Evidence-based medicine

Marijuana During Pregnancy: How Should Physicians Advise Pregnant Women?

By M2|2017-10-08T11:26:51+00:00August 30th, 2017|Evidence-Based Medicine, Uncategorized|

Marijuana During Pregnancy: How Should Physicians Advise Pregnant Women?

As some states have legalized marijuana in recent years, for medical use and/or recreational use, the use of marijuana during pregnancy has also increased; almost 4% of pregnant women said they had used marijuana in the past month in 2014, compared with 2.4% in 2002, according to a recent study published in the Journal of the American Medical Association.

The New York Times recently highlighted the stories of several women who had written in about their experiences taking the drug while they were pregnant; of the “hundreds” of readers who wrote in, “most had smoked, while a few vaped or ate marijuana-laced edibles,” the article says. “Roughly half said they had used pot for a medical reason,” such as nausea or back pain.

“Most felt marijuana use had not affected their children, or were not sure; just a handful worried the children might have suffered cognitive deficits.”

However, the acceptance of marijuana has “outstripped scientific understanding of its effects on human health…Often pregnant women presume that cannabis has no consequences for developing infants. But preliminary research suggests otherwise.”

Indeed, “cannabinoids readily cross the placenta, entering the fetal circulation and brain, and higher fetal levels are seen with chronic use,” Jennifer Gunter, MD, an ob/gyn, points out in a June 2017 commentary.

“Another concern is that doses of THC [tetrahydrocannabinol, the main psychoactive ingredient] in marijuana have increased dramatically, from 4% in 1995 to 12% in 2014, with labs in Colorado reporting THC concentrations in some strains as high as 30%,” Gunter says. “Women choosing to use marijuana in pregnancy will be exposed to significantly higher doses compared with 20 years ago.” Also, “many strains that claim to be high in CBD [cannabidiol, the ingredient that may help nausea and pain] in fact contain little, if any.”

As for the various ways in which marijuana may be taken, “while women may think that marijuana concentrates and edibles are healthier because they do not involve smoking, they can still have significant and potentially harmful solvent residue from processing with chemicals such as butane,” she says.

“The endocannabinoid system is complex and not fully understood,” Dr. Gunter points out. “Animal studies show that prenatal exposure to THC, even at low doses, causes long-lasting neurologic changes among exposed progeny.” And in a recent meta-analysis of 24 studies of sufficient quality, women who use cannabis during pregnancy were found to have an “increased risk for anemia.” That study also found that “fetal exposure reduces birth weight and increases the need for neonatal intensive care unit admission.”

The American College of Obstetricians and Gynecologists (ACOG) recommends asking all women about marijuana use, Gunter notes. “Given the unsubstantiated reports of safety that women may find online, prenatal providers should be prepared to provide clear information about the safety concerns in a nonjudgmental way. It’s important that women get this information from their health providers so that they have accurate data to inform their medical decision-making. Prenatal providers should encourage women to report nausea and vomiting early and not downplay symptoms, as lack of help from traditional medicine may be one reason that women turn to marijuana.”

Gunter notes that ACOG “specifically recommends against advising marijuana use for nausea and vomiting in pregnancy. ACOG also recommends that providers help women who are using marijuana for medical reasons to find alternatives with pregnancy safety data.”

“Discussions about marijuana can be hard as the ‘safety’ of the drug seems entrenched,” she notes. “But I’ve found that many patients are receptive when I explain to them the extremely high concentrations of THC in modern strains, the often low levels of CBD despite advertising to the contrary, and concerns about solvents.”

This discussion highlights the fact that while some patients may assume that marijuana is safe and effective, and the main ob/gyn association recommends its members point patients toward prescription alternatives, the truth is we simply don’t know whether marijuana is safe or effective for pregnant women to treat symptoms such as nausea and pain.

This is yet another example of where data is lacking. What should physicians do in any situation in which there is insufficient data to make a recommendation? The answer as I see it: Admit researchers don’t have the answer yet. Although I realize this may be uncomfortable for many docs, it’s ok to say, “I don’t know.”

What the evidence suggests so far is the potential for cannabinoids to affect the brain and circulatory system of the baby in the womb. Thus, pointing out the potential risks of marijuana use during pregnancy, as noted by Dr. Gunter above, while acknowledging the overall lack of conclusive data, would seem the appropriate approach.

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Lung Cancer Screening: Who Gets To Decide?

By M2|2017-10-09T02:02:29+00:00March 10th, 2017|Evidence-Based Medicine, Uncategorized, What do we pay for and why|

Lung Cancer Screening: Who Gets To Decide?

While the U.S. Preventive Services Task Force (USPSTF) has issued recommendations on annual screening for lung cancer using low-dose computed tomography (CT), and Medicare uses similar criteria for determining coverage of lung cancer screening, a recent article in the Journal of the American Medical Association (Katki, et al.) offers a new enhanced risk-based model for determining who should undergo this type of screening.

Katki, et al., used data from the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial, the National Cancer Institute’s National Lung Screening Trial, and the 1997-2001 National Health Interview Survey to develop and validate statistical models to estimate lung cancer incidence and death.

In an accompanying editorial, Michael Gould, MD, MS, Kaiser Permanente Southern California, Department of Research and Evaluation, says the findings are “provocative and support the notion that an enhanced risk-based approach to screening is potentially more effective and more efficient than performing a risk assessment based only on age and smoking history.” (There are about nine million adults in the U.S. who meet USPSTF criteria for lung cancer screening.)

However, while this new lung cancer death model constitutes an “important contribution” to the discussion of who should be screened and when, the “overwhelming majority of patients who undergo low-dose CT screening will not benefit, even using enhanced risk assessment,” Gould says. The enhanced risk-based screening “was projected to only marginally increase the number of lung cancer deaths averted from estimates of approximately 5 per 1,000 screened” to “approximately 6 per 1,000.”

In addition, the limitations of the risk-based model include the fact that the authors “did not consider the increased risk of procedure-related complications or reduced operability that would accompany screening when performed in a population at higher risk,” he says. “For lung cancer screening to be effective, patients need to be fit enough for surgery.” And while less invasive treatments exist, they “have not yet been shown effective in the context of lung cancer screening,” Gould notes. “Thus, a valid counterargument is that the net benefit of screening is highly uncertain in populations (even high-risk populations)” that differ from those that informed the risk-based model.

Other limitations include the social dimensions; for example, given that the risk-based approach “preferentially includes more African-Americans and more individuals with lower educational attainment, compared with screening using the USPSTF criteria,” implementation of enhanced risk-based screening will “require more intensive outreach to communities that have experienced limited access to screening programs,” he says.

Looking more broadly and summarizing the current state of lung cancer screening, he notes there are now “multiple statistical models of lung cancer risk—which ones are most accurate? How does risk evolve dynamically over time?”

At issue is the fundamental question of who gets to decide about lung cancer screening.

This question will be answered differently, depending on whether we examine it from a policy perspective or from an individual patient care perspective. While policymakers are likely to focus on the trade-off in costs – in both dollars and lives – between screening efficiency and avoided deaths, “in clinical practice, the decision to screen is very personal and should be individualized for each patient,” says Gould.

One idea is to let the patient decide whether to undergo testing. Gould recommends offering lung cancer screening to high risk patients who don’t meet the USPSTF or Medicare criteria and letting the patient choose whether to be tested. However, what Gould looks past is the cost to the patient when such a choice is made. Policymakers make recommendations on what insurers should pay for, and cancer screening is a great example. There is a reason for the screening recommendations to have a cut-off value – and that reason is cost.

Letting the patient decide, also means, letting the patient pay. A more nuanced view would be to pay for lung cancer screening in some instances, but not in others. If lung cancer screening to high-risk patients is cost-effective, shouldn’t insurers cover this intervention?

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Millions of Men Screened for Prostate Cancer Despite Evidence to Stop

By M2|2017-10-09T02:06:47+00:00November 7th, 2016|Uncategorized|

Millions of Men Screened for Prostate Cancer Despite Evidence to Stop

Despite the fact that the U.S. Preventive Services Task Force (USPSTF) has recommended against using prostate-specific antigen (PSA) testing, physicians continue to use this as a method to screen men for prostate cancer in the U.S.

According to a review of data on 92 million men presented recently by Centers for Disease Control and Prevention (CDC) researcher Shahram Shahangian, Ph.D., the impact of the recommendations has been “very modest,” with a roughly 10% decline in utilization since the Task Force’s 2008 recommendation against use of PSA-based screening for prostate cancer in men younger than 50 and older than 74. (In 2012, the Task Force revised its recommendations, urging against any PSA-based screening.)

Beyond this modest overall decline in PSA-based screening, “the fact that testing continues in the older population, where there should not be any testing done, is very disappointing,” Dr. Shahangian told Medscape.

It’s interesting to note some groups believe there is still a limited role for PSA screening. For example, the American Urological Association recommends offering PSA screening to men 50 to 69 years old who have a minimum of 10 remaining years of life expectancy, as long as there is informed consent and shared decision making between the health care provider and patient.

Dr. Yair Lotan of University of Texas Southwestern’s Harold C. Simmons Comprehensive Cancer Center told Urology Times, “One of the problems is if you follow the U.S. Preventive Services Task Force recommendation against PSA screening and don’t even discuss it with patients, you are not giving your patient the important option of screening. You have to be honest about discussing the pros and cons and help inform patients about the value of PSA testing.”

Why does the U.S. health care system continue to reimburse for testing that is no longer based on the latest evidence?

When the evidence does not support a health care intervention, who should pay? When a patient is warned PSA screening is no longer recommended, as suggested by Dr. Lotan as part of shared decision making, but the patient wants the screening anyway, should they have to pay for it?

There is a relatively easy fix for this persistence of non-recommended testing; both public and private payers could simply stop reimbursing for the test. However, cases like this point to a broader question: who gets to decide whether and when a widely used and accepted practice, particularly in oncology, should no longer be paid for?

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Cardiac Rehab Programs: Yet Another Evidence-Based Intervention That Isn’t Paid For

By M2|2017-10-09T02:07:38+00:00November 7th, 2016|Evidence-Based Medicine, Social Determinants of Health, Uncategorized, What do we pay for and why|

Cardiac Rehab Programs: Yet Another Evidence-Based Intervention That Isn’t Paid For

Evidence shows cardiac rehabilitation programs –which teach patients who have had a cardiac event about exercise, diet and prescription drugs – substantially cut the risk of dying from another cardiac problem; they also improve quality of life and lower costs. But as Kaiser Health News notes, fewer than one-third of patients whose conditions qualify for cardiac rehab actually participate.

One of the main reasons for the low participation rate is cost; patients must generally pay a co-pay to participate in such programs – about $20 per session for regular Medicare beneficiaries, and anywhere from zero to over $60 per session for Medicare Advantage enrollees and those who are privately insured.

Aside from cost, other barriers include distance/travel time to the facility, lack of referrals at the time of hospital discharge, and capacity of existing cardiac rehab programs. This is particularly troubling because in spite of the increased likelihood of death within five years of a first heart attack, certain populations are less likely to be referred for cardiac rehabilitation, including women, minority populations and patients of lower education levels of socioeconomic status.

[Note to readers: I am a bit obsessed about the evidence for cardiac rehab, as well as the social determinants of health that prevent it from being routinely recommended and included it as Case 17 in the textbook I co-edited, Essential Case Studies in Public Health: Putting Public Health into Practice, published by Jones and Bartlett.]

What do we pay for, and why?
In considering innovation and value, there are frequently situations in which patients are receiving a health care service that runs counter to recommendations based on the latest evidence- clearly a waste, but politically difficult to stop, especially if it runs counter to patient or provider preferences. However, this is an example of where the evidence clearly supports reimbursing for the intervention, but the service is underutilized considering its value to the patient and the system.

As noted, this low participation rate in cardiac rehab is due in part to patients’ reactions to time requirements, but can also be blamed on health insurer cost-sharing requirements that discourage use of a valuable intervention. To be clear, studies show 25% reduction in all-cause mortality rates and 31% reduction in hospital readmissions, translating into millions in annual savings.

Medicare is inching forward with its Cardiac Rehabilitation (CR) Incentive Payment Model which pays hospitals incentive payments based on total cardiac rehabilitation use for patients in their care after a heart attack or bypass surgery. Hospitals can receive $25 per cardiac rehabilitation service for the first 11 services they provide and the payment increases to $175 per service after those first 11 services.

If the evidence shows significant reductions in adverse events and cost of care for those who participate, is it time for payers to reflect that increased value in lower co-pays? And perhaps more importantly, is it time for payers to require providers to recommend cardiac rehab for everyone who could benefit, regardless of their gender, race or income?

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