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Comparative Clinical Effectiveness Research: Setting Priorities At The IOM

March 20th, 2009 by Dr. Val Jones in Health Policy
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What would it be like to have most of healthcare’s key stakeholders in one room, and allow each of them to take turns at a podium in 3 minute intervals? It would be like the meeting I attended today at the Institute of Medicine.

The goal of this public forum was to allow all interested Americans to weigh in on prioritization rankings for comparative clinical effectiveness research (CCER). CCER, as you may recall from my recent blog post on the subject, is the government’s new initiative to try to establish “what works and what doesn’t” in medicine. Instead of answering the usual FDA question of “is this treatment safe and effective?” We will now be asking, “is this treatment more safe or more effective than the one(s) we already have?”

There are many different treatments we could study – but let’s face it, 1.1 billion isn’t a whole lot when you consider that some CCER studies (like the ALLHAT trial) cost upwards of 100 million a piece. So we have to think long and hard about where to channel our limited resources, and which treatments or practices we want to compare first.

The public forum attracted most of the usual suspects: professional societies, research organizations, industry stakeholders, health plans, and advocacy groups. But the imposed time limit forced them to really crystallize their views and agendas in a way I’d never seen before.

I “live-blogged” the event on Twitter today and if you’d like to see the detailed quotes from all the presenters, feel free to wade through the couple of hundred comments here.

For those of you more interested in the “big picture” I’ll summarize my take home points for you:

Almost everyone agreed that…

1. The process for establishing research priorities should be transparent and inclusive of all opinions.
2. More information is good, and that CCER is a valuable enterprise insofar as it provides greater insight into best practices for disease management.

Most agreed that…

1. Preventive health research should be a priority – so that we can find out how to head off chronic disease earlier in life.
2. CCER should be considered separately from cost effectiveness decisions.
3. One size doesn’t fit all when it comes to patient needs and best disease treatments.
4. Physicians should be included in the CCER research and clinical application of the findings.
5. Research must include women and minorities.
6. CCER should not just be about head-to-head drug studies, but about comparing care delivery models and studying approaches to patient behavior modification.
7. CCER should build upon currently available data – and that all those who are collecting data should share it as much as possible.

Some agreed that…

1. There is a lack of consistent methodology in conducting CCER.
2. We need to be very careful in concluding cause and effects from CCER alone.

The best organized 3 minute presentations:

In my opinion, the industry folks had the best presentations, followed by a powerful and witty 3 minutes from the American Association for Dental Research. Who knew the dentists had such a great sense of humor? Here are the top 4 presentations:

#1. Teresa Lee, AdvaMed – best all around pitch. In three short minutes, Teresa persuasively argued for transparency in CCER priority-setting, presented her top disease research picks (including hospital acquired infections and chronic diseases like asthma, diabetes, and clinical depression), the importance of physicians and patients making shared decisions about care (rather than the government imposing it), and the need to distinguish CCER from cost effectiveness.

#2. Randy Burkholder, PhRMA – “Without physician input, the questions we pose via CCER will not be clinically relevant.”

#3. Ted Buckley, BIO – “What’s best for the average patient is not necessarily best for every specific patient.”

#4. Christopher Fox, American Association for Dental Research – he said that “his good oral hygiene made it possible for him to deliver his presentation today.”

Most innovative idea

Dr. Erick Turner of Oregon Health and Science University suggested that FDA trial data be used as the primary source of CCER-related data analysis rather than the published, peer-reviewed literature since journals engage in publication bias – they tend to publish positive studies only.

Most shocking moment

Merrill Goozner, from the Center for Science In The Public Interest, essentially told the public forum hosts that the event was a terrible idea. He suggested that industry stakeholders were inherently biased by profit motives and should therefore not be allowed to influence the IOM’s CCER priority list. The crowd squirmed in its seats. For me, Merrill’s suggestion was like saying that a plan to reform the auto industry should exclude car manufacturers because they have a profit motive. Sure profit is a part of it, but reform is just not going to happen without buy in and collaboration. As I’ve argued before – there’s no such thing as complete lack of bias on anyone’s part (patients, doctors, nurses, dentists, health plans, advocates, or industry). The best we can do is be transparent about our biases and include checks and balances along the way – such as inviting all of us biased folks to the table at once.

I’m glad that happened.

Attention Health Policy Makers: How To Win Docs And Influence Patients

February 25th, 2009 by Dr. Val Jones in Health Policy, Opinion
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Pretty much everyone agrees that we need to improve the quality of healthcare delivered to patients. We’ve all heard the frightening statistics from the Institute of Medicine about medical error rates – that as many as 98,000 patients die each year as a result of them – and we also know that the US spends about 33% more than most industrialized country on healthcare, without substantial improvements in outcomes.

However, a large number of quality improvement initiatives rely on additional rules, regulations, and penalties to inspire change (for example, decreasing Medicare payments to hospitals with higher readmission rates, and decreasing provider compensation based on quality indicators). Not only am I skeptical about this stick vs. carrot strategy, but I think it will further demoralize providers, pit key stakeholders against one another, and cause people to spend their energy figuring out how to game the system than do the right thing for patients.

There is a carrot approach that could theoretically result in a $757 billion savings/year that has not been fully explored – and I suggest that we take a look at it before we “release the hounds” on hospitals and providers in an attempt to improve healthcare quality.

I attended the Senate Finance Committee’s hearing on budget options for health care reform on February 25th. One of the potential areas of substantial cost savings identified by the Congressional Budget Office (CBO) is non evidence-based variations in practice patterns. In fact, at the recent Medicare Policy Summit, CBO staff identified this problem as one of the top three causes of rising healthcare costs. Just take a look at this map of variations of healthcare spending to get a feel for the local practice cultures that influence treatment choices and prices for those treatments. There seems to be no organizing principle at all.

Senator Baucus (Chairman of the Senate Finance Committee) appeared genuinely distressed about this situation and was unclear about the best way to incentivize (or penalize) doctors to make their care decisions more uniformly evidence-based. In my opinion, a “top down” approach will likely be received with mistrust and disgruntlement on the part of physicians. What the Senator needs to know is that there is a bottom up approach already in place that could provide a real win-win here.

Some 340 thousand physicians have access to a fully peer-reviewed, regularly updated decision-support tool (called “UpToDate“) online and on their PDAs. This virtual treatment guide has 3900 contributing authors and editors, and 120 million page views per year. The goal of the tool is to make specific recommendations for patient care based on the best available evidence. The content is monetized 100% through subscriptions – meaning there is no industry influence in the guidelines adopted. Science is carefully analyzed by the very top leaders in their respective fields, and care consensuses are reached – and updated as frequently as new evidence requires it.

Not only has this tool developed “cult status” among physicians – but some confess to being addicted to it, unwilling to practice medicine without it at their side for reference purposes. The brand is universally recognized for its quality and clinical excellence and is subscribed to by 88% of academic medical centers.

In addition, a recent study published in the International Journal of Medical Informatics found that there was a “dose response” relationship between use of the decision support tool and quality indicators, meaning that the more pages of the database that were accessed by physicians at participating hospitals, the better the patient outcomes (lower complication rates and better safety compliance), and shorter the lengths of stay.

So, we already have an online, evidence-based treatment support guide that many physicians know and respect. If improved quality measures are our goal, why not incentivize hospitals and providers to use UpToDate more regularly? A public-private partnership like this (where the government subsidizes subscriptions for hospitals, channels comparative clinical effectiveness research findings to UpToDate staff, and perhaps offers Medicare bonuses to hospitals and providers for UpToDate page views) could single handedly ensure that all clinicians are operating out of the same playbook (one that was created by a team of unbiased scientists in reviewing all available research). I believe that this might be the easiest, most palatable way to target the problem of inconsistent practice styles on a national level. And as Senator Baucus has noted – the potential savings associated with having all providers on the same practice “page” is on the order of $757 billion. And that’s real money.

I highly recommend a bottom up approach, not top down. That’s how you win docs and influence patients.