Friday, November 04, 2011

Technical Evaluation, Testing and Validation of the Usability of Electronic Health Records

Pulished in draft from the National Institute of Standard and Technology September 2011

The report summarises the rationale for Usability Protocol for an Electronic Health Record (EHR) that encompasses procedures for (1) expert evaluation of an EHR user interface from a clinical perspective and a human factors best practices perspective, and (2) validation studies of EHR user interfaces with representative user groups on realistic EHR tasks.

Examples of usability issues that have been reported by health care workers are include:
• Some EHR workflows do not match clinical processes create inefficiencies,
• Poorly designed EHR screens slow down the user and sometimes endanger patients,
• Large numbers of files containing historical patient information are difficult to search, navigate, read efficiently, and identify trends over time,
• Warning and error messages are confusing and often conflicting
• Alert fatigue (both visual and audio) from too many messages leading to users ignoring potentially critical messages, and
• Frustration with what is perceived as excessive EHR user interaction (mouse clicks, cursor movements, keystrokes, etc.) during frequent tasks.

A three step process is proposed for the design and evaluation of EHR as follows:

Step One: During the design of an EHR, the development team incorporates the users, work settings and common workflow into the design. Two major goals for this step that should be documented to facilitate Steps Two and Three are: (a) a list of possible medical errors associated with the system usability, and (b) a working model of the design with the usability that pertains to potential safety risks.

Step Two: The Expert Review/Analysis of the EHR step compares the EHR’s user interface design to scientific design principles and standards, identifies possible risks for error and identifies the impact of the design of the EHR on efficiency. This review/analysis can be conducted by a combination of the vendor’s development team and/or by a dedicated team of clinical safety and usability experts. The goals of this step are: (a) to identify possible safety risks and (b) identify areas for improved efficiency.

Step Three: The Testing with Users Step examines the critical tasks identified in the previous steps with actual users. Performance is examined by recording objective data (measured times such as successful task completion, errors, corrected errors, failures to complete, etc.) and subjective data (what users identify). The goals of this step are to: (a) make sure the critical usability issues that may potentially impact safety are no longer present and (b) make sure there are no critical barriers to decrease efficiency. This is accomplished through vendor-evaluator team review meetings where vendor’s system development and evaluation teams examine and agree that the design has (a) decreased the potential for medical errors to desired levels and (b) increased overall use efficiency due to critical usability issues.

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