No abstract

While patient and public involvement (PPI) in health and social care research has progressed successfully in the last decade, a range of difficulties with the evidence base exist, including poor understanding of the concept of impact, limited theorization and an absence of quantitative impact measurement. In this paper, we argue that a paradigm change towards robust measurement of the impact of involvement in research is needed to complement qualitative explorations. We argue that service users should be collaboratively involved in the conceptualization, theorization and development of instruments to measure PPI impact. We consider the key advantages measurement would bring in strengthening the PPI evidence base through a greater understanding of what works, for whom, in what circumstances and why.

Objective. To compare work disability and job loss in early rheumatoid arthritis (RA) patients receiving adalimumab plus methotrexate (adalimumab ؉ MTX) versus MTX alone. Methods. In this multicenter, randomized, controlled trial, patients with RA for <2 years who had never taken MTX and who self-reported work impairment were randomized to adalimumab ؉ MTX or placebo ؉ MTX for 56 weeks. Primary outcome was job loss of any cause and/or imminent job loss at or after week 16. Secondary outcomes included disease activity, function (Health Assessment Questionnaire [HAQ] score), and RA quality of life (RAQoL) questionnaire score. Work was evaluated with work diaries and the RA Work Instability Scale. Results. Although job loss during the 56-week study was significantly lower with adalimumab ؉ MTX (14 of 75 patients) compared with MTX alone (29 of 73 patients; P ‫؍‬ 0.005), the primary end point was not met (12 of 75 versus 20 of 73 patients; P ‫؍‬ 0.092), likely owing to early drop out in the MTX group. There were significant improvements in American College of Rheumatology 20% response criteria, 28-joint Disease Activity Score, ⌬HAQ, ⌬RAQoL, and working time lost in the adalimumab ؉ MTX group. Twenty-four serious adverse events were reported in 17 participants, with no differences between groups. Conclusion. Adalimumab ؉ MTX reduced job loss and improved productivity in early RA when compared with MTX alone, which supports the early use of anti-tumor necrosis factor therapy and suggests its cost efficacy.

The ARC booklet with or without the mind map was associated with a significant increase in knowledge. Poor readers had poor educational attainment and poor knowledge acquisition. The information on the mind map was not more accessible to them. Different educational strategies will be necessary to educate these patients.