Reporting of patient-reported outcomes in recent trials in rheumatoid arthritis: a systematic literature review

U Kalyoncu ^1*, M Dougados ¹, J-P Daurès ² and L Gossec ¹

¹ Paris Descartes University, Medicine Faculty; Rheumatology B Department, Cochin Hospital, Paris, France
² Université MONTPELLIER I, EA 2415 Epidémiologie, Biostatistique, Santé Publique, Montpellier, France

^* To whom correspondence should be addressed. E-mail: umutkalyoncu{at}yahoo.com.tr.

Accepted 16 March 2008

Abstract

Objectives: Patient reported outcomes (PROs) have been increasingly recognized as important in rheumatoid arthritis (RA). The objective of this study was to assess the frequency of use of different PROs in recently published RA articles and to compare the tools used through a systemic literature review.

Methods: Data source: In PUBMED Medline database, articles reporting any type of clinical study for adult RA patients, published between February 2005 and February 2007, and reporting any type of PRO were analyzed. Articles were excluded if they did not concern adult RA or if they did not report any PROs. Data extraction: demographic characteristics of patients, study design, treatment assessed and all PROs. Data analysis: descriptive.

Results: Of 109 reports, 50 (45%) were randomized controlled trials and 59 were other types of studies. A total of 63 questionnaires or tools for PROs were used, corresponding to 14 domains of health. Frequently reported domains (and most frequent tools) were function, 83% (most frequent tool, Health assessment questionnaire, HAQ), patient global assessment, 61% (most frequent tool, visual analog scale, VAS), pain, 56% (VAS), and morning stiffness 27%. Domains such as fatigue, coping or sleep disturbance were infrequently reported.

Conclusions: PROs are reported with great heterogeneity in recently published trials in RA. Some domains which appear important from the patient’s perspective are infrequently reported. Further work is needed in this field.