Abstract
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.
| Original language | English |
|---|---|
| Article number | e030879 |
| Pages (from-to) | e030879 |
| Journal | BMJ Open |
| Volume | 9 |
| Issue number | 12 |
| DOIs | |
| Publication status | Published - 5 Dec 2019 |
Bibliographical note
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.Funding
Based on this study, a multifaceted eHealth strategy for patients who had presented to primary care (ie, general practice and physiotherapy) with LBP was not effective in improving back pain beliefs, disability, or absenteeism. However, the CUA based on QALYs showed promising results. The multifaceted eHealth strategy should be studied in a different population, that is, a more mixed group of participants in terms of background (eg, education, nationality), and participants with LBP and poorer health states at start of the intervention. Contributors AS collected, prepared and analysed data and prepared the manuscript. JMvD assisted in cost-utility analyses, interpreted data and revised the manuscript. FS, PJME, RB, MT and JRA were all involved in design of the study, interpretation of data and revising the manuscript for intellectual content. Funding This study was funded by the Netherlands Organisation for Health Research and Development (ZonMw), grant number 80-83700-98-133053. Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work (other than funding agency); no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work. Patient consent for publication Not required. Ethics approval The Medical Ethics Committee of the VU University medical centre assessed this study’s design and procedures, and in accordance with the local regulatory guidelines and standards for human subjects protection in the Netherlands (Medical Research Involving Human Subjects Act (WMO), 2005), this study proved to be exempt from further medical ethical review. Provenance and peer review Not commissioned; externally peer reviewed. Data availability statement Data are available upon reasonable request.
| Funders | Funder number |
|---|---|
| ZonMw | 80-83700-98-133053 |