81 Effectiveness and cost-effectiveness of e-Exercise low back pain - study protocol with 5000 replications will be used to estimate 95% confidence intervals around the cost differences (ΔC). Incremental cost-effectiveness ratios cost (ICERs) will be calculated by dividing the difference in costs by the difference in effects (ΔC/ΔE). Uncertainty surrounding the ICERs will be graphically illustrated by plotting bootstrapped cost-effect pairs on cost-effectiveness planes and by estimating cost-effectiveness acceptability curves. To test the robustness of the study results, several sensitivity analyses will be performed (88). Timeline Recruitment of physiotherapy practices began in January 2018. The trial started in July 2018. Until January 2020 patients are able to enroll in the study. The follow-up will last until January 2022. Analysis of short-term effectiveness will start in March 2020, analysis of 12-month (cost)effectiveness will start in January 2021. DISCUSSION This paper describes the design and methods of the e-Exercise LBP trial. The aim of the presented study is to investigate the short-term as well as the long-term effectiveness and cost-effectiveness of e-Exercise LBP compared to usual physiotherapy in patients with LBP. E-Exercise LBP is a stratified blended care intervention in which an eCoaching smartphone application is integrated into primary care face-to-face physiotherapy. A major strength of this study is that the e-Exercise LBP trial is part of a multi-phase development and implementation process which was based on the Center for eHealth Research (CeHRes) Roadmap (37). This holistic framework provides guidance during the participatory development of eHealth in order to enhance future implementation. As part of the development of the e-Exercise LBP intervention, needs and values of end-users and various stakeholders (e.g., physiotherapists, developers) were used to develop the first prototype (33). Next, the prototype was tested on feasibility in a pilot study (33). Based on experiences of patients and physiotherapists several important adaptations were made to the prototype of the e-Exercise LBP intervention. A first important adaptation is the development of a smartphone application, which was based on the web-based application used in the prototype. Secondly, the content of the smartphone application was stratified to match the stratification of face-to-face care for patients at low, medium or high risk for developing persistent LBP. As a result, the content of the smartphone application for low-risk patients was provided immediately instead of spread out over 12 weeks. The graded activity functionality was made mandatory for patients with a high risk for developing persistent LBP. On top of that, each information theme was enriched with an assignment in order to stimulate self-reflection. Overall, we believe that the improved smartphone application with various options for physiotherapists to personalize the 4
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