Ok maybe just for this project. I have explored both informed consent and paradigms for many years. Informed consent was an avid interest since my teens and throughout all of my career paths. It includes both theoretical interests as in my PhD thesis and quite practical applications as in my nursing and clinical research work.
Meanwhile I became aware of Paradigms in graduate school studying the work of Thomas Kuhn. It was and remains challenging to wrap my head around what exactly is a paradigm. These remained separate tracks of interest until very recently. You see I struggled with why informed consent failed to protect patient rights and/or lend itself to the best decisions for particular patients.
Then I remembered Kuhn’s description of scientific revolutions. When you treat the scientific theories of a certain epoch as a paradigm with norms about what to look for and how to go about your business these activities ran into stumbling blocks. These were puzzles that proved to be resistant to elegant solutions with the tools that paradigm provided. Oh, like phlogiston is a good example. As a substance it is supposed to explain how fire works on substances like wood and metals. When you burn wood, the remaining ash is lighter than when you started. The explanation was simple. The phlogiston left the wood. The problem is that when you burn certain metals they weigh more. Oops. Well then phlogiston has negative weight. Not sure why that would help. Finally, the idea was that it was more of a principle than a thing. Like we consider energy today. Patchwork responses each of which makes the theory less elegant and less powerful. Most importantly it was less persuasive to the practitioners of the “science. They dropped it even though in many areas it still had great explanatory power.
It seemed to me that the history of informed consent followed similar path. The courts in the US struggled mightily with their version of negative weight which was how much information was sufficient to protect patient rights? What we all saw was that informing wasn’t working in clinical practice. It wasn’t from a lack of effort in terms of revising consent forms to be more digestible for patients.
Consequently, I undertook the project of treating informed consent as a paradigm for a subset of physician patient interactions. Indeed, the other paradigm it evolved into, shared decision-making, made for a rather tidy paradigm shift. The journey through this was rather eye-opening. The paradigms had a certain information flow to them. The information content was directed by many hidden expectations, concepts and beliefs. These were the tools the participants brought to the experience. It formed the lens of the paradigm. It brought certain things into focus and gave them priority. Other things were filtered out or achieved a lesser role.
I thought to myself what if we turned our attention to the lens itself. This might tell us more about the why the activity failed and serve as a guide of what to look out for in the shared decision-making paradigm. On inspection (got to love all the visual metaphors) I realized that ethics, decision theory, behavioral economics and the paradigm for health care interactions all played a significant role on what tools are available for making a successful interaction. Choices we make among those will have a bearing on the chosen paradigm.
One of the notable pieces of this with informed consent in clinical practice was how long it took to migrate to something else. It wasn’t as if it didn’t have critics back in the 1970s. If you take its documented starting point to be in 1767 with an English court case, then it is about 230 years to say we are done. You could go back farther I suppose to Hippocrates. You could mark it as more recent with the US cases from Schloendorff v Society of NY Hospital in 1912. In any case it took a long time to get to the point of rejecting the practice in favor of a new one. I don’t want to see similar lag time on either the improvement or eventual rejection of shared decision-making. I took all of this to heart and wrote The Paradigm Lens:
Informed Consent to Shared Decision Making. The focus was on clinical practice. The one way flow of information is a major reason for informed consent's failure. The reasons why this is so are more than I expected when I started out.
The shared decision-making paradigm is in its early days of figuring out what belongs in the paradigm and what is left out. There are a lot of areas that people have been researching. Aids to understanding is one such area. Is it better to give people a video, slide presentation, a discussion, a document or some hybrid? How do we get the patient’s values involved? It is very reminiscent of other paradigm shifts in history with a flurry of activity early on.
There are some noteworthy differences between informed consent in medical practice and informed consent in clinical trials/studies. One difference to note is that in clinical practice the health care professional and the patient share the same goals. They both want to mitigate the patient’s disease or symptoms or increase longevity. It is not clear to me that the research paradigm is the same for subjects and investigators. The patient may be in a desperate situation seeking out any help having exhausted all other available therapeutic options. Or they may want to be of service to others or both. Investigators may also overlap with some of these or not. In an early phase trial there is less likely to be benefit to the participants. The investigators want to get confirmatory results. They will accept results that don't confirm the research question but most likely grudgingly.
I want to move forward in the area of clinical research next. There are more stakeholders involved and I intuitively sense that these different goals of the stakeholders will make a difference in the paradigm. Of course, I also intuitively thought the Philadelphia Phillies were going to win the 2022 World Series and was wrong about that.
Stay tuned to this space for more posts.
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