The MyPlate Unrest

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This review of the MyPlate situation will tie back to another recent subject, but first, what is the situation? MyPlate is a graphic that was created to replace the old Food Pyramid. Its message is described more thoroughly by the official dietary guidelines, which are revised every five years. The revision rule was made for excellent reasons — because new information is acquired, and knowledge grows.

During the most recent committee’s efforts, some parties tried to remind the authorities that things had changed since the previous edition. For starters, it had been discovered that scientists took payola to blame obesity on dietary saturated fat, instead of sugar and carbohydrates. Everybody just went along with it for decades.

The U.S. Dietary Guidelines still recommend carbohydrates over fats, and by doing that, science writer Matt Ridley says they ignore too many scientific findings. He cites Professor Christopher Ramsden’s re-analysis of a 45-year-old study, which actually showed that the risk of death is higher with vegetable oils than with butter.

It also found that cutting fats from the diet can do much more harm than good. Ridley says:

Scientists are performing a screeching U-turn on dietary advice, away from demonizing fats and towards demonizing carbohydrates. In the case of obesity, they cannot quite bring themselves to admit it. They want to tell us not to eat sugars, yet they won’t exonerate fat.

The National Cattlemen’s Beef Association publicized its opinion that the proposed guidelines should be critiqued from a “purely scientific and methodological perspective,” implying that the guidelines — as they stood — were not entirely scientific, or even very methodological. It is always tempting to be skeptical, when lobbyists step into an affray. But these days, lobbyists are everywhere, and unavoidable. They can’t always be wrong, and occasionally might be right, even if for the wrong reasons, like naked greed, as sometimes happens.

Language problem

Traditionally, the six food groups are: veggies, fruits, grains, dairy, beans/meats, and fat. Protein is a nutrient contained in some of those food groups. For the sake of rational parallelism, the items on the plate should all be same-level entities.

The Physicians Committee for Responsible Medicine (PCRM) said:

MyPlate is an illustration that divides a serving plate into three common food groups — vegetables, fruits, and grains — and one nutrient category — protein — an anomaly that perpetuates the myth that protein is absent in vegetables, fruits, and grains, and that people must take special care to include protein in their diets.

The PCRM would like to remove the dairy group altogether, maintaining that the consumption of dairy products “fuels the nation’s diet-related disease epidemics.” Dairy products have not really done a whole lot for bone health, and they negatively impact health by increasing the risk of several cancers, along with Parkinson’s, Alzheimer’s, and cardiovascular disease. Also, somewhere between 30 and 50 million Americans face the daily discomfort and embarrassment brought on by lactose intolerance.

The organization also wants to replace “protein” with “legumes,” to discourage the eating of meat, especially red meat, which is described as high in fat, saturated fat, and cholesterol. They are keeping their old-school attitude:

Evidence indicates that meals high in saturated fat adversely affect the compliance of arteries, increasing the risk of heart attacks.

From Harvard’s T. H. Chan School of Public Health came a rival paradigm, the Healthy Eating Plate (HEP), which its creators pointedly mention “was not subjected to political or commercial pressures from food industry lobbyists.” Here’s the quick rundown of the main differences:

  • MyPlate did not used to advocate whole grains, but was revised to recommend that at least half a person’s grains be whole. The HEP is whole grains all the way.
  • MyPlate is fine with red meat and processed meat, while the HEP recommends limiting red meat, and getting protein through fish, poultry, and beans.
  • MyPlate “does not distinguish between potatoes and other vegetables.” The HEP is anti-potato.
  • MyPlate doesn’t mention oils or fat. The HEP is in favor of olive, canola, and other plant oils, and against butter.
  • MyPlate recommends dairy, but the HEP wants everyone to drink water.

Your responses and feedback are welcome!

Source: “The Exoneration of Dietary Fat,” RationalOptimist.com, 04/14/16
Source: “The money behind the fight over healthy eating,” Politico.com, 10/07/15
Source: “USDA’s MyPlate Is Making Americans Sick, Says Doctors Group,” PCRM.org, 08/10/17
Source: “Healthy Eating Plate vs. USDA’s MyPlate,” HSPH.Harvard.edu, 09/14/11
Image by ChooseMyPlate.gov

Nudge-o-Nomics

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Childhood Obesity News looked at the work of University of Chicago behavioral economist Richard Thaler, who studied people’s decision-making around money. With law professor Cass Sunstein, Thaler developed the notion of the nudge, “a subtle, non-coercive government intervention that can have outsize impacts because of human cognitive biases.” An example of how this principle is applied can be found in our post, “Behavioral Economics and School Lunches.”

For Forbes.com, Andrea Renda describes nudging as “a way to gently steer individuals towards specific forms of behavior by engaging in so-called ‘choice architecture‘.” And what might that be? Renda elaborates on the concept:

It was, de facto, the consolidation of two fields of social science: marketing and public policy, where the former was convincingly applied to the latter. The same techniques that had been applied for decades by corporations to conquer end users’ attention and willingness to pay were now being put to use in public policy, with a view to improving social welfare and policy effectiveness.

So, in other words, this is all manipulation, which is often regarded as a sneaky and underhanded way of doing things. Is manipulation always bad? Some philosophers would say yes. Others would say it’s the only way to get things done.

Folk wisdom has always recognized the successful techniques that characterize relationships between the sexes. Women whisper to each other the secret of getting a man to do something. Trick him into thinking it was his idea. Men pass along the arcane knowledge of how to handle a woman. Listen to her advice, say “Yes, dear,” and then go ahead and do what you meant to in the first place.

The “gently steer” language pertaining to choice architecture is reminiscent of a technique shared in parenting classes. Don’t ask a child, “What do you want for supper?” Instead, structure the question to preclude any unacceptable answer. “Do you want peas or corn?” Both are vegetables, so the parent wins either way. Meanwhile, the child is given the illusion of choice, and blissfully enjoys a fantasy of autonomy.

Experts have discovered how to take that principle and scale it up to the science of running an entire country. Renda says:

Finally, with the advent of big data analytics and artificial intelligence, the possibilities for governments to nudge individuals by engaging in advanced choice (or code) architecture appear to be exponentially increasing… The popularization of behavioral economics in the form of relatively straightforward experiments paved the way for a successful age of direct implementation in policymaking…

There are two main forms of nudging. One persuades the individual to choose a course of action more beneficial to himself; the other aims to persuade a person to do what is best for society as a whole. Ostensibly, the government practices these techniques to wisely guide, as a mother or a father would, the choices the citizens make.

One type of gentle, mental manipulation convinces a person to go for health, safety and prosperity, instead of cigarettes. Another type convinces people to not toss leftover medications into the toilet, because it harms the environment and the creatures living in it. In a perfect world, it would stop there.

Your responses and feedback are welcome!

Source: “This headline is a nudge to get you to read about Nobel economist Richard Thaler,” Vox.com, 10/09/17
Source: “When The Nobel Prize Goes Pop: Richard Thaler And The Uncertain Future Of ‘Nudge’,” Forbes.com, 10/21/17
Photo credit: symphony of love on Visualhunt/CC BY-SA

Gurus of the Irrational

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We have been discussing the work of Daniel Kahneman and Amos Tversky. In the words of Michael Lewis, they demonstrated that people, including experts of every kind, “unwittingly use all sorts of irrelevant criteria in decision-making.” One of those fallacious criteria is cognitive bias, which is so insidious because it is largely unconscious.

Lewis lists several of the research team’s examples of how thinking goes astray. The examples are reminiscent of a certain genre of riddle that has been a cultural feature for decades. For example:

A window cleaner is cleaning the windows on the 25th floor of a skyscraper. He slips and falls. He is not wearing a safety harness and nothing slows his fall, yet he suffers no injuries. Explain.

Answer: The window cleaner is cleaning the inside windows.

It’s not a trick question, but it could baffle someone whose cognitive bias brings up a mental picture of a window cleaner situated on a suspended platform outside a building. As long as a person is oblivious to the alternative possibility, that the cleaner could be working on the inner side of the glass, the riddle will not be solved. To entertain the cognitive illusion that window washers can only be in one place — outside — is to blind oneself to reality and guarantee that the answer will not be found.

Kahneman and Tversky also identified a logical error they called the conjunction fallacy, which is too complicated to go into here; and developed a school of thought around decision-making. Lewis says:

In their most cited paper, cryptically titled “Prospect Theory,” they convinced a lot of people that human beings are best understood as being risk-averse when making a decision that offers hope of a gain but risk-seeking when making a decision that will lead to a certain loss.

Dylan Matthews describes the work of Richard Thaler, another behavioral economist who proves that humans are not rational in their decision-making. He took an interest in “identifying specific kinds of irrationality that could be predicted and modeled ahead of time.”

Thaler described the peculiar mental accounting by which a person decides how to spend or save, depending on where the money comes from. Then, there is the endowment effect:

The basic idea is that people are strongly averse to giving up goods they already have, to the point of refusing to sell the goods for a price higher than what they paid for the goods to start with.

The endowment effect is closely related to loss aversion — the finding that people try harder to avoid losses, and put forth less of an effort to pursue gains. Writer Carl Richards phrased the concept like this:

We feel the pain of loss more acutely than we feel the pleasure of gain. In other words, we may like to win, but we hate to lose.

Childhood Obesity News has brought this up before in relation to the Fear of Missing Out (FOMO) syndrome. First, admittedly it is rational to miss something we once had, and that we lost. But the other face of FOMO is people getting all bent out of shape over missing stuff they never had. FOMO fever gets out of control and drives bad decisions. If you stop and think about it, it is pretty unreasonable to miss something we never had in the first place.

The weirdness

Paradoxically, this is exactly what we encourage an obese child to do. We hope the young person will feel desire for something he or she has never known: the pleasure of living in a fit, agile, non-obese physical frame. More importantly, we want them to abandon all the survival skills and coping mechanisms they have learned over the years. They know that sweets heal emotional pain. They know that binge eating fills up the emptiness. These are the pillars of truth on which the universe rests.

And then… there is pressure to change everything. Imagine if someone comes to you with a fabulous plan for living on the moon. “You’ll love it,” they gush. “You’ll be a whole new person!” But the person you are has already put in a lot of hard work figuring out how to make it in the Terran environment. You know how to breathe Earth’s air and walk around in Earth’s gravity. For these and other reasons, the moon colony will probably be a hard sell.

We want to maintain the status quo. As the old saying goes, “Better the devil you know than the devil you don’t.” Richards says:

The endowment effect is so powerful, people value their existing level of health so much, that they’d pay 50 times more to preserve their current level of health than to get a little healthier.

It has been an ongoing mystery, why many kids admit to several horrendous varieties of misery, and yet seem so unwilling to work for change. Is it possible that an obese teenager would pay 50 times more to preserve her current level of health than to get a little healthier? What an absurd idea — yet apparently, the endowment effect is a powerful force working against the efforts to help teens get healthy.

Your responses and feedback are welcome!

Source: “The King of Human Error,” VanityFair.com, December 2011
Source: “10 Smart Riddles,” Psysci.co, undated
Source: “This headline is a nudge to get you to read about Nobel economist Richard Thaler,” Vox.com, 10/09/17
Source: “Overcoming an Aversion to Loss,” NYTimes.com, 12/09/13
Photo credit: darkday via Visualhunt/CC BY

The Contradictions Within

lion-woman

Childhood Obesity News left off last time with speculation about whether clinical trial subjects, who might otherwise be tempted to somehow violate protocol, could be inspired by altruism to do better. This question is especially interesting for children and adolescents, who already have issues around their relative lack of power in the world.

Can the chance to take part in an important scientific study help to rev up the motivation? Can the vital nature of the mission impress kids enough so they take very seriously the need for full cooperation? Can a simple appeal to scientific integrity inspire them?

Various authorities have explored the issue of ownership, and language is a tool in promoting this idea. For instance, the Cenduit corporation characterizes their experimental subjects as “stakeholders,” which of course they are. The literature for one of their products reads as follows:

Patient Reminders are personalized, automated SMS, email, and voice messages sent to the patient or caregiver. Reminders help stakeholders arrive on time and prepared for their clinic visit. The result is higher quality investigational procedures completed within the time window demanded by the protocol and reduced instances of patient early withdrawal and lost to follow-up.

Perhaps that is a clue. A fertile field for inquiry is how to gain a real investment of commitment from the participants. Dr. Fred Kleinsinger mentions this detail:

I know that the term “nonadherence” has replaced “noncompliance” in some circles because “nonadherence” is less value-laden and does not imply a rigid hierarchical relationship between physician and patient.

Of course, we always hope that people will act in a way that makes sense. Whether undergoing a course of treatment laid out by the family physician, or participating as a subject in a big formal research project, we hope that people will act in ways that benefit themselves, but surprisingly they often do not. We also hope they will do the right thing regarding the study protocol, perform the actions they are supposed to perform, and refrain from the others.

In 2002, psychologist Daniel Kahneman was awarded the Nobel in economic science. His research and writing partner Amos Tversky would have won too, were he not already deceased. Together they proved that humans are not nearly as rational as we suppose. They did what Jim Holt calls “ingeniuous experiments” and discovered more than a score of cognitive biases that can twist our thinking processes into knots of futility.

The two-person team posited the existence of two separate operating systems in each of our minds. For convenience they are called System 1 (automatic, instinctual impulses and reactions) and System 2 (self-control, which is effortful). Kahneman wrote:

Constantly questioning our own thinking would be impossibly tedious, and System 2 is much too slow and inefficient to serve as a substitute for System 1 in making routine decisions. The best we can do is a compromise: learn to recognize situations in which mistakes are likely and try harder to avoid significant mistakes when the stakes are high.

This may seem far afield from obesity, but exactly what is going on when an obese person is confronted by a brand new bag of chips? System 1 urges immediate and thorough consumption, while System 2 struggles to think rationally over the rustling sound of a torn package. By the time System 2 reports in with the logical analysis — “This will not benefit your effort to achieve better health” — the mouth is already experiencing a crunch orgy and a salt rush.

The words of a famous commercial — “Bet you can’t eat one!” — prove true once again, as the heedlessly delinquent System 1 taunts, “Are you kidding? I can eat one whole party-size package! Ha ha ha!”

Your responses and feedback are welcome!

Source: “Patient & Protocol Compliance In Clinical Trials,” ClinicalLeader.com, 03/30/15
Source: “Understanding Noncompliant Behavior: Definitions and Causes,” NIH.com, Fall 2003
Source: “Two Brains Running,” NYTimes.com, 11/25/11
Source: “Of 2 Minds: How Fast and Slow Thinking Shape Perception and Choice [Excerpt],” ScientificAmerican.com, 06/15/12
Photo credit: cajsa.lilliehook on Visualhunt/CC BY-SA

Protocol Compliance and Data Quality

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Protocol compliance is the professional term for what the clinician/researcher needs from the subject/patient. Data quality is what the practicing physician and the inquiring scholar both hope to gain from their relationships with everyday people.

More and more, it is assumed that technology is the answer to everything, and should be deployed early and often. Technology seems to promise protocol compliance throughout the treatment or study, which it can only measure but not deliver.

At the very least, technology can tip off the researcher that some confabulation is going on. Moe Alsumidaie writes:

To elaborate, if a study team detects via engagement analytics that a patient is at risk of not adhering to study requirements, study teams can implement proactive methods to re-engage the patient; essentially reacting through targeted engagement strategies.

To put it more simply, “The key to patient adherence is early and responsive intervention” which is coincidentally true of so many things, for instance, childhood obesity. For another publication, Alsumidaie elaborated on how the non-adherence issue can “easily be addressed with novel technologies” like Artificial Intelligence and patient-centric study design models:

In the future, it is likely that advanced technologies and patient centric study design will not only make studies more convenient and accessible for patients, but also improve patient compliance with study procedures and IMP, generate higher data quality and ultimately shorten study duration and minimize cost impact.

But what is a patient-centric study? Jim Lane says:

Patient centricity initiatives frequently focus on trial awareness, protocol design, advocacy reach-out, and communication of study results. The fundamental issue of non-compliant patient behaviour and its mitigation, through such measures as continuous trial support, encouragement, and patient engagement, must feature prominently and be part of core trial activities.

Can patient compliance be encouraged by appeals to altruism? When drug trial subjects are released from the constant observation stage, they know they are expected to take their pills and maintain their diaries. The weight-losers know they are supposed to measure, calibrate, and record according to protocol. But for some people, a word like “compliance” can trigger their anti-fascist paranoia, and those quirks need to be taken into account.

When subjects revert to being part of the outpatient population once again, it is probably an innate human tendency to shout “Free at last!” — and act accordingly — even when the freedom is spurious, and even when the behavior is against the person’s own best interests.

For the subjects of a study, non-compliant behavior is inimical to the best interests of society as a whole, because it messes up an expensive scientific project and delays the discovery of new ways to save lives. But sometimes, a person just doesn’t care.

Within the narrow confines of a delusion, this makes sense. If even one’s own self-interest does not count for much, the desire to help the world is unlikely to be very strong, either.

Your responses and feedback are welcome!

Source: “Technology Tips on Improving Clinical Trial Patient Adherence,” AppliedClinicalTrialsOnline.com, 02/13/15
Source: “Non-Adherence: A Direct Influence on Clinical Trial Duration and Cost,” AppliedClinicalTrialsOnline.com, 04/24/17
Source: “Can Patient Engagement Improve Protocol Compliance?,” Longboat.com, 02/21/17
Source: “The Secrets of a Successful Clinical Trial: Compliance, Compliance, and Compliance,” NIH.gov, April 2011
Photo on Visualhunt

Understanding Non-Compliant Behavior

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Childhood Obesity News mentioned Dr. Fred Kleinsinger, who has done a lot of work regarding NCB, or non-compliant behavior. Why do some patients knowingly sabotage their treatment and/or the scientific research they might be involved in? Why are physicians not given better preparation for dealing with patient non-adherence to protocol? Fortunately, there is a skill set that can be taught and learned.

Clinicians need to understand that psychological issues carry a big stick. Whether in ongoing treatment for a chronic condition, or in the context of a formal study, there will be participants who suffer from depression, denial, and other psychological maladies whose symptoms can clash with the health care professional’s immediate objectives. Dr. Kleinsinger gives these examples:

In evaluating depression as a cause of NCB, I do not only include patients with a clear diagnosis […] but also patients whose depressed mood and defeatist attitude sabotage their ability to deal with their medical condition. Patients with bipolar disorders are often unpredictable, and their degree of compliance varies, depending on their mood state.

Some patients feel rewarded for remaining sick. In my experience, the most common reward is being classified as medically disabled.

This concept of “secondary gain” is part of the dynamic in some families. Often, one member is compensated, with attention and deference — by being served, by being relieved of responsibility in joint efforts — for being unwell. Sometimes, they have no other sense of identity or source of self-esteem. If a person does not care about seeking her or his own happiness, the doctor’s satisfaction or lack of it will not matter in the slightest.

Every so often, a patient comes along who manifests severe psychiatric illness. Once in a blue moon, something really bizarre turns up.

The everyday interactions

Fortunately, most doctor/patient or researcher/patient relationships do not carry so much freight. The majority of interactions are benign and fruitful, and can be more so when the professional takes some pains to facilitate things. This author’s initial recommendation has to do with framing. When NCB is encountered, it is to be considered not a failure, but a challenge.

With the caveat that this is not the whole answer, but only a starting place, it is vital to doublecheck that the patient understands what is expected, and why. Listening is important.

Does the patient have any suggestions about how their self-care behavior could be optimized? Dr. Kleinsinger adds:

Using the general categories I have suggested — and any of your own creation — develop a differential diagnosis for the cause or causes of the patient’s NCB… Discussing the case with a colleague may help generate a fresh perspective and a new approach.

How to Reduce NCB

Moe Alsumidaie wrote that there is evidence that “gamification invokes intervention with patients,” and added:

Gamification essentially enables patients to visualize study progress and rewards patients for adhering to study outcomes. Gamification is typically deployed via a mobile application or a web-based platform…

Gamification does not necessarily delight older people; it’s more of a youth thing. Text messaging, however, strikes a chord with a wider demographic group. Alsumidaie says:

A recent analysis has proven that text messaging effectively increased clinical trial recruitment and enrollment, which may suggest that text messaging can also be an effective and efficient tool that captivates patients during clinical trial conduct.

On the other hand, there is some evidence that people don’t want to cope with more gadgets, even familiar or user-friendly ones. So that could go either way. Devices are definitely helpful in solving one problem, the distortion caused by time lag. Retrospective reactions (like journaling at the end of each day) are increasingly frowned upon.

Your responses and feedback are welcome!

Source: “Understanding Noncompliant Behavior: Definitions and Causes,” NIH.com, Fall 2003
Source: “Technology Tips on Improving Clinical Trial Patient Adherence,” AppliedClinicalTrialsOnline.com, 02/13/15
Photo credit: Richard Riley (rileyroxx) on Visualhunt/CC BY

Non-Compliant Behavior and Obesity

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Childhood Obesity News talked about non-compliant behavior, or NCB, in relationship to clinical trials, and in the context of chronic illness. There is more to say about that, because obesity is certainly a chronic condition, and so is diabetes, which frequently comes along for the ride.

In America’s past, “doctor’s orders” were almost as sacred as holy writ. Resistance surely existed, but the phenomenon of self-injury through non-compliance was not studied.

Dr. Fred Kleinsinger has written about the tendency of patients in ongoing treatment to omit certain behaviors that they have been asked to perform, even though it interferes with the effectiveness of treatment. He says:

I believe that were we able to sufficiently understand our patients, their lives, what their illnesses mean to them, and how they cope with their illnesses, every act of noncompliance would seem to make sense — at least at some level.

His early, touchingly naive belief was that the patients simply didn’t get it. If only they could be led to understand the importance of carrying out their part of the bargain, everything would work out. He says:

My solution, therefore, for all noncompliant behavior was to repeat — more emphatically — why my recommendations were important and to reiterate my explanations and dire predictions until I felt that the patient could comprehend and would comply.

Well, that didn’t work. Piling on information turned out not to be the answer. Dr. Kleinsinger became convinced that it is not patients, but doctors, who need to get a clue. He notes that few physicians have been trained to identify the causes of non-adherence, and even fewer have the skills to prevent or counteract NCB.

It appears that a study manager would also benefit from learning the same skills that can help the family physician to secure better compliance. He says:

I have found that, similar to many other problems in medicine, NCB is caused by multiple, often intertwined factors… Any patient may be influenced by more than one of these causative factors, and I am sure many other factors exist that I have not yet encountered or do not yet understand.

I found that making the effort to understand the causes of each patient’s NCB helps me tailor an approach to removing obstacles and encouraging the patient’s full participation in their own health care.

What might those obstacles be? Cultural issues, for sure. Doctors forget how intimidating they are, even when they try hard to relate. The patient might be too polite or too frightened to indicate any lack of understanding. Or they may not even know that they don’t understand. Something could be going on with the patient, like the beginning of dementia.

The ultimate non-compliance joke

(This is ancient, and paraphrased from the original, wherever it may be.)

A girl recovers from rheumatic fever, which weakens the heart and makes pregnancy a life-threatening risk. But these are the old days, and there is a cultural assumption that people don’t do the thing that results in babies unless there is a wedding first. Also, people speak in euphemisms. So when the doctor sits the girl down for a serious talk, he does not speak plainly. Instead, he asks her to promise that, for the sake of her health, she will never get married.

Years later, the doctor runs into the woman, surrounded by a passel of children, obviously her own. With bafflement and injured dignity he says, “I thought we agreed that you should not marry.”

She says, “Oh Doctor, I did follow your advice. My parents disowned me, and the church excommunicated me, and even my babies’ father doesn’t understand. But I never did get married.”

This fable illustrates the crucial need for clarity. The moral of the story is, of course, to be as sure as possible that patients and study subjects understand what they are signing up for. But even then, it’s not a complete answer — as Dr. Kleinsinger learned.

Your responses and feedback are welcome!

Source: “Understanding Noncompliant Behavior: Definitions and Causes,” NIH.com, Fall 2003
Photo credit: The Library of Congress on Visualhunt/No known copyright restrictions

Science and Rebellion

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In the world of clinical trials, there are different varieties of compliance. Researchers must follow certain rules if they want to be published and enjoy official validation. When a corporation hopes to bring a drug or device to the market, there are massive regulations (except when there are not, but that is a topic for another day.)

Then, there is the type of compliance expected from patients, whether under the long-term care of a primary physician; or participating in a clinical trial of some medication, treatment, procedure, or technological aid. In either case, patients are expected to fulfill certain expectations, both for the sake of their own health, and to assure the reliability of the endpoint data. And yet they routinely disappoint, sometimes with non-compliant behavior (NCB) so egregious it might be characterized as “cheating.”

How do patients mess things up?

Sometimes they back out of the study at the last minute, or begin and then drop out, which is their perfect right, of course, but for statistical purposes both count as non-adherence. Sometimes patients do not comply with the treatment regimen or adhere to the study procedures. They may neglect to keep good records or to report adverse events.

As medical writer Moe Alsumidaie puts it, “Patient adherence can apply to several different clinical trial facets.” Longboat’s Jim Lane mentions these examples:

— Not fasting before a visit, resulting in the visit needing to be rescheduled for lipid profile, blood glucose test,. etc.
— Forgetting to take investigational medicinal product on the morning of the visit, resulting in the site not being able to complete pharmacokinetic analysis
— Forgetting to bring unused medication, resulting in the site not being able to carry out a compliance check
— Forgetting to complete PRO questionnaires, diet diaries etc. at a specified time before the visit
— Taking prohibited medication between visits, resulting in potential safety risks as well as potentially assigning causality to investigational medicinal product versus the prohibited medication

Lane cites research suggesting that patients are often unreliable, and unlikely to be well equipped for the responsibilities involved in taking part in studies. They may feel overwhelmed by fitness trackers and other gadgets.

Alsumidaie suggests reasons for NCB, including that people are just plain busy, and despite their best intentions, they don’t always get around to things, even important things. Subjects may lie to researchers because they don’t want to be dropped from the clinical trial, for whatever reason.

Maybe they just don’t want to cause disappointment. Possibly, consent forms are too complicated, and the patients/subjects don’t understand what they are signing up for.

Your responses and feedback are welcome!

Source: “Technology Tips on Improving Clinical Trial Patient Adherence,” AppliedClinicalTrialsOnline.com, 02/13/15
Source: “Can Patient Engagement Improve Protocol Compliance?,” Longboat.com, 02/21/17
Photo credit: Schezar on Visualhunt/CC BY

Non-Compliant Behavior in Clinical Trials

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Childhood Obesity News has been looking at the question of NCB, or non-compliant behavior, searching for hints as to why youngsters in an obesity study might fudge their reports and sabotage the program that exists only to help them. The literature on that particular problem is scant, but giving some attention to work that has been done in various arenas might help increase understanding. (We already talked about one situation, where patients with chronic conditions fail to follow “doctor’s orders.”)

A clinical trial, according to the World Health Organization, is “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” The definition from the National Institutes of Health adds a couple of details. Intervention might include no intervention, or a placebo, and they more expansively speak of “health-related biomedical or behavioral outcomes.”

Big Pharma’s role

The type of clinical trial with a narrow focus is found throughout the pharmaceutical industry. The company wants to know the specifics of a certain compound. First, is this depression medicine safe, or does it make people’s blood pressure go up? Second, does it seem to work, to alleviate depression, on a small sample of people? If so, then with approval it enters the third stage, randomized and blind testing on hundreds or thousands of patients.

In the first stage, a clinical trial generally pays healthy volunteers to put aside their ordinary lives for a while. The researchers need to track every detail of how the substance is absorbed, metabolized, and excreted. Aside from its intended purpose, what else does it do? What happens when the dosage is increased? It is easy to understand why corporations build their own dorm-like facilities and require study participants to remain under surveillance for the length of the trial.

Many purposes of clinical trials

Inpatient trials are not necessarily limited to pharmaceutical research, and when outpatients are involved, the range of possible applications is vastly wider. In this scenario, treatment and research are dual goals. Science will be advanced, and the patient will benefit.

The trials of Dr. Pretlow’s W8Loss2Go weight loss intervention, for instance, were designed to both help and learn. So in that type of situation, a subject who “cheats” in any way does two different types of harm — to the research effort, and to the self.

Jim Lane writes:

Protocol non-compliance at clinical research sites is a well-recognized problem… A proliferation of protocol deviations can fatally undermine study results, thereby nullifying years of effort and dedication.

NCB breaks the integrity of the research. It produces skewed outcomes that have to be thrown out. A clinical trial is a resource-intensive endeavor, so one consequence is the waste of funds that could have been usefully spent elsewhere. Also, the patient could lose out on whatever benefits might have occurred as the result of close adherence to the program.

When a drug is involved, this can be downright hazardous. Skipping a dose might cancel out the efficacy entirely; double-dosing could be toxic. In clinical trials of investigational medical products, research has found that, by 150 days in, approximately 40% of patients had strayed from compliance in some way.

This brings up a side question. Lane writes:

Sponsors spend a lot of time, effort, and money finding deviations, implementing corrective and preventive actions, and cleaning data. The combined cost of CRA resources [number-crunching Clinical Research Associates], sophisticated centralized analytics, and data clean-up activities can be enormous.

What if people started to be totally forthcoming when, for instance, filling out self-reportage questionnaires for research purposes? How would that translate into what one company elegantly terms the “increased reliability of the endpoint data”?

To account for a predictable number of cheaters, exceptions are already built into the algorithms. Would honesty just mess everything up?

Your responses and feedback are welcome!

Source: “Can Patient Engagement Improve Protocol Compliance?,” Longboat.com, 02/21/17
Source: “Non-Adherence: A Direct Influence on Clinical Trial Duration and Cost,” AppliedClinicalTrialsOnline.com, 04/24/17
Source: “Patient & Protocol Compliance In Clinical Trials,” ClinicalLeader.com, 03/30/15
Photo via Visualhunt

Compliance and Rebellion

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Given the shortage of information on why children and teenagers might not follow the rules of a study they have agreed to participate in, Childhood Obesity News is looking at reports on situations that are somewhat related.

Non-compliance can occur in any setting, and in different scenarios it shows up in different ways. Despite these various manifestations, the urge to rebel seems to all come from the same deep psychological wellsprings. This probably includes the tendency of some kids to “cheat” when enrolled in a voluntary program that is meant to help them.

Non-compliant behavior is so pervasive that it has been awarded its own set of initials, as seen in an article by Dr. Fred Kleinsinger:

NCB is likely one of the most common causes of treatment failure for chronic conditions, though this is not widely or consistently recognized.

If looked at through certain lenses, that could sound dangerously like victim-blaming. Those who address the issue are generally careful to note that non-compliance is often unintentional or inadvertent. Sometimes it is unavoidable.

Patients who are minors or disabled must depend on the good will of others to help them carry out doctors’ orders. Grownups without support systems are vulnerable too. Once home from being X-rayed and having a splint applied, a mother of two small children will not be lying around with her ankle elevated above her heart.

Whether the NCB is intentional, unavoidable, or whatever, it hurts patients and frustrates doctors. There seems to be a certain irreducible amount of apparently intransigent resistance, and medical professionals wonder why.

Worse yet, Jim Lane calls patients “notoriously non-compliant” by their very nature, and cites research showing that “No methodology accurately predicts which patients will and will not adhere to a treatment plan”:

Non-compliant behaviour by patients… is pervasive in normal clinical care and there’s plenty of research that confirms this.

He quotes a Food and Drug Administration study of people being treated for chronic medical conditions. According to that agency’s stats, somewhere between 14% and 21% of patients don’t fill their original prescriptions, and of those who do, 30% to 50% fail to follow the instructions on the bottle.

For the moment, we leave aside people who are subjects in formal medical testing. This is about patients afflicted with chronic conditions, and their everyday, ongoing care.

What causes poor medication compliance? Patients may not feel that the medication is helping, or may believe that it will interfere with their daily activities. It might be too difficult to open the container, or to swallow the pill. They might be afraid of potential side effects, or experience actual side effects. The instructions might be confusing, or the total number of meds they are expected to take might be confounding. Sometimes they just forget.

Your responses and feedback are welcome!

Source: “Working with the Noncompliant Patient,” NIH.gov, Spring 2010
Source: “Can Patient Engagement Improve Protocol Compliance?,” Longboat.com, 02/21/17
Source: “Patient & Protocol Compliance In Clinical Trials,” ClinicalLeader.com, 03/30/15
Photo credit: Internet Archive Book Images via Visualhunt/No known copyright restrictions

Childhood Obesity News | OVERWEIGHT: What Kids Say | Dr. Robert A. Pretlow
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