Health for life

Blood pressure is effectively lowered by mindfulness-based stress reduction (MBSR) for patients with borderline high blood pressure or "prehypertension." This finding is reported in the October issue of Psychosomatic Medicine: Journal of Biobehavioral Medicine, the official journal of the American Psychosomatic Society. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health.

"Our results provide evidence that MBSR, when added to lifestyle modification advice, may be an appropriate complementary treatment for BP in the prehypertensive range," writes Joel W. Hughes, PhD, of Kent State (Ohio) University and colleagues.

Mindfulness Practice Leads to Drop in Blood Pressure

The study included 56 women and men diagnosed with prehypertension -- blood pressure that was higher than desirable, but not yet so high that antihypertensive drugs would be prescribed. Prehypertension receives increasing attention from doctors because it is associated with a wide range of heart disease and other cardiovascular problems. About 30% of Americans have prehypertension and may be prescribed medications for this condition.

One group of patients was assigned to a program of MBSR: eight group sessions of 2½ hours per week. Led by an experienced instructor, the sessions included three main types of mindfulness skills: body scan exercises, sitting meditation, and yoga exercises. Patients were also encouraged to perform mindfulness exercises at home.

The other "comparison" group received lifestyle advice plus a muscle-relaxation activity. This "active control" treatment group was not expected to have lasting effects on blood pressure. Blood pressure measurements were compared between groups to determine whether the mindfulness-based intervention reduced blood pressure in this group of people at risk of cardiovascular problems.

Patients in the mindfulness-based intervention group had significant reductions in clinic-based blood pressure measurements. Systolic blood pressure (the first, higher number) decreased by an average of nearly 5 millimeters of mercury (mm Hg), compared to less than 1 mm Hg with in the control group who did not receive the mindfulness intervention.

Diastolic blood pressure (the second, lower number) was also lower in the mindfulness-based intervention group: a reduction of nearly 2 mm Hg, compared to an increase of 1 mm Hg in the control group.

Mindfulness-based interventions Could Prevent or Delay Need for Antihypertensive Drugs Ambulatory monitoring is an increasingly used alternative to clinic-based blood pressure measurements. However, 24-hour ambulatory blood pressure monitoring showed no significant difference in blood pressure with the mindfulness-based intervention.

"Mindfulness-based stress reduction is an increasingly popular practice that has been purported to alleviate stress, treat depression and anxiety, and treat certain health conditions," according to Dr Hughes and coauthors. It has been suggested that MBSR and other types of meditation may be useful in lowering blood pressure. Previous studies have reported small but significant reductions in blood pressure with Transcendental Meditation; the new study is the first to specifically evaluate the blood pressure effects of mindfulness-based intervention in patients with prehypertension.

Although the blood pressure reductions associated with mindfulness-based interventions are modest, they are similar to many drug interventions and potentially large enough to lead to reductions in the risk of heart attack or stroke. Further studies are needed to see if the blood pressure-lowering effects are sustained over time.

The researchers argue that mindfulness-based interventions may provide a useful alternative to help "prevent or delay" the need for antihypertensive medications in patients with borderline high blood pressure.

"Maybe you should go back to the hospital!"

Ask most wonks - especially ones who never took care of a patient - about "readmissions," and, after quoting this article, these health policy Urkels will tell you that returning to a hospital is the poster-child of all that ails U.S. medical care. Providers who cant get it right the first time, they say, are not only giving slipshod care, but are double dipping because their mistakes generate even more fat fees the second time around.

"Balderdash!" says the Disease Management Care Blog. Many Medicare inpatients are so sick that its a miracle that they get to go home in the first place.  Keeping patients in the hospital can be more life-threatening than the home environment and, when things dont get well after a discharge, its often more a function of social support than medical skill. 

That doesnt mean that CMS is going to listen to docs and back off of its Hospital Readmissions Reduction Program (HRRP). Using risk-adjusted actuarial projections, every U.S. hospital will be prone to a possible payment reduction if their observed rate of readmissions for heart attack, heart failure, and pneumonia exceeds the expected rate. Based on those projections, approximately two thirds of hospitals could be penalized.

Writing in the New England Journal of Medicine, Karen Joynt and Ashish Jha point out that hospitals are concerned because 1) readmissions fall outside of their control and 2) the actuarial projections are imperfect.  As a result, hospitals that care for the most fragile and socioeconomically disadvantaged are at risk for paying more than their fair share of CMSs $280 million claw-back penalty. 

The NEJM authors recommend three modifications to CMS HRRP:

1. Include patients socioeconomic status in any risk adjustment modeling. One easy-to-obtain modifier, for example, could be whether the patient is on Supplemental Security Income.  Patients on SSI are less able to cope, which is why they quality for the program in the first place.

2. Include hospitals mortality rates in any risk adjustment modeling.  Hospitals with special expertise are less likely to have borderline patients die on their inpatient services, which means theyll have their more than their fair share of fragile survivors.

3. Limit the penalty to readmissions that occur within hours or days of a discharge, instead of the current problematic policy of counting any readmission that occurs within 30 days.  It makes sense to believe that a premature discharge or slipshod discharge planning is at fault if the patient returns within 3 days instead of three weeks.

Since its unlikely that HRRP program is going away, the DMCB agrees with the three recommendations.  In the meantime, it also suggests:

1. CMS should be held accountable by Congress to execute well on the program,

2) Claims analytics - possibly using a "Big Data" approach - should be applied to Medicare claims to examine whether hospitals are turning to two potential options to undermine the program:

a) gaming the system by altering how they "code" the billing for their readmission patients, or

b) accepting the penalty because of favorable income from readmissions.

Image from Wikipedia

"I need to call someone..."

The Disease Management Care Blog apologizes in advance for a long post about an important study comparing two state-of-the-art weight loss interventions.  Get some caffeine and hang in there.  If you are interested in the science of disease management and its role in obesity, you will not be disappointed.

Talk to some of the Ayatollahs dominating the academic medical-industrial complex about telephonic disease management and theyll give you the same look that they give to something unsightly that they just discovered on the end of their finger after rubbing their nose.  The idea that some remote (ugh!), telephone-based (bleh!) for-profit (yuck!) company could contribute anything to their vision of the health delivery is health policy apostasy.

But what how does this ideology stack up against the evidence?  

Until recently, we haven’t really known because there were few head-to-head comparisons of traditional “disease management” vs. traditional patient counseling.  But now we have the just-published POWER (“Practice-based Opportunities for Weight Reduction” study that was funded by the NHLBI and (whoa!) Healthways.  The authors were from Johns Hopkins University, which has a long-term consulting agreement with Healthways. They had final say on the research methodology and the papers contents.

POWER was a prospective clinical trial that randomly assigned patients to one of three weight loss intervention strategies.  One consisted of “remote” telephonic treatment counseling, the second provided in-person counseling and the third was a control group.  The in-person sessions were provided by Johns Hopkins employees while the remote telephone counseling was provided by Healthways.

Study patients with obesity and at least one risk factor (hypertension, hyperlipidemia or diabetes) were recruited from six Baltimore primary care practices from 2008 through 2009.

All the interventions used basic nutritional and exercise guidelines that were delivered with state-of-the art “social cognitive theory,” "behavioral self-management,” “positive reinforcement” and “motivational interviewing.” Both of the intervention groups had access to a web site with learning modules plus feedback. If there was no log-on to the web site every 7 days, patients were sent a reminder email. 

Persons in the disease management-style remote support arm of the study got 12 weekly calls lasting 20 minutes for three months, which was followed by 3 monthly calls.   Persons assigned to the traditional in-person coaching arm got nine group sessions and three individual sessions over the 3 months followed by one group and two individual monthly sessions over three months. 

Participants’ weight loss was assessed at 6 and 24 months.

The patients primary care physicians received summary reports and encouraged their patients’ participation.

Readers should note that this was an “effectiveness” trial.  Unlike “efficacy” trials, the protocol dispensed with the usual run-in period or making sure patients were adherent to the protocol before or during the study.

1370 persons were screened and 415 were randomized.  64% were women, the mean age was 54 years, 41% were black, 97% had commercial insurance and the mean BMI was a hefty 36.6.

After randomization, there was some drop out: 366 were weighed at 6 months, 355 at 12 months and 392 at 24 months. 

At 6 months: the control group lost 1.4 kilograms (kg) while there was 6.1 kg lost in the remote support, and 5.8 kg. lost in the in-person group.  Thats 3.1 lbs vs. 13.4 lbs vs. 12.8 lbs.

At 24 months, the weight loss .8 kg in the control, 4.6 Kg in remote support and 5.1 Kg for in-person.  Thats 1.8 lbs, 10.1 lbs and 11.2 lbs. That translates to body weight changes of 1.1%, 5.0% and 5.2%.  The percent of persons hitting at least 5% weight loss was 18.8% in the control group, 41.4% in the in-person support group and 38.2% in the group getting remote support. 7.8% of controls, 27.5% and 18.8% of controls, remote and in-person support patients, respectively, reached a BMI less than 30  

There was no statistically significant difference in weight loss outcomes between the two intervention groups.  In other words, the small changes between the disease management and in-person counseling could have been the result of chance.

What can readers conclude?

1.  This was a solidly performed study with important implications for a still-evolving national strategy in the battle against obesity.  If an intervention can lead approximately 40% of persons to lose 5% of their weight over two years, maybe the science of non-invasive weight reduction has gotten to the point where insurers should cover it.  While the DMCB remains suspicious about “mandates” and “the minimum benefit,” there are other policy levers that could be pushed to make this happen.  This is doubly true when you think about the costly alternatives of drugs and weight loss surgery.

2.  Seen through the lens of a disease management vs. in-person counseling competition, the industry’s “best” (Healthways) went toe to toe with the health system’s best (Johns Hopkins) and it was a tie.  When it comes to weight loss, it now comes down to who can do it cheaper and who can scale it.

3.  While this was a solid study, readers should be aware of its imperfections.  Since there were so few patients on Medicare or Medicaid, we dont know how this would work in patients with public insurance. This was not double blinded, so it’s possible that the outcomes were skewed because patients and their doctors were aware of their assigned treatment arm. The drops-outs weights went unmeasured and their data could have changed the results.  There was a high reliance on group sessions in the "in-person" arm of the study, which may not be as effective as one-on-one counseling. The in-person sessions were also “remote” from the PCPs’ offices and may have been a poor substitute for the one-on-one counseling envisioned for a robust PCMH.  Successful weight loss is usually defined at 10% of body weight at one year instead of 5% at 2 years.  It’s also difficult to discern the relative contribution of the web site vs. the physician support vs. the nurse counseling.  We don’t know what happened to the patients’ blood pressure, cholesterol levels or their blood glucose control.  Finally, Hopkins had a doubtful but potential conflict of interest in a study that showed non-superiority vs. one of their customers.

4 While the DMCB doesn’t want to quibble, close scrutiny of the p-values in a table comparing the percent of persons reaching a BMI less than 30 for the in-person vs. remote support cohorts shows that it came quite close to being statistically significant at p = .07.  In other words, Healthways (27.5%)  almost beat Johns Hopkins (18.8%).  Using the same criteria in this study widely hailed as proving that Group Health’s medical home saves money, Healthways did beat Johns Hopkins.

5  Healthways deserves kudos for submitting to and committing resources to a clinical trial.  To the DMCB, the search for scientific truth is a price of doing business.  Their shareholders may think that cash is better spent on pursuing customers or driving efficiencies, but this research is an investment that will yield returns over the long run.  Other for-profits "get it" and so does Healthways.  The only question is why isnt this spashed on the companys web site?

6  If both interventions are equivalent, the DMCB suggests that they are not necessarily exclusive.  A truly enlighted approach to this would be to let patients choose which form of counseling they per.  Whats more, if patients were allowed to choose, the amount of weight loss for both groups would probably be even greater.

7. Last but not least, this is further evidence that "disease management" has grown up.  This "DM Ver 2.0" is based on far more sophisticated principles of behavior change than those used in the Medicare Health Support debacle.  Whats more, this Johns Hopkins paper reminds us that physicians, in the course of routine patient encounters, are simply not an option when it comes to weight loss counseling.  Theyre too busy and their job is to provide a supporting role.

"POWER" - one more acronym and one more piece of evidence to use in defense of disease and population-based care management.

In a randomized trial that included nearly 15,000 male physicians, long-term daily multivitamin use resulted in a modest but statistically significant reduction in cancer after more than a decade of treatment and follow-up, according to a study appearing in JAMA. The study is being published early online to coincide with its presentation at the Annual American Association for Cancer Research Frontiers in Cancer Prevention Research meeting.

"Multivitamins are the most common dietary supplement, regularly taken by at least one-third of U.S. adults. The traditional role of a daily multivitamin is to prevent nutritional deficiency. The combination of essential vitamins and minerals contained in multivitamins may mirror healthier dietary patterns such as fruit and vegetable intake, which have been modestly and inversely associated with cancer risk in some, but not all, epidemiologic studies. Observational studies of long-term multivitamin use and cancer end points have been inconsistent. To date, large-scale randomized trials testing single or small numbers of higher-dose individual vitamins and minerals for cancer have generally found a lack of effect," according to background information in the article. "Despite the lack of definitive trial data regarding the benefits of multivitamins in the prevention of chronic disease, including cancer, many men and women take them for precisely this reason."

J. Michael Gaziano, M.D., M.P.H., of Brigham and Womens Hospital and Harvard Medical School, Boston, (and also Contributing Editor, JAMA), and colleagues analyzed data from the Physicians Health Study (PHS) II, the only large-scale, randomized, double-blind, placebo-controlled trial testing the long-term effects of a common multivitamin in the prevention of chronic disease. The trial includes 14,641 male U.S. physicians, initially age 50 years or older, including 1,312 men with a history of cancer at randomization, who were enrolled in a multivitamin study that began in 1997 with treatment and follow-up through June 1, 2011. Participants received a daily multivitamin or equivalent placebo. The primary measured outcome for the study was total cancer (excluding nonmelanoma skin cancer), with prostate, colorectal, and other site-specific cancers among the secondary end points.

PHS II participants were followed for an average of 11.2 years. During multivitamin treatment, there were 2,669 confirmed cases of cancer, including 1,373 cases of prostate cancer and 210 cases of colorectal cancer, with some men experiencing multiple events. A total of 2,757 (18.8 percent) men died during follow-up, including 859 (5.9 percent) due to cancer. Analysis of the data indicated that men taking a multivitamin had a modest 8 percent reduction in total cancer incidence. Men taking a multivitamin had a similar reduction in total epithelial cell cancer. Approximately half of all incident cancers were prostate cancer, many of which were early stage. The researchers found no effect of a multivitamin on prostate cancer, whereas a multivitamin significantly reduced the risk of total cancer excluding prostate cancer. There were no statistically significant reductions in individual site-specific cancers, including colorectal, lung, and bladder cancer, or in cancer mortality.

Daily multivitamin use was also associated with was a reduction in total cancer among the 1,312 men with a baseline history of cancer, but this result did not significantly differ from that observed among 13,329 men initially without cancer.

The researchers note that total cancer rates in their trial were likely influenced by the increased surveillance for prostate-specific antigen (PSA) and subsequent diagnoses of prostate cancer during PHS II follow-up starting in the late 1990s. "Approximately half of all confirmed cancers in PHS II were prostate cancer, of which the vast majority were earlier stage, lower grade prostate cancer with high survival rates. The significant reduction in total cancer minus prostate cancer suggests that daily multivitamin use may have a greater benefit on more clinically relevant cancer diagnoses."

The authors add that although numerous individual vitamins and minerals contained in the PHS II multivitamin study have postulated chemopreventive roles, it is difficult to definitively identify any single mechanism of effect through which individual or multiple components of their tested multivitamin may have reduced cancer risk. "The reduction in total cancer risk in PHS II argues that the broader combination of low-dose vitamins and minerals contained in the PHS II multivitamin, rather than an emphasis on previously tested high-dose vitamins and mineral trials, may be paramount for cancer prevention. … The role of a food-focused cancer prevention strategy such as targeted fruit and vegetable intake remains promising but unproven given the inconsistent epidemiologic evidence and lack of definitive trial data."

"Although the main reason to take multivitamins is to prevent nutritional deficiency, these data provide support for the potential use of multivitamin supplements in the prevention of cancer in middle-aged and older men," the researchers conclude.