B12 for stroke prevention: an exercise in motivated reasoning

Disclosure: I am a member of the Physician Advisory Board and freelance writer for the Medical Post.

I opened my print copy of the Medical Post last month to find this, an article which attempts to make the argument that there is a link between B vitamin deficiency and stroke, and that supplementing with methylcobalamin reduces the risk of stroke.

For anyone familiar with the evidence on this topic, there is absolutely no high-quality evidence to support this claim.

Rather than write a rebuttal, I thought it would actually be clearer to do a line-by-line evaluation of each claim/study cited in the article, and to give the actual context of what the evidence actually shows.

Here we go (the article will be presented in italics):

The first major trial of B vitamins to lower homocysteine for stroke prevention was the Vitamin Intervention for Stroke Prevention (VISP) trial, published in 2004.23 It showed no benefit.

He is absolutely correct. Here’s the link to the JAMA article from 2004. 3,680 patients, multi-centre trial. No effect on vascular outcomes.

Then in 2006 the Norwegian Vitamin Trial (NORVIT) and HOPE 2 trial were published in the New England Journal of Medicine, with an accompanying editorial by Loscalzo, who suggested that the null effects may be due to high levels of unmetabolized folic acid. Following that, the cant became “homocysteine is dead.” 

The NORVIT trial was an RCT 3,749 patients looking at B vitamin supplementation and an outcome of a composite of recurrent myocardial infarction, stroke, and sudden death attributed to coronary artery disease. No benefit.

HOPE 2 randomized 5,522 patients to B vitamins or placebo and found no benefit in the the primary outcome of a composite of death from cardiovascular causes, myocardial infarction, and stroke.

Keep in mind what preceded these studies. Years of observational trials showing that  lower homocysteine levels are associated with lower rates of coronary heart disease and stroke. Folic acid and vitamins B6 and B12 lower homocysteine levels. Thus, one would think that B vitamins should reduce cardiovascular disease. But this is why we do clinical  trials, to see if treatments truly work, not just work hypothetically.

However, the HOPE-2 trial actually showed a 23% reduction of stroke, in a population with better renal function than the other two trials.

In HOPE-2, stroke was not a primary outcome, but was part of a larger composite vascular outcome. There was no reduction in the primary outcome with the intervention of B vitamins. I wish we could ask the HOPE-2 study’s authors whether they think the effect on stroke is meaningful! Oh wait, we can“With regard to the risk of stroke, we observed an absolute reduction of 1.3 percentage points and a relative reduction of 24 percent among patients assigned to the active-treatment group. However, these results must be interpreted with caution. The number of strokes in our study was much lower than the number of coronary events, the confidence intervals around the estimated risk reduction are wide, and the results are not adjusted for the multiplicity of outcomes compared. Also, we found no effect of treatment on transient ischemic attacks. From a biologic perspective, a treatment benefit restricted to stroke would be difficult to explain. Furthermore, the two other large trials of homocysteine-lowering vitamins that have been completed did not show a beneficial effect of treatment on stroke. Therefore, we believe that the apparent beneficial effect of B vitamin supplements on stroke in our trial may represent either an overestimate of the real effect or a spurious result due to the play of chance.” I guess they weren’t impressed either.

An analysis of the VISP trial excluding participants with impaired renal function showed a 34% reduction of stroke/MI/cardiovascular death comparing high-dose vitamins among persons who could absorb B12 well versus low-dose vitamins in persons with lower B12 levels at baseline.

This can be described as “torturing the data until it confesses”. They took the original VISP data, then did a subsequent analysis of whether looking only at normal renal function patients AND excluding those with high and low B12 vitamin levels would result in a lower stroke risk. Doing post-study analyses like this are potentially hypothesis-generating, but cannot be seen as reliable to guide clinical practice.

The French Su.Fol.OM3 trial, in a population with even better renal function and a lower dose of B12 (only 20 mcg daily), reported a 43% reduction of stroke. 

Here again, the primary outcome was major cardiovascular events, defined as a composite of non-fatal myocardial infarction, stroke, or death from cardiovascular disease. No benefit was seen in that primary outcome. Now as for that secondary outcome of stroke, I wonder what the authors had to say….why look at that! They did address it! “In our trial, allocation to B vitamins was associated with a 46% reduction in the risk of ischaemic stroke among patients assigned to B vitamins and a trend towards increased cardiovascular mortality, with an unexpected, significant increase in the number of deaths from any cause among patients receiving B vitamins (not specifically linked to cancer). The latter two results must be interpreted with caution, since the number of statistical tests performed on secondary end points was large and the number of events was small, and the confidence intervals around the relative risk estimates are wide.” I cannot say enough about the humility and academic honesty of the authors of these major trials, and it is truly an example of the peer review process working well. Consider how dangerous it would be for researchers to be claiming that every secondary outcome measure is indeed evidence in favour of treatment. Our clinical lives would be chaos with the degree of medical reversal that would ensue with subsequent trials showing conflicting results.

Then in 2010, we reported significant harm from B vitamins including 1,000 mcg/day of B12 (cyanocobalamin) among patients with diabetic nephropathy. Decline in renal function was accelerated by high-dose vitamins, and cardiovascular events were doubled. In 2011 Stampfer and I hypothesized that harm from cyanocobalamin among participants with renal impairment cancelled out the benefit of B vitamins among participants with good renal function.

The JAMA study from 2010 did indeed show that in patients with diabetic nephropathy, B vitamins worsened both eGFR and vascular outcomes. But to assert that somehow implies that B vitamins would thus reduce vascular risk in those without renal disease? There is simply no logic there. Replace B vitamins with NSAIDs. In patients with diabetic nephropathy, NSAIDs are certainly known to worsen both eGFR and vascular outcomes. Following his logic, in patients without renal disease, NSAIDs would then reduce vascular outcomes? That simply isn’t true, and is in fact quite the opposite.

The final piece of the puzzle fell into place with the publication of the Chinese Stroke Primary Prevention Trial, which reported a 25% reduction of stroke with folic acid alone in patients with hypertension receiving enalapril. Among participants with LDL-C >2 mmol/L, the reduction of stroke was 31%.

The study randomized patients to enalapril plus folic acid or enalapril alone, and did in fact find a reduction in stroke risk. But here were the authors with an explanation of why their findings differed from VISP and NORVIT: “In this population without folic acid fortification, we observed considerable individual variation in plasma folate levels and clearly showed that the beneficial effect appeared to be more pronounced in participants with lower folate levels. In comparison, the VISP study was conducted in the United States, a region with folic acid fortification. Mandatory folic acid fortification in North America has had a significant positive effect on the population’s plasma folate levels. The mean folate levels at baseline in the VISP study was about 28 nmol/L (12.4 ng/mL), which was about 50% higher than that in the CSPPT trial. Therefore, it is not surprising that previous folic acid trials conducted in high folate regions generally yielded null results, which were likely due to the “ceiling effect” of folic acid supplementation.” Pretty clear reasoning. Our rates of folic acid deficiency in North America are so low that in Ontario, the government will not actually pay for the test to be performed, because it is of such low value.

Importantly, among participants with impaired renal function, folic acid slowed the decline of renal function and reduced a composite event that included progression to dialysis and mortality. 

Again, another post-hoc analysis aimed at mining a trial for data. You’ll notice that no nephrologists are actively pushing folic acid on their patients for vascular protection.

This means that the problem with the early trials was not unmetabolized folic acid; it was probably due to cyanocobalamin. A meta-analysis of trials stratified by renal function and dose of cyanocobalamin supports that hypothesis.

They looked at the VISP data again! 13 years later! If at first you don’t succeed….

 B vitamins do reduce the risk of stroke, if not MI, but we should be using methylcobalamin or oxocobalamin, not cyanocobalamin. It is important to use B12 in addition to folic acid because of the very high prevalence of metabolic B12 deficiency, which is largely unrecognized.

If you move the goalposts enough times, eventually the field goal will be good.

Only a small fraction of total serum B12 is active (~ 6-20%). This means that a serum B12 in the lower end of the reference range (~ 160-600 pmol/L) may not contain adequate levels of active B12. In order to confirm adequacy of functional B12 it is necessary for the serum B12 to be above 400 pmol/L, or it is necessary to measure holotranscobalamin, or one of the metabolites that becomes elevated in metabolic B12 deficiency: the specific metabolite, methylmalonic acid (MMA), which is not available in most routine biochemistry labs, or total homocysteine (tHcy), which is a reasonable surrogate for MMA in folate-replete patients. Since we have folate fortification of the grain supply, it is reasonable to measure tHcy for this purpose.

None of this is remotely relevant to clinical outcomes. It’s mechanism-based jargon. Testing total homocysteine for what purpose?

Vitamin B12 deficiency is extremely common in the elderly; ~20% of the elderly have inadequate active B12; among vascular patients the percentage is much higher: in my stroke prevention clinic, metabolic B12 deficiency was present in 10% of patients below age 50, and 30% above age 70.

Why does this matter? Not only does B12 deficiency cause neuropathy, myelopathy and dementia; it also raises levels of tHcy, a clotting factor that markedly increases the risk of stroke. High levels of tHcy quadruple the risk of stroke in atrial fibrillation.

Yes, and nothing we have done in North America to reduce homocysteine in isolation has ever done anything to reduce vascular risk. Time to put this theory to bed. Again. Research dollars are a finite resource, and should not be spent chasing this theory any further.

Advertisements

Guarding against pseudoscience at Western University

As a member of the faculty at Western University, I was absolutely thrilled that last weekend’s Homecoming featured a panel discussion on the topic of pseudoscience. The panel consisted of: Dr. Jen Gunter, an obstetrician-gynecologist, Western alumnus, and prominent online voice for science-based medicine; Dr. Marina Salvadori, a local pediatric infectious disease specialist and passionate vaccine advocate; Mark Speechley, PhD and Dr. Saverio Stranges from the Department of Epidemiology and Biostatistics.

The talk was engaging, dealing with issues ranging from our society’s move away from appreciating the value of expertise, to vaccine denialism, to celebrity promotion of pseudoscientific products. My only quibble was with the short duration, as one hour was only a fraction of the time needed to tackle such a pressing topic, but hey, it’s Homecoming weekend, every minute is valuable.

So after a terrific talk, I waiting in line to greet Dr. Gunter (my Twitter buddy!) and Dr. Salvadori (who saved my cousin’s life in 2008, long story…) when, to my left, a fairly irritated man was needling Dr. Speechley with the demand that he “define pseudoscience for him”. Dr. Speechley politely explained that a definition could include beliefs and practices that appear scientific, but are not. The man was not satisfied, and repeatedly demanded a more specific definition. I couldn’t help but interject myself into the discussion, so I elaborated a bit further as to what a definition could entail. Again, he was not satisfied with our explanations. I sensed that he was clearly not interested in an actual discussion, but was rather trying to troll us into some ideological debate he wanted, so I asked him what he did for a living, to try and get a sense of where the heck he was coming from. He refused to answer. Giant red flag.

Before I had even a second to think of what to say next, he had moved on rapidly to explaining to us how he personally used homeopathy, and used it for all of his family, and who were we to tell him what works and doesn’t work.

There it was. The sacred cow. His love of homeopathy. Of course.

The rest of our conversation was a failed attempt at explaining to him that he and his family are free to pursue whatever treatments they desire, but he crosses a line when he attempts to convey to others that pseudoscientific treatments are based on any sound science. Oh, and I finally managed to get him to tell me what he did for a living. He’s an ENT surgeon. Frightening.

So where does that leave us? After an hour of kumbaya about science and fighting pseudoscience, this discussion brought me right back down to earth with the realization that pseudoscience is right in our midst on a daily basis, even promoted by those who we assume should know better.

There wasn’t any time for any questions to be taken from the audience, but here is the comment I wanted to deliver:

There was a lot of discussion during the talk about the role of health care professionals and the government in terms of education and policy around science, but we need to realize the important role that academic institutions like Western can play in terms of leadership in battling pseudoscience. Sadly, we have seen a proliferation of institutions in North America providing legitimization for pseudoscientific practices: UC Irvine accepting a $200 million gift to launch an “integrative health” institution, the fact that most American hospitals have a department dedicated to “integrative medicine”, and even the University of Toronto has its own “Centre for Integrative Medicine”. There is absolutely nothing from stopping Western from being the next university to fall prey to this trend. There has long been a course in the 4th year medicine curriculum about Complementary and Alternative Medicine, taught by “alternative practitioners”, with the students not provided with an ounce of scientific skepticism about these practices (as faculty, I provided an open lecture this year to any interested medical students, entitled “Scientific Skepticism in Medicine”). Western’s Departments of Health Sciences and Kinesiology have offered a course in “Integrative Health“, which….well just look at the syllabus. It’s horrifying.

To administrators who simply shrug and question what the magnitude of harm there could possibly be in allowing unscientific concepts to proliferate an institution, let me remind you of the institutional embarrassment that these individuals and concepts can bring to an institution. Do you think Yale was pleased at being referenced along Dr. Oz during his testimony before congress? Do you think the Cleveland Clinic had a few regrets about the fact the medical director of their Wellness Institute created an online firestorm after his blog that regurgitated anti-vaccine talking points? Do you think UBC is happy that two anti-vaccine researchers have made national headlines for having a paper retracted for the second time over accusations of fraudulent data?

There are consequences to allowing pseudoscience to flourish, because when there is the inevitable embarrassment, health professionals like myself will lay the blame at the feet of those in power who did not stand up for science.

Let’s be international leaders at Western, bucking the ongoing trend towards quackery, and setting a new standard for creating a health community dedicated to science-based medicine.

OMA/MOH Negotiations: Part Deux

My last blog post raised a few very specific ideas within primary care that I hope to see addressed in the upcoming negotiations between the OMA and the Ministry of Health.

While I love practical minutiae, I think it’s also important to step back and address some of the larger issues of how primary care is organized and funded.

First it is vital to clearly delineate the accountabilities within the system, which are currently blurred to the point of being non-existent. From a funding standpoint (for care deemed clinically necessary, third party care excluded), there should only be two lines of accountability, one between the insurer (government) and policy holders (patients), and the other between the insurer and care providers (physicians). Patients should not be financially accountable to physicians, nor vice versa, and their relationship should be strictly clinical. I’ll explain later why this is important.

Patients in Ontario (and Canada, for that matter), generally do not fully understand the fact that their taxes are paying into a health insurance policy, and that like any insurance policy, there are benefits, expectations, and restrictions to the type of care that their insurance covers. I don’t blame patients for this. The fault for this lack of clarity lies with the insurer (government), who is understandably fearful of the political ramifications of being seen to “restrict” care by enforcing any semblance of limitation on “insured care”. Second opinions, two visits for the same issue in one day, anything goes!  But can you imagine Anthem or Aetna in the US demonstrating this type of ambiguity with what their  policies cover? Tax payers don’t want to pay more taxes to cover increasing costs, so we need to have open discussions around what is medically necessary and appropriate. Clear answers are needed to the question of what does the insurer guarantee to patients, and what expectations are there of patients. Physician organizations can and should be engaged to provide their objective expertise to guide what should be covered by a provincial insurer, but the reason that there can be no physician-patient financial accountability is that physician recommendations and behaviour may be seen as being influenced by financial motives.

And the provider-physician accountability? Not as clear as you would expect. Should be pretty simple, too. Agree to a framework of what is covered by the insurer, what the expectations are of physicians, and compensate appropriately for the insured care that is provided. But rather than having a strict framework guide physician activity, we often have physician entrepreneurs stretching the boundaries of what the current loose framework intended. House calls for non-disabled patients, specialist clinics that bring stable patients back repeatedly for routine follow-up with expensive imaging tests, and niche clinics opening up for any new market that they identify (eg. “biochemistry nutrition clinics”, “functional medicine clinics”, “cannabinoid medicine clinics”, etc.). With many of these clinics, the horse is coming before the cart. The physicians have a OHIP billing number, and it’s essentially a blank cheque to bill the government for any semi-clinical interaction with patients, until the CPSO or the ministry deems the clinic’s practices egregious enough to intervene (which is rare).

So where am I going with this? I have a fairly radical plan for how primary care funding could be re-organized.

First we need to address the issue of the “access bonus” for those in a FHO model with negation for family physician billings outside of their FHO. The initial rationale for the concept was innovative: use the outside billings as a surrogate marker for the degree of access FHO physicians are providing. With better access, patients should be seeking care elsewhere less frequently. Unfortunately, it has proven to be a poor surrogate in many areas of the province, including areas without a walk-in clinic (ER visits don’t contribute to negation, physicians get their total access bonus regardless of actual access) and the GTA where commuting patients will seek convenient care at a walk-in rather than attending the after-hours clinic their FHO is providing (FHO provides the access, still gets negated). But apart from the inequality of the system, this mechanism is fundamentally flawed because it violates one of the principles of accountability I raised earlier. Lines of financial accountability should not exist between patients and physicians. In the case of the access bonus, it has strained many physician-patient relationships as physicians have often clumsily attempted to educate patients about what the access bonus/negation issue entails, while the patient hears “You are costing me money by seeking health care”.  This is not healthy for these relationships. We need a new system.

Here we go.

First, take the FHO/FHG/FNH models and replace them with two capitation “tracks” that family physicians can decide between for their practice. Track 1 would see 80% of their income from capitation fee, with a 20% fee-for-service shadow billing for patient encounters. Track 2 would see a 60/40 split. Depending on which Track a physician chooses, they would be locked in for 3 year periods (the math involved in switching between tracks more frequently would be a nightmare). Capitation figures would be adjusted based on a formula of patient complexity, the data of which would be taken from the accurate EMR coding of patient problems (with agreed-upon standards of what makes a patient eligible to be given a certain diagnosis/problem).

Next, when a patient is rostered to a family physician, within a 30km radius of their provider they are only insured to see their provider group. If a patient chooses to seek care at a walk-in or other family physician within that 30km radius, it would not be an OHIP-insured service, while outside of that radius it would be insured (on vacation, visiting family, work, etc.). There would have to be point-of-care OHIP validation available in real-time for walk-in providers to determine whether the patient visit would be insured or would be patient-pay. For those without valid OHIP cards who present for care, there would also have to be a live ministry-run system available for dealing with issues of coverage during all clinic hours.

If a patient repeatedly is seeking care outside of their provider network/radius, it is the INSURER (the province) that then can de-roster the patient and make that patient a “fee-for-service patient” (that is, each service covered by OHIP is paid as fee-for-service, not covered by capitation rates). The ministry would then be incentivized to attempt to find the patient a primary care group that is closer to the patient’s geographic area, as the province does like the relative cost-certainy that capitation models bring.

For physicians in these new capitation “tracks”, there would be NO cap on fee-for-service billings provided to patients who have been excluded from capitation by the ministry, as the fact that they are “fee-for-service patients” is out of their hands (there is currently a cap on these billings for capitated physicians).

There would also be no further clawback on access bonus payments. The payments would all be made in full to all physicians, but with strict accountability for after-hours clinic availability (7 days a week, 3 hours/d), and adequate patient access for new-onset complaints (3rd next available appointment within 24 hours). For those in rural areas, providing scheduled after-hours care through emergency departments would be allowable if negotiated directly with the LHIN. If physicians are found not to be meeting the access requirements, there would be a tiered warning system, with repeated violations ultimately resulting in termination of their capitation contract, reverting the physician to an exclusively fee-for-service model. Some physicians may see these requirements as oppressive, but if we are going to create a model whereby payments are essentially guaranteed and patients are restricted from seeking care elsewhere, we must provide them with impeccable access to our services.

(There would also have to continue to be a significant financial advantage for physicians to be in a capitation “track” model over a fee-for-service model to provide the incentive to stay within the organized capitation system.)

Patients themselves can opt to be “fee-for-service patients” within a practice and the province, but then would not be guaranteed the provisions of access to after-hours clinics or the 24-hour clinic appointment guarantee.

So there’s my preliminary framework. Lots of work still to be done (and I’m sure exceptions and situations I haven’t considered), but I hope we can start moving our system forward with some new innovations, because the current blurred lines of accountability are frustrating both patients, physicians, and the government.

AAA screening in older males: Should we?

Last week, a Danish group made headlines with their Lancet study showing that “Triple-screening” older men for abdominal aortic aneurysm (AAA), peripheral arterial disease (PAD), and hypertension reduced 5-year mortality by 7%.

This was seen as validating the current Canadian guidelines that call for all males 65-75 years old to undergo a one-time ultrasound to rule out a AAA, in addition to women with risk factors (smoking history, family history of AAA, or cerebrovascular disease).

So, is it time to move forward with a formal population-based screening program? Let me provide some food for thought using some of my own practice data.

In the Danish study, 21% of the subjects were active smokers at baseline. In my practice 10 of 154 (6.5%) men 65-75yo are smokers (3 of the 10 smokers smoke only cigars or pipes infrequently, and 3 men in the cohort have no smoking data available). We know that smoking is the strongest risk factor for development of AAA, as current smokers are 7.6 times more likely to have an AAA than nonsmokers, and even ex-smokers are 3.0 times more likely to have an AAA than nonsmokers. Screening a population where smoking is less prevalent will provide far less of a mortality benefit than was seen in the Danish population, with a larger number needed to screen.

In response to the Canadian guidelines, I have made an effort in my practice to increase AAA screening rates over the past few years, with 113 of 157 (72.0%) men 65-75yo completing an ultrasound screen. Of the 113, only 2 have a AAA, which is significantly lower than the 3.3% AAA rate seen in the Danish study. Lower smoking rates overall likely translating to the lower rate of AAA.

Looking at all age groups, 14 of my patients have a current or past AAA (7 men, 7 women). 10 of the 14 are former smokers, and none are current smokers. 12 of the 14 are over the age of 75.

The number needed to screen for men >65yo to prevent one AAA related mortality is 769, but this includes both smokers and non-smokers which are likely inflating the numbers. If we are going to implement a program, let’s start with the high-yield groups of smokers/ex-smokers first where we know we will see a see the biggest benefit.

Ontario Osteoporosis Strategy Technical Report – My practice-level data/insight

The Ontario Osteoporosis Strategy recently released its technical report which I encourage all family physicians, endocrinologists and orthopaedic surgeons to read. The report takes data from ICES and CIHI and brings to light some interesting province-wide and LHIN-wide trends in osteoporosis screening.

The main takeaway for me from the report is that the current system is doing a generally poor job of screening patients for osteoporosis. Top level points include:

  • In 2014/15 only 13% of men and 28% of women aged 68-70 had received a BMD in the past 5 years

osteolhin2

  • In 2014/15, there was a three-fold difference between high and low rates for standardized BMD testing following a hip fracture (low of 11.9 in Erie St. Clair; high of 38.6 in Toronto Central)

osteoLHIN.png

It goes without saying, but there is an awful lot of improvement when you look at that table. Many eligible patients not being screened at all, and many not receiving appropriate care post-fracture.

But before every LHIN jumps out of their seat wanting to improve this as a quality metric, we need to step back and practically evaluate which groups would truly benefit from screening.

The 2010 Canadian clinical practice guidelines recommend screening all individuals >= 65 years old (men and women) for osteoporosis. The Osteoporosis Self-Assessment Tool is a validated screen that is useful in determining which patients would warrant a BMD. The formula is Weight (kg) – Age (years), and if <10, increased risk of osteoporosis and BMD is warranted.

How do these two approaches to screening compare in a real-life setting? I looked at my practice-level data and will share the insights here.

In a practice of 2200 patients, 243 women >= 65yo were identified, 224 of whom have had at least one lifetime BMD (92%). 250 men >= 65yo were identified, 107 of whom have had at least one lifetime BMD (43%).

l went through my patient data and analyzed which patients have a calculated OST < 10 and would qualify for BMD screening, sorted by age cohort.

First, the men (11 patients were excluded because of no recorded weight):

65-69yo: 9/75 have an OST <10 (12%)

70-74yo: 24/61 (39%)

75-79yo: 23/37 (62%)

80-84yo: 26/31 (84%)

>=85yo: 31/31 (100%)

And the women (21 patients were excluded because of no recorded weight):

65-69yo: 34/52 have an OST <10 (65%)

70-74yo: 38/59 (64%)

75-79yo: 29/38 (76%)

80-84yo: 32/33 (97%)

>=85yo: 47/47 (100%)

In total, 45% of men >=65yo would qualify to be screened with BMD according to the OST, and 77% of women >=65yo would qualify.

Certainly looking at the male data, it appears that using the age 65 cut off is a very crude screen and may lead to over screening with BMD. But what about the most important outcome, which men actually required treatment for osteoporosis as a consequence of screening those >=65yo? (using Mayo Clinic resource as shared decision-making tool)

I identified 14 male patients in my practice who are currently being treatment for osteoporosis (either with bisphosphonate or denosumab): 10 patients >=65yo, 6 patients 50-64yo, and 1 patient <50yo. Interestingly, only one of the 14 patients was identified as having osteoporosis through the >=65yo screening program. The remainder were identified as requiring a BMD because of other risk factors:

– 5 with compression fractures (2 of whom have alcohol use disorder)

– 2 on prednisone

– 2 with rheumatoid arthritis

– 1 with Parkinson’s

– 2 with alcohol use disorder

– 1 with Prader-Wili

Out of 107 men >=65yo who received at least one lifetime BMD, only ONE patient lacking any other risk factors apart from age warranted (and agreed to) treatment for osteoporosis.

A few points to consider:

  • If we are going to target osteoporosis screening as a quality metric to improve, I think it behooves us to isolate screening in women >=65yo as the actionable, measurable metric, rather than including both men and women in the cohort. Screening all men >= 65yo will not be a cost-effective intervention, as it will not identify a significant number of men who will actually warrant treatment, and will instead result in many completely fruitless BMDs, at a cost of millions of dollars to the system. While likely not measurable as a widespread metric, the preferred approach to screening in men should be risk factor-based, with a particular focus on screening men with a history of corticosteroid use, alcohol use disorder, RA, those on aromatase inhibitors, and those with a previous fragility fracture (and screening men with chronic back pain with plain x-ray to rule out compression fracture).
  • The OST should be encouraged as the initial screening evaluation prior to BMD, and that it be highlighted to physicians that 100% screening compliance is not the suggested target in women >=65yo (only 77% were eligible according to OST in my patient population).
  • The technical report mentioned that of those on treatment for osteoporosis, 38% of individuals received a follow-up BMD within 2 years. While the report frames this as a proportion that should be increased, I would take the opposite approach to this data. Ordering a repeat BMD within the first 2 years of treatment for osteoporosis is rarely indicated as the results should not often change treatment. Any change in the BMD within 2 years of starting treatment is just as likely to be inherent variability in the test as compared to a meaningful change due to treatment. We should be targeting that 0% of patients receive a follow-up BMD within 2 years of starting treatment.

Certainly there is tremendous room for improvement in how we are systematically screening for osteoporosis in Ontario, especially in those who have already experienced a fragility fracture and in women >=65yo. We must, however, also ensure that any widespread quality improvement efforts must be rational in who it targets and careful to avoid over screening in extremely low-risk populations, such as men who lack any risk factors other than age.

OMA/MOH Negotiations: A few suggestions for primary care

With a binding arbitration mechanism finally in place, negotiations between the OMA and the MOH are set to commence in the next month. Sections and districts are being consulted for their priorities in negotiations with the objective of developing a cohesive mandate.

While there will be broad consensus on many high-level issues that stretch across multiple specialties (appropriate funding of system growth, funding to improve physician staffing in under-service remote areas, etc), I want to get a bit more granular to raise some fairly narrow issues that are specific to primary care.

(Disclaimer: I don’t consider these to be anywhere near the most important issues to primary care, but simply a few issues where I think we can see some innovation.)

  1. Fix FHO oversight, and open them back up to all family physicians in all regions

Restricting FHO entry to those in under-serviced areas may have initially seemed like wise policy that would drive physicians to those areas, but instead has resulted in multiple unintended consequences. We have a two-tiered system within primary care of those in a capitation model and those who are stuck in a fee-for-service model which the ministry themselves has decried as antiquated. The difference between the two models is far more than one of finances: it potentially changes the manner in which care is delivered, where capitation incentivizes the physician to innovate, providing alternative methods of care delivery (phone, telemedicine, staff delegation) and removing the incentive to initiate potentially unnecessary visits. When we are dealing with fundamental principles of care delivery, this simply cannot be determined and restricted based strictly on geography. If it’s a good model, it’s a good model in North Bay, it’s a good model in Niagara Falls. But here’s the caveat: we need to fix what is currently happening in some FHOs. FHOs are contracted to provide a minimum number of after-hours clinics, and a small group simply aren’t meeting their obligations, partly answering why we haven’t seen much of an improvement in access despite large investments into FHOs. (I note a “small group”, because I know that the majority of FHO docs who are meeting their responsibilities bristle at any mention that some docs aren’t. If you are doing your mandatory clinics, you are completely exempt from this criticism). Part of the issue is that the ministry hasn’t enforced the requirements, but this can be easily remedied. Start enforcing the rules, and mandate that FHOs transparently advertise their after-hours clinics availability (websites, phone, push e-mails). I won’t comment on specific measures of access during office hours for new or urgent issues, but I think we’re well overdue to see some consistency around this issue across the province.

2. Revising the K030 and Q040 for diabetes management

Family physicians bill a K030 as a visit code for diabetes visits (max 4 per year), and are eligible to bill a Q040 code ($60) once per year “if the physician has rendered a minimum of three K030 services for the same patient in the same 12 month period to which the Q040 service applies”.

K030.png

Makes sense in theory to improve quality of care, but a few unintended consequences. If a patient comes in for assessment of a unrelated intercurrent illness where diabetes was not reviewed but a physical exam was completed, the physician is essentially forced to bring back the patient for a “diabetic visit” which can just as easily be done over the phone or by other telemedicine means. This leads to unnecessary visits and often inconveniences patients who are stable.

Proposal: Change the K030 into a Q030 tracking code, which can be billed either through provision of in-person or virtual care of all of the features of the Diabetes management Incentive at each visit (except the foot examination and neurologic examination, which should only be required once a year). Three Q030 codes in a 12-month period to be eligible for the Q040 code, which should be increased to the $125 range (matching CHF Q050 code) to properly incentivize physicians to do more virtual care and to properly remunerate the requirements of diabetes care.

3. Complete overhaul of the preventive care bonus program

With all of the innovation taking place in primary care in the province, somehow we are still stuck with the same five metrics for nearly a decade now (influenza vaccination, childhood immunizations, colorectal cancer screening, cervical cancer screening, and mammograms). Kiran et al showed in 2014 that in Ontario, “pay-for-performance scheme was associated with little or no improvement in screening rates despite substantial expenditure”. Total bonus payout can be as high as $12,800. Surely we can use that money to actually improve some areas of care. (Disclaimer: I have a compliant practice population and regularly hit all of my maximum targets. Any alteration may actually impact me negatively. But let’s tinker with it anyways.). Here are some ideas:

  • Take a small portion of the existing bonus money and leave it to reward the existing five metrics, but change the measured outcome from “test or treatment completed” to “test or treatment was offered to patient” and implement a tracking code for each. Make the threshold 95% compliance to obtain the bonus. Childhood immunizations discussions must occur in person, the other 4 interventions can be done virtually (batch email, snail mail, phone, etc). This will enable informed, patient-centred decision making, and will eliminate the tension between physicians and patients when patients refuse an intervention that may affect the physician’s income. If the bonuses for these metrics are completely eliminated, I do fear that we may see a significant decline in screening and immunization rates, as many patients complete these interventions because of their relationship with the primary care physicians (and would not be as compliant if Cancer Care Ontario or public health departments were the only bodies encouraging the interventions).
  • Develop an advance care planning framework (workbook, custom form, etc.), and establish bonus money thresholds for percentage of patients 65+ years of age for whom the established framework has been either completed or offered (for patients who refuse to engage in discussion). Codes should be established for both the visit where this discussion occurs, as well as making the bonus sufficiently generous given the large number of patients this initiative will encompass.
  • Dedicate the majority of incentive money towards EMR maturity programs, specifically a focus on rewarding data integrity and standardization over a 3-year period. Identify priorities (linking problem lists to ICD-codes according to defined algorithms, appropriately labelling data elements including lab results, imaging, immunizations, vitals, etc). There are massive disparities across the province in how effectively and consistently physicians are entering their data, and an incentive program would reward physicians who have 1) invested in an electronic medical record and 2) are interested in working towards maximizing the potential of their EMR to improve quality of care in their practices. Future agreements can focus on specific renumeration for participation in quality improvement initiatives using their high-quality data.

4. Tighten up house call restrictions

We have seen some entrepreneurs in the GTA create companies that offer the convenience of physician house calls. While of course I support the availability of house calls to all Ontarians, some of these programs risk putting simple patient convenience ahead of continuity of care, as well as markedly increasing health care costs with otherwise mobile patients costing the system 3-7 times the cost of a regular office visit. A few simple suggestions:

  • Strict enforcement that house calls are only available to patients who are physically disabled and unable to attend an office visit in person. Lack of adequate transportation and convenience (e.g. parent with febrile child would not qualify). This must be clearly advertised by these companies, the patient’s disability must be clearly documented for auditing purposes, and patients who do not qualify should be able to pay out of pocket for the total cost of these convenience house calls.
  • For patients requesting house calls who are rostered to a physician group, any house call physician outside of that group must 1) have prior consent to see the patient or 2) make an attempt to contact the on-call physician of that group to ensure that they are not able or willing to see the patient.

5. Change the billing framework for “physicals” and “Periodic health examinations”

In the last agreement, for patients without a chronic disease, any “checkup” or “physical” would become known as a “Periodic Health Visit”, code K130/131/132 to be billed at $50.00. (For those without chronic disease, this was a marked reduction from the A003, a general assessment, billed at $77.20 (pre-unilateral action)).

Here’s my radical suggestion, in keeping with the Choosing Wisely campaign: Change the K130/131/132 to a Periodic Health Review, billed at $30 once per 12 months, which can be done either in-person (in conjunction with a visit code) or virtually. The review will simply include a questionnaire including all of the history-taking components of the Preventive Care Checklist, with no required physical examination component. Patients can either monitor their own BP and weight to be recorded in the EMR, or they can stop into the office to have this measured (recording these vitals once yearly would be required to bill the K130/131/132). A003 will still be able to be billed for patients for a physical for follow-up of a cancer diagnosis or other life-threatening illness requiring a head-to-toe exam (eg. CKD patients should have a focus physical exam at regular appointments, and thus do not require an annual A003). If patients who do not meet the criteria request any hands-on annual physical examination, this should be not OHIP covered, and available to patients at OMA rates.

 

 

Crazy ideas, I know. We’ll see what happens with the negotiating parties.

Cheaper PPI options: An EMR QI exercise

Back in December 2016, I was doing some work around proton pump inhibitor (PPI) costs in Ontario and did some digging into my EMR data to see what savings could be found.

Here was my Twitter thread about the topic.

In short, I identified 414 of my patients on a PPI, 314 (76%) of which were on rabeprazole or pantoprazole, the two cheapest options. I calculated the potential monetary savings by switching every patient in my practice who is on a more expensive PPI (esomeprazole, lansoprazole, omeprazole, dexlansoprazole) to generic rabeprazole; projected tally would be $22,340 over the course of a year. Not an insignificant sum.

It’s one thing to project a cost savings. But would it actually work?

I embarked on a very simple intervention in January 2017. Using my EMR (Telus PS Suite), I created a reminder that would place the note “Consider switch to cheaper PPI” on the chart of every patient on esomeprazole, lansoprazole, omeprazole, dexlansoprazole, or pantoprazole.

ppi4.png

That reminder would appear on their chart, and would prompt a discussion at their next appointment about a potential trial of rabeprazole.

ppi

(I am intentionally omitting the issue of de-prescribing from this analysis, as de-pescribing PPIs has been another important undertaking in my practice, yet this analysis was strictly looking at looking at cost-saving from cheaper PPIs. The above reminder did prompt many instances of de-prescribing, but these were not as easily quantifiable retrospectively. In addition, I bristle at the idea of openly quantifying and applauding the cost savings from de-prescribing, as it would rightfully raise the question in patients’ eyes whether we are de-prescribing out of concern for their health, or simply to save money. This analysis looks at cost-savings from switching from one PPI to another, the goal of which is to produce no clinical negative change).

Of the patients who were engaged in a discussion, many were found not to be appropriate for a rabeprazole trial, either because of intolerance or lack of efficacy from previous trials of rabeprazole. Other patients were not open to a trial because of lack of interest in “rocking the boat” or because of an upcoming trip and concern about impacting travel insurance.

ppi3

28 patients (some private pay, some publicly-funded) who required ongoing PPI therapy (due to ongoing indication or due to previous failure with PPI wean) agreed to a rotation to rabeprazole as a trial. 7 patients described a clinical worsening of symptoms (most within the first two weeks), and requested to be put back onto their initial PPI (5 patients on lansoprazole, 1 on pantoprazole, and 1 on omeprazole).  21 patients saw no clinical change, and those 21 have been found to be stable at the 3-month mark post-rotation (11 on lansoprazole, 4 on omeprazole, 4 on esomeprazole, and 2 on pantoprazole).

The cost savings were as follows (using rabeprazole 20mg tablet, $0.24/pill):

  • Esomeprazole – $1.86 per pill ($1.62 savings/d, $591.30/yr per patient)
  • Omeprazole – $0.41 per pill ($0.14 savings/d, $51.10/yr per patient)
  • Lansoprazole – $0.50 per pill ($0.26 savings/d, $94.90/yr per patient)
  • Pantoprazole – $0.30 per pill ($0.06 savings/d, $21.90/yr per patient)

Total yearly savings from these 21 patients now stable on rabeprazole: $3657.30

A few things to take away from this:

  1. This was a ridiculously simple intervention, and took me virtually no time to create the reminder or to have those discussions with patients.
  2. This should be a wake-up call to the Ministry of Health on the importance of working with physicians on finding efficiencies in our system. Physicians know where these efficiencies are, so allow innovation and creativity, reward it appropriately, and we’ll find the money.
  3. It is critical that the first script for the rabeprazole be of short duration (I prescribed two weeks), otherwise 3 months of wasted pills for the 25% failure rate would have erased some of the cost savings.
  4. Most practices will likely see greater savings than I achieved in my practice, as I have been consciously working to prescribe exclusively rabeprazole for some time now. Even if you assume my prescribing rate to be on par with the Ontario average (2200 patients), extrapolating this out to Ontario’s population of 13.6 million, this simple intervention would amount to a provincial total of $22.6 million.
  5. Note that most of the savings were found in switching patients from esomeprazole. Please don’t use it unless you are absolutely handcuffed. It is insanely expensive compared to others in the class.

All of us have these opportunities in our practices for small interventions that we may actually find some element of satisfaction in evaluating, especially with the power of a well-functioning EMR behind us.