Objectives: Patient-reported outcomes (PROs) have been increasingly recognised 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: (1) Data source: In PUBMED MEDLINE database, articles reporting any type of clinical study for adult patients with RA, published between February 2005 and February 2007, and reporting any type of PRO. Articles were excluded if they did not concern adult RA or if they did not report any PROs. (2) Data extraction: demographic characteristics of patients, study design, treatment assessed and all PROs. (3) Data analysis: descriptive.
Results: Of 109 reports, 50 (45%) were randomised 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 analogue 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 that appear important from the patient's perspective are infrequently reported. Further work is needed in this field.
Kalyoncu, U. and M. Dougados, J. P. Daures, L. Gossec
Disease Category: Rheumatology
Disease Name: Rheumatoid arthritis
Age Range: Unknown
Sex: Either
Nature of Intervention: Any
- None
- Systematic review of outcome measures/measurement instruments
- Systematic review of outcomes measured in trials
- COS uptake study
- Systematic review
To obtain all recently published articles reporting any type of PRO in RA, an extensive literature search was performed in PUBMED MEDLINE database on 12 February 2007. 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, to obtain an exact view of the status of recent research in the field of RA, as data regarding fatigue or other important PROs were published over the last 5 years.
Inclusion criteria comprise articles reporting any type of clinical design, including patients with RA, and reporting patient-reported results. Articles were excluded if they did not concern RA, or if they did not focus on patient-based outcome measures (eg, articles reporting as main results laboratory outcomes, radiographic scores or genetic examination). Reviews, editorials and letters were also excluded because we were interested in obtaining an overview of the use of PROs in original research articles. The selection process was performed based on the titles and abstracts of the articles, then on full texts.
Data were obtained on year of publication, funding sources (public or private either clearly reported or extrapolated from authors’ affiliations), study design (randomised controlled trial (RCT), open-label trial, prospective cohort, retrospective study) and number of patients. Demographic data such as sex, mean age, mean disease duration, treatments under evaluation and maximum duration of follow-up were recorded for each report. The quality of the publications was determined by use of the Jadad scale (score 0–5) where a high score reflects high quality.