Electronic Monitoring Feedback for Improving Medication Adherence and Clinical Outcomes in Early Rheumatoid Arthritis: A Randomized Clinical Trial

Figures & data

Figure 1 Study design of the RCT: electronic monitoring feedback (EMF) versus usual care.

Abbreviation: PPC, pharmaceutical pre-consultation.

Figure 2 Flowchart of study participants.

Abbreviation: CQR, Compliance Questionnaire on Rheumatology.

Table 1 Baseline Characteristics of Study Participants for Both Study Arms

Patient Characteristics	Intervention	Usual Care
	(N=47)	(N=46)
Age (years), mean (SD)	58.1 (13.6)	59.9 (13.9)
Female, N (%)	33 (70.2)	28 (60.9)
Disease-related characteristics
Anti-CCP status positive, n (%)	22 (46.8)	25 (54.3)
RA according to ACR-2010 criteria, n (%)	34 (72.3)	31 (67.4)
Standard disability index score measured with HAQ, median (IQR)	0.25 (0–0.75)	0.375 (0.125–1)
DAS28-CRP, mean (SD)	2.5 (1.1)	2.7 (1.1)
Treatment characteristics
Methotrexate, oral, n (%)	17 (36.2)	10 (21.7)
Methotrexate, subcutaneous, n (%)	30 (63.8)	36 (78.3)
Hydroxychloroquine, n (%)	33 (70.2)	34 (73.9)
Biologic DMARD (yes), n (%)	2 (4.3)	0 (0.0)
Beliefs about medicines
Sum scale score for necessity beliefs, median (ICR)	18 (16–21)	19 (18–21)
Sum scale score for concern beliefs, median (ICR)	14.5 (10–17)	15.5 (12–17)
Self-reported adherence to medication
Proportion of adherent patients measured with CQR, n (%)	36 (81.8)	35 (77.8)
Proportion of low adherence measured with MMAS-8^®, n (%)	8 (27.6)	9 (27.3)
Proportion of medium adherence measured with MMAS-8^®, n (%)	21 (72.4)	24 (72.7)

Table 2 Study Results of the RCT: Effectiveness of Electronic Monitoring Feedback (EMF) in Standard Care

	Intervention	Usual Care	p-value
Primary study outcome at 12 months
Proportion of adherent patients measured with CQR, n (%)	12 (60.0)	19 (61.3)	0.93
Secondary outcomes at 12 months
Sum scale score for MMAS-8, median (IQR)	7 (6–7)	7 (6–7)	0.27
Sum scale score for necessity beliefs, median (IQR)	18 (17–21)	19 (16–20)	0.76
Sum scale score for concern beliefs, median (IQR)	14 (9–17)	14 (12–17)	0.79
Necessity differential score, median (IQR)	4 (2–7)	3 (2–6)	0.56
Clinical outcomes at 12 months
Time to methotrexate discontinuation (weeks), median (IQR)	15.7 (9.1–33.6)	21.9 (19–28.4)	0.31
Time to TNF-alpha inhibitors (weeks), median (IQR)	17 (9.9–40.9)	11.9 (5.7–22)	0.55
Proportion of patients on TNF-alpha inhibitors, n (%)	11 (23.4)	11 (23.9)	0.95
Standard disability index score measured with HAQ, median (IQR)	0 (0–0.25)	0.125 (0–0.625)	0.25
DAS28-CRP, median (IQR)	1.99 (1.31–2.61)	1.64 (1.24–2)	0.27

Figure 3 Kaplan–Meier survival estimates: discontinuation of methotrexate in both study arms.

Figure 4 Kaplan–Meier survival estimates: initiation of bDMARDs in both study arms.