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In the world of patient education, processes, policies, and oversight differ vastly. There is no overarching governance structure. There isn't an accreditation process for educational interventions or patient advocacy organizations that develop the education.
Medical education for healthcare professionals has a stringent governance structure in place to ensure that every healthcare provider has access to unbiased education. There are regulations around the commercial support of medical education, as well as an accreditation process for both educational activities and the organizations that develop the education.
Transparency is imperative; if an educational intervention is deemed promotional in nature, it must be disclosed as such. This ensures that healthcare professionals have access to a spectrum of options and are essentially making informed medical decisions based upon all the facts and sound judgment. The aim of structural governance in medical education is to protect healthcare professionals from information that may steer them down the wrong path for a particular patient, without a full understanding of all the options.
In the world of patient education, processes, policies, and oversight differ vastly. There is no overarching governance structure. There isn't an accreditation process for educational interventions or patient advocacy organizations that develop the education. There is no mandate, for instance, that patient advocacy organizations put in place a content validation process or a conflict of interest policy to ensure that patient education truly puts every patient first. There aren't formal instruments or regulatory bodies to assess bias (or to even define it) in patient education, or requirements that patient education undergo peer review prior to dissemination.
The "participatory medicine" movement is underway where networked patients are shifting from being mere passengers to responsible drivers of their health, and clinicians are encouraging them as full partners. To encourage this partnership, the tools and resources we use to educate, empower, and engage patients in their care are essential. Each patient deserves access to all the facts through unbiased interventions to allow for informed medical decisions that will ultimately affect their outcome. Patients are key decision makers and should be given the equivalent of what healthcare professionals receive, but in laymen's terms. Patients navigating chronic illnesses may not have the skillset to understand how to detect bias or distinguish between promotional and independent education, where the distinction can be subtle.
In addition, trusted entities such as patient advocacy organizations don't always have the training or policies necessary to ensure content validation processes and to address conflicts of interest. There is often a misconception that all ".orgs" are trusted sources of information and this is simply not the case. A .org is not always indicative of a non-profit, and a non-profit is not always indicative of unbiased education. Patient advocacy organizations often serve as lifelines for patients and caregivers, helping them navigate complex processes, understand options, and obtain a support system.
However, standards across patient advocacy organizations vary, and this variation can affect patients who may not have the trained eye of a media critic, or understand the need to ascertain the credibility of educational resources. With the advent and flexibility of the Internet, where a majority of patients access health information, it's more important than ever for us to arm patients with credible information. Finding valuable and reliable information on the Internet is like mining for gold; patients must sift the nuggets from the garbage.
How can we apply what we've learned about ethics in research to ethics in patient education? For decades, research ethics have benefited from the development of various codes and guidelines, but no similar code exists to guide in the ethical involvement in education. The World Medical Association Declaration of Helsinki states, "Even the best current interventions must be evaluated continually (through research) for their safety, effectiveness, efficiency, accessibility, and quality." Principles of continuous evaluation should equally apply to educational interventions.
What can we learn from the compliance-driven, continuing medical education/continuing education industry, which was a reactive model enforced due to legacy practices and resulting regulation? How can we implement a more proactive self-regulation model with more flexibility to allow for strategic partnerships between industry and patient advocacy organizations? How can patients and patient advocacy organizations better leverage the medical expertise and knowledge that pharmaceutical companies have access to in an appropriate and transparent manner? How can we strategically partner across healthcare sectors to improve patient outcomes?
Over the next few months, ideas will be crowd-sourced to gather standards for a code of ethics, a set of guiding principles for those committed to ensuring every patient is put first. The goals of the code of ethics are:
» To establish a set of overarching guiding principles around the development and support of patient education that can be adopted across the healthcare spectrum to ensure every patient is put first.
» To put in place the appropriate processes, policies, and training for those developing patient education to alleviate bias.
» To put a spotlight on the issues and make patients and caregivers aware of some of these gaps and the need to ensure they are searching for information from credible resources.
» To prominently recognize those organizations that have committed to the code of ethics making this information available to patients.
Healthcare professionals, who have had years of rigorous training, have the appropriate safeguards in place to ensure they have access to unbiased education, but who is protecting our patients that might be navigating the healthcare system for the first time? When patients access education, they need to understand the origin of the information and how it's managed, the funding source, the medical accuracy review process, how current the information is, and privacy policies if any information is being collected. All of that must be done—on top of managing their condition. The adoption of an industry code of ethics would allow patients to focus on what's most important—managing their condition and getting well. A few guiding principles follow.
» Unbiased. Education must be scientifically rigorous and credible with a standard or tool for defining and assessing bias in education.
» Evidence-based. Decisions on patient education content must be made in the best interest of patients and based on validated evidence and accepted standards of care.
» Transparency. Supporter and sponsor involvement must be disclosed in the development and support of education. If education is developed in collaboration with another organization, education should be disclosed as "developed in collaboration" rather than solely depicting a logo, which can also be linked to "independent" education. Leveraging the medical expertise of pharmaceutical companies can be extremely beneficial, as pharmaceuticals companies are well positioned to develop exemplary resources, but this should be disclosed to those receiving the education. Transparency around involvement is important.
» Conflict of interest. Any conflict of interest must be disclosed to patients. It is understandable that conflicts of interest may surface from time to time and organizations should have conflict of interest resolution processes in place to address them.
» Content development. Procedures should be put in place to ensure that educational content developed is reviewed and endorsed from a scientific standpoint by medical experts.
» Need based. Education should be based on measured and documented needs that address specific educational gaps—not perceived needs.
» Peer reviewed. Education should undergo rigorous peer review prior to dissemination to ensure information is objective.
» Outcomes-based. Interventions should incorporate a plan to measure outcomes with standard approaches for assessing retention or behavior change.
We ask Pharm Exec readers: What else would you suggest including in the code of ethics? What other ideas do you have? What barriers to adoption do you foresee?
Sarah Krug is CEO of CANCER101 and President of The Society for Participatory Medicine, and formerly the Director of Global Education at Pfizer Pharmaceuticals. She can be reached at email@example.com.