The clinical assessment and remote administration tablet

Abstract

Electronic data capture of case report forms, demographic, neuropsychiatric, or clinical assessments, can vary from scanning hand-written forms into databases to fully electronic systems. Web-based forms can be extremely useful for self-assessment; however, in the case of neuropsychiatric assessments, self-assessment is often not an option. The clinician often must be the person either summarizing or making their best judgment about the subject's response in order to complete an assessment, and having the clinician turn away to type into a web browser may be disruptive to the flow of the interview. The Mind Research Network has developed a prototype for a software tool for the real-time acquisition and validation of clinical assessments in remote environments. We have developed the clinical assessment and remote administration tablet on a Microsoft Windows PC tablet system, which has been adapted to interact with various data models already in use in several large-scale databases of neuroimaging studies in clinical populations. The tablet has been used successfully to collect and administer clinical assessments in several large-scale studies, so that the correct clinical measures are integrated with the correct imaging and other data. It has proven to be incredibly valuable in confirming that data collection across multiple research groups is performed similarly, quickly, and with accountability for incomplete datasets. We present the overall architecture and an evaluation of its use.

Keywords: case report forms; clinical assessments; electronic data capture.

Figure 1

The flow of information for study setup and data collection using CARAT. The currently usable databases are the FBIRN human imaging database (HID) and the MRN medical imaging computer information system (MICIS), but others can be modeled in the web service. The study definition portion determines which CRFs are required in what layout for which visits and subject types within the study. The CRF XML layout captures how the questions should be presented on the tablet and the validation steps required. Following the administration of the assessments, the subject’s responses are sent via the web service back to the available database.

Figure 2

The workflow for CARAT, expanding on the data collection parts of Figure 1. Following study setup, data collection can proceed through the needed steps of interviews, validation, correction, addition of other notes or annotations, and final submission.

Figure 3

The data model for CARAT is lightweight, combining an individual’s responses with their study-specific information and response validation prior to inserting the information in the database. The upper row indicates those parts of the model that draw from study setup, while the lower row indicates the parts that are populated during data collection. The solid bulleted connections indicate a many-to-one relationship: a single CRF pulls from many questions, and a completed assessment includes several responses.

Figure 4

An example of a questionnaire on CARAT, demonstrating: (1) Annotations may be stored for any question by clicking the pencil icon (the pencil icon then displays in green). (2) Data types and reasonable responses are enforced, with error messages available to clarify. (3) Navigation through a form can be done using either the navigation tree or the buttons on the lower right corner. (4) Conditional skipping of questions: Here, since the participant answered “Yes” about English being their primary language, the follow-up question is not required. (5) Required fields are marked with a red icon.

Figure 5

Example question with a drop-down menu and extended text.

Figure 6

Example of error messages to identify which questions the error occurred on, what the error was, and what page of the assessment it occurred on.