Creating Electronic Versions of Paper-and-Pencil Clinician Reported Outcomes

equivalence article headline

The use of electronic devices to collect clinician-reported outcome (ClinRO) measures is rapidly increasing worldwide.  With industry moving toward electronic data collection, creating clear guidelines on the recommended approach for establishing equivalence between the electronic version of a clinician-administered measure and the paper version is of utmost importance. Current proposals regarding a standardized approach are based on the existing recommendations created for electronic PROs.  Establishing a standardized electronic clinician-reported outcome (eClinRO) measure provides many benefits including: eliminating duplication of data, reducing the likelihood of transcription errors, enabling real-time access for data review, and ensuring accurate and complete data collection.

As part of a large industry-sponsored study, Bracket set out to establish a method for establishing the equivalence of a ClinRO and its electronic version. As adoption of electronic Clinical Outcomes Assessments (eCOA) increases, the process of establishing equivalence is critical. Bracket collaborated with the sponsor to define such a process. In this article, those methods are detailed.

One important finding when migrating a ClinRO to an electronic version is the need for measurement equivalence testing:

“…scale comparisons will typically require cognitive debriefing or usability testing to document the similarities between the 2 versions of the scale and thereby provide evidence to support the equivalence of the 2 versions.”

The full article is available on the Therapeutic Innovation & Regulatory Science website.

FULL CITATION: Establishing Equivalence of Electronic Clinician-Reported Outcome Measures. Therapeutic Innovation & Regulatory Science. 2015 December. doi: 10.1177/2168479015618693. Epub 2015 Dec 10.
JOURNAL: Therapeutic Innovation & Regulatory Science
AUTHORS: Fuller, RM, McNamara, CW, Lenderking, WR, Edgar, C, Rylands, A, Feaster, T, Sabatino, D, Miller, DS.
YEAR: 2015

Using SMS and Text Messaging to Improve Patient Compliance


sms screenshot 2Medication compliance and adherence are critical factors to understanding clinical trial success. In a randomized trial, ensuring that patients are taking their medication is an important quality step for investigators. Bracket has announced the addition of an SMS text messaging component to our Bracket RTSM platform. This platform will be used to issue Patient Reminders via SMS and help keep patients compliant throughout a clinical trial.

SMS text messaging has shown to be a useful intervention for improving compliance and adherence in numerous published studies. Diabetes, psychiatry, and gastrointestinal studies are just a few that have shown patient compliance can be improved through daily SMS reminders.

Bracket SMS Patient Reminders are managed through our Bracket RTSM platform. All messages and patient data are encrypted and stored safely. The service is available globally, and the reminders can be tailored to specific dosing regimens and communications types on a study-by-study basis.

For more information on how you can utilize SMS Patient Reminders in an upcoming study, please contact Bracket.