Date: Sunday, November 8, 2015
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: In a systematic literature review (SLR), frequency of patients reported outcomes (PROs) related with rheumatoid arthritis (RA) was evaluated between 2005 and 2007 (1). Relatively low frequent outcome measures at this SLR were fatigue, utility, psychological status, coping, sleeping disturbance, productivity losses, wellbeing and leisure. Although pain and function are essential domains for patients, priority of patients also include fatigue, emotional well-being, sleep, coping and physical well-being (2). Objective of this study was to assess frequency and changing trend of PROs related with RA at the last 2 years.
Methods: Literature search was performed in PUBMED MEDLINE database on 01 January 2015. Publications were identified through a search that used the following exploded MeSH term: (‘‘arthritis, rheumatoid’’ (MeSH)) with a limitation to ‘‘humans’’, ‘‘all adults: 19+ years’’, ‘‘English’’, ‘‘published in the last 2 years’’ and ‘‘clinical trials’’. Publications were limited to articles referenced in PUBMED in the last 2 years. Demographic characteristics of patients, study design, treatments assessed and all PROs assessed. Results were compared with previous SLR (1).
Results:Of the 479 publications identified by the literature search, 250 were included in the analysis. Of the 250 publications, 113 (45.2%) were randomized controlled trials. One hundred-forty different tools were reported in this SLR. Function (83.4% vs 68.0%), pain (55.9% vs 40.0%), patient global assessment (63.3% vs 49.2%) and quality of life (19.2% vs 18.4%) were still essential PROs. Frequency of fatigue (13.7 vs 14.4), psychological status (7.3 vs 9.6), productivity losses (5.5 vs 6.4) and sleeping disturbance (1.8 vs 2.4) were not changed over time. On the other hand, frequency of morning stiffness (26.6 vs 10.0), coping (6.4% vs 2.0%) and utility (16.5 vs 5.2) were decreased. Although fatigue assessed with valid tools (VAS 7.2%, FACIT 4.8%), other less frequent domains (psychological status, productivity losses, sleeping disturbance, coping) did not have constant and specific tools for RA.
Conclusion: Eight years later, we still did not determine any significant change about PROs in RA trials. Priority of patients, for instance fatigue, psychological status, productivity losses, sleeping disturbance, coping were not sufficiently appear RA trials. One of the major challenge of those PROs was also related with tools. Tools about psychological status, productivity losses, sleeping disturbance and coping had high heterogeneity and low specificity for RA.
- Kalyoncu U, Dougados M, Daurès JP, Gossec L. Reporting of patient-reported outcomes in recent trials in rheumatoid arthritis: a systematic literature. Ann Rheum Dis. 2009;68:183-90.
- Gossec L, Dougados M, Rincheval N et al. Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiative. Ann Rheum Dis. 2009;68:1680-5.
To cite this abstract in AMA style:Kilic L, Erden A, Gossec L, Kalyoncu U. Fatigue, Coping, Sleeping Disorders and Productivity Were Still Not Frequently Reported in Rheumatoid Arthritis Trials Published in 2014-2015: A Systematic Literature Review [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/fatigue-coping-sleeping-disorders-and-productivity-were-still-not-frequently-reported-in-rheumatoid-arthritis-trials-published-in-2014-2015-a-systematic-literature-review/. Accessed December 4, 2021.
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