ERT, a global solution provider for high-quality patient safety and efficacy endpoint data collection, is authorized to provide validated, electronic versions of commonly used health-related Quality of Life (QoL) questionnaires on SITEpro Tablet—its patient data collection system for use at sites. The questionnaires, developed by professor Elizabeth Juniper, measure QoL among patients in clinical trials of asthma and rhinoconjunctivitis treatments.
SITEpro enables biopharmaceutical companies to capture important Clinical Outcome Assessments (COAs)—including patient, clinician and observer reported outcomes (PROs, ClinROs and ObsROs)—via an electronic tablet. Patients and site personnel use SITEpro during site visits to respond to questionnaires about their health and QoL as they participate in clinical trials. The authorization will give biopharmaceutical companies confidence that SITEpro is an effective tool for measuring QoL as medical products are developed.
In order to receive authorization, the screen shots for SITEpro Tablet were formatted to be as similar as possible to the validated paper versions of the questionnaires. In addition, ERT demonstrated that patients were able to use, understand and complete all three questionnaires on both SITEpro Tablet 10” and SITEpro Tablet 12” data collection devices. The specific assessments authorized include the Asthma Control Questionnaire (ACQ), the standardized version of the Asthma QoL Questionnaire (AQLQ) and the standardized version of the Rhinoconjunctivitis QoL Questionnaire (RQLQ).
“Evidence strongly suggests that the most accurate method for capturing health status data is to have patients respond to our questionnaires during investigative site visits,” said Juniper. “By formatting the screen shots to be as similar as possible to the original paper versions, and by checking the usability of the tablet versions in patients, the probability of obtaining valid data is high.”