The adoption of Electronic Patient-Reported Outcomes (ePRO) in clinical research marks a significant evolution in the way patient-centered data is collected. These digital solutions, which are rapidly becoming essential for directly collecting patient and caregiver experiences, guarantee reliable and timely data. Used optimally, particularly in decentralized clinical trials, ePROs, including ePROMs and ePREMs, are fundamental to effectively evaluating outcomes and experiences of care. This guide takes a closer look at strategies for optimizing the effectiveness of ePRO, further enriching the quality and scope of clinical research.
Framework for the use of ePRO
It is essential to clearly define the objectives and context of ePRO use, focusing on the relevance and timeliness of the data relating to the treatments under study.
It is advisable to formalize the rationale for using ePRO, as opposed to historical data collection by a caregiver, or paper-based data collection. It may be useful to provide this to the relevant authorities.
Synopsis and Protocol
Precise definition of the data to be collected is essential. It must be limited to the information required for analysis, and be operationally feasible. It is therefore advisable to allow for breaks, e.g. at weekends, and to limit the number of times data is collected (no more than once a day).
Assess the risks and feasibility of ePRO for each target group (constraints of the disease, age of the population…), considering appropriate alternatives if necessary: remote collection by an operator via telephone, involving a caregiver at home…
Use paper-based data collection only as a last resort. Although it may seem an easy solution, the impact on data quality is detrimental (numerous missing, unreliable, out-of-date data).
Building and validating ePRO forms
Questions must be formulated in such a way as to be understandable and accessible to the target population.
Validation of questionnaires by experts and/or patient associations is recommended to ensure their relevance and reliability.
Many questionnaires are available under license and have the advantage of being validated for use in a specific context. In this case, you need to pay particular attention to the constraints that can often limit their use (paper version only, or web version, formatting, item numbering).
Intuitive design of the ePRO tool
Develop an intuitive ePRO tool, with features that facilitate understanding and save time for the patient (and thus have a positive impact on the completeness and quality of the data collected):
- Simplified connection to ePRO (link in email, short, clear URL)
- Setting up dynamic questionnaires adapting content according to responses received
- Setting up value selectors: cursor for value scales, calendar date selection…
- Set default values (current date)
ePRO can provide patients with a summary of their activity in the form of a dashboard:
- Completed items (including completion rate)
- Actions to be taken (Alerts)
- Reminders of upcoming deadlines as defined in the protocol (appointments with healthcare professionals, home examinations, etc.).
The ePRO portal must offer clear information, easily accessible IT support, and appropriate authentication and tracking functionalities.
Data Control and Analysis
As a general rule: it’s best to avoid controls that could prevent patients from entering their data.
Nevertheless, a limited number of non-blocking controls should be implemented:
- Outliers (values well outside the norm, impossible dates, etc.)
- Completeness (make sure all mandatory data is present)
- Temporality (time window for data collection)
- Critical data for analysis (threshold values, compliance, adverse events, forbidden treatments, etc.)
These checks can be addressed both to patients (messages in ePRO or on the patient’s device) and to healthcare professionals (summary or alert emails), particularly in the case of too much missing data or failure to meet protocol deadlines.
During site visits, it may be possible to include the investigator in the data entry (if the patient is unable to do so) and/or validation process. This requires shared access to the tool by both parties.
Don’t neglect metadata, particularly those identifying the source and date of collection. They are essential for selecting the data used in statistical analysis.
Regulatory Compliance and Data Security
It is essential to scrupulously comply with personal data protection regulations depending on the country of collection and processing (GDPR, HIPAA, PILP, APPI). This aspect must be integrated into the study approval process (DPIA: Data Protection Impact Assessment).
Particular attention must be paid to the use of identifying information in patient authentication and follow-up operations. Depending on the regulations and methodologies adopted, the following authentication methods may be considered:
- An email/SMS to the patient
- A patient card
- An email to the investigator, who will pass on the connection information received to his patients
The ePRO and all related documents given to the patient must be included in the CPP/EC submission file.
Commitment and Accessibility for Participants
In order to improve participant engagement, we recommend implementing various strategies:
- Inform the patient, reminding them of the principles of the study, how it will be carried out and what they will have to do.
- Make the collection medium attractive & user-friendly (graphics, use of images, etc.)
- Reassure the patient by using the study or sponsor’s graphic charter (logos, colors, etc.).
- Integrate help as closely as possible with content
- Pay particular attention to application ergonomics
- Independently of the validation of patient questionnaires, seriously consider having the ePRO solution tested by patients or their associations.
The challenges of digital accessibility must be addressed and appropriate solutions proposed:
- Offering tools that can be used offline
- Enabling BYOD use
- Making digital devices available directly to patients or self-service in investigation centers
- Provide internet connection facilities (Dongle, etc.)
- Web Content Accessibility Guidelines (WCAG): Sizes/colors of text, icons and buttons
Support and Training
Full support and training will be provided to users to ensure effective use of ePRO.
The implementation of support tools such as FAQs, video tutorials and a dedicated technical support service (hotline, chat or chatbot…) is essential. Medical questions should be addressed by the healthcare professional in charge.
Don’t forget that the healthcare professional will often be your ePRO’s first sales representative. He or she must therefore be trained in the tool and convinced of its effectiveness.
Continuous Assessment and Improvement
Carry out regular evaluations of ePRO usage to identify areas for improvement via measurable KPIs created from aggregated user paths (time taken to enter data per question, number of checks triggered, number of login attempts, etc.).
Engage in a continuous improvement process based on KPI analysis and technological advances.
The effective integration of ePRO into clinical research offers an unprecedented opportunity to collect data reported directly by the patient. These better, more patient-centered practices not only improve the quality and accuracy of the data collected, but also enrich the overall experience of study participants. These strategies pave the way for more effective research and significant advances in the medical field, making a significant contribution to improving healthcare.
Published on: Jan 12, 2024