Health Literacy Best Practices Needed in Clinical Trials Search Engines

Have you ever spent hours on government websites looking for health information or their policies and procedures, or simply left out of frustration?  Have you ever gone to a clinical trial search engine site trying to find experimental drugs and therapies to try, or compare the different options but felt overwhelmed?  You’re not alone.  Clearly, most clinical trial search engines are not patient-focused.  Yet when we ask our healthcare providers for more information on clinical trials, they always point us to the search engines.  The problem is that these clinical trial search engines are not written or designed with health literacy in mind.         

Health literacy is the ability to access, understand, and use health information to make decisions.  It doesn’t necessarily have to do with someone’s ability to read or their education, but whether or not health information is relatively easy to find, accessible to those with visual or hearing impairments or other disabilities, and written in plain language.  Many government websites have cluttered website layouts, too small of a font size (10-point), are difficult to navigate and find the information you need, and are written with lots of medical and scientific jargon.

Studies have shown that health literacy is linked to increased emergency room visits and hospitalizations, people being able to correctly take their medications, people following up on medical appointments, being an active participant in their health care such as self-care and preventive health screenings, and participation in clinical trials.  It’s no wonder, when you consider how the common clinical trial search engine is designed and its content.  They may be sufficient for a doctor or clinical researcher, but are far from helpful for the person with an actual disease or condition or their caregivers.  The search engines seemingly rely on the fact that your doctor or a different health care professional will help the patient and their family access the information on the clinical trials sites.

One such example is www.clinicaltrials.gov.  Over the years, this National Institutes of Health administered site has improved with the addition of a table showing you the course of action for those assigned to the treatment group versus placebo or control group.  However a lot of the information is written in medical and scientific jargon.  In fact they have to devote a separate page on their website to define these terms.  Not really a health literacy best practice.  Several of the search engine hits list outcome measures, which is typically of interest to the researcher or treating doctor but not the patient.  Navigating the various trials can also be challenging.  The study titles they use are overwhelming and not all completed studies post their results or publications.  A recent study by Utami et al (2014) shows how consumers or patients have trouble navigating clinical trial search engines and what content and layout would be best suited for a patient or consumer centered search engine.   

     

In 2007, Senators Norm Coleman (R-MN) and Tom Harkin (D-IA) introduced a bill known as the Health Literacy Act, which would have provided critical funding to expand health literacy research and best practices and developed federal and state-based patient centered resource centers.  The bill, S2424 had bipartisan support, was co-sponsored by Susan Collins (R-ME) and Amy Klobuchar (D-MN), and had support or endorsement from organizations such as AARP, U.S. Chamber of Commerce, America’s Health Insurance Plans (AHIP), National Health Council, Institute of Medicine (IOM) Roundtable of Health Literacy, American Medical Association (AMA), Institute for Healthcare Advancement (IHA), etc.  Unfortunately it stalled in Senate and never was passed.

In 2010 three major initiatives were put in place to try to address health literacy.  It was a major step forward but did not have the major funding and widespread impact that the Health Literacy Act would have delivered towards improved consumer health information.    

1.      The Affordable Care Act directly and indirectly addressed health literacy by incorporating health literacy into professional training (section 5301) and streamlined procedures for enrollment into Medicaid, the Children’s Health Insurance Program, and the state-based insurance exchanges (section 1413) (Koh et al, 2012).

2.      National Action Plan to Improve Health Literacy, unifies health literacy goals and strategies for the country and is based on the following two principles:  a. All people have the right to health information that helps them make informed decisions and b. Health services should be delivered in ways that are understandable and lead to health, longevity, and good quality of life (Koh et al, 2012).  

3.      Plain Language Writing Act of 2010 (PL 111-274): Purpose of this Act is to improve the effectiveness and accountability of Federal agencies to the public by promoting clear Government communication that the public can understand and use.

Predating these efforts was a 1998 Amendment to the Rehabilitation Act, which requires federal agencies to make electronic and information technology accessible to people with disabilities.  Known simply as Accessibility or Section 508 Compliance, everyone must be able to view online information including documents, websites, and videos regardless of their disability.  Web Content Accessibility Guidelines were established that enables content on the Web to be accessible to a wider range of people with disabilities, including blindness and low vision, deafness and hearing loss, learning disabilities, cognitive limitations, limited movement, speech disabilities, photosensitivity and combinations of these.  Some examples of how this is implemented include video captions and web materials that are compatible with assistive technologies such as screen-readers.  Although this had been in law for over a decade, it had not been implemented to its full extent resulting in lawsuits. 

So what needs to happen?  People with ALS, their caregivers, and advocates need to demand that clinical trial search engines be health literate.  They need to implement consumer or patient-focused website design, plain language, numeracy, and accessibility standards.  Clinicaltrials.gov is one of the major search engines, so let’s start there.  Ask policymakers to reintroduce the National Health Literacy Act to provide real funding towards revamping ClinicalTrials.gov and making other health information accessible.    

References

Koh HK; Berwick DM; Clancy CM; Bauer C; Brach C; Harris LM; Zerhusen EG (2012).  New Federal Policy Initiatives to Boost Health Literacy Can Help the Nation Move Beyond The Cycle of Costly ‘Crisis Care.’ 

Senator Norm Coleman’s Office.  Coleman, Harkin Introduce National Health Literacy Act.  [Press Release], December 6, 2007.  Washington, DC.  http://votesmart.org/public-statement/309745/coleman-harkin-introduce-national-health-literacy-act#.VU5LDiFViko

Utami D, Bickmore TW, Barry B, Paasche-Orlow MK (2014).  Health Literacy and Usability of Clinical Trial Search Engines.  Journal of Health Communication: International Perspectives, 19: sup2, 190-204.