Health Literacy—An Important Element in Patient-Centered Outcomes Research

Patients, their families, and clinicians face a wide range of complex and often confusing choices when it comes to addressing health and health care concerns. They need trustworthy information to decide which option is best for them. Unfortunately, traditional medical research, for all of the remarkable advances in care it produces, has not been able to answer many of the questions that patients and their clinicians face daily. Even when reliable information does exist, it is not always available to patients, or those who care for them, in ways they can understand or use most effectively. Clear communication approaches and active dissemination of findings to all audiences in easy-to-understand formats are critical to increasing the awareness, consideration, adoption, and use of research findings by patients, caregivers, and health care providers.

My awareness of health literacy as an important issue started more than a decade ago. During this time, the transition to making health information electronically based was rapidly occurring. While I have watched this phenomenon continue to unfold, I keep asking myself, Is this what patients want? I am concerned about those who do not have access to this information both in terms of true access—not having a means to access and locate the information—but also in terms of whether they would understand it if they could access it. During my time as a researcher, my work focused on the communication of health information to patients and whether they could understand and use information to make informed health decisions. Two years ago, I was fortunate enough to join an organization whose mission aligned with my passion: the Patient-Centered Outcomes Research Institute (PCORI).

PCORI was created by Congress in 2010 to fund comparative clinical effectiveness research to assist patients, clinicians, and other health care stakeholders in making informed health decisions (Patient Protection and Affordable Care Act of 2010). To respond to this charge, PCORI’s board of governors, methodology committee, and staff have created a stakeholder-driven approach to clinical effectiveness research, involving end users from across the spectrum of research, from the identification of research topics and study inception through study planning, conduct, analysis, and dissemination. PCORI’s mission statement (PCORI, 2016) commits to “help[ing] people make informed health care decisions, and improv[ing] health care delivery and outcomes by producing and promoting high integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader health care community.”

Everyone at some point in time has experienced a health care situation in which health literacy was a problem. Helping people to make informed health care decisions not only has been a focus in my career but has become more personal as I help my parents, who are now being faced with making more complex health care decisions as they age. I also have listened to my friends’ experiences as they are faced with making decisions on behalf of their children and/or parents. One friend recently spoke at a PCORI meeting and shared her experience about interacting with a health care team as the health agent for her father. She was charged with making any and all health decisions for him, as he was unable to communicate. She recounted, “When I was told my father had encephalopathy it did not sound too far from Snuffleupagus.” She said it was difficult for her to feel like she was able to give input as a caregiver because there was no time for her to stop and analyze and truly understand the options as they were continually presented to her in language she was not familiar with—medical jargon.

In order to be able to use evidence to inform and improve decision making, patients and their families need access to the information, and they need to understand it. Low health literacy is associated with, but not limited to, poor understanding of the complex nature of one’s own health (Bailey et al., 2014), a lack of knowledge about medical care and conditions (Kalichman & Rompa, 2000; Williams, Baker, Parker, & Nurss, 1998), low understanding and use of preventive health services (Oldach & Katz, 2014), poorer overall health status, and earlier death (Institute of Medicine, 2009, 2011). Health literacy is fundamental to health care that requires individuals to have a more active role in decisions and management and thus is a priority for PCORI. Currently there is no universal agreement on the definition or the conceptual dimensions of health literacy (Berkman, Davis, & McCormack, 2010; Sørensen et al., 2012). I find the modified definition put forth by Berkman and colleagues (2010) to be the most useful to implement in the context of PCORI’s mission: “The degree to which individuals can obtain, process, understand, and communicate about health-related information needed to make informed health decisions” (p. 16). Using this definition, I have classified PCORI’s efforts for supporting health literacy into three key areas.

First, PCORI is fulfilling its mission by including patients and stakeholders from populations served in the design, implementation, and evaluation of health information and services. Too often community members are not included in the development and design of information and services, or they are consulted only for the evaluation component. It is particularly important to pay attention to the voices of individuals with limited health literacy when planning programs and preparing materials that aim to address health literacy. The use of participatory design (i.e., stakeholder engagement) can result in products that meet the needs of target populations (i.e., are written in language they understand and made available in ways they can access). PCORI awardees have reported that patient and stakeholder input resulted in changes to study outcomes, goals, methods, interventions, and materials. These contributions enhance the appropriateness of study materials and the relevance of research questions and outcomes to study populations (Forsythe et al., 2016).

Second, people may need support beyond simple knowledge to use this evidence to improve decision making. This support may need to include helping people understand uncertainty involved in their decision options and the evidence informing those options, facilitating communication between patients and clinicians, enabling self-management, providing emotional support, and attaining a value-concordant decision (Elwyn et al., 2013; Epstein & Street, 2007). The Communication and Dissemination Research Program at PCORI is currently funding and seeking to further fund projects comparing strategies aimed at informing and empowering patients, caregivers, and other health care decision makers so that they know what questions to ask and have the information needed to provide support in shared decision making.

Third, there is a high priority on translating and disseminating research findings, including making findings accessible and usable to people with low health literacy. Part of PCORI’s current research and a component of upcoming dissemination efforts is to provide research evidence in a form that people can understand, aligning the information provided with the abilities and skills of the general public. Making information available to the public on completion of studies is a required deliverable for PCORI. The institute’s authorizing legislation specifically states that PCORI shall release research findings no later than 90 days after the conduct or receipt of research findings, and the findings must be made available to clinicians, patients, and the general public in a manner that is comprehensible and useful to patients and providers in making health care decisions (Patient Protection and Affordable Care Act of 2010). This is a novel requirement for a funding organization given that a recent review documented that only 29% of completed clinical trials conducted by faculty at major academic centers were published within 2 years of study completion (Chen et al., 2016). Plans have been developed to release research results that are accessible to patients, clinicians, and the public, and PCORI is in the process of implementing those plans.

Although there has been significant expansion of health literacy research over the past decade, much work still remains. We at PCORI are focused on helping the field mature by funding actionable, user-driven, patient-centered outcomes research (PCOR). PCOR considers patients’ needs and preferences and focuses on outcomes most important to them. PCOR findings can help patients and other health care stakeholders, such as caregivers and clinicians, make better informed decisions about their health and health care options. Although supporting PCOR is important, for one to make an informed decision, one must have access to information generated from research that is accessible and in a usable format. At the intersection of health literacy and PCOR is where PCORI can make a substantial contribution.

Definitions of health literacy and frameworks incorporating the concept highlight the deleterious effect low health literacy has on health outcomes. What is the relationship of health literacy to PCOR? One view is that health literacy is a necessary condition, the patient-centered piece of PCOR, but we can also separate both concepts and consider health literacy and PCOR as independent yet equally important factors that determine health-related decisions and actions. By funding research in which context is key—the context of the patient (i.e., is inclusive of an individual’s preferences and needs and incorporates a wide variety of settings and diversity of participants) and the context of the health situation (i.e., investigating optimizing outcomes while addressing burden to individuals)—we hope to better understand the relationship between health literacy and PCOR.

Too often there exists a chasm of knowledge between what information is available and what patients and caregivers understand. Being provided with information that is useful and understandable is fundamental to the success of individuals reaching optimal health. As a scientist, a patient, and a caregiver, I feel fortunate and proud to contribute to PCORI’s ultimate goals, which are to (a) substantially increase the quantity, quality, and timeliness of useful, trustworthy information available to support health decisions; (b) speed the implementation and use of PCOR evidence; and (c) influence clinical and health care research funded by others to be more patient centered in hopes of fostering a healthy and health-literate society.