Strategies to Minimize Participant and Healthcare Provider Burden in Clinical Trials

Patient-reported outcomes (PROs) are a cornerstone of clinical trials, providing invaluable insights into treatment efficacy, patient experiences, and health-related quality of life (HRQoL). Despite their importance, the collection of PROs can place significant burdens on both trial participants and healthcare providers. These burdens often threaten data quality, increase dropout rates, and complicate clinical workflows. Addressing these challenges requires a nuanced approach that balances efficiency, equity, and data integrity.

This article explores practical strategies for reducing these burdens while enhancing the quality of data collection. Drawing on evidence-based practices, ethical considerations, and insights from recent research, it also examines how technology and global perspectives can further streamline the process.

Participant Burden: Challenges and Solutions

The Weight of PRO Collection

Participants face several challenges when completing PROs, including:

1. Cognitive and Emotional Strain: Complex, lengthy, or redundant questionnaires can exhaust participants. For instance, oncology patients with cognitive impairments often find PROs particularly taxing (Atkinson et al., 2019).
2. Time and Accessibility Barriers: Rigid schedules and technological hurdles can discourage participation, especially among elderly or underserved populations.
3. Ethical Concerns: Excessive burden risks violating ethical principles of autonomy and beneficence, reducing trust in clinical research.

Aiyegbusi, Cruz Rivera, and Roydhouse et al. (2024) propose 19 recommendations to address these burdens, emphasizing the importance of clear communication, streamlined surveys, and dynamic feedback loops. Their work underscores that reducing respondent burden requires a comprehensive, participant-centered approach.

How to Lighten the Load for Participants

1. Simplify Questionnaires Without Sacrificing Quality

• Short, concise surveys enhance participant engagement without compromising data validity. Tools like adaptive questioning, which tailors questions based on previous responses, minimize redundancy and cognitive strain (Einarsson et al., 2021).
• Clear, jargon-free language that considers literacy and cultural nuances ensures inclusivity and improves response accuracy (Aiyegbusi et al., 2024).

2. Flexible Administration Options

• Offering asynchronous survey completion empowers participants to provide responses at their convenience, reducing logistical challenges.
• Hybrid models that combine digital and paper surveys accommodate those lacking access to technology, bridging the digital divide (Aiyegbusi et al., 2024).
• Platforms like Castor ePRO provide flexibility, allowing participants to complete surveys on their own devices, while retaining paper-based options for those with limited digital access.

3. Leverage Technology Thoughtfully

• Platforms like Castor ePRO allow participants to use their own devices (Bring Your Own Device or BYOD approach), offering flexibility while reducing costs (Loewenstein et al., 2024).
• Low-tech alternatives must remain available to ensure equitable participation, particularly in resource-limited settings (Aiyegbusi et al., 2024).

4. Ethical and Cultural Sensitivity

• Inclusive tools and tailored support can enhance participation among underrepresented groups. For instance, multilingual surveys and caregiver support ensure that trials remain accessible and equitable across diverse demographics.
• Ethical considerations, such as transparency about survey length and goals, build trust and foster engagement (Aiyegbusi et al., 2024).

5. Dynamic PRO Designs and Feedback Loops

• Dynamic PRO designs that adapt based on real-time participant input can significantly reduce cognitive fatigue and improve data accuracy. Real-time feedback mechanisms, as recommended by Aiyegbusi et al. (2024), help participants navigate surveys intuitively and minimize errors.

Provider Burden: Streamlining Workflows

The Strain on Healthcare Providers

Providers tasked with facilitating PRO collection face distinct challenges:

1. Administrative Overload: Manual data entry and the integration of PROs into clinical workflows can overwhelm already overburdened providers (Ulrich et al., 2005).
2. Systemic Challenges: Limited infrastructure, particularly in under-resourced settings, exacerbates these issues.

Reducing the Load for Providers

1. Embed PROs into Existing Systems

• Integrating PROs into electronic health records (EHRs) automates data collection and reduces repetitive tasks. This allows providers to access real-time data seamlessly during consultations, improving workflow efficiency (Hartman et al., 2024).

2. Delegate Responsibilities

• Assigning PRO-related tasks to dedicated staff, such as research coordinators, alleviates the burden on providers. This enables clinicians to focus on patient care while ensuring data quality.
• Platforms like Castor ePRO can further streamline this process by offering centralized data management and tools to monitor participant responses in real time.

3. Training and Education

• Comprehensive training ensures providers understand the importance of PROs and equips them to administer and interpret these tools effectively (Einarsson et al., 2021).
• Workshops and easy-to-use resources can address resistance to adopting PROs into routine practice (Aiyegbusi et al., 2024).

Enhancing Data Returns: Making Every Response Count

Strategies for Maximizing Data Value

1. Real-Time Monitoring and Analytics

• Advanced dashboards provide immediate feedback on survey completion, data quality, and missing responses. Predictive analytics, based on interim data, enable timely trial adjustments, ensuring efficient use of resources (Lounsbury et al., 2024).

2. Longitudinal Analysis for Comprehensive Insights

• Collecting PROs at multiple timepoints helps researchers track treatment impacts over time, revealing patterns and outliers. This approach offers a holistic understanding of patient outcomes (Orozco-Levi et al., 2024).

3. Combining PRO Data with Clinical Metrics

• Integrating PROs with clinical and biomarker data creates multidimensional insights into patient health. Aligning PRO findings with imaging data can enhance trial conclusions and impact (Lenacapavir Study, 2024).

4. Transparent Reporting to Stakeholders

• Sharing tailored reports with participants, providers, regulators, and payers builds trust and demonstrates the value of PRO data. Personalized feedback also encourages participant engagement and enhances trial retention (Aiyegbusi et al., 2024).

Ethical and Practical Considerations

Balancing Efficiency with Equity

While simplifying tools and leveraging technology can improve efficiency, researchers must ensure these strategies do not compromise inclusivity or data validity. For instance, while ePROs are highly effective in high-resource settings, they may alienate participants in low- and middle-income countries (LMICs) without adequate digital infrastructure. Employing hybrid approaches that include paper-based options can mitigate these disparities (Aiyegbusi et al., 2024).

Ethical Research Design

Ethical considerations must guide all burden-reduction strategies. Researchers have a responsibility to ensure:

• Trials remain accessible to vulnerable populations (Ulrich et al., 2005).
• Participants are fully informed about the trial’s demands and their rights (Aiyegbusi et al., 2024).
• Data collection processes respect cultural and contextual differences, aligning with recommendations for culturally sensitive research practices (Einarsson et al., 2021).

Final Thoughts

Reducing the burdens associated with PRO collection is essential to maintaining high-quality data, improving trial retention, and fostering trust among participants and providers. Researchers can ensure that trials remain efficient and ethical by adopting participant-friendly survey designs, integrating PROs into clinical workflows, and leveraging real-time analytics.

Equally important is the commitment to inclusivity. Bridging the digital divide and addressing systemic inequities will enable clinical trials to reflect the diversity of the populations they aim to serve. Insights from recent research, particularly the 19 recommendations outlined by Aiyegbusi et al. (2024), highlight the importance of innovative, participant-centered strategies to reduce burdens while maintaining data integrity. These strategies will play a pivotal role in advancing patient-centered outcomes and driving innovation in healthcare.

Discover Castor’s ePRO Offering

Simplifying the collection of patient-reported outcomes is a critical step toward improving clinical trial efficiency and enhancing participant engagement. Castor’s ePRO platform offers an intuitive, flexible solution designed to reduce participant and provider burden. With features like BYOD (Bring Your Own Device) capabilities, adaptive questioning, and centralized data management, Castor ensures that data collection is streamlined without compromising quality.

References

1. Aiyegbusi, O.L., Cruz Rivera, S., Roydhouse, J. et al. Recommendations to address respondent burden associated with patient-reported outcome assessment. Nat Med, 30, 650–659 (2024). DOI
2. Atkinson TM, Schwartz CE, Goldstein L, et al. Perceptions of Response Burden Associated with Completion of Patient-Reported Outcome Assessments in Oncology. Value Health, 22(2), 225–230. (2019). DOI
3. Briz-Redón Á. Respondent Burden Effects on Item Non-Response and Careless Response Rates. Mathematics, 9(17), 2035 (2021). DOI
4. Einarsson H, Cernat A, Shlomo N. Reducing Respondent Burden with Efficient Survey Invitation Design. Survey Research Methods, 15(3), 207–233 (2021). DOI
5. Hartman V, Zhang X, et al. Developing and Evaluating Large Language Model–Generated Emergency Medicine Handoff Notes. JAMA Network Open (2024). DOI
6. Loewenstein A, et al. Global Insights on Challenges in Managing Age-Related Macular Degeneration. Ophthalmology and Therapy (2024). DOI
7. Orozco-Levi M, et al. Pathway to Care and Disease Burden of Pulmonary Arterial Hypertension. BMJ Open (2024). DOI
8. Ulrich CM, Wallen GR, Feister A, Grady C. Respondent Burden in Clinical Research. IRB: Ethics & Human Research, 27(4), 17–20 (2005). DOI