Original Title: Evalueringsrapport vedrørende SelfBack app til behandling af uspecifikke lænderygsmerter

Authors' objectives: SelfBack is an evidence-based and data-driven system designed for use on smartphones by patients. The purpose of the app is to facilitate, enhance, and strengthen patients’ self-management of non-specific low back pain. The goal of this health technology is to reduce pain-related functional impairment associated with non-specific low back pain. This applicant-initiated evaluation reviews the current evidence on the use of the SelfBack app for individuals (≥15 years) presenting in general practice with an episode of non-specific low back pain, where more than 4 weeks have passed since symptom onset within four perspectives: Clinical effectiveness and safety, the Patient perspective, Organizational implications, and Health Economics. The Danish Healthcare Quality Institute based their recommendation on the use of the SelfBack on the findings in the evaluation report.

Authors' results and conclusions: Clinical effect and safety: The clinical effectiveness and safety of the SelfBack app is evaluated based on a systematic review identifying two studies for inclusion. The expert committee noted that few participants were recruited from general practice; most were enrolled via physiotherapists, chiropractors, or back pain clinics. Since this evaluation focuses on patients presenting in general practice with non-specific low back pain lasting more than four weeks, the study population may not be representative. Consequently, the committee accepted the evidence with reservations, acknowledging that actual treatment effects may differ for the target population. Across key outcomes, the SelfBack app did not demonstrate clinically relevant improvements compared to usual care: • Physical Function: Minor differences at 3 and 9 months, but not clinically relevant. • Self-Efficacy: Statistically significant improvement, yet not clinically relevant. • Health-Related Quality of Life: No overall clinically relevant effect; a Danish sub analysis suggested a potential benefit, though very uncertain. • Pain Intensity: No clinically relevant reduction in average or worst pain. • Work Ability: Minimal, non-relevant effect. • Use of Pain Medication: Statistically significant reduction, but not clinically relevant. The SelfBack app is considered safe, with no increased risk of adverse events. Overall, the expert committee concluded that the SelfBack app does not yield clinically relevant benefits, but the quality of evidence is rated low to very low, limiting confidence in the findings. Patient perspective: Five predefined themes are explored using the scientific literature, unpublished reports, expert opinions, and internal evaluations from the applicant. The expert committee accepted the evidence base and considers the identified qualitative literature to be generally reliable. Despite credible sources, the expert committee found that the evidence is based on a patient population and study context that were not directly transferable to the current evaluation. It was noted that there may be selection bias in the inclusion and interpretation of patient statements, leading to an overly positive portrayal of attitudes toward the SelfBack app. The expert committee believes actual patient views in Danish clinical settings may be more mixed than presented in the applicant’s presentation of evidence. Currently, there is insufficient literature to clarify patient preferences regarding general practice treatment with or without the SelfBack app for managing non-specific low back pain. The limited data on patient preferences presented in the application does not enhance understanding of patient preferences substantially. Organizational implications: The evidence base for evaluation of the organizational implications consists of scientific literature, reports, presentations from the Danish College of General Practitioners (DSAM), clinical input, and internal documents from the applicant. Although most sources are not peer-reviewed, the expert committee considers the evidence base sufficiently comprehensive. The committee finds that the patient-oriented SelfBack app may be implemented within the current framework of the Danish public healthcare system. However, there are significant barriers to implementing the optional Clinical Dashboard oriented at clinicians treating patients with non-specific low back pain. The Clinical Dashboard’s functionality and role in patient-provider and provider-provider communication remain unclear, and its lack of integration into existing systems may hinder cross-sector collaboration. The expert committee recognizes a need for additional treatment options, and the SelfBack app shows promise for patients and general practitioners with a certain level of technological literacy. The expert committee notes that patients with non-specific low back pain represent a complex patient group, whose optimal treatment may involve collaboration between different healthcare providers. In this context, the committee emphasizes that patients may seek healthcare services without prior access via general practitioners. The expert committee comments that limiting access to the SelfBack app exclusively through general practice, as is an assumption for the current evaluation, may result in inappropriate and unequal access to the technology. Health economics: The health economic evaluation of the SelfBack app consisted of a published, peer-reviewed cost-utility analysis. In addition, a budget impact analysis was prepared by the Danish Healthcare Quality Institute. The health economic evaluation is performed as an economic evaluation alongside the clinical trial from which the clinical data were retrieved. The cost-utility analysis estimates that using the SelfBack app over a nine-month period yields a QALY gain of 0.03 compared to usual care, with an associated cost difference of DKK 1,716. This results in an incremental cost-effectiveness ratio of DKK 54,729 per QALY. The analysis uses Danish EQ-5D-5L data and preference weights, aligning with the preferred methodology of the Danish Treatment Council. The expert committee finds the cost estimation approach appropriate and considers that any resource impact will occur within the analysis timeframe. Based on the included uncertainty pertaining to the input parameters, there is a 91% probability that using the SelfBack app will lead to additional costs. The expert committee concludes that the app is unlikely to be cost-saving under current usage assumptions. The concerns stated regarding the representativeness of the clinical data apply for the economic analyses as well. The budget impact analysis estimated the five-year regional costs based on a volume licensing model. As the economic evaluation and the budget impact analysis are based on different cost assumptions, the direct comparison of their results is unsuitable.

Project Status: Completed

Year Published: 2025

URL for published report: https://www.sundk.dk/media/m3cd22zk/anbefaling-selfback-app.pdf

English language abstract: There is no English language summary available

Publication Type: Not Assigned

Country: Denmark

Organisation Name: The Danish Health Technology Council

Contact Address: Niels Jernes Vej 6a, 9220 Aalborg