medwireNews: A nurse-led education intervention may improve safety competency among people initiating biologics for spondyloarthritis (SpA) or rheumatoid arthritis (RA), French study findings indicate.
“Prevention of [biologic] adverse effects is an important issue and is usually addressed by recommendations and training of rheumatologists and [healthcare professionals],” write Catherine Beauvais (Sorbonne Université, Paris) and co-authors in RMD Open.
They add that “educating patients on safety matters has not been evaluated in controlled trials.”
To address this, the researchers randomly assigned 127 patients with SpA (69.3%) or RA (30.7%) to receive usual rheumatologist-led care alone (n=63) or in combination with a nurse-led safety education intervention (n=64) at the initiation of a first subcutaneous biologic.
Those in the intervention group received face-to-face education by a nurse at baseline and after 3 months that focused on safety skills and self-injections and was supported by a booklet outlining relevant messages. The mean duration of the initial meeting was 65 minutes, with the follow-up session lasting 44 minutes, on average.
The aim of the intervention was “to increase patients’ awareness of the risks of [biologics] to help them make their own decisions about whether or not to contact their rheumatologist and to give them the knowledge to inform their GP or other [healthcare professionals] so they can handle these risks,” the researchers remark.
Using the validated BioSecure questionnaire, which assesses competence in dealing with fever, infections, vaccination, and other situations, Beauvais and team found that individuals in the intervention group showed “higher safety skills” at 6 months than those in the control group.
Specifically, the mean score was 81.2 points on a scale of 0 to 100 in the intervention group versus 75.6 points in the control group, a significant difference.
Of note, women reported a significantly higher mean BioSecure score overall than men (81.0 vs 74.9 points).
Individuals who received the intervention reported significantly greater improvements in the secondary outcome measure of coping compared with those who received usual care, but other secondary outcome measures such as disease activity, psychologic well-being, beliefs about medication, self-efficacy, and severe infection rate were similarly improved between the two groups.
In addition, exploratory analyses showed that BioSecure subscores were higher in the intervention group than in the control group for infections, adherence-related behaviors, and vaccines, particularly willingness for the influenza and tetanus vaccines.
Beauvais and team conclude that their study “represents a significant advance in the field of safety management by showing a beneficial effect of a nurse-led intervention to increase patients’ safety skills related to [biologics].”
They therefore suggest that “delivering a patient education session may be useful to patients starting a first [biologic]” but acknowledge that further “studies will be necessary to assess whether the rate of severe adverse events is lowered by such an intervention.”
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