Solutions for PRO research challenges
Barriers to Conducting PRO Research
Using the Right Tools for the Right Populations
First, valid PRO information should be collected via appropriate PRO measures (PROMs). PROM development and validation is an iterative process that involves rigorous methodology. It is also essential to keep in mind that the validated instruments should only be used in populations for which they has been validated. Some PROMs are appropriate for use across a range of patient populations, while others are disease or subgroup specific. For example, a recent study investigated the validity of using a shortened version of the Expanded Prostate Cancer Index Composite (EPIC-26), EPIC-CP, to measure quality of life for prostate patients. The results demonstrated that although the shortened version is valid for use with most prostate cancer patients, in a small subset of patients with rectal bleeding, the longer instrument should be used because of its superior performance in that sample.1
This example illustrates how the choice and any modifications of a particular PROM should be determined only after careful consideration of the research goals and target population, ideally by a PRO scientist working in collaboration with the subject expert, eg, an oncology practitioner.
Recruitment Issues
The second challenge for conducting PRO research is recruitment. Electronic data collection methods, particularly via the internet, substantially facilitate recruitment. This is because patients can complete questionnaires from any place where the internet is available both inside and outside of clinics visits. However, recruitment remains a major issue, particularly because most PRO studies conducted by pharmaceutical companies use very strict eligibility criteria. Specifically, the criteria for oncology studies typically include tumor type, disease stage, past and current treatment, and comorbidities. For one study conducted by Cardinal Health Specialty Solutions, out of 800 soft-tissue sarcoma patients who had been treated in a particular community oncology practice, only 16 matched the long list of inclusion and exclusion criteria and were found to be eligible to participate.
Because the recruitment process is so challenging, the companies that can produce good research often need to outsource the patient identification. Vendors who specialize in patient identification and recruitment are expected to have a low barrier of access to patients, be able to confirm eligibility criteria using electronic medical records (EMRs), and be experts in oncology in order to ensure professional communication with patients.
Data Analysis
Establishing an Oncology Research Network for PRO
The Concept
Benefits for Study Sponsors
Benefits for Oncology Practices
Launching the Oncology Research Network
As a result of discussions with physicians and practices, we have obtained agreements to name the participating practices as our PRO research collaborators. We have signed 2 practices from RainTree GPO—the largest independent group purchasing organization (GPO) for community oncology practices and recently acquired by Cardinal Health—to participate in patient and physician recruitment for a current PRO research project in mantle cell lymphoma and chronic lymphocytic leukemia.
We are actively recruiting additional practices, with plans to expand to other community and academic centers. Our ultimate goal is to establish a standing oncology research network with a broad range of practice types that are geographically distributed across the country. This research network would be a good starting point for fruitful and mutually beneficial collaboration between Cardinal Health, biopharma companies, clinicians, and patients in order to promote patient-centered care and PRO research.
The Unique Position of Cardinal Health
Access to Patients
Expertise in PRO and Data Analysis
In addition, Cardinal Health Specialty Solutions has a qualified team of experts with the clinical, industry, and academic experience necessary for conducting professional and successful PRO research. Our team contains experienced PRO researchers, data analysts, and oncology nurses and physicians. Therefore, Cardinal Health understands the complexity of the oncology landscape and can execute studies evaluating outcomes among oncology patients. This same team can also provide expertise in survey design and data analysis.
Altogether, Cardinal Health is ideally positioned to solve many of the key challenges in conducting PRO research and can perform the effective and qualified research needed to satisfy the growing demand for this type of research within the healthcare community in order to support patient-centered care.
How to Learn More
The Cardinal Health Patient-Centered Research Solutions Center offers a further review of articles, research abstracts and other resources to help guide your patient-centered research strategy. Visit us at www.cardinalhealth.com/PRO.
If you would like to inquire about conducting a study or are interested in learning more about the Cardinal Health Oncology Research Network, please contact us at BioPharmaAnalytics@cardinalhealth.com.
References
1 Lee JY, et al. Multinational prospective study of patient-reported outcomes after prostate radiation therapy: detailed assessment of rectal bleeding. Int J Radiat Oncol Biol Phys 2016; 96:770-777.
2 Wu AU, et al. Adding the patient perspective to comparative effectiveness research. Health Aff (Millwood) 2010; 9:1863-1871.
FOCUS Magazine
Explore the importance of Health Economics and Outcomes Research (HEOR) and real-world data in meeting the demands of a dynamic healthcare system.