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<sec> <title>BACKGROUND</title> Computer-assisted clinical coding (CAC) tools are designed to help clinical coders assign standardized codes, such as the <i>ICD-10</i> (<i>International Statistical Classification of Diseases, Tenth Revision</i>), to clinical texts, such as discharge summaries. Maintaining the integrity of these standardized codes is important both for the functioning of health systems and for ensuring data used for secondary purposes are of high quality. Clinical coding is an error-prone cumbersome task, and the complexity of modern classification systems such as the <i>ICD-11</i> (<i>International Classification of Diseases, Eleventh Revision</i>) presents significant barriers to implementation. To date, there have only been a few user studies; therefore, our understanding is still limited regarding the role CAC systems can play in reducing the burden of coding and improving the overall quality of coding. </sec> <sec> <title>OBJECTIVE</title> The objective of the user study is to generate both qualitative and quantitative data for measuring the usefulness of a CAC system, Easy-ICD, that was developed for recommending <i>ICD-10</i> codes. Specifically, our goal is to assess whether our tool can reduce the burden on clinical coders and also improve coding quality. </sec> <sec> <title>METHODS</title> The user study is based on a crossover randomized controlled trial study design, where we measure the performance of clinical coders when they use our CAC tool versus when they do not. Performance is measured by the time it takes them to assign codes to both simple and complex clinical texts as well as the coding quality, that is, the accuracy of code assignment. </sec> <sec> <title>RESULTS</title> We expect the study to provide us with a measurement of the effectiveness of the CAC system compared to manual coding processes, both in terms of time use and coding quality. Positive outcomes from this study will imply that CAC tools hold the potential to reduce the burden on health care staff and will have major implications for the adoption of artificial intelligence–based CAC innovations to improve coding practice. Expected results to be published summer 2024. </sec> <sec> <title>CONCLUSIONS</title> The planned user study promises a greater understanding of the impact CAC systems might have on clinical coding in real-life settings, especially with regard to coding time and quality. Further, the study may add new insights on how to meaningfully exploit current clinical text mining capabilities, with a view to reducing the burden on clinical coders, thus lowering the barriers and paving a more sustainable path to the adoption of modern coding systems, such as the new <i>ICD-11</i>. </sec> <sec> <title>CLINICALTRIAL</title> clinicaltrials.gov NCT06286865; https://clinicaltrials.gov/study/NCT06286865 </sec> <sec> <title>INTERNATIONAL REGISTERED REPORT</title> DERR1-10.2196/54593 </sec>