"Fusing" Randomized Clinical Trials and Big Data: Another Value Proposition for Population Health?

Randomized controlled trials are the crown jewel of clinical research.  By allocating patients to one of two or more treatment protocols (or "arms"), they can ascertain cause and effect while also eliminating any known or unknown bias from the results.  As a result, they often provide "the" answer to the big questions about the true value of medical interventions.

Unfortunately, they're also difficult, expensive, time-consuming, can only gauge average impact, often exclude many "real world" patients, require patient consent and have made little impact on day-to-day health care. 

Enter Big Data.

Defined as the "rapid analysis of (multiple) data sets using sophisticated machine-learning strategies," it is inexpensive, fast, uses readily available information, can give insight at an individual level, don't necessarily require patient consent, and also have had little impact on day-to-day health care.

So, Derek Angus suggests in the latest issue of JAMA that the two approaches can be fused:

1. Use electronic record based machine intelligence to scour the clinical data bases to find candidates for the trials, prompt the doctors to recruit the patients and then enter them immediately at the point of care;

2. Change the entry criteria as the application of Data to the randomized trial results begin to show that one arm is showing greater promise versus other arms;

3. Tilt the randomization toward one arm of the randomized trial if it begins to show a clinical advantage;

4. Have organizations commit to recruit ALL patients who would meet entry criteria to participation in the randomized trial.

To his credit, the author points out that there would be some challenges. Increased complexity could increase the threat of hacking of electronic health records. Convoluted recruitment, assignment and data analysis could be vulnerable to manipulation.  Without high numbers of participants, heterogeneity could introduce hidden biases and undermine confidence that any observed results are real. Despite assurances that there is increased odds of actually benefitting from participation, physicians and their patients may still be reluctant to cooperate.

While this paper is really about using Big Data to help increase the efficiency of randomized trials, the Population Health Blog finds the concept intriguing. It wonders if large academic centers and traditional research sponsors have the flexibility to change their usual way of doing business.

The PHB makes note of one additional barrier: a small but additional burden on clinical workflows. While it may only take a few more minutes for a physician or nurse to deal with the prospect of a clinical trial, the multiple inefficiencies of the EHR have already added up to a significant burden. While the merits of clinical research are significant, front-line nurses and docs could view this as just one more hassle.

Since Population Health Management service providers already possess expertise in big data and electronic records, applying this to randomized trials may represent a new value proposition for the industry. Now that would be a big impact.

Short HIA training course: gauging interes

From Marla Orenstein from Habitat Health Impact Consulting:

We are currently trying to gauge the level of interest in having a short HIA training workshop (2-3 days) held in different cities — possibly including yours!  We have developed a very brief survey to help us find out where there might be interest.  If you or anyone from your organization might be interested in a short HIA training workshop, we would really, really appreciate it if you would fill this survey out.  It would also be enormously helpful if you could pass the message along to anyone else who you think might be interested.  The survey takes under 3 minutes to complete.

The survey can be accessed here: https://ardethevans.typeform.com/to/Qinesx

How Much Does Sugar Contribute to Obesity?

Last week, the British Medical Journal published a review article titled "Dietary Sugars and Body Weight", concluding that "free sugars" and sugar-sweetened beverages contribute to weight gain.  But what are "free sugars", and why does the scientific literature suggest that the relationship between sugar intake and body weight isn't as straightforward as it may initially appear?

Read more »

Stress Can Be a Fitness Killer

I am not a fan of stress and how it can make me feel.  Unfortunately, stress is part of the life package deal with no opting out button.  Stress can become a chronic ugly thing with negative physical and emotional side effects.  Studies are also linking stress to hypertension, heart disease, and weight gain.  Who the heck wants a whole bunch of extra fat with the heart attack waiting to happen sign sitting on our stressed out shoulders?

So many of us are living in a constant state of stress whether from family problems, illness, financial strain, or unhappy marriages and are accepting it as our normal way of life.  Stress places wear and tear on our body as cortisol is leaking out of the adrenal glands in abundance and causing increased blood pressure and waistlines. Stress, straight up is a fitness killer.  I for one refuse to live in a constant state of stress and do implement healthy strategies to eliminate it from my life.

The way stress is handled is the answer to maintaining our health and fitness.  Some use stressful situations to make excuses to eat crappy, give up on themselves, and have a bitter resentful attitude about life.  This of course leads to all that "comfort food" over-eating, no exercise, and blaming everyone for self-induced problems.  Chronic stress behaviors like this lead to the ultimate fitness killer and eventual body riddled with illness and unhappiness. Stress can be either out of our control which we need to learn to let go, or fixable.

"Life is 10% what happens to us and 90% how we respond to it." I love this true statement and live this philosophy to reduce stress and maintain my fit and healthy life.  Learning to let go and remove stresses not within our control is important to healthy boundaries and improving the quality of our life.  Also, reviewing our priorities and eliminating things creating a "too busy" life will make for a happier, healthier you. Focusing on how to become a better you is the only thing that falls under the "fixable stress" category.  We tend to put undue stress on ourselves and from un-meaningful things in life.  Who cares what others are thinking, saying or even doing that may be about you?   Learning to let go, walk away from unimportant things, and picking up positive growth from the stresses in life will create a stronger, healthier person.

I enjoy a great workout when I feel stressed or anxious and use it as "cheap man's" therapy for self improvement.  God and I have pretty good talks during that time as well and usually within that sweaty hour, I have put the stress behind me and ready to move on with a positive day.  I also do not reach for  "junk" food to comfort me or fill some sort of empty void during times of stress.  I am a mindful eater and think before throwing just anything in my face.  My body, mind, and spirit are worthy of more than trash in the form of food or a bitter attitude.  I also like to deep breathe during my stretch time and contemplate everything about life.  I choose to be happy and healthy and that calls for action and choices to respond to stress in a healthy way.

Read my recent article "Is Stress and Cortisol Making You Fat"  on the about.com network for great information on how stress contributes to increased fat.

IS STRESS MAKING ME FAT?

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Darla

More Thoughts on the Recent Low-fat vs. Low-carb Metabolic Ward Study

The recent low-carb vs. low-fat study has provoked criticism from parts of the diet-health community.  Let's examine these objections and see how they hold up to scientific scrutiny.
Read more »

Scaling Mindfulness to Population Health and Tobacco Addiction: The Science Behind the Art

Think about it....

Years ago, the young Population Health Blog was a part of a nurse-led tobacco cessation program.  Hundreds of patients later, we reported the one-year quit rate of over 30%. That seminal research catalyzed the creation of other nurse-based programs in asthma, diabetes and heart failure. The PHB and colleagues didn't know it at the time, but it was the start of an almost 20 year journey in population health that continues to pay dividends today.

The art and science of population health continues to evolve, however.  That's why the PHB is always happy to hear from the leadership of outfits like Craving to Quit.  And this is something different.

As readers may know, "apps" are becoming an important part of the population health landscape, but what the PHB didn't know is that an app could be combined with the science of "mindfulness."

Mindfulness?  Conscious intention was a part of the PHB's martial arts training, but it didn't know that there was a science to it and that could be applied to health care.

Mindfulness can be defined as being attentive to and aware of what is taking place in the present. By consciously stepping back and being aware of the status of your well being, the accompanying cognitive insight enables the "user" to better cope and manage the wide array of emotional states. That can include enhancing a state of wellness or, conversely, combating depression, anxiety, addictions and cravings  The PHB didn't know this, but it's been a subject of intense basic neuroscience as well as clinical real-world research (here and here) for years.  And if you're wondering if there is a Buddhist pedigree in all of this, you're right.

Enter Craving to Quit.

It's seeking to scale one-on-one mindfulness to populations using an app that can be used to combat tobacco addiction.  Users can prompt attentive mindfulness to manage nicotine-withdrawal related cravings.  Add in feedback, access to a community of like-minded users, live expert addiction coaching, plus a library of video-based instructional resources and - boom! - an academic backwater of "mindfulness" turns into a robust population-based intervention.

And credit to the leadership at CtoQ for committing the resources to precisely measure their outcomes for the scrutiny of peer review.  They're conducting an Institutional Review Board - approved randomized clinical trial to further document the impact of mindfulness. As the PHB has written here, without a disciplined approach to documenting outcomes, population health service providers are putting themselves and the industry at significant risk.

Being mindful of an attitude of plenty, this is good news for the art and science of population health.
No wonder it caught CNN's attention. It's worth paying attention to.
 
Their success is our success.

A New Human Trial Undermines the Carbohydrate-insulin Hypothesis of Obesity, Again

The carbohydrate-insulin hypothesis of obesity states that carbohydrates (particularly refined carbohydrates and sugar) are the primary cause of obesity due to their ability to increase circulating insulin, and that the solution to obesity is to restrict carbohydrate intake.  Numerous studies have tested this hypothesis, more or less directly, in animals and humans.  Despite the fact that many of these studies undermine the hypothesis, it remains extremely popular, both in the popular media and to a lesser extent among researchers.  A new human trial by Kevin Hall's research team at the US National Institutes of Health offers very strong evidence that the carbohydrate-insulin hypothesis of obesity is incorrect.  At the same time, it offers surprising and provocative results that challenge prevailing ideas about diet and weight loss.

Read more »

I am Struggling with Orthorexia: a True Testimonial

After writing an article on the topic of Orthorexia Nervosa, an undiagnosed eating disorder where healthy eating is taken to an unhealthy extreme, and on the about.com network, I received an outpouring of emails from people struggling with the disorder or tendencies to the behavior.  I was deeply moved with the many thanks for addressing the issue and providing awareness of the Orthorexia condition.  Upon sharing the article on my Stay Healthy Fitness Facebook there was also quite a bit of backlash and reference to Orthorexia being "bullshit" and just another money making disorder for the doctors.  I did provide a follow-up blog as I do fall under the category of a "clean eater" but there is a difference in healthy eating and healthy obsessive eating.  I ended the blog write with this statement:

"Orthorexia is a mental health issue not a clean eating issue, although sparked by "pure" foods.  It is an issue that requires us to look past the food and into the mind of a struggling person."

With that I now want to introduce you to a struggling Orthorexic who has offered to share her story with privacy conditions and I have agreed to do so.  Her story is authentic and her struggle is real:

"I really appreciate your article on orthorexia. I have those tendencies, but I am not sure if I fall into the orthorexia category or anorexia category. I am 50 years old and mother of two children. I have a degree in advertising and passionate about the health and fitness field.  I do most of my work from home so I can spend time with my kids.  For the last 25 years, I have worked-out faithfully and followed a relatively healthy diet.  When I turned 38, however, things seemed to "fall apart". I began having joint problems and acne issues. My thyroid issues worsened. After some research, I eliminated gluten and found relief in my joints, but not my skin. After further research, I found the paleo diet. It helped somewhat with the thyroid issues. I now eat a diet free of all grains/soy/beans/sugar/potatoes and most dairy.  Basically, I eat eggs, meat, veggies, fruit, nuts, and fats. I tried AIP to clear my acne but it did not produce the desired results. My acne is worse and I lost about 15 pounds. (I am below 100 pounds.)  I am 5'1" tall. I am not quite sure how to pull myself out of this one but I am trying to. After "eating clean" for so long, it is a bit hard to add things back so that I can gain the much needed weight.  My weakness is anything chocolate, peanut butter and/or ice cream.  It is hard, but sometimes I have to give myself permission to indulge. I still have to work on the guilt afterwards. But baby steps...

I am currently seeing a naturopath for my under active thyroid.  He has been a God-send.  He is aware of my anorexia tendencies and intercepted what could have been a much more serious situation than I am in right now. He accepted me as a patient in the middle of a tailspin. The MD that I had been using for years decided to make a HUGE adjustment in my thyroid medication. The end results were not what he expected and told me to see a specialist. I chose to find a naturopath instead.  He is wonderful.  But sometimes, it is hard to stop the tailspin mid tailspin!  I have dealt with anorexia since I was 18 years old.  That is a whole other story that I hope to share someday in hopes of helping those in the same situation.  In the past, I just starved myself.  This time is different.  I am eating but I am eating so cleanly and never deviating--until recently.  Anorexia restricts food--plain and simple, no explanation needed when I refused food.  This time it feels like life is restricted. How do you try and explain that I eat good-for-me food not THAT?!  I am not saying that eating healthily is a bad thing.  But there needs to be balance.  Of course, if you have sensitivities, then stay clear of the trigger foods.  I have, through all this, found some sensitivities (gluten and soy) and I avoid them to the best of my ability.  But relaxing and enjoying a not-so-good-for-you treat is still a struggle.  I somehow feel that I have failed because I "gave in".  Shouldn't the important thing be that I am enjoying a rare treat with my children?  Believe me, they have noticed that I no longer share in the special times.  What kind of example am I setting for them?  I do not want them to think that it is all or nothing. They eat pretty healthily.  They now eat more fruits and vegetables and much less processed foods. Beyond that,  I am so uncomfortable in my own body because I finally was "able to see" how thin I was thanks to my husband hurting my feelings.  I thank God he was just plain honest even though it hurt.  My acne is embarrassing as well.  I never thought that I would be fighting acne at my age even with all the positives changes that I have made.  It is worse now than when I was in my teens.  

Thank you for addressing this issue and giving me awareness.  I hope to get myself back.  My dream is just to be healthy and be able to help others suffering like I do.  If you feel that my story can help someone, then please use it. I feel like we all go through things for a reason. If my story would bring awareness, I would feel blessed!" 

Sincerely,

An Orthorexic

READ THE ARTICLE

If you have not had the opportunity to read my article on "Orthorexia: Clean Eating Gone Wrong" , take a few moments to become aware of an issue that is more problematic than realized. I am thankful to this beautiful woman who reached out completely vulnerable sharing her life and struggle with orthorexic tendencies and I pray for her recovery.  I also hope that her story has touched you as it did me.  Orthorexia is definitely not "bullshit" and bringing this issue to the forefront is timely.  Awareness of the condition is important so that we may be able to help those who are struggling or at the very least understand the mentality of someone suffering with Orthorexia.  

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Stay Healthy!

Darla

Channeling the Fox News Rebublican Debate for Health Care Reform

Last night, the Population Health Blog secured a suitable beverage supply, pulled up a chair and tuned to the Republican Party debate. As predicted, there was little substantive attention to health reform.

That won't stop the PHB.   Lacking specifics, it's offering an important public service by channeling the debate's bombast to a hypothetical question:

"Specifically, what is the first thing you would do on the first day of your administration, as the next U.S. President, to control the growth of health care spending?"

Chris Christie - "I'd do hugs, not drugs!"

Scott Walker - "Since they've hacked all our medical records anyway, let's outsource it to China."

Rand Paul - "Stop the outsourcing of how we pay for it to China!"

Ben Carson - I've done brain surgery on conjoined Siamese Twin health policy specialists; one lost their brain and when I was done, I couldn't tell the difference between the two!"

Donald Trump - "You're stupid for even asking that, but I'd build a wall around every hospital."

Jeb Bush - "If everyone ate some milquetoast everyday like I do, they'd be calm and healthy, like me!"

Ted Cruz - "I'd shut down the government."

John Kasich - "If all Americans would only go to Ohio hospitals, costs would go down."

Marco Rubio - "I had a $100,000 in educational loans, and I look forward to $100,000 in loans to pay for my health care bills."

Mike Huckabee - "The purpose of health care is not not kill people or break things!"

The Gap Between Rank and File Physicians and Their Leaders

Awaiting our orders

Talk about a study in contrasts.

According to this Commonwealth Fund and Kaiser Family Foundation survey, only a minority of "front-line" primary care providers (including a sample of non-physicians) believe that the major linchpins of health reform such as value-based payments, Accountable Care Organizations (ACOs) and medical homes are having a "positive impact on medical care."

The survey relied on a representative national sample of 1,624 primary care docs and 525 nurse practitioners and physician assistants who were working in primary care practices.  64% and 87%, respectively, were compensated with a mix of salary and/or capitation and 55% of the docs' had incentives that were based on quality, patient surveys or cost. Just under 30% were participating in some sort of ACO arrangement.

Only 33% of the physicians and 40% of the non-physicians believed medical homes are beneficial. 

26% of the physicians also viewed ACOs negatively.  Among the physicians who were in an ACO, "three of 10 said ACOs are having a positive impact, one-quarter said their impact is negative, and 20 percent said they have no impact."

What's more, 50% and 40% of physicians and non-physicians believe quality incentives are having a "negative" impact on the quality of care.

And how bad is it? 47% and 27% of physician and non-physicians are considering retirement "earlier than they thought they would."

And then there is this separate report by the "American Association for Physician Leadership."  According to partner "Navigant Center for Healthcare Research and Policy Analysis," this survey of 2,398 of the Association's members shows that "55%" believe the Affordable Care Act has "more good than bad," that "69%" felt that physicians should be held "accountable for costs of care" and that 57% agreed that ACOs will "be a permanent model for risk sharing."

And just was is the AAPL?  The Population Health Blog didn't know this, but it's the rebranded American College of Physician Executives (ACPE).  Being a member of AAPL doesn't necessary mean that a doc occupies a position of leadership in a hospital or clinic, but the credential suggests a strong interest in that career path.

Why the disconnect between physician leaders and rank and file primary care physicians? 

It could be argued that their vantage point enables the leaders to be better aware of the realities of health reform and that those realities have yet to be communicated or accepted by primary care physicians.  Cue the narrative about education, aligning incentives, letting the malcontents quit and questioning whether physicians should even be in charge.

But the PHB isn't sure that quite explains everything.

The recent controversy over maintenance of certification (MOC) is a telling example of how easy it is for otherwise smart and respected physician leaders who are advancing quality and value to get it really wrong.  Thanks to all the publications, webinars, meetings, PowerPoints in the closed-information loops of health reform, it's too easy for well-meaning leaders to recycle Washington DC's value-based nostrums.  The PHB is running into many of them, and the group-think is getting both boring and alarming.

In other words, just because "leaders" are championing change doesn't mean the rank and file "get it."  There is also no guarantee that there won't be inconvenient raising of ethical concerns, a reprise of the anti-managed care backlash, a strike threat or even acts of civil disobedience.

Based on the input of physicians who are at the front lines and are seeing the impact first hand, health reform remains very much a work in progress.  And maybe it's the physician leaders that don't get it.

Stay tuned.

Image from Wikipedia

I Maintain a Healthy Perspective About Fitness

I love being healthy, eating healthy and how I feel as a healthy woman.  I have been living this lifestyle most of my life and at 51 have a healthy handle of what being healthy means.  I teach health and fitness as my occupation and since it is my passion really do not consider it work.  There is something to be said about the existence of living a healthy lifestyle.  My clients know that I don't teach perfection, but progress and it is not a lifestyle of complete restriction, but a healthy balance of eating right 80 to 90 percent of the time and regular exercise.

I do not believe in taking things to extremes and making health feel like a burden for me or anyone else.  My mental game is what I want to address here and keeping health in perspective.  I am all about eating organic, non-GMO, and cooking at home to be in control of what I am eating 80 to 90 percent of the time.  I am human and will indulge in occasional adult beverages and will not turn down a slice of my Mom's lemon meringue pie. I enjoy partaking in my treats now and then and do so guilt free.  I also do not spend endless hours in the gym to maintain my physique and believe an effective workout can be completed in 60 minutes or less.  I also feel my workouts are a healthy outlet and not a punishment for eating crappy. I make sure to get in 5 workouts per week with two recovery days.  I would call my healthy lifestyle realistic, maintainable, and mentally positive.

I do the best I can to eat healthy and realize that I will not be GMO free. None of us will be able to accomplish this task unless we are growing our own foods, and even then, what is in the soil?  Is it truly GMO free?  Did a bird carry over tainted corn or other seeds into my garden?  What about pesticides flying over into my garden?  I would not be able to eat at all if I began over obsessing about my healthy foods and started eliminating essential nutrients because my focus was on purity and quality of food instead of what my body needs to function daily.  What if I began eliminating my Mom's pie and stopped going out with my husband and friends because I was afraid of the food?  This would not be healthy thinking or healthy living.

READ THE ORTHOREXIA ARTICLE

In addition to being a fitness trainer and coach, I am a freelance writer and Sports Nutrition Expert for the about.com network.  I recently researched and wrote an article on Orthorexia, an undiagnosed eating disorder that takes healthy eating to an unhealthy extreme.  I was surprised to see such negative comments and backlash exposing orthorexic behaviors.  It appears that the "meat" of the article was missed and a nerve was touched for those who are "clean" eaters.  I fall into the eating clean category and as I shared earlier, there is a difference between eating healthy and "obsessive" eating healthy.

The article was an exposure of the mental thinking surrounding eating clean or "pure" not that eating healthy is a bad thing ... that would be ludicrous.  Would you say that binging and purging, over-eating, anorexia, and exercise addiction are unhealthy and mentally and emotionally related?  I welcome knowledge as power on all subjects related to health and we should not be birds with our heads stuck in the sand avoiding up and coming issues surrounding the health and fitness industry.  When food phobia becomes so severe that it affects quality of life in an unhealthy way, I would agree it warrants time and attention.  Orthorexia is a mental health issue not a clean eating issue, although sparked by "pure" foods.  It is an issue that requires us to look past the food and into the mind of a struggling person.

The article posted on the about.com network is a very informative read on the subject of Orthorexia.  I hope that is can also be re-read with a more open mind.

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I Keep it Healthy

Stay Healthy!

Darla