Returning Individual Research Results to Participants

Historically, returning individual research results to study participants has not been a standard or common practice. The longstanding justifications for this are that 1) there are risks associated with the return of potentially inaccurate results to participants, 2) research is designed for the benefit of society, not individuals, and 3) participants may have a “therapeutic misconception” and mistakenly believe the research will yield results that will benefit their clinical care (Botkin et al, 2018). Recently, the National Academies of Sciences, Engineering, and Medicine (NASEM) spearheaded a committee charged with determining if and when it is appropriate to return individual research results. The committee produced a NASEM Consensus Report in which they recommend that research results be shared with patients more often to support the development of trust and to demonstrate respect for participants (Committee on the Return of Individual-Specific Research Results Generated in Research Laboratories et al. 2018).

As background, there are currently two contrasting rules regarding the return of results:

• Centers for Medicare & Medicaid Services (CMS) prohibit the return of results from laboratories that are not certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
• The Health Insurance Portability and Accountability Act of 1996 (HIPAA) allows the return of results requested by a participant, regardless of whether or not they were produced in a CLIA-certified laboratory.

The NASEM committee recommends a transition away from these rules in favor of a process-oriented approach that emphasizes transparency and communication of results to research participants. Clinical information is potentially valuable to participants, and this value should be considered in balance with the feasibility of returning results on a study-by-study basis to determine whether and how to return these results. It may be more feasible to return results from a traditional, explanatory trial that uses informed consent, because investigators will be able to explain the timing and the content of the results that will be returned to participants. However, if consent is waived, as is often the case with ePCTS, then returning results to participants is more complicated. There are many questions to be answered when it comes to returning results, such as: What data should be returned? When and how often? How do we contextualize the results and minimize potential harms? How should clinicians be involved? (Wong et al 2018). More work is needed to test processes and techniques and determine best practices for returning results, particularly for ePCTs. Additionally, effective communication strategies for returning results are needed, such as innovative methods for enhancing the quality of the reports for participants.

Dissemination Options for Trial Results

Lay audiences, including patients, caregivers, and others who are not experts in clinical research, often do not have access to clinical journals. Therefore, alternative dissemination media to scientific publications may be the most appropriate. Community-based stakeholders may already have communication channels open to patients and caregivers, and teaming with these stakeholders from the beginning can help formulate the appropriate messages and the best means for disseminating results.

Key Point: When communicating to stakeholders who are not routinely engaged in the clinical research enterprise, ensure that the information is accessible by disseminating through the following:

• Patient advocacy groups
• Government and study-specific websites
• Newsletters
• Emails
• Social media
• News media

An example of a study-specific website is the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) trial which is comparing the effectiveness of two daily doses of aspirin (81 mg vs 325 mg). The consent form and protocol for ADAPTABLE are available on the study website.

Case Study: Interactive Autism Network

A good example of a dissemination tactic aimed at patients and their caregivers comes from one of the Patient Centered Clinical Research Network’s (PCORnet’s) Patient-Powered Research Network partner, the Interactive Autism Network (IAN). Information about upcoming studies, opportunities to enroll in studies, and summary results from research are all disseminated through the network’s website. Notably, the summary results from IAN studies are written in clear, easy-to-read language (see figure); at the end of each article, additional resources are provided, as well as a reference list for the scientific literature cited in the article.

Summary Results Posted at iancommunity.org

• IAN research participants include approximately 15,000 children and 7,500 adults with autism, 22,000 parents, and 13,000 siblings.
• IAN has connected people with autism and their families to 500 research studies, and, thanks to IAN research participants, the IAN team has produced 31 scientific research papers. IAN’s research on elopement has influenced policy.
• The IAN community website has about 1,000 articles highlighting research on autism treatments and therapies, challenging behaviors, early intervention, genetic discoveries, social issues, healthcare, the transition to adulthood, and adult issues.

Plain Language

When disseminating information to patients and other stakeholders, the use of plain language that is clear, professional, and easy to understand is recommended. The National Institutes of Health (NIH) has created a one-page guide to clarify the difference between observational studies and randomized clinical trials, but this guide does not communicate information about the unique aspects of pragmatic clinical trials, such as what is meant by embedded research, cluster randomized trials, or stepped wedge designs. Communications aimed at a broader audience, such as the public, should explicitly define these terms. For communicating the results, the NIH has also created a Checklist for Communicating Science and Health Research to the Public.

In brief, NIH recommendations for clinical trials are:

• Describe the clinical trial phase
• Give a breakdown of the study participants’ demographics
• Identify and explain the limitations of the study’s endpoint
  • Surrogate endpoints
  • Composite endpoints
• Check the study’s sample size and address potential limitations
• Clearly explain risk
  • Absolute risk
  • Relative risk/risk ratio
• Discuss both the benefits and drawbacks

To communicate the results of pragmatic (or embedded) research, we recommend adding the following information:

• Brief background about why the project is important and the gaps in knowledge the project is intended to address
• Rationale for a pragmatic approach, including an explanation of the specific design (cluster randomized, stepped wedge, etc.)
• Decisions the trial is intended to inform for the patient, caregiver, and clinician
• Use of data from the EHR and the privacy protections
• Generalizability of results

Storytelling

Another dissemination tactic is to use storytelling methods. Presenting factual data and personal stories has been found to help people use the information and results from studies. Brason Lee commented in an American Journal of Public Health commentary:

“It is about writing reports in a way that inspires readers to care enough to move forward. It is about showing readers rather than telling readers what it is like to be in a given situation….one of the greatest challenges in disseminating research for public policy use may ultimately rest in how the story is packaged for presentation.” (Lee 2015)

The communications departments in universities, research institutions, and healthcare systems can provide invaluable help in making a message clear and compelling.

Resources for Patients

CERTAIN Patient Advisory Network's INSPIRE Research Portal is an online library of resources designed for patients and researchers partnering on patient-centered outcomes research (PCOR), which is described as healthcare studies that actively engage patients in the research process from start to finish.  The portal includes resources for patients and researchers to use together, as well as those specific to each group.

When patients are involved in research projects, it can be helpful to provide them with additional resources, including: