Optimizing Data Collection in Post-Surgical Pain Studies & The Role of Clinical Assessments

Authors: Rolana Avrumson, MS, VP Clinical Projects, Clinical Assessment Technologies; Barry Dussault Executive Director, Project Management, Franchise Area Lead, Pain

Upwards of 58% of patients experience moderate to severe post-surgical pain, while some research places that figure even higher at a staggering 80%. These data highlight both the prevalence of post-surgical pain and the critical need for comprehensive, non-opioid treatments aimed at alleviating it. Understanding and managing post-surgical pain is pivotal in clinical research for improving patient outcomes and care strategies. However, the collection of accurate and reliable data in these pain studies presents a unique set of challenges, from the subjective nature of pain to the variability in patient compliance and assessment methodologies. The intricacies of post-surgical pain studies necessitate innovative approaches to data collection, where the subjective and fluctuating nature of pain can significantly impact the quality of data gathered.

Here, we delve into how these challenges can be navigated with the aid of clinical assessment services, leveraging the expertise of Worldwide Clinical Trials’ Clinical Assessments Technologies (CAT) team.

The Complexity of Data Collection in Post-Surgical Pain Studies

Quantitative Measures & Qualitative Assessments

Over the past 50 years, clinical trial methods for evaluating treatments for acute pain have dramatically evolved and improved. These include developing early phase trial designs that minimize variability and enhance assay sensitivity, minimize bias through blinding and randomization to treatment allocation, and measure clinically relevant outcomes such as movement-evoked pain.

However, further improvements are needed, including:

1. Refinement of trial designs that address specific factors (e.g., patient-related and injury-/surgery-specific) relevant to acute pain either through a focus on a specific subpopulation or through patient stratification
2. Development and implementation of new patient-centered outcome measures most relevant to the acute pain condition and treatment intervention of interest
3. More robust trial design development for acute pain conditions other than postsurgical pain
4. Greater attention to trial quality, including more comprehensive assessment and safety outcome reports

Challenges in Data Collection

We must consider the challenges in collecting data for post-surgical pain studies as they can introduce difficulty to the study. Some of the challenges include:

• Subjectivity of Pain: Pain is inherently subjective, varying greatly among individuals, which complicates the standardization of measurement. While tools are available for patient stratification in some contexts, such as disease progression studies, it is significantly more challenging to do so in pain research studies.
• Temporal Variability: Pain levels can fluctuate significantly, necessitating frequent and timely assessments. A naturally associated challenge becomes deciding on the best times to take measurements and how to balance capturing the best data without overloading patients or sites.
• Compliance Issues: Ensuring consistent patient participation in reporting pain levels post-surgery can be challenging. Patients may be pain-free and not inclined to continue providing data or, conversely, might be in too much subjective pain to want to continue participating if the study feels too burdensome. It is vital to convey to the participant the emphasis on well-being over data collection, further complicating compliance-related issues.
• Placebo Response: Placebo response is often high risk in pain studies due to various external and intrinsic factors that can impact patient perception of their participation in the trial, treatment assignment, and personal experiences. In particular, the patient’s beliefs and expectations about the clinical trial and the expectation of analgesic response can significantly influence subjective reports of symptom severity and adverse events. It is critical to address this concern and implement mitigation strategies to lower placebo response in pain trials.
• Data Integrity and Consistency: Achieving uniform data collection across different study sites and personnel is a persistent hurdle to which studies should pay attention, highlighting the need for uniform and standardized training at each site.

Data collection challenges seem unavoidable, but not all must be. Choosing a partner with dedicated assessment expertise to sidestep these challenges will significantly enhance the outcomes of your trial.

Addressing Challenges with Worldwide’s Clinical Assessment Technologies Team

Worldwide’s in-house CAT team exists to overcome these obstacles through integrated assessment and endpoint quality support. With an in-house team comprising neurologists, physiotherapists, neuropsychologists, psychiatrists, and psychologists, CAT services enhance data quality and reduce variability. Our approach is multifaceted. We confidently provide sponsors with the following assurances:

• Training and Scale Management: We provide in-depth training across all components of your scale and assessment choices, ensuring clinician and patient raters are fully capable of and confident in administering scales accurately. The CAT team takes it further by providing accessible scale management support to assure quality data.
• Enhanced Signal Detection: We prefer strategies that minimize errors and improve data reliability as primary and secondary endpoints. We achieve this by having dedicated professionals who are experts at removing and eliminating avoidable administrative issues and inaccurate cost analyses on potential assessments.
• Targeted Placebo Response Training and Intervention Strategies: We provide detailed and focused training on placebo response, research alliance, and accurate reporting to sites and patient raters. Understanding the concept of placebo response, level-setting patient and site beliefs and expectations in a trial, and providing sites with the tools to effectively address these concerns with patients will provide greater confidence in the data obtained, improve patient compliance, and result in quality data.
• Operational Management: Data management and assessments can pose a physical nuisance if in-person collection is required. We expertly leverage electronic clinical outcome assessments to circumvent this challenge for streamlined data capture and management.
• Endpoint Quality Management: The CAT team emphasizes the precision of endpoint data to support robust study conclusions. At Worldwide, we achieve this precision endpoint detection through our unwavering support to clinicians and operations teams. We provide detailed clinical outcome assessment recommendations through evidence-based reviews, decades of accrued knowledge, and integrated support directly from our scientific experts.

Choose the Right Team: High-Quality Post-Surgical Pain Studies are Feasible

The challenges inherent in post-surgical pain studies necessitate a thoughtful approach to data collection that accommodates pain’s complex, subjective nature while maintaining accuracy and consistency. Worldwide’s CAT team offers a robust suite of services designed to improve the quality and reliability of pain data. By integrating advanced assessment techniques and ensuring rigorous endpoint quality management, we proudly exceed the standard requirements of clinical research in pain management. This ensures that your study can conduct high-quality studies with the confidence that the data collected will support substantial insights for your trial.

Explore how Worldwide’s CAT team can support your study and join us in advancing the field of pain research. Together, we can transform today’s challenges into tomorrow’s breakthroughs. Contact us today!