” Eligible studies included patients with confirmed osteoarthritis (OA), as well as a specific definition of OA flare, either in quantitative or qualitative methods. Data collected from each study enabled a description of the characteristics of the definition for OA flare.
Researchers identified 23 articles considered for final inclusion. These included 15 were clinical trials, including one meta-analysis; three studies for the development and validation of a diagnostic tool; and five prognostic studies, including a literature review. Twelve studies used flare in their designs, two used flare as an inclusion criterion and eight included flare as an outcome. One study used both a flare inclusion and outcome.
Most of the studies reported flare as an increase in pain using the WOMAC, VAS or global assessment and one study documented the precursors and aftereffects of pain flare. These studies used qualitative methods, including the timing of the increase in pain (sudden or short duration).
Researchers evaluated the publications to identify the following components for the definition of flare: as a concept of pain; as factors other than pain; as composite factors; and as a global analysis.
“While the majority of studies reported flare as an increase in pain using standardized outcome measures, only one study reported the antecedents and consequences of a pain flare using qualitative methods,” the researchers wrote.
They concluded, “The recent focus on chronic care programs and self-management strategies for OA heightens the need for a patient-reported outcome measure of OA flare. There is a need for an instrument that identifies comprehensive aspects of flare in OA that does not only summarize exacerbation of pain, but also encompasses other functional aspects described by patients.” -by Jennifer Byrne
Disclosure: The researchers report no relevant disclosures.