VALIDATE approach on medication adequacy clinical decision support systems: Holistic assessment for optimal technology adoption.

• Holistic health technology assessment is required for optimal scoping/evaluation. • Considering stakeholders' values is key to plan the assessment of any intervention. • Reasons for overridden alerts & barriers/facilitators are as vital as clinical data. • Technological approaches are not enough to prevent medication errors. • Solutions for the whole/integrated process are needed. Lately, Health Technology Assessment (HTA) has narrowed its scope to analyses of mainly clinical and economic benefits. Recent challenges emphasize the need for holistic assessments to obtain accurate recommendations for decision-making considering empirical facts and stakeholder's values. VALIDATE approach considers stakeholder's views and empirical facts allowing for more comprehensive HTAs. This study frames the assessment for clinical decision support systems (CDSS) using VALIDATE. A systematic review of the literature was conducted to gather evidence on the CDSS's effectiveness and published stakeholder perspectives. Considering the retrieved information, semi-structured interviews with stakeholders were conducted to uncover issues around CDSSs such as problem definition regarding the occurrence of medication errors, judgement of existing preventive methods and previous experiences with CDSSs, background theories regarding thoughts on future impact and personal beliefs, and barriers/facilitators for implementation. When including multi-stakeholder views, reasons different from the literature are shown to interfere with CDSS acceptance/implementation, such as: i) Occurrence of ME (no traceability of medication taken/poor patient empowerment), ii) Technology as a tool to prevent ME (insufficient if only implemented at one point-of-care), iii) Previous experiences with CDSSs (low CDSSs development due to drug prescription being lastly digitalized in hospitals) and iv) CDSSs metrics (data inputted should be measured to control CDSSs performance). Including multi-stakeholders views in scoping technology evaluation brings added value and new information for the assessment, resulting in more comprehensive assessment; otherwise, it can lead to inaccurate information resulting in inaccurate decisions on if, when and how to adopt CDSS. Including varied stakeholders into health technology assessment provides a deeper understanding of what value can a technology bring in. The present study develops a framework to assess clinical decision support systems (CDSS) considering different stakeholders. They were interviewed to understand their perspective on different parts of the problem CDSSs try to solve (medication errors) and the solution itself (CDSSs). Some reasons on the interviews were different from the literature published so far, that are shown to hinder CDSS acceptance/implementation, such as: no traceability of medication taken/poor patient empowerment, CDSSs being insufficient if only implemented at one point-of-care, low CDSSs development due to drug prescription being lastly digitalized in hospitals and CDSS metrics (data inputted should be measured to control CDSSs performance). This approach can improve both implementation chances and posterior assessment of CDSSs. [ABSTRACT FROM AUTHOR]