As CEO of a startup whose main product provides advanced clinical decision support (CDS), I read with interest the draft guidelines for CDS software that The CDS Coalition came out with recently. I was also curious to see how our application, Infera, stacks up against the guidelines. I am happy to report that it stacks up really well. Read on for more details:
The Coalition’s three main recommendations are that any CDS software should provide the following:
- Disclosure of the intended use, 2. Disclosure of the outputs from the CDS expert system, and 3. Disclosure of the clinical rationale for the recommendations or rankings.
Let’s look at the recommendations in more detail:
Transparency: The CDS Coalition holds transparency as a great priority. They conclude that any end-user of a clinical decision support tool should be provided with a complete understanding of the framework of the CDS engine to ensure that recommendations are safe and effective for their patients. The coalition also suggests that a transparent CDS tool must provide validation at each decision step so that the user is comfortable with its recommendations.
In Infera, users are provided with an explanation at each step of the decision process. Users also have access to the logic of entire care pathways, which allows them to trace the path of each decision from start to finish. This is presented in a coherent mind map format. The maps enable users to review the completeness of the clinical care pathway and the appropriateness of its recommendations.
Intended use: The transparency guidelines also suggest disclosure of the intended use of the CDS tool and the clinical rationale or confidence level for its recommendation. Infera displays an intended use statement for each care pathway before running its CDS engine. Recommendations generated from the Infera CDS engine are displayed along with the corresponding strength of recommendation and quality of evidence whenever these ratings are available. For topics where official college or society guidelines are sparse, recommendations generated from the Infera CDS tool contain additional information about the clinical rationale and a list of references on which the recommendation is based.
The CDS Coalition describes the purpose of the guidelines as follows: “A purpose of the guidelines is to make sure that companies are very deliberate and thoughtful about when they cross the line to take over decision-making from the healthcare professional. The bottom line is that we think these design guidelines are needed to bring focus and attention to design decisions around whether, and if so how, to leave the healthcare professional in control of the decision-making.”
Infera was built to be a powerful CDS tool which is completely transparent to the clinical end-user. We are glad to note that the design of Infera has been validated by the CDS Coalition guidelines. We will continue to build more content and enhance the user experience.