Traditional methods for the monitoring and assessment of patients with Central Nervous System (CNS) disorders tend to be subjective and, therefore, prone to errors and human bias. Patients with CNS disorders, such as Parkinson’s or Alzheimer’s disease, battle symptoms that make data collection based on patient recall on patient-reported outcomes (e.g. PROs) challenging. Clinicians capturing data in CNS studies may be required to visually assess a patient’s condition, or use another imprecise form of measurement, like a stopwatch.
While solutions like ePROs (electronic patient reported outcome assessments) and eClinROs (electronic clinician reported outcome assessments) can go a long way towards improving data integrity, they may have little impact on data quality and accuracy if patients, caregivers and clinicians don’t possess the know-how to use the technology to accurately record their assessments. Further, it is imperative that study patients, caregivers and clinicians not only understand how to use study devices, but understand their role in the study and how to complete or administer assessments correctly.
ERT’s eCOA solution offers Advanced Training that mitigates bias, reduces user variability, and ultimately improves the accuracy of outcome assessments. This can be critical in CNS trials, when demonstrating even small differences in the tolerability or efficacy of a drug can lead to an approval.
Here’s how it works:
ERT’s eCOA team creates a tailored online training program designed to optimize patient data collection. Patients are required to undertake the training, which covers:
- Patients’ roles and responsibilities as study participants
- How to use the handheld devices to complete the ePROs
- How to answer questions about their symptoms accurately
ERT’s eCOA handheld solution is then used to deliver questionnaires as well as alarm reminders for dosing and data recording.
The training serves to help reduce variability in patient reports by instructing each patient to walk through the ePRO process and interpret their symptoms in the same way as other patients in the study. Training also serves to enhance patient engagement by explaining to the patient their important role and contribution to the study.
Caregivers and Patients
There are two types of caregiver training: observer training and patient assistance training. For patients who are not capable of completing an ePRO assessment on their own, caregivers can be trained as observers on how to effectively complete observer reported outcome (ObsRO) assessments. Some patients can complete their own assessments with a little bit of help from their caregiver. In these cases, caregivers should be trained on how to best assist the patient in completing their ePRO assessment. Advanced training for both types of caregivers is critical, as adding individuals to the process increases the risk of bias and variability in reporting.
ERT’s Advanced Training allows both patients and caregivers to receive the necessary training on the same device that the assessments will be entered. The trainings are easily accessible via the eCOA application and can be added to the study workflow, meaning sites and sponsors will see whether training is completed or not. Users follow easy to understand prompts to go through the appropriate training, which covers the details of how to enter outcome assessments on the device and how to recognize and avoid bias. They then take a quiz on what they learned, and once the training quiz is passed, users receive access to the assessment on the device. They are now ready to enter symptom data with confidence that the assessments are being recorded correctly.
ERT’s Advanced Training provides clinicians with protocol-specific training. This includes a review of scoring conventions, visit workflows, interview best practices, and how to administer ClinROs, minimize bias and placebo effect, and educate patients on the importance of PRO data. Clinicians are trained using real-world scenarios to help them reduce bias and produce accurate, high-quality data in their eClinRo assessments.
Clinicians are asked to complete an interactive multimedia training module. They begin with a pre-qualification survey to ensure that basic skill and experience needs are met. To keep variability low, clinicians are instructed on how best to standardize assessment administration including techniques for good patient interviews. Quizzes on comprehension of the training material then evaluate raters, with any incorrect answers being followed by in-depth explanations of the correct answer. Once the quiz is passed, clinicians are then qualified to begin recording eClinRO data. All training performance data is available for sponsors to review.
In CNS indications that rely heavily on outcome assessments to prove safety or efficacy, training is an effective way to reduce the risks of discovering data quality issues later in the development process. For example, high-quality training can help to minimize subjectivity and bias in even the most challenging types of assessments, such as:
For Site/Clinician Reporters:
- MADRS (Montgomery-Åsberg Depression Rating Scale)
- HAM-D (Hamilton Depression Rating Scale)
- HAM-A (Hamilton Anxiety Rating Scale)
- CGI (Clinical Global Impression Scales)
- PANSS (Positive and Negative Syndrome Scale)
- CDR (Clinical Dementia Rating Scale)
- MoCA (Montreal Cognitive Assessment).
For Patient and/or Caregiver Reporters:
- Seizure diaries
- Migraine diaries
eClinical solutions have been proven to improve compliance and integrity. But when end users vary widely – from non-expert patients to experienced clinicians – effective training is crucial to realizing the full benefits of the technology being employed.
Solutions like ePRO, eClinRO and eObsRO can be optimized through ERT’s Advanced Training to ensure minimal rater variability, reduced rater bias and fewer human errors.
For more information on how ERT’s eCOA solutions can help you achieve more clarity in your CNS clinical trial endpoint data, visit ert.com/therapeutic/central-nervous-system-clinical-trials.