When cancer study populations are non-diverse, the results are stark: less varied samples for scientists, reduced production of therapeutic options for minority-specific tumors and a general lack of access to the benefits of research. Underrepresented populations may face barriers to participation in clinical trials and biobanking. These barriers include lack of insurance, high out-of-pocket expenses, concerns about invasive procedures and negative side effects, general fear and suspicion, low research literacy, and lack of familiarity with research topics.1 In order to recruit individuals from underrepresented populations and ensure true informed consent, researchers require better resources for communicating study information with participants.
Toward this end, Torres et al., working with 28 partner institutions connected with the Cancer Disparities Research Network (CDRN), employed a user-centered design cycle to develop a standardized research communication tool intended to enhance research literacy.1 First, the team met with stakeholders to set goals and select the research concepts for the tool, which they then broke into three groupings (basic research, trial specific information and patient rights) for inclusion in a paper prototype made up of 33 laminated flashcards. They referred to federal guidelines for plain language (headings, bulleted lists, short sentences, manageable sections), adopted lay language (4th–10th grade reading levels as assigned by the Flesch-Kincaid readability metric), and liberally employed graphics.
The team then recruited potential end users for feedback via semi-structured interviews. Qualified participants were patients (n = 10) and clinical trial recruiters (n = 5) from a Chicago academic medical center. These individuals viewed the tool, marking cards that required feedback. Torres et al. conducted interviews (30–45 minutes long) with the participants regarding overall impressions, research content, design elements and word choices. They used these interviews to pull common themes and refine the tool.
Overall impressions: The participants reported the tool to be successful in terms of readability and information density. They also felt it effectively explained research concepts using lay language and effectively opened communication. Some participants indicated that it would make sense to more directly discuss the benefits of research participation.
Research content: In the “basic research information” grouping, recruiter participants recommended enhanced information on the topic of informed consent, leading the team to create additional cards to address this topic. They also added cards on the topic of “standard of care” to address patient participant concerns regarding the concept of control groups. In the grouping “trial-specific information,” both sets of participants indicated gaps in the topic of biobanking logistics. As a result of expressed distrust regarding randomization, the team also added cards about blind and double-blind studies. Finally, the participants reported overall satisfaction with the “patient rights” grouping, although the authors did add information about specific rights (interpreter, materials in preferred language, etc.), privacy protections and the option to withdraw participation.
Design elements: On this measure, the participants indicated positivity with regard to visual elements but recommended that the team alter the images to enhance diversity and better represent all populations.
Word choice: In this category, the participants made suggestions that led the team to de-emphasize technical terms (remove bolding and underlining, for instance) in favor of highlighting plain language. Other specific feedback led the group to replace “scientist” with “researcher,” “sick” with “unhealthy” and “leftover samples” with “unused portions.”
In sum, Torres et al. offer their research communication tool as a highly functional instrument capable of facilitating necessary conversations surrounding research issues and hopefully increasing the participation of individuals from underrepresented populations in clinical trials and biobanking initiatives. They indicate that the next step in the development of this tool is translation into other languages and cognitive/usability testing using representatives from underserved communities.
1. Torres, S., et al. (2015) “The development of a communication tool to facilitate the cancer trial recruitment process and increase research literacy among underrepresented populations,” Journal of Cancer Education, doi: 10.1007/s13187-015-0818-z.