REXINSTRUMENT: EXPLORING AN OPEN-SOURCE STANDARD FOR CONFIGURING

CLINICAL RESEARCH INSTRUMENTS

Charles Tirrell, BS, Leon Rozenblit, JD, PhD, Frank Farach, PhD Prometheus Research LLC, New Haven, CT

DISCLOSURES

• I disclose that I have a relevant financial relationship with Prometheus Research, LLC, as an employee and incentive unit holder.

PROJECT SCOPE• The problem space is born out of academic research and

support for large research funding organizations

• Forms are specifically based on the mental health and behavioral research domains

• The focus is on electronic data capture of form data, not EMRs

• Data flows into an integrated research data management platform, such as RexDB

REXDB

PROJECT HISTORY

• 2003 - First version of “ROADs” using XML config developed

• 2005 - Initial Release of RexDB for Small Research Groups at Yale

• 2007 - RexDB used for Simons Simplex Collection (Multi-collection sites, significant form versioning)

• 2012 - Development of RexSurvey for self-administered questionnaires (Second RexDB EDC system)

REXENTRY

• Clinical Instrument Data Entry (staff members)

• Primary Needs • Rapid Data Entry • Accuracy

REXSURVEY

• Self Administered Questionnaires (patients, parents, teachers)

• Primary Need • Ease of Use for Direct

Reporters

PROBLEM SPACE

• Configuring a clinical or behavioral research instrument to be used in an electronic data capture (EDC) system requires the specification of metadata describing the content, structure, display, and presentation logic for the instrument form.

• Many EDC systems collect these metadata elements in an application-specific manner, making it difficult to share and repurpose instrument configurations for different EDC technologies.

CHALLENGES

• Instrument versioning

• Internationalization of instrument content

• Sharing of data definition elements between EDC platforms (question text, hints, pagination, etc)

• Requirement that data resulting from both cases to be merged together into a single data exploration source

LIMITATIONS OF COMMON FORMATS

• REDCap’s commonly-used configuration format is not open source and cannot be compiled into any format other than REDCap

• CDISC, while leveraging the powerful Object Definition Model (ODM), is too complex and heavy-weight for form-centric data entry systems.

OUR APPROACH

• Define all instrument metadata needed for delivery

• Separate the meta-data definition from the display properties

• Support the transformation of the instrument definition file into formats supported by a variety of platforms

OUR APPROACH (CON’T)

• Be human readable and editable

• Be extensible with respect to unanticipated attributes

• Be available under a liberal open-source license that would encourage the evolution of a user/developer community

CONFIGURATION DATA

• Data element definition (variable name, data type)

• Rapid data entry parameters (keyboard shortcuts, show-when logic, skip logic)

• Question-level display information (question titles, hints, hide/disable logic)

• Grouping information (pagination, sections)

• Mode-specific presentation instructions

CONFIGURATION

• Instrument Config • Data Definition

• Form Config • EDC Specific Display

Definition

WHERE ARE WE NOW?

• RexSurvey uses a prototype version of the new instrument definition format

• RexEntry uses database tables to configure forms

• Documentation is complete regarding the new instrument definition format

• Backend development is nearly complete for RexSurvey and RexEntry in a “next-generation” branch

FUTURE AIMS• Draft an open metadata standard for the definition of mental

health research instruments (Complete)

• Develop programs to translate instrument definitions from four EDC applications to the open standard and vice versa

• Develop an infrastructure for an open, sharable library of instruments through the Open Science Framework

• Develop a prototype tool in RexDB to read from and write to a library of instruments hosted on the Open Science Framework

FOR MORE INFORMATION

• For all Prometheus Research Open source Code Repositories https://bitbucket.org/prometheus

• Specific Repos

• instrument-nextgen - Instrument Definition Documentation • rexdb.study - RexDB Study Management Application • rexdb.survey - RexSurvey EDC Tool • rex.forms-provisional, rex.instrument-provisional - Code in progress

with new instrument definition (next_generation Branch) • Project Website - www.rexdb.org