283 General discussion 9 of evaluation, known as formative evaluation, draws its roots from educational assessment where it is used to assess students’ learning process and to adjust learning and teaching practices accordingly, rather than solely judging students’ performance. In the development of eHealth, formative evaluation, which involves continuous evaluation, adaptation, and re-evaluation, plays a central role. On the other hand, summative evaluation aims to assess whether the desired endpoints have been reached. In educational assessment, it would determine whether students pass the test. The cluster RCT ACCEPTANCE protocol in chapter 5 is a form of summative evaluation, aimed at investigating the effectiveness of a smart inhaler asthma self-management programme on medication adherence and clinical outcomes. By also assessing usability, acceptability, and cost-effectiveness the study results provide a comprehensive understanding of clinical and patient benefits the meta-analysis presented in chapter 6 is another form of summative evaluation as it aims to demonstrate a pooled effect of comparable interventions on multiple clinical outcomes. Unique challenges in the summative evaluation of eHealth with RCTs and meta-analysis As mentioned before, one of the critical challenges of large-scale eHealth uptake and implementation is the uncertainty surrounding the effectiveness of eHealth interventions, particularly in terms of health benefit (40). Therefore, evaluating the effectiveness of eHealth interventions (summative evaluation) is essential to provide evidence of their impact on patients and healthcare systems. However, determining what outcomes should be included and considered important can be challenging, as stakeholders (patients, healthcare professionals, payers) may have differing perspectives. Having a clear value proposition helps prioritize outcomes and endpoints. Additionally, involving end-users in the design of the evaluation study facilitates the inclusion of outcomes that are meaningful to them, such as diseaserelated quality of life (chapter 5). Randomized controlled trials (RCTs) have long been considered the golden standard for evaluating interventions (41). Based on the principles of randomization and creating controlled settings, RCTs are able to isolate the impact of an intervention and ensure comparable groups from the start, thereby minimizing the potential for systematic bias affecting the results. Similarly, meta-analysis as conducted in chapter 6, is considered the golden standard for synthesizing, and summarizing the results of multiple studies and forms the cornerstone of evidence-based medicine. By pooling, meta-analysis enhances statistical power and provides more accurate estimates of the interventions’ effect (42). However, eHealth presents unique challenges that make RCTs less suitable for evaluating their effectiveness and poses difficulties in performing and interpreting meta-analysis results. One challenge is that eHealth interventions are often complex interventions that are difficult to standardize and replicate across various healthcare settings. RCTs, typically conducted in tightly controlled settings with a highly selected study population and with additional resources, may fail to consider the complex healthcare context in
RkJQdWJsaXNoZXIy MTk4NDMw