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Effectiveness and cost-utility of a multifaceted eHealth strategy to improve back pain beliefs of patients with non-specific low back pain: a cluster randomised trial [with consumer summary]
Suman A, Schaafsma FG, van Dongen JM, Elders PJM, Buchbinder R, van Tulder MW, Anema JR
BMJ Open 2019 Dec;9(12):e030879
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVES: To assess the effectiveness and cost-utility of a multifaceted eHealth strategy compared to usual care in improving patients' back pain beliefs, and in decreasing disability and absenteeism. DESIGN: Stepped-wedge cluster randomised trial with parallel economic evaluation. SETTING: Dutch primary healthcare. PARTICIPANTS: Patients diagnosed with non-specific low back pain by their general practitioner or physiotherapist. Patients with serious comorbidities or confirmed pregnancy were excluded. 779 patients were randomised into intervention group (n = 331, 59% female; 60.4% completed study) or control group (n = 448, 57% female; 77.5% completed study). INTERVENTIONS: The intervention consisted of a multifaceted eHealth strategy that included a (mobile) website, digital monthly newsletters, and social media platforms. The website provided information about back pain, practical advice (eg, on self-management), working and returning to work with back pain, exercise tips, and short video messages from healthcare providers and patients providing information and tips. The control consisted of a digital patient information letter. Patients and outcome assessors were blinded to group allocation. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was back pain beliefs. Secondary outcome measures were disability and absenteeism, and for the preplanned economic evaluation quality of life and societal costs were measured. RESULTS: There were no between-group differences in back pain beliefs, disability, or absenteeism. Mean intervention costs were 70- and the societal cost difference was 535-in favour of the intervention group, but no significant cost savings were found. The incremental cost-effectiveness ratio indicated that the intervention dominated usual care and the probability of cost-effectiveness was 0.85 on a willingness-to-pay of 10,000/quality adjusted life year (QALY). CONCLUSIONS: A multifaceted eHealth strategy was not effective in improving patients' back pain beliefs or in decreasing disability and absenteeism, but showed promising cost-utility results based on QALYs. TRIAL REGISTRATION NUMBER: NTR4329.
Reproduced with permission from the BMJ Publishing Group.

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