Posts Tagged ‘AHRQ’

Time Sensitive: AHRQ Requests Comments on Obesity Tx in Medicare

March 10th, 2014

The federal Agency for Healthcare Research and Quality (AHRQ) has issued a draft topic refinement document on therapeutic options for obesity in the Medicare population. The Medicare population includes those over 65 years of age and are ruled disabled by the Social Security Administration.

The draft lists key questions such as “what is the comparative effectiveness of interventions that are intended to improve outcomes by reducing obesity?” “How well does treatment-induced reduction in BMI predict obesity-related outcomes?” Comments are open until March 20, 2014.

Click here for more information.

 

AHRQ: Policy-based non-evidence evidence?

June 17th, 2013

 

Summary: Preventing weight gain among adults is a national health care priority. So I read with interest a recent AHRQ effectiveness review which found scant evidence of any strategy to prevent weight gain working. AHRQ went on to conclude that, “there was no evidence that not adopting a strategy to prevent weight gain is preferable.” In addition, contrary to the implication, AHRQ reviewers did not look for evidence when or if weight gain might be desirable. They seemed to put in that conclusion to buttress the Healthy People 2020 policy goals. AHRQ’s reviews are meant to inform policy; not for policy to spin research reviews. Here’s the story.

Now I concede to no one my respect for the Agency for Healthcare Quality and Research (AHRQ).  I have always felt they were a very reliable source for objective evaluations of research data, often used to drive policy. In fact their mission includes the goal to “Improve health care outcomes by encouraging the use of evidence to make informed health care decisions.”

I believe we have their literature reviews and assessments some twenty times or more on this site. When policy-makers say a recommendation is “evidence-based” they usually mean an AHRQ review of the literature supports it. And AHRQ likes it that way.

Recently AHRQ published Strategies to Prevent Weight Gain Among Adults, one of a series of Comparative Effectiveness Reviews, developed by the Johns Hopkins Evidence Based Practice Center,

This review examined 58 publications from 51 studies on maintenance of weight or prevention of weight gain among adults involving over a half-million patients. Studies targeting a combination of weight loss with weight maintenance or weight loss exclusively were considered outside the scope of the review. Studies had to have at least one year of follow-up with a weight outcome.

The results,given the billions of dollars invested by governments at all levels and by private companies and individuals, are pretty grim. Only two interventions were found to have moderate strength evidence of effectiveness. The first was a workplace intervention involving both individual diet and physical activity with environmental intervention that resulted in significant and meaningful prevention of BMI increases at one year and weight gain at 24 months compared with no intervention. The second intervention involved aerobic and resistance exercise performed at home by women with cancer compared to no intervention.

Additional analysis revealed, “Potentially effective interventions with low strength of evidence include a clinic-based program to teach heart rate monitoring, a combination intervention for mothers of young children, small group sessions to educate college women, and physical activity among individuals at risk of cardiovascular disease and diabetes. Potentially effective approaches described in observational studies having low strength of evidence include eating meals prepared at home among college graduates and less television viewing among individuals with colorectal cancer. When reported, adherence to interventions tended to be below 80% percent. There were no adverse events among the few trials that reported on adverse events. Trial study quality tended to be poor due to knowledge of the intervention by the study personnel who measured the weight of the participants or lack of reporting on this item. This lack of blinding the outcome assessor along with inclusion of studies that were not designed to prevent weight gain resulted in a low strength of evidence for the majority of comparisons.”

The authors conclude, “The literature provides some, although limited, evidence about interventions and approaches that may prevent weight gain. Although there is not strong evidence to promote a particular weight gain prevention strategy, there is no evidence that not adopting a strategy to prevent weight gain is preferable.”(Emphasis in original.)

I must admit to a certain whiplash reading that last sentence. ‘No evidence on not adopting a strategy?’  On the critical national issue of prevention of weight gain, limited evidence that anything works but “no evidence” that not doing something is better? Eh?

  1. So, my first question was, “Did they look for evidence of ‘not adopting a strategy”?

Well, yes and no. Yes: they had excluded from their review studies involving three classes of patients in whom strategies preventing weight gain are commonly not recommended: (a) pregnant women, (b) patients with wasting diseases, such as cancer, HIV/AIDs, eating disorders, and, (c)  lean persons with a BMI of 18.5 kg/m2 or less. See inclusion and exclusion criteria. So, they knew strategies to prevent weight gain were not ‘preferable’ for these rather sizeable groups. (FYI, weight loss for cancer patients is a current research issue in the cancer field, see Downey Obesity Report, May 5, 2012.

But also the answer was No. They did not look for other categories for whom prevention of weight gain might not be indicated. The description of the review states, “We aimed to compare the effectiveness, safety, and impact on the quality of life of strategies to prevent weight gain among adults. Self-management dietary, physical activity, orlistat and combinations of these strategies were considered.” The reviewers developed six Key Questions. By starting with the strategies, as opposed to asking, “For whom is prevention of weight gain contra-indicated?” they missed some key groups.

A quick search of PubMed revealed several, rather sizeable groups, such as:

Older women, one study found higher fat mass was associated with better survival.

The frail elderly, for whom weight loss may be associated with adverse outcomes. (In one study, weight loss among elderly Mexican Americans was shown to predict death. Of those who had lost 5% of weight, 28% died, compared to 19.7% whose weight had remained stable and 15.2% of those who gained weight after 5 years.) See also, The danger of weight loss in the elderly.

Patients with COPD, for whom weight loss is a significant driver of costs and mortality. Overweight and obesity is protective of mortality in patients with COPD.

Patients with Cystic Fibrosis for whom higher BMI is associated with improved lung function.

Patients with Parkinson’s Disease for whom weight loss reduces quality of life.

Nursing Home Patients for whom weight loss can be an indicator of dysphagia, depression and malnutrition.

Patients with psychiatric disorders for whom weight loss is often contraindicated because of low adherence to program protocols and because many anti-psychotic drugs cause weight gain. (However, there are studies and views to the contrary,  see http://well.blogs.nytimes.com/2013/04/15/a-battle-plan-to-lose-weight/)

Patients with ALS who have a high risk of malnutrition as well as patients with multiple sclerosis.

Patients hospitalized with pneumonia for whom obesity is associated with better short term survival.

The point is not when weight gain should be avoided or when overweight or obesity is protective. The point is that contrary to AHRQ’s conclusion that “there is no evidence that not adopting a strategy to prevent weight gain in preferable” (Emphasis in original), there is ample preliminary evidence, at least, that, in significant populations, not adopting a strategy to prevent weight gain is not only preferable, it may be protective.

  1. Is there a problem with recommending pursuit of weight prevention strategies which are likely to be futile?

Well, there are several problems on both an individual and societal level.

With repeated weight loss attempts, weight gain is likely to follow. Dr. N. John Bosonworth argued in 2012 article that, “sustained weight loss is achieved by a small percentage of those intending to lose weight. Mortality is lowest in the high-normal and overweight range. The safest body-size trajectory is stable weight with optimization of physical and metabolic fitness. With weight loss, there is evidence for lower mortality in those with obesity-related comorbidities. There is also evidence for improved health-related quality of life in obese individuals who lose weight. Weight loss in the healthy obese, however, is associated with increased mortality.” He advises weight loss only for those with obesity-related comorbidities.

Ross and Janiszewski, among others, argue that exercise, independent of weight loss, is preferable as a strategy to reduce cardiovascular disease risk. Indeed, one recent study out of Europe of over 250,000 men and women found that high levels of physical activity reduced waist circumference in both men and women, reducing the odds of becoming obese by 7% and 10% respectively.

Perhaps more importantly (to me at least), the statement that “Although there is not strong evidence to promote a particular weight gain prevention strategy, there is no evidence that not adopting a strategy is preferable,” is a tortured linguistic effort to continue to blame individuals for their personal failure to avoid weight gain, even though the recommendations of the experts have failed. This is simply a perpetuation of stigma without evidence from the federal agency whose raison d’etre is evidence-based conclusions. That such personal blame and stigmatization is harmful and counterproductive is now beyond conjecture.

(As a point of personal privilege, I have to note that I have observed over the years that, when strategies proposed by ‘experts’ in the field run aground (rather predictably I might add) the blame falls on the persons who are overweight or obese whose lack of adherence or whose hedonistic tendencies are seen as undercutting the recommendations of the professional. I cannot recall one instance where reviewer(s) concluded that the recommendations might be wrong or at least should be re-evaluated.)

For many years a chorus of critics have seen a sinister conspiracy between the government and weight loss industry. According to their view, the conspiracy promotes an unrealistic and unattainable body image goal on the public, especially on women and young women, leading to obsessive attention to fatness in the society. In turn, this can lead to dangerous or ineffective weight loss efforts, body image dissatisfaction and loss of self-esteem. (This concern receives passing acknowledgement in a single paragraph on p.120 of the review.)

Unfortunately, the conspiracy theorists might find support in this review. Who benefits, they could well ask,  from pursuit of ineffective weight prevention strategies? Not the person trying to prevent weight gain. The review already established that no particular strategy is particularly effective. So, pursuing some strategy only can mean the transfer of time but mainly money to programs, services or products to assist in the weight gain prevention effort and the diversion of such time/money away from other activities, which might be more useful to the individual or society, such as expanding one’s education, time caring for children or one’s parents, volunteering at schools, nursing homes, etc.  As we have seen with the debate over employer wellness programs, more and more employers are imposing sizeable financial penalties on workers who fail to achieve a weight maintenance target or weight loss goal which could be up to 30% of one’s individual or family health insurance premium. (See Downey Obesity Report.) So the costs of the loss or prevention activity can be substantial and the cost of failure can be substantial as well.

Finally, there is the issue of the credibility of the country’s public health authorities and confidence in their recommendations, that when they say there is “no evidence” it is fair for readers to assume they looked for evidence and found none.

I emailed one of the authors. I wrote, “On reflection, it seemed that there were a number of plausible reasons why not adopting a strategy for some individuals might be reasonable, e.g. diversion of time and money from a potentially more productive area into a less productive area for one. Likewise, on a societal level, some might argue that the attention to preventing adult weight gain diverts public and private funding into largely futile areas, contributes to anti-fat attitudes, eating disorders, etc. It may also be thought to contribute to the idea that preventing weight gain is relativity easy and failure to do so reflects a character flaw, thus diverting funding from research on prevention in adults into programs.On looking over the review, I couldn’t see where this issue was a key question or was part of the study design. So I was wondering how this conclusion was reached. Could you let me know?”

The author admitted, “We did not specifically examine whether weight gain prevention should be attempted or not. I think that the statement at the end of the report that you refer to is trying to reflect the national priorities regarding preventing weight gain set forth in Healthy People 2020 in light of the obesity epidemic. (Emphasis added.) There are potential pros and cons with supporting weight gain prevention. You have listed out several potential cons in your email, but I do think that we need to weigh them against the potential benefits such as reduction of or improved control of weight-related conditions like hypertension, diabetes, joint pain, etc. that cause substantial morbidity in our country. Since we do not have good evidence that any particular program successfully leads to weight gain prevention, we cannot really know yet whether these programs lead to benefits or harms.

Ultimately, I think the take away from the report is that we need to do more research to better understand how best to prevent weight gain, and to determine what are the benefits and harms of successful weight gain prevention programs. Such information might make it easier to understand whether this should continue to be a national priority.”

Fair enough, but that’s not what the review’s conclusion states. Supporting Healthy People 2020 is not AHRQ’s job. While we are not even half-way between Healthy People 2010 and Healthy People 2020, we know that the adult population with obesity is increasing and the adult population at normal weight is decreasing. This might be reversed but there are not any secular trends out there providing much hope.

At some point in the near future, a policy-maker (or the head of a supermarket chain) is going to point to this report as ‘evidence’ that preventing gaining weight is achievable and everyone can do it. AHRQ cannot control how their reports are used. But they need to keep straight that their evidence is meant to inform policy decisions; not that policy decisions should spin evidence reports.

Recently, Francis Collins, Director of the National Institutes of Health and Griffin Rogers, Director of the National Institute on Diabetes, and Kidney Diseases stated in an article, The next generation of obesity research: No time to waste:

Americans spend more than $60 billion annually on weight-loss programs and products, yet scant evidence exists that these expenditures translate into lasting weight loss. Given the health consequences of obesity, the United States needs rigorous data on what approaches can help achieve and maintain healthy body weights over the long term.

Indeed, research has provided—and will continue to provide—the foundation of evidence needed to confront the obesity crisis in the most effective and efficient manner. Among the many questions to address are: Why are some individuals more susceptible to obesity? Can the knowledge of biology and behavior be used to develop and better target intervention strategies? What current strategies really work? For whom? Can these approaches be scaled up?

To address this need, research must proceed swiftly on 2 parallel fronts. The first is to devise practical and effective strategies for intervention, with special emphasis on preventive strategies that can be rapidly implemented in health care and community settings.

Likewise, in 2011, Luckner, Moss and Gericke wrote, “responding to the obesity epidemic requires robust evidence to help prioritize the allocation of scarce resources to preventive interventions.”

In this critical area, AHRQ needs to stick to the rigorous evaluation of scientific studies; not engage in buttressing failing public policies.

 

 

Bariatric Surgery for low BMI Evaluated

June 12th, 2013

The Agency for Healthcare Research and Quality has issued a Comparative Effectiveness Review on “Bariatric Surgery and Nonsurgical Therapy in Adults with Metabolic Conditions and a Body Mass Index of 30.0 to 34.9 kg/m2

Bariatric surgery is standard medical practice for patients with a BMI of 40 kg/m2 or for patients with a BMI between 35 and 40 kg/m2 who have significant comorbid conditions, such as type 2 diabetes. In recent years, there has been considerable discussion around providing bariatric surgery for patients with a BMI between 30 and 35 kg/m2 for type 2 diabetes and other metabolic conditions.

The reviewers for AHRQ concluded, “According to blood glucose outcomes, there is moderate strength evidence of efficacy for RYGB (Roux-en-Y Gastric Bypass), LAGB (Laparoscopic adjustable Gastric Banding), and SG (Sleeve Gastrectomy) as treatment for diabetes and IGT (impaired glucose tolerance) in patients with a BMI between 30 kg/m2 and 35 kg/m2 in the short term (up to 2 years). The strength of evidence for BPD (biliopancreatic diversion with duodenal switch) is rated low because there are fewer studies, and these have smaller sample size. Evidence on comparative effectiveness of surgical procedures is insufficient. Short-term adverse events are relatively minor; strength of evidence is low due to small sample size with low power to detect rare events. Strength of evidence is insufficient regarding adverse events in the long-term (2 years or more postsurgery). Longitudinal studies of bariatric surgery patients are needed to assess overall safety and comparative effectiveness regarding diabetes-related morbidity such as kidney failure and blindness.”

 

Employer Wellness Issue Heats Up

May 20th, 2013

The Equal Employment Opportunity Commission (EEOC) held a long hearing on May 8, 2013 on employer wellness programs. Opponents made a strong case that there was virtually no way that a mandatory health-contingent wellness plan could not discriminate against protected classes of workers. (See statement of Judith Lichtman) On the other hand, the more pro-business representatives argued that Congress and the Administration supported the changes in the Affordable Care Act and the programs where here to stay. It seems that all parties are urging the EEOC to provide guidances to employers.

The testimony came amid a backdrop of waiting for the final regulations from the Obama Administration. The comment period closed in January and many were expecting we would have final regulations by now. Politico reported that a group of corporate CEOs with the Business Roundtable were in Washington recently to lobby the Administration to avoid further weakening of the regulations.

Forbes magazine was reporting the CVS-Caremark was penalizing workers $600 annually if they failed to complete a health risk assessment. The article noted that most companies did not provide such stiff penalties but many were moving in that direction.

Meanwhile, several research articles provide only lukewarm support for weigh loss employer wellness programs.

A Health Affairs article by Ron Goetzel and colleagues, found only 22 % of employer health care costs could be attributed to 10 modifiable health factors (including obesity). This is actually a drop from 24.9% in 1998, even though rates of obesity have increased and costs related to obesity have gone up. Obesity contributed the most excess costs at $347 per capita. Goetzel, Pei, et al,

Another recent paper was a longitudinal study at the worker productivity in terms of absenteeism, presenteeism and job performance associated with changes in 19 modifiable well-being risks. These included physical health risks, health behavior risks, social and emotional health risks work-related risks and financial health risks.  The researchers found that, “Obesity, high cholesterol, tobacco use and excessive alcohol generally contributed to productivity changes insignificantly or unfavorable, possibly because of its multicolinearity with other risks that are closely correlated.” However, they noted that, “Health-related risk explained only a portion of the total productivity variances. For example, Riedel et al found that health risks accounted for 7.8% of the total variance in productivity impairment and acknowledged that the majority of the variation was left unexplained. Lenneman et al also found only 8.5% of the variance in productivity was contributed by health risks…We found that reductions in work-related well-being risks and financial health risks significantly contributed to improvement in productivity measures especially for measures of presenteeism and job performance that were not attributable solely to the more narrow definition of physical health.” They found modest numbers of workers were able to make improvements: 25% reduced their physical health risks 26% improved their health behaviors 16% improved their social and emotional health, 31% improved their work-related risks and 13% their financial health risks. Improvements in absenteeism, decrease in presenteeism and a modest improvement in job performance accompanied such changes. They calculated these improvements were equivalent to a savings of $468 per person per year. Shi, et al.

Ted Kyle reports in his blog that one program, Healthy Blue Living, requires obese participants to wear a pedometer which uploads their physical activity to the employer wellness program. The employees must meet daily step goals if they want to keep full health benefits. Not doing so could cost them each $2000 a year. Kyle notes (and I strongly agree) that this constitutes human experimentation without the protection of the federal regulation protecting human subjects, 45 Code of Federal Regulations Part 46. In fact, the program is not that successful. Promotional material notes that only 16% who agreed got their weight under a BMI of 30.

Yet another study published in Health Affairs looked at one hospital system’s wellness program. The program provide a substantial incentive/penalty for participation in a health risk assessment (which included automated feedback) signing a health pledge, health fairs and physician referrals. The study found a significant reduction in hospitalizations for conditions related to the conditions covered by the wellness program. However, there was an increase in medication costs. Combined with the costs of the wellness program and incentives, the authors concluded, “It is unlikely that the program saved money.” Gowrisankaran G, et al. A Hospital System’s Wellness Program Linked to Health Plan Enrollment Cut Hospitalizations But Not Overall Costs, Health Affairs 32 (3) 2013; 477-485. Gowrisankaran

A second paper also published in Health Affairs reviewed randomized controlled trials of workplace wellness programs. Their review raises doubts the employees with health risk factors such as obesity and tobacco use spend more money on medical care than others. They concluded that workplace wellness programs show little evidence of saving costs through health improvements without being discriminatory.  To test the assumptions of workplace wellness programs the authors, “reviewed research on the relationships among financial incentives, behavior, health status, and medical spending. We focused on randomized controlled trials involving four conditions- smoking, hypertension, high cholesterol and obesity- that are typically included in health-contingent programs. In our review, we found mixed evidence that employees with these conditions have higher health costs than other employees, which undermines the argument that employees with the conditions are particularly effective targets for incentives. We also found little evidence that working-age people change their behavior as a result of financial incentives, particularly over the long term. These findings suggest that program savings many not, in fact, derive from health improvements. Instead, they may come from making workers with health risks pay more for their health care than workers without health risks do. If true, this conclusion would jeopardize long-standing regulatory efforts, maintained in recently proposed Affordable Care Act regulations to prevent workplace wellness from being “a subterfuge for underwriting or reducing benefits based on health status. (citations omitted) Since low-income workers disproportionately suffer from conditions typically targeted by health-contingent programs, savings arising outside of health improvement may entail hidden, regressive redistributions increasing the burden imposed on low-income workers. “

In effect, they point out, wellness plans shift costs with the most vulnerable employees, those from low income groups with the most health risks probably subsidizing the healthier workers. Horwitz, JR, Kelly, BD, DiNardo, JE, Wellness Incentives in the Workplace: Cost Savings Through Cost Shifting to Unhealthy Workers, Health Affairs, 32 (3), 2013:468-476. Horwitz

The Agency for Healthcare Research and Quality (AHRQ) has issued another independent review. This time they reviewed studies of strategies to prevent weight gain in adults. The reviewers looked at 51 trials involving 555,783 subjects with at least one year of follow-up and a weight outcome. A meaningful difference between groups was considered to be 0.5 kg of weight (1.1 pound) or 1 cm of waist circumference. They found moderate evidence that workplace programs for the prevention of weight gain in adults. One study combining diet, physical activity and environmental components resulted in meaningful and statistically significant prevention of BMI change at 12 months and another that combined internet based diet and physical activity counseling resulted in significant prevention at 24 months. However, a third study found no difference. AHRQ Strategies to Prevent Weight Gain Among Adults, Comparative Effectiveness Review No. 97, AHRQ

Also cited as, Gudzune K et al Strategies to prevent weight gain in workplace and college settings: A systematic review, Prev Med. 2013 Mar 22. Gudzune

 

Obesity Related Hospitalizations Soar

December 4th, 2012

Obesity-related hospitalizations have tripled from 1996 to 2009. In 2009, there were approximately 2.8 million hospital stays for which obesity was either a principal or secondary diagnosis. The share of obesity-related hospitalizations increased from 3% of all stays (excluding infants and maternal) in 1996 to more than 9% of all stays in 2009. Hospitalizations in which obesity was the principal diagnosis increased 13-fold from 10,100 in 1996 to 132,900 in 2009.  Hospitalizations in which obesity was the secondary diagnosis increased from 766,600 in 1996 to 2,716,200 in 2009, a 3.5 fold increase.

Mean cost per stay for hospitalizations with obesity as a secondary diagnosis compared to no-obesity relationship was 9% higher in 2009 over 2004. Overall, hospital stays with any mention of obesity accounted for $33.4 billion (10.2%) of aggregate hospital costs in 2009.

The most common procedure for which obesity was the principal diagnosis was bariatric surgery, which was unchanged from 2004.

The most common procedure for which obesity was the secondary diagnosis was osteoarthritis, increasing by 27% from 2004. Coronary atherosclerosis was the most common principal diagnosis accounting for 6.8% of all stays in 2004. It decreased 37% to become the third most common diagnosis in 2009. Chronic obstructive pulmonary disease and bronchiectasis increased 34%, rising from the 14th most common procedure to the eighth.

The report is based on HCUP database, sponsored by the Agency for Healthcare Research and Quality. AHRQ: Adult Obesity Hospitalization Statistical Brief 137

 

House Republicans to Eliminate AHRQ

July 19th, 2012

July 18, 2012 Politico reports that House of Representatives Republicans are proposing to cut funding for the Agency for Healthcare Research and Quality (AHRQ), a key federal health services funding agency responsible for the US Preventive Services Task Force (USPSTF) and comparative effectiveness research. https://mail.google.com/mail/u/0/?tab=wm#search/Politico/1389a4a9d8fbca7e

Updated AHRQ Recommendations

June 25th, 2012

The US Preventive Services Task Force has issued new recommendations for clinical diagnosis and treatment of adult obesity. 12 to 26 sessions in the first year can help people manage their weight.” While obesity and encouraging healthy lifestyle choices are related health issues, Dr. Grossman emphasized that the Task Force issued two separate recommendations. He explained, “The Task Force’s obesity screening recommendation focuses on offering or referring obese patients to comprehensive weight management programs. This recommendation is intended to improve all health outcomes, and not only risks for cardiovascular disease. The healthy lifestyles recommendation focuses only on counseling to encourage healthy lifestyle choices to prevent cardiovascular disease.”

In a separate recommendation, the Task Force determined that for people who have low risk for heart disease, counseling to encourage healthy lifestyle choices, such as a healthful diet and physical activity, offers only small benefits in reducing the risk for cardiovascular disease.

The Task Force also stated that this counseling may be beneficial to some people, depending on their individual risk factors, including known cardiovascular disease, high blood pressure, and high cholesterol.

See the Clinical Statement AHRQ_USPSTF_ Adult obesity

And the Evidence Support: http://www.uspreventiveservicestaskforce.org/uspstf11/obeseadult/obeseart.htm

In a separate paper, the USPSTF did not recommend counseling for cardiovascular disease, finding weak evidence for behavioral counseling for diet and physical activity in primary care. Annals: USPSTF recommendation on counseling for cvd

 

 

Comments Sought on Gestational Diabetes

June 16th, 2012

The Agency for Healthcare Research and Quality (AHRQ) has a draft document available for comment on screening and assessment of gestational diabetes. Gestational diabetes has been implicated as a factor in childhood obesity and is a serious health concern for the mother. Please take the time to review and comment. AHRQ: Draft Comments Gestational Diabetes