Transitioning PROs from paper to digital: Maintaining data integrity and patient experience

Patient-reported outcomes (PROs) provide important insights for clinical trials. Traditionally conducted in paper format, PROs capture data directly from patients about their condition, treatment impact, and quality of life.

In recent years, due to a growing preference for digital solutions and advancements in technology, we have seen a noticeable shift from paper to electronic PROs (ePROs). However, this transition presents unique challenges in ensuring the data and patient experience are consistent regardless of the format used.

Better data and compliance

Results within a trial conducted in 2023 showed ePRO yielded higher quality data than paper-based diaries and produced significantly better subject compliance - sometimes as high as 97%. ePROs also offer the advantages of improved data accuracy, real-time data insights and greater patient convenience, but the viability of this option is highly dependent on the application of faithful migration best practices.

Faithful migration involves meticulously adapting the design, content, and user interaction associated with a paper PRO to an electronic format in such a manner that the patients’ interpretation and responses remain consistent across both versions. This critical process, which is more than just digitising content, aims to preserve the intent of each question, maintain data reliability and validity, and uphold the overall integrity of the clinical outcomes assessment.

Challenges of faithful migration

Migrating from paper to electronic formats presents challenges, such as ensuring ePROs replicate their paper counterparts accurately. This process goes beyond simple text conversion, requiring a deep understanding of each question’s context and nuances. Designing ePROs with user-friendly interfaces that emulate the simplicity of paper is essential. The design should cater to the varied technological skills of patients and ensure clarity and consistency across different devices.

In terms of the mechanics of administration, training both patients and clinical staff to complete the electronic format adeptly is necessary to overcome any technological challenges. Most importantly, preserving the original integrity of the PRO in the electronic versions is vital. This can be accomplished by meticulously examining how any modifications made to question wording, response options, and overall flow impact interpretation of the electronic format. Even minor changes can potentially impact the accuracy and consistency of the data. The final ePRO must achieve equivalent patient responses to maintain the validity of the clinical outcomes assessment.

Strategies for successful migration

Effective migration strategies from PRO to ePRO require a blend of technological innovation and strategic planning. Some methods include:

1. Taking a user-centred design approach to developing ePROs, which draws from industry insights and focuses on making the electronic versions as intuitive and easy to navigate as the paper versions. This tactic minimises confusion and maximises user engagement.
2. Using advanced software solutions to ensure the electronic format replicates the paper version’s look and feel, including question layout, response formats, and the overall user journey. For instance, using responsive design methods ensures ePROs are accessible and functional across various devices, ranging from smartphones to tablets, catering to the diverse tech preferences of patients.
3. Carrying out rigorous pilot testing in smaller groups before full-scale implementation. This testing phase helps identify usability issues, understand patient feedback, and make necessary adjustments to the ePRO design.
4. Creating continuous feedback loops to collect patient responses throughout the migration process ensures ePROs remain true to their intended purpose. This ongoing dialogue between developers, clinicians, and patients helps fine-tune ePROs and meet the needs and expectations of the end-users.

Implementing these strategies provides the backbone of a successful migration from paper to ePROs, guaranteeing the integrity of patient-reported data is maintained, while embracing the advancements of digital healthcare.

Maintaining equivalency and accuracy: In summary

Addressing equivalency in the migration from paper to electronic formats is critical to preserve the scientific accuracy of these instruments. Equivalency ensures that responses gathered electronically maintain data validity by being consistent with what would have been collected on paper. Achieving this requires a detailed approach, ensuring each aspect of the PRO is closely examined and adapted for the digital environment.

Maintaining the scientific accuracy of PROs during migration also involves ensuring the questions’ intent, wording and context remain unchanged. The scale of responses, the order of questions, and the visual layout can impact how participants understand and respond to the items. Any alterations in these elements could lead to variations in data, affecting the outcome of the clinical studies.

Feedback from respondents is invaluable in identifying discrepancies or issues in the electronic format. Incorporating regular feedback mechanisms allows for continuous improvement to the ePROs to ensure they remain true to the original design and purpose. An iterative refinement process guided by direct user feedback helps fine-tune the ePROs, safeguarding their effectiveness and accuracy in collecting patient data.

Faithful migration is a cornerstone in establishing equivalency when changing to electronic patient-reported outcomes in clinical research. Following this philosophy guarantees that the transition from paper to digital format does not compromise patient data integrity, reliability, or scientific accuracy.

Meticulously preserving the essence of the original PRO instruments during the digital transition means ePROs will continue to provide invaluable insights into patient experiences, enhancing the quality and effectiveness of patient-centric healthcare research.

The future of ePROs in clinical trials

The future of ePROs in clinical trials is dominated by emerging trends and the potential offered by continuous technological advancements. As the healthcare sector increasingly embraces digital transformation, ePROs are set to become more integrated, efficient, and patient-centric.

Meanwhile, technological advancements are poised to enhance the ePRO user experience, making them more interactive and engaging. Features like voice recognition and natural language processing could simplify data entry for patients, especially those with physical or visual impairments. Integrating ePROs with other digital health tools, like wearables and mobile health apps, will also enable more comprehensive health monitoring and provide a holistic view of the patient’s condition and treatment efficacy.

ePROs hold immense potential for clinical trials and healthcare. Their increased adoption will streamline research processes and place a greater emphasis on patient-centric care. By harnessing the power of technology, ePROs will continue to make clinical trials more efficient, inclusive, and reflective of real-world patient experiences.