There has been an abundance of literature published recently about making patient reported outcome (PRO) assessment inclusive and equitable. As recounted here last week, PRO is a patient’s self-reported status of their condition devoid of potentially biased analysis from the healthcare community. 

To improve research, avoid health disparities, and promote unbiased care for the clinical benefit of all, PRO collection must include multicultural and diverse populations as much as possible.  

The Importance of Equity and Inclusion in PRO 

While significant strides have been made to improve PRO inclusion in clinical trials and routine clinical practice, strategies to include underserved groups are in short supply. This is particularly true in drug development, where clinical trials are expected to provide information about therapeutic agents in target populations.   

Diversity in clinical trials is essential to ensure that new treatments and technologies are pertinent to every population they intend to serve. Unfortunately, populations in most clinical trials do not always reflect such characteristics. This “health data poverty” limits analysis of treatment outcomes by the group and can bias clinical trial results.  

To avoid further health disparities, strategies should be deployed to include groups that represent the full scope of the target population. Otherwise, these underserved groups may receive suboptimal clinical care due to a range of cultural, socioeconomic, and logistical reasons.  

The Diversity Disparity 

Although advances have been made, significant challenges still must be overcome in using multilingual and culturally validated PROs to include minority ethnic groups in research. For example, a review of cancer trials in the National Institute of Health portfolio found that only 17% reported ethnicity data. And none reported using multilingual PRO measures.   

According to data provided by Mass General Brigham’s hospital network, when tablets used for PRO collection were removed from clinics to minimize the spread of COVID-19, the capture of PROs quickly shifted to the use of the online portal. Patients who self-identified as black provided PROs at half the rate of white patients, and patients who identified as Hispanic virtually stopped completing PROs altogether. 

Overcoming Barriers to PRO Diversity 

To increase engagement with individuals from all relevant demographics within the target population, consider the following actions:  

  • Adapt questionnaires for different cultures and subgroups; be sure to communicate the objective of the PRO assessment, who will access the data, and how it will be used. 

  • Provide alternate modes of collecting PRO data, such as phone, mail, interactive voice response, or encouraging patients to bring their own device.  

  • Develop an education program that will lead to more diverse enrollment in your clinical trials—and explain to stakeholders why that’s important. 

  • Engage regulatory agencies early in the process to promote inclusivity.  

  • Involve individuals that represent target populations to help identify relevant concepts to measure, develop, collect data, and design the PRO system. 

  • Assess whether PRO measures are consistent across all groups (e.g., based on measurement equality or differential item functioning that shows the extent to which something might be measuring different abilities for members of different subgroups). 

  • Use a checklist that guides evaluators through each of the 5 health technology assessment (HTA) phases: Scoping, Evaluation, Recommendations and Conclusions, Knowledge Translation and Implementation, and Reassessment.

Why it Matters 

The pharmaceutical industry and its regulators have put increasing emphasis on placing patients at the center of drug development and post-market research, seeking to improve their experience and ensure maximum value for their medication use. Now, earlier in development, manufacturers and even investors are considering patient expectations around data collected during trials, which will lead  to more robust utilization of the product once on the market. 

Syneos Health Communications is unique in our ability to bring together real world evidence collected outside the traditional clinical realm of randomized controlled trials (RCTs). This includes the use of pragmatic clinical trials (PCTs) that measure treatment effectiveness, as opposed to efficacy, and represent the most rigorous real-world research design.  

PCTs incorporate real-life practice conditions, more representative patient populations, nonintrusive forms of data collection, and active-comparator analyses. More important, they happen in the real world. So, things like comorbidities, unsupervised adherence, and patient-physician communication are more variable and uncontrolled.  

About the Author:

Glenn Herdling is an Associate Creative Director at Syneos Health with more than 20 years of experience in healthcare communications. A staunch advocate for behavioral science, value-based healthcare, and health literacy, Glenn began his career at Marvel Comics where he learned that simplicity is the prime directive of any storytelling.