Surveys (eCOA, ePRO, ClinRO, PerfO)

Electronic clinical outcome assessments (eCOA) are measures of how a participant feels or functions and can be collected through various mechanisms, including surveys, eDiaries, self- and caretaker-reported measurements, symptom trackers, ecological momentary assessments, and more.

eCOA provide a decentralized and more flexible method to collect participant data for digital clinical trials and research.

There are four major types of electronic outcomes:

1. Participant-reported outcomes (PROs) – data reported directly by a participant without interpretation by a clinician or trained healthcare professional
2. Clinician-reported outcomes (clinROs) – data reported by a clinician or trained healthcare professional, often involving an interpretation of the participant’s observable behaviors or measurements
3. Performance outcomes (PerfOs) – measurement based on a standardized task
4. Observer-reported outcomes (ObsROs) – data reported by an observer (e.g., parent or guardian)

eCOA confer a number of benefits on clinical trials and research compared to traditional methods of collecting clinical outcome assessments.

Use Case: Providing Mental Health Precision Treatment (PROMPT) Study

The University of Michigan PROviding Mental health Precision Treatment (PROMPT) study uses the MyDataHelps™ digital clinical trial and research platform to understand patient characteristics that influence incidences of depression and anxiety and to evaluate the impact of new digital treatments on mental health. To this end, PROMPT collects eCOA through surveys (PHQ9, GAD7) at baseline, 6 weeks, 18 weeks and 12 months. In addition, participants complete a daily mood survey. eCOA collection for PROMPT with the MyDataHelps™ platform shows impressive compliance rates—daily mood score surveys are completed at 82.6% on average, 92% of participants have submitted their 6-week surveys, and 81% have provided their 18-week surveys.

Why collect eCOA with MyDataHelps™?

Easy-to-configure
Build surveys, publish with a click of a button, and begin collecting data in just hours. You can also use or customize previously validated survey measures from prior projects or the survey library.

Efficient change management
Automated version control makes survey revisions and related regulatory submissions straightforward.

Electronic performance outcome measures
Remotely collect PerfOs using active tasks (e.g., ResearchKit Active Tasks) like memory tests and timed walks.

Multiple methods to reach participants
Collect eCOA through Android, Apple, and Web devices.

Flexible solutions
Surveys are customizable with a wide variety of built-in question types, including multiple choice, free text, numeric, date, and more. MyDataHelps™ can also use HTML webview steps for other use cases. In addition, surveys can be designed to allow for coordinator-entered responses or participant-provided information.