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No one ever ran a blinded trial on handwashing. It became standard practice around the world anyway. Narinder Singh Parhar, an internal medicine, hospital medicine, and critical care physician, calls evidence-based medicine one of the field’s great achievements and credits it with saving millions of lives. This episode is based on his article “Evidence-based medicine needs a broader view of evidence,” published on KevinMD. He also believes medicine has begun to confuse one research method with science itself, and names the questions a blinded drug trial was never built to answer. You will hear why elderly patients carrying several diagnoses and several medications so often fall outside the study group. He makes the case for pragmatic trials, prospective cohorts, pilot programs, and functional outcomes when the question is not a single drug. You will also hear why he wants physicians running their own research and what to ask when a new guideline arrives attached to a product. Press play to hear why he says evidence-based medicine must be protected and should never become methodology-based medicine.
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Transcript
Kevin Pho: Hi, and welcome to the show. Subscribe at KevinMD.com/podcast. Today, we welcome back Narinder Parhar. He is an internal medicine and critical care physician. Today’s KevinMD article is “Evidence-based medicine needs a broader view of evidence.” Narinder, welcome back to the show.
Narinder Singh Parhar: Thanks, Kevin. Good to be here.
Kevin Pho: All right. What’s your latest article about?
Narinder Singh Parhar: Well, it’s basically about science and scientific inquiry, and how we could best use it to advance medicine as well as our health care.
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Kevin Pho: Now, for those who didn’t get a chance to read it, tell us a little bit more about what they missed.
Narinder Singh Parhar: Yes, definitely. Over the last several months, I was in the process of developing an HEO health care model, which includes some simple, easily adaptable, but helpful interventions, like walking, muscle preservation, joint preservation, sleep hygiene, sound nutrition, balance improvement, ergonomics, etc. I found that our standard double-blind model of an RCT is unable to assess the beneficial outcomes of such interventions.
But sometimes the evidence is just staring us in the face that an intervention does help. Especially in our practices, we find that some novel interventions or novel techniques might be as beneficial as an RCT outcome, but they don’t have a double-blind study. So then I looked more into it: how to think critically about it, and how to share it with our colleagues, both in medicine and in science in general.
I just want to make a statement that I’m a strong believer in evidence-based medicine. It has transformed the practice of medicine, improved safety in health care, and saved millions of lives. But in my opinion, focusing only on an RCT as the tool for testing an intervention might make us miss some of the other important evidence, which could be just as helpful. I’m afraid that we are confusing one research methodology with science itself.
Science, as we know, is not a single or exclusive study design. It’s a method of inquiry. An RCT is great if it is trying to answer a question about a single-molecule pharmaceutical drug, which is easy to blind and easy to give a placebo arm. But for measuring the outcomes of behavioral changes, or of health maintenance or health enhancement practices, this tool is not well suited. So in my opinion, we as a medical community need to open our minds and be willing to test other tools as well for different interventions. As I think I wrote in the article, we can evaluate these simple, adaptable health enhancement interventions with pragmatic trials, prospective cohorts, observational studies, pilot programs, functional outcomes, health care utilization, and population health data.
Kevin Pho: So you look back at history, and there are a couple of events where they didn’t necessarily need randomized controlled trials for those interventions to become the standard of care.
Narinder Singh Parhar: Right, definitely. We still practice some of those important interventions that were not tested in a double-blind study. Organ transplantation is one very prominent one. I don’t think there were RCTs or double-blind studies on organ transplantation; it’s hard to do that. Similarly, joint preservation or joint replacement surgery is based basically on physiology, our understanding of joint function, surgical innovation and improvement, and registries and long-term outcomes. Another is trauma surgery. I mean, who would dare to create a double-blind placebo in trauma surgery?
In the same context, the precision medicine and individual therapies that are coming up, like gene therapy, cannot have a placebo arm. They cannot be blinded. Another important practice that we have already adopted nationwide, and now globally, is universal handwashing. We did not require a double-blind or placebo-controlled arm for it. Our observations and biological plausibility, as well as measured infection rates, made the impact. So we are using all of it. These examples are not against the rigor of scientific inquiry. They just remind us that sometimes we need different tools.
Another point is that I practice internal medicine, and so many of our patients are elderly. They have multiple diagnoses, they are on multiple medications, and often they don’t fit into the rigidity of the select study groups. So that’s another limitation. I find that these studies fail to answer questions in those populations. When I was developing that model, I found that limitation, and it created an inquiry in my mind about how we could address it.
Kevin Pho: How can we decide which interventions become the standard of care using a randomized controlled trial, and which interventions could become the standard of care using less rigorous evidence? You mentioned things like observational studies and retrospective studies, for instance.
Narinder Singh Parhar: I think the time has come, especially with health care costs going up by leaps and bounds and our population aging fast. We will need so much of our financial resources for all of us that we really need to conserve our attention, our energy, and our resources to last a longer time. For interventions that are simple and adaptable, as we talked about, there are ways to measure their outcomes. Even with a pilot study, we can measure the reduction in falls and fractures in a group that is, say, above age sixty-five. We know how statistically vulnerable they are to falls and femoral neck fractures, hip fractures, etc. If a particular intervention can make a difference, we can test it, measure it, pilot it, and then scale it.
Kevin Pho: When it comes to randomized controlled trials, haven’t there been multiple times in the past where a randomized controlled trial disproved something that was previously the standard of care? I’m thinking about hormone replacement therapy. I’m thinking about recent trials on lipoprotein(a) showing that drugs that lower lipoprotein(a) don’t necessarily reduce cardiovascular mortality. So where do you draw the line when it comes to using these randomized controlled trials or not?
Narinder Singh Parhar: Well, one golden rule is that we should always be looking at the evidence. Number one, when a new guideline is coming out, especially if it comes with the financialization of a product, then as a physician community we really should look at it, as they say, as devil’s advocate too. What kind of patient selection was involved? Is there any fine print that has not been shared with us? Was there any negative outcome that was not reported? So I agree with you that there are some proven studies that first claimed benefits, but later they had to be retracted as the product or the practice was scaled to a larger population.
Kevin Pho: So going forward, what do you want physicians to do when they look at evidence, or when they request the evidence behind an intervention? What would you like physicians to do to help broaden their thinking and their interpretation of the evidence?
Narinder Singh Parhar: Personally, I feel that, number one, physicians should get involved and spend some time in clinical research of their own, because it broadens them to the language of research, the research lingo. It also fine-tunes them to the common problems they see in their practices, problems that may not be as profitable for any big corporation to invest big dollars in, but that are important from the health care perspective. Coming back again to fall prevention, fracture prevention, obesity, weight control, and sleep hygiene: Those are important issues that I think we should pay attention to.
In my opinion, the physician community should lead and guide medical research. We have lost so much control over it that most of the research we read is coming from sponsored studies, and most of those are about a new molecule. Of course, number one, we don’t want to discourage capital investment in research, but sometimes it can be a double-edged sword as well. In medical school, we definitely are not trained to become businesspeople or business executives. We do have our responsibility toward our patients: patient first, safety first. That is something we should keep in mind all the time when evaluating a study, listening to a medical rep, or attending a CME that is sponsored by, say, ABC company. Just, again, be careful.
Another thing is that I think the practicing physician community should itself be ready and willing to create some CME material, and not just depend on free CME hours or conferences. We are in the trenches. We know what CME is. As a physician community, I know it’s hard for practicing physicians, but we need to take some responsibility sometimes, and some lead in it.
Remember, in one of the podcasts, we talked about how physicians feel that they are powerless in the examining room. That did not happen overnight. It happened over a few decades, when, one step at a time, we lost the interest of the larger profession. Some of us might have just fallen for that: “Oh, this is personal gain here.” So we need to correct it step by step. There are several things we need to correct to bring professional autonomy back, professional importance back, and patient safety and patient interests back to the center. There are several things we need to do, one step at a time.
Kevin Pho: We’re talking to Narinder Parhar, an internal medicine and critical care physician. Today’s KevinMD article is “Evidence-based medicine needs a broader view of evidence.” Narinder, we’ll end with your take-home messages to the KevinMD audience.
Narinder Singh Parhar: What I want to reiterate is that evidence-based medicine is one of medicine’s great achievements. We must preserve and protect it. But at the same time, evidence-based medicine should never become methodology-based medicine. We should broaden our view of evidence, of scientific evidence, and try to find out which particular tool is better for finding out or gauging the results of a novel intervention.
Kevin Pho: Narinder, thank you so much again for sharing your perspective and insight. Thanks for coming back on the show.
Narinder Singh Parhar: Thanks, Kevin.
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