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Issue 3

Table of Contents

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Randomized trials versus common sense and clinical observation

Dr. Joe Camoratto PT, DPT

Key takeaways:
  • Bias can and will get in the way of objectively observing nature as it unfolds around us
  • By performing science in a controlled environment, we have the ability to spot things that could potentially influence or bias the answer we are looking for
  • An incomplete understanding of the physiology of the body lends itself to assuming things that are not true base on leaps in our own fault logic

 

Wow, we have so much to get into. Welcome back and lets do it!

Have you ever stopped and asked yourself “why do we have science?” It’s a simple enough question that I’m sure is glanced over all too often. As rehab professionals, we are somewhat of scientists ourselves. We have expensive education in medical science. We observe nature every day. We read scientific literature (hopefully) and apply all of the aforementioned to those people whom we serve. I think it’s safe to say that we are medical scientists. So why is the question leading this paragraph not brought more so to the front of our brains?

I’ll tell you why. BIAS. Bias is the little voice in our heads that steers us into believing whatever thoughts, perceptions or notions pop into our brains. It’s the thing that tells us that we are the heroes of our story, and as the main character, why else would we deviate from what we are telling ourselves? Well, if this is the first time you’re questioning this internal activity, you likely haven’t deviated from what you tell yourself. But that’s ok! Just the act of self scrutiny or questioning oneself and the road that you took to get to where you are, ideologically, is a huge step.

“90% of life is just showing up” – some smart person, probably

This still doesn’t answer the question “why do we do science?” The short answer is because we are attempting to limit the amount of bias that is entering our trials set out to understand the world around us. As the hero in the story, you can see how things can start to be influenced and altered both internally and externally when questioning the nature of our reality. Let’s not stray too far from the main point here.By performing science in a controlled environment, we have the ability to spot things that could potentially influence or bias the answer we are looking for, and shut them up.

We have the ability to, let’s say, add in a group of people that get nothing and see if they change over time differently than a group that does get something (an intervention). We also have the ability to control for things like the biases that those same people that are, or are not, getting the intervention act onto the results. If you have any foot in the door of science, you will know that I’m slowly introducing what’s called a Randomized Controlled Trial, aka the meat and potatoes of today’s first article. Let’s break down the words in this wonderful noun.

Randomized: participants are randomly chosen to be in a group, without their knowing of which group they are in. It also attempted to evenly distribute baseline characteristics that may influence results. Sometimes there can be another layer added to this in a double blinded study in which those awesome people who are running the experiment also are unsure of what group those participants are in.

You can see how this would do a mostly wonderful job of, right off the bat, hiding the ability for bias and internal/external influence from confounding, or messing up, the results of the test.

Controlled: In medicine, we are always trying to figure out if something is better than nothing, or vice versa. Is this thing that we are doing to or giving the patient, better than if we did absolutely nothing at all and just left them alone. That’s where the control group comes in. The control is a group of cool people that get absolutely nothing, Willy Wonka style (good day sir).

The point of them missing out is that if the intervention group and the control group both turn out the same, we can safely say that the intervention did no better than nothing, and shove it out the door and into the garbage (we will come back to this because it unfortunately doesn’t happen as often as it should). We can also say with greater certainty that if the intervention group responded differently, for better or for worse, than the control group, then it must have been from the intervention.

Ok great, so why do we need RCTs or science any way? My eyeballs see objective reality and I know I’m right so why not just leave it at that? Just like I was alluding to earlier, science aims to look at, for the most part, one thing at a time. This way we can say that whatever the outcome ended up being, it was very likely due to that single thing we were looking at. Humans as a single piece of this puzzle are supremely complex systems in and of themselves. Add in more complex factors like environmental influence, past experiences and beliefs systems (to name a few) and you can see that looking at one thing at a time is a great idea.

For example: If you got food poisoning from something you ate today, but the list of things you ate include a toaster strudel and hospital coffee for breakfast, gas station sushi and a slurpee for lunch, a can of lentils for snack and a vanilla snack pack for dinner, it would be difficult to pick out which thing exactly caused that next day explosion to occur.

SURE we could look at colors and try to time things and make inferences based on what information we have, but figuring out where to leave your 1 star review on google would be an educated guess at best. In a controlled experiment, we would have you come in, stomach empty, and each some gas station sushi, and then watch you, intently for 1 to 36 hours to see how you responded.

SCIENCE!

So in summary, a randomized controlled trial (RCT) is the act of taking one group, giving them an intervention, taking another group and giving them a comparison intervention (sometimes nothing), and seeing if after a certain amount of time, their responses differ. Yes we can add in things like a placebo group (placebo controlled clinical trial) or we can add in other intervention groups and compare them all together, but let’s just keep it simple.

So lets consider common sense, like our first article, Randomized Trials Versus Common Sense and Clinical Observation does. It truly does a wonderful job of taking multiple scenarios where clinicians and scientists made common sense leaps involving complex systems, leaving aside RCTs, and ended up harming, maiming and killing people for no reason whatsoever.

The authors go over three different reasons that the common sense of the clinicians fell short:

  • Incomplete understanding of pathophysiology
  • Biases and unmeasured confounding
  • Incomplete understanding of balance of benefits and risks in complex systems

 

Incomplete understanding of pathophysiology

In the 1970s, investigators identified an association between premature ventricular contractions and mortality following myocardial infarction (MI), and cardiologists routinely used anti-arrhythmic drugs to treat patients with non-sustained ventricular tachycardia.

When the hypothesis that treating ventricular ectopy with Class I antiarrhythmic drugs would improve outcomes was tested in the randomized controlled CAST (Cardiac Arrhythmia Suppression Trial), patients assigned to antiarrhythmic drugs had higher mortality than those assigned to placebo. You can imagine the feelings of doom and gloom of everyone involved in something like this, both clinician and patients alike, when the scientists realized that everyone was dying due to lack of understanding of how the body works

I liken this reason to anything and everything that attempts to break up fascia or release muscle or whatever other tissue structure in the both that exists. An incomplete understanding of the physiology of the body lends itself to assuming we can break up the tissue with our own tissue. It’s a good thing this doesn’t actually work or massage therapists would be like yellow-jackets: one session and their hands and elbows would be toast forever! (S/o to bees) Worse still, imagine what the patient will think about the resiliency of their tissue if you advertise that it’s so easily deformed!

Biases and unmeasured confounding

“One important bias is healthy user bias. Observational studies showed associations among folate; vitamins B6, B12, C, D, and E; and multivitamin supplementation with lower cardiovascular mortality, but in large, well-conducted RCTs, supplements failed to improve cardiovascular outcomes. Among the reasons why RCTs failed to replicate the results of the observational studies might be that patients who took vitamins or other supplements tended to be healthier than those who did not”

What’s that? The guy who spends 10 hours a week surpassing the physical activity guidelines, getting 8 hours of sleep, eating sufficient amounts of lean protein/fruits/veggies/dietary fiber and has a great social support system says that foam rolling and static stretching is what keeps him limber? Interesting.

Incomplete understanding of balance of benefits and risks in complex systems

“In patients with diabetes mellitus, observational studies, consistent with common sense, showed associations between higher blood pressure and worse glycemic control and worse cardiovascular outcomes. However, when patients with diabetes mellitus were randomized to intensive or standard blood pressure control and to intensive or standard glycemic control, intensive blood pressure control did not reduce the risk of cardiovascular events, and intensive glycemic control lowered the risk of MI but increased the risk of mortality. Both intensive treatment strategies caused a higher likelihood of adverse events compared with standard therapies”

Recommending someone stop lifting heavy weights to spare their low back/knee/shoulder pain without understanding the important interplay that painful exercise can have on confidence/self efficacy levels, activity tolerance, training intensity and health promoting behavior is missing the forest for the trees. Complex systems are difficult to understand because they are complex. Using science as a slow and methodical process for better understanding relationships between multiple factors should not be overlooked

Let’s bring it home with a fan favorite: Shoulder Impingement

In 1972 Dr. Charles Neer, orthopedic surgeon extraordinaire, wrote a nifty blog piece about how the primary cause of shoulder pain was to be blamed by acromion absolutely wrecking the supraspinatus tendon and bursa. He laid out a recommendation that surgery was a fine option for freeing up room underneath the acromion to give the underlying structures room to breathe, and effectively altered the last 50 years of shoulder understanding, care and the well being of many millions of patients.

Unfortunately for Chuck, and even more unfortunately for all those millions of patients, it turns out that there is a constantly growing stack of RCTs showing that subacromial decompression is no better than sham (placebo). Not only that, but exercise (go figure) is AS GOOD as surgery! What a great showing of lack of understanding of pathoanatomy, biases and the interplays of complex systems! Man if only there was something that Dr. Neer could have done at the time to help him see.

Its tough to hear those clinicians who tout their ability to be “ahead of the science” or who have “seen it work” for their patients, or even those who claim that “science doesn’t have a study for that”. For the rest of us that know that science has massive roll in determining where to spend our time and effort for our patients, RCTs are a great way to go. Hopefully the rest of the rehab world can let clinical practice catch up with the science, rather than the other way around.

 

References:

 

Effectiveness of physical activity interventions delivered or prompted by health professionals in primary care settings: systematic review and meta analysis of randomized controlled trials

Dr. Joe Camoratto PT, DPT

Key takeaways:
  • Physical activity interventions delivered by health professionals in primary care significantly increased MVPA (moderate-vigorous physical activity) versus control groups
  • Interventions with at least five contacts had a larger effect compared with those with less than five contacts
  • Trials that used self report measures showed that intervention participants reported achieving 24min/week more MVPA than controls
  • Eighteen trials reported weight and there was a significant reduction of 1kg favoring the physical activity intervention groups versus control

 

Seemingly blessed by the research gods, we have been blessed with an RCT just in time for this month’s research review, rolling in right after our piece on the importance of RCTs! While I don’t want to beat a dead horse, I’m going to do it anyway, because it’s important and the patients need it. So let’s get to beating:

Not enough people are physically active enough. This 2022 study published just 4 weeks ago leads us through the interesting and difficult experience of trying to lead our patients to water and have them drink it at the same time. I’m talking of course about our ability as healthcare providers to influence the behaviors of patients in the context of increasing physical activity.

One in 4 adults are insufficiently active if we are going by the WHO and Department of Health standards. Those include:

  • 150-300 minutes per week of moderate intensity aerobic activity

OR

  • 75-150 minutes of vigorous aerobic activity

AND

  • At least 2 days per week of moderate intensity muscle strengthening activity to all major muscle groups

What is the importance of physical activity you ask? Well, without providing any citations, lets make a list:

  • Increased bone density
  • Increased muscle cross sectional area (size)
  • Increased muscle force production (strength)
  • Increased ligament stiffness
  • Increased synovial joint production
  • Decreased blood pressure
  • Decreased risk of cardiovascular disease
  • Decreased risk of cancer
  • Decreased risk of diabetes

 

These are just off the top of my head…

With the WHO wanting to decrease physical inactivity by 15% by 2030, something big needs to happen. What entity is large enough, has enough interactions and has the authority and expertise to make medical recommendations? Health professionals!

“On average, 70-80% of adults visit their general practice at least once each year. Therefore, health professionals in primary care have a unique opportunity to routinely prompt and provide physical activity interventions to patients through the millions of health consultations that take place worldwide each week”

Great! There is only one, hugely frustrating and difficult to overcome problem. Behavior change is exceedingly hard

What this study did was it brought together all of the studies that looked at the attempts to increase patient physical activity through behavior change. Specifically the moderate-vigorous physical activity (MVPA) each week. It looked at quite a lot of studies for that matter. This meta analysis and systematic review brought together a whopping 46 randomized controlled trials with 16,198 participants!

It also looked at secondary outcomes of total physical activity and sedentary time. We know from things like the Physical Activity Guidelines themselves that physical activity has what’s called a dose dependent response, meaning that there relationship between dose of exercise and health outcomes going in both directions. Increased activity means decreased morbidity and mortality, and decreased activity means increased morbidity and mortality.

Let’s create some sound bites here regarding the findings of this giant SR/MA:

  • Physical activity interventions delivered by health professionals in primary care significantly increased MVPA versus control groups
  • Interventions with at least five contacts had a larger effect compared with those with less than five contacts
  • Trials that used self report measures showed that intervention participants reported achieving 24min/week more MVPA than controls
  • Eighteen trials reported weight and there was a significant reduction of 1kg favoring the physical activity intervention groups versus control

 

Ok sweet, we’ve got some nice little snippets to share on social media

To finish things off for this article, the authors were nice enough to go over barriers not only for patients, but also for health professionals as well.

Patient Barriers:

  • Lack of motivation or means to achieve MVPA
  • Afraid to physically exert themselves
    • Older or frail patients
    • Pregnant women
    • Cardiovascular disease

 

Health Professional Barriers

  • Lack of specialized knowledge of skills to do so
  • Consider it inappropriate to promote more vigorous exercise

 

The patient side of these barriers are unsurprising. The lay population lacks the knowledge of the benefits of physical activity, how to implement them, if they are safe or doesn’t prioritize them. Barriers to entry and public health as well as prioritizing health promoting behaviors and behavior change in and of itself is a multi series research review that we will not be getting in to here. Just knowing that these were the barriers can help set up health professionals for knowing how to approach intervening though.

The health professional side of these barriers is a bit disappointing to say the least, but at the same time, handling people’s health is stressful and challenging. If you haven’t been through a mentorship like Across The Continuum, you might not otherwise pick up the specialized knowledge or skills to implement physical activity guidance or recommendations. Not to mention if you are in the 80% of Americans that don’t meet the guidelines.

Just the same, considering it inappropriate to recommend more vigorous activity likely comes from a place of trying to do no harm. People who are in rehab, in the doctor’s office or in the hospital are unfortunately easy targets for assuming that they should take it easy. Hopefully the word can continue to get out that the benefits far outweigh the risks of incorporating physical activity into medical care (maybe send them the first research review!)

 

References: