There are many very old sayings within Jewish lore about wisdom. One of them, from the Mishnah Pirkei Avot (chapter 4) states that “who is the wise person? The one who learns from all others”. Another saying (from the middle ages) goes “there is no one wiser than one who has experienced [an event, an illness, children, etc.]”.
These phrases are very appropriate for the present topic, related to patient involvement in the design of medical research studies. An excellent review of this issue can be read here. One could easily argue that it is self evident that patient interviews are a basic requirement for designing a research study on the disease that the patients have. More so, it is totally reasonable to have patients (with the disease being studied) on the research board that decides how to actually implement the research study.
For example, if you’re doing a study on patients with Parkinson’s disease, it does seem obvious that you would want to ask such individuals how best to collect information from them. If you send a written form in the mail to a patient with Parkinson’s, they may not be able to hold a pencil in order to record their responses. If your study requires that the patient present twice a month to the research lab, this could be a major stress and cost to a Parkinson’s patient.
Many people imagine that physicians are aware of these issues and sensitive to them. The answer is, no, they are not. This is not because physicians do not care. It is simply that reading a book about a disease and how to diagnose and treat it, does not give you an insight into living with that disease. And unfortunately, doctors tend not to be trained to ask about issues beyond diagnosis and treatment.
One would imagine that patients would jump at the opportunity to be intimately involved with the development of research into their personal diseases. However, it can be intimidating for a patient to sit amongst experienced physicians who readily and regularly use medical terminology.
In truth, these patient advocates may be harshly challenged when they do voice their opinions. Nevertheless, the physicians must accept this cultural change and at least try to find compromises between their perspectives and those of the patient members of the research committee. This is not a nicety. For research to be effective, it must be planned as well as possible. And you really cannot design a research plan for a disease without the input of people who have the disease.
Sometimes, the “best thing” is when one of the physicians either personally suffers from the disease being studied or has a loved one who is suffering from the disease. This gives the doctor a personal perspective that he/she was previously lacking.
Even so, being a doctor who experiences an illness is very different than a non-medical professional facing the same disease. The physician can still “pull strings” and get access to care and information that would not be available to the non-physician-patient. So even when the physician knows firsthand about a disease, he/she is still not the ideal person to make sure that the patient experience is fully considered in the design of the research study.
There is no question that technology can help in making the patient’s participation in such research planning committees much smoother. For one, a smart phone could be used simply to Google terms that the patient-committee member (PCM) is unfamiliar with. A much better solution would be to digitally share a detailed list of topics that will be discussed at the upcoming meeting, so that the PCM can read about them and familiarize themselves with the concepts and terminology.
In any patient study, one of the most important things is the collection of data. Software should be designed [as a webpage or as an app] that allows any patient (not just the PCM) to record all critical events related to the research. For example, if we return to the Parkinson’s patient I mentioned before, there should be an option for such a patient to record sudden weakness or other side effects from the medication being tested.
The PCM may be the first person to point out that the Parkinson’s patient may not be able to manually handle activating a smart phone and clicking on the right buttons to record these events. If the interface requires that the Parkinson’s patient actually type information, this may be totally impractical. The PCM may be the only one to raise these points. Of course, these excellent points should lead to a fundamental change in the software, because without these changes, the software will not be used and critical information will be lost.
An organization by the name of PCORI was set up in the United States, via the affordable care act, specifically to make sure that patients were included in research design. Significant funds have been set aside for such patient-inclusive research projects. I personally believe that this will spur a fundamental change in a great deal of clinical research, even without the constant pushing of formal organizations.
There is a restaurant in Israel that offers people the experience of having a meal in total darkness. The point is to appreciate for a short time how a blind individual would feel in a similar situation. I personally have never gone to this restaurant, although at least one of my children has. I personally don’t want to have this experience. I truly believe I would not do well with the emotional impact. It should be clear then, that the many years of experience I have as a physician and in research, mean nothing if I were to be helping to design a study related to blind individuals.
I would like to think that I am wise enough to learn from others who actually have experience with what I am treating and researching. And I obviously hope the same for all the researchers in the medical field.
Thanks for listening and Shana Tova