Electronic Clinical Outcome Assessment

Electronic clinical outcome assessments (eCOA) are integrated into Vitalograph’s validated clinical trials solutions allowing multiple endpoints to be collected in clinic or at home, and centralized.

eCOA are collected by Vitalograph on the COMPACT™  Medical Workstation (in-clinic) and the In2itive™ e-Diary (home setting). eCOA, along with all other assessments, are managed and centralized through Spirotrac® software. We offer eCOA when we are also collecting respiratory endpoints using the COMPACT or In2itive e-Diary. Vitalograph has a number of pre-validated PROs available and we liaise with eCOA license and copyright holders as required.

Centralizing the eCOA data with the other respiratory endpoints creates an efficiency in respiratory trials.  It reduces costs and specification time as well as the need for managing and collating multiple datasets.  The eCOA are run through Spirotrac software and collected on Vitalograph In2itive e-Diaries or COMPACT.

Vitalograph views eCOA as a natural extension of the respiratory devices already being provided to trials and so only pass through associated licensing and copyright fees and require no additional device or service fees.

We provide a cost-effective and simple alternative to dedicated eCOA vendors.

Vitalograph offers a single, integrated spirometer and e-Diary validated as a medical device. eCOA data collection is enabled by Spirotrac® software to centralize the Patient Reported and Clinician Reported Outcomes (PRO and ClinRO) data with other respiratory endpoints

  • Innovative validated solutions for clinic and home use.
  • Large touch screen devices with intuitive workflows for ease of use.
  • eCOA only or combined endpoint options.
  • Contemporaneous access to study data via Vitalograph Web Portal.
  • Device solutions are configurable to meet protocol requirements such as:
    • Symptom scores
    • Medication use
    • ePRO questionnaires
    • Adaptable workflows
    • Custom alerts, alarms and reminders
  • Integrated wireless cellular/mobile communications option.
  • Live spirometry blow quality feedback – promoting high-quality, reliable data.
  • Integrated animated help file options supporting training and compliance.
  • Date/time stamps ensure data integrity.
  • Automatic end-to-end secure data transmission.

Vitalograph supports a full range of validated respiratory electronic PRO and ClinRO.

The eCOA are run through Spirotrac software and collected on Vitalograph In2itive e-Diaries or COMPACT Medical Workstation. This means we have complete control of the question sets and can be very flexible as regards content. For example, sponsor’s own questionnaires can be integrated and validated in Spirotrac software, providing efficiency and simplicity for your study. In addition to eCOA, Vitalograph solutions can measure lung function endpoints at home e.g. Peak flow, FEV1, and others.

Pre-integrated and validated ePRO questionnaires:

  • Respiratory – asthma
    • ACQ                MAPI
    • AQLQ(S)12+  MAPI
    • AQ20               Prof P Jones
    • ACT                 Quality Metric
  • Respiratory – COPD 
    • EXACT            Evidera
    • EXACT E-RS  Evidera
    • CAT                 GSK
  • Health status     
    • EQ5D-3L         Euroqol
    • EQ5D-5L         Euroqol
    • SGRQ              Jones PW

Technical Specification