When I reported on the IOM’s prioritization of topics for comparative effectiveness research (CER) three weeks ago, I highlighted the positive evolution in CER thinking represented by the listing. Whereas CER often has been about comparing the effectiveness an established drug to a newer, more expensive one, we need to do more than that. I wrote:

I’m all for trying to find out whether me-too drugs add any significant value. However, the greatest opportunities for implementing delivery system change that improves care effectiveness and efficiency relate to innovations in how care is organized and delivered, and how insights are communicated to the broad range of health care actors — most notably consumers.

There are some good CER articles in today’s New England Journal of Medicine. In “Comparative Effectiveness — Thinking beyond Medication A versus Medication B,” Kevin G. Volpp, M.D., Ph.D., and Anup Das, have made similar arguments.

In considering the allocation of federal resources for comparative-effectiveness research (CER), however, it is important that we maintain a broad view of ways of improving the health of the population. As many as 40% of premature deaths in the United States are attributable to Americans’ own health-related behaviors. If CER’s full potential for improving the population’s health is to be realized, such comparisons must go beyond those between medication A and medication B or device A and device B: we must also assess medications or devices in comparison with behavioral interventions, either alone or in conjunction with other approaches. In addition, since many diverse aspects of care delivery have a direct effect on patients’ health outcomes, we should assess policy-based interventions and their relative effectiveness in improving health.

In many cases, it seems clear that patients’ individual health-related behaviors are the proximate cause of disease and of the need for medical treatments. For example, obesity is a major risk factor for hypertension, diabetes, lower back pain, and other conditions. Patients who are able to lose weight may be able to reduce or eliminate their use of medications for these conditions. It therefore makes sense to compare, among patients with diabetes, medication-based approaches to the treatment of diabetes with, for example, the effects of behavioral approaches to weight reduction.

How we focus the CER agenda would be important enough just by virtue of the injection of dramatic increases in federal CER funding — $1.1 billion from the American Recovery & Reinvestment Act (ARRA). But the stakes have grown even greater this week given President Obama’s negotiations with leaders on Capitol Hill regarding how CER can play a critical role in long-term cost control and real reform of the delivery system.

If we maximize the potential of ARRA CER resources by investing in this second-generation approach to CER, we might actually have the combination of information and infrastructure that can bend the long-term cost curve while improving the delivery system.

Molly Coye (CEO of the Health Technology Center) and Joe Kvedar (Director of Partners’ Center for Connected Health) made a compelling argument for patient-centric health care reform on the Health Affairs Blog yesterday. Coye & Kvedar effectively articulate the rationale and importance of ensuring that our best shot at health care reform in many years improves the care delivery system by focusing on consumers’ health and health care needs. What would have made the piece even more helpful is if they tied that argument more directly to what’s actually going on in Washington, both on the legislative front and in implementation of the American Recovery & Reinvestment Act (ARRA).

Coye  & Kvedar “propose adding two synergistic goals to the policy conversation:

1. Support people in taking shared responsibility for their health outcomes, and make tools available to help them.
2. Pay providers for success in supporting patient self-management, and for preventing the onset or exacerbation of disease, rather than for units of service.”

I completely agree. Although many policy leaders still don’t understand these important points, it’s important to identify where progress has been made and think about how to build on those efforts.

For example, in the implementation of ARRA, the first draft definition of “meaningful use” of health information technology (HIT) includes several patient-centric expectations in order for providers to be rewarded the tens of billions of dollars in incentives in ARRA offers for HIT implementation. If implemented (and strengthened modestly), this approach could have a significant impact on achieving (in Coye/Kvedar’s words) “important transformation of the care delivery process itself, so that patients are fully integrated and in many cases manage their care for prolonged periods with little interface with the physician.”

ARRA also allocated $1.1 billion for comparative effectiveness research (CER). If the CER agenda evolves with five consumer-oriented principles in mind, it has the potential to dramatically improve care delivery effectiveness by providing useful information to consumers and clinicians. The release of the Institute of Medicine’s top 100 priorities for CER provides at least some indication that CER leaders recognize the importance of using these resources to advance patient-centered care.

Although most of the media attention and public debate around health care reform legislation has focused on ideological issues, there is quieter, important work going on with respect to delivery system reform that could pave the way for more patient-centered care delivery. If, for example, the Wyden-Gregg patient decision aids legislation gets integrated into the broader reform bill (and legislators can overcome their ideological divisions and pass something), that could be an important step in the direction of a more rational payment system that encourages information therapy (Ix) — patient-centered care, shared decision making, and participatory medicine. Other important delivery system reforms could be integrated into the final legislation, and I completely agree with Coye & Kvedar that we need to “wrap these concepts [and what they call ‘patient-provider communications tools’] into the implementation of the patient-centered medical home projects and demonstrations.”

It’s important that industry leaders like Coye and Kvedar continue to advocate for achieving patient-centric health care reform. It’s equally critical that we collectively identify practical strategies for integrating those arguments into the development of new bills and the implementation of recently passed legislation.

The Institute of Medicine (IOM) released its list of the top 100 topics that should be addressed in comparative effectiveness research (CER) now — thanks to $1.1 billion in the American Recovery & Reinvestment Act — that the federal government actually has the resources to do substantial CER. IOM has prioritized the list by creating four quartiles, noting that the first quartile is the highest priority group, etc.

In order for the federal government to make good use of the huge pot of CER money, there are at least five things that they need to do to ensure its value and actually change care delivery. I’m all for trying to find out whether me-too drugs add any significant value. However, the greatest opportunities for implementing delivery system change that improves care effectiveness and efficiency relate to innovations in how care is organized and delivered, and how insights are communicated to the broad range of health care actors — most notably consumers.

That’s why I was heartened by the IOM’s top 100 list — though certainly I’d move a few up a quartile or two. The list has many projects that fit my priorities, including a strong emphasis on CER to reduce health disparities.

Here are some examples of potentially valuable CER projects in the first quartile:

• Compare the effectiveness of dissemination and translation techniques to facilitate the use of CER by patients, clinicians, payers, and others.
• Compare the effectiveness of comprehensive care coordination programs, such as the medical home, and usual care in managing children and adults with severe chronic disease, especially in populations with known health disparities.
• Compare the effectiveness of interventions (e.g., community-based multi-level interventions, simple health education, usual care) to reduce health disparities in cardiovascular disease, diabetes, cancer, musculoskeletal diseases, and birth outcomes.
• Compare the effectiveness of literacy-sensitive disease management programs and usual care in reducing disparities in children and adults with low literacy and chronic disease (e.g., heart disease).

And those in the second quartile that really should be moved up:

• Compare the effectiveness of shared decision making and usual care on decision outcomes (treatment choice, knowledge, treatment-preference concordance, and decisional conflict) in children and adults with chronic disease such as stable angina and asthma.
• Compare the effectiveness of strategies for enhancing patients’ adherence to medication regimens.
• Compare the effectiveness of patient decision support tools on informing diagnostic and treatment decisions (e.g., treatment choice, knowledge acquisition, treatment-preference concordance, decisional conflict) for elective surgical and nonsurgical procedures—especially in patients with limited English-language proficiency, limited education, hearing or visual impairments, or mental health problems.
• Compare the effectiveness (including resource utilization, workforce needs, net health care expenditures, and requirements for large-scale deployment) of new remote patient monitoring and management technologies (e.g., telemedicine, Internet, remote sensing) and usual care in managing chronic disease, especially in rural settings.

Some from the third quartile that definitely could be prioritized higher:

• Compare the effectiveness and cost-effectiveness of conventional medical management of type 2 diabetes in adolescents and adults, versus conventional therapy plus intensive educational programs or programs incorporating support groups and educational resources.
• Compare the effectiveness of alternative redesign strategies—using decision support capabilities, electronic health records, and personal health records—for increasing health professionals’ compliance with evidence-based guidelines and patients’ adherence to guideline-based regimens for chronic disease care.
• Compare the effectiveness of different quality improvement strategies in disease prevention, acute care, chronic disease care, and rehabilitation services for diverse populations of children and adults.
• Compare the effectiveness of different strategies to engage and retain patients in care and to delineate barriers to care, especially for members of populations that experience health disparities.

And finally some from the fourth quartile that I also think deserve higher ranking:

• Compare the effectiveness of different techniques (e.g., audio, visual, written) for informing patients about proposed treatments during the process of informed consent.
• Compare the effectiveness of different disease management strategies for activating patients with chronic disease.
• Compare the effectiveness of different delivery models (e.g., home blood pressure monitors, utilization of pharmacists or other allied health providers) for controlling hypertension, especially in racial minorities.

These examples are not meant to be an exhaustive accounting of all the worthy projects proposed by the IOM. There was considerable attention to re-thinking the locus of care delivery — that is, evaluating the comparative effectiveness of emphasizing care that transpires outside traditional health care delivery settings. It’s also important to note that there are also a number of projects on the list that specify the need to assess CER using patient-reported outcomes.

I’m looking forward to the evolution of the CER agenda.

Building on my post last week about comparative effectiveness research (CER), there were three pieces in last week’s New England Journal of Medicine on CER. I thought that Jerry Avorn, MD, delivered the best summary statement on the debate that erupted in advance of ARRA funding of CER: “Given the quality and cost crises we face, preserving ignorance would have been a poor strategy for improving the effectiveness, safety, and affordability of health care.”

In “The Neglected Purpose of Comparative-Effectiveness Research,” Aanand Naik, MD, and Laura Petersen, MD, MPH, raise some important issues:

“Surprisingly little attention has been paid to what we believe is the most critical question facing CER: Will its results significantly improve the quality and safety of the health care received by the average patient? Policymakers and research funders, such as the National Institutes of Health, often assume that the final steps in the translation of clinical research — the decision to act on new medical evidence and its implementation in routine care — are seamless and automatic, whereas we know that changing the behavior of physicians and patients is difficult. Though we agree that the need for CER is clear, many of the assumptions regarding the most important aspect of such research — the ultimate implementation of its findings into health care — have little empirical support.”

Or, perhaps more directly to the point:

 ”These efforts suggest that some researchers and policymakers guiding the three tiers of evidence translation have come to understand that a shift is needed from the ’science of recommendation to a science of implementation.’ … We also need evidence-based methods for discovering and describing how the findings of clinical trials and CER can be efficiently implemented and incorporated into routine practice.”

Naik and Petersen are absolutely right. Building these insights into what I reported on last week, here are five guidelines for the evolution of CER:

1. CER is critically important to filling information gaps for clinicians and patients.
2. If we want to CER to truly help patients, they need to be at the table in CER design to identify priorities and ask research questions.
3. CER findings need to be broadly disseminated, including to consumers, which means that they need to be translated into a way that makes CER findings meaningful to consumers.
4. CER dissemination is not enough to ensure the consumer engagement in care that is so critical to better, more efficient health care.
5. We need to work just as hard (through both innovation design and scientific research) to develop creative strategies — like information therapy (Ix) — to ensure that CER findings are well integrated into the care delivery process in a way that supports shared decision making (SDM) and participatory medicine.

Any suggested additions, amendments, or comments?

There was a song from the 1960s musical “Hair,” that begins “LBJ took the IRT…” Some days in DC, it feels like the wonks’ version of that. In other words, an abundance of acronyms but a lot more debate about HIT and “meaningful use” and a lot less long, flowing hair and “youth of America on LSD.”

There was an excellent briefing on Capitol Hill yesterday, organized by AARP and sponsored by the Alliance for Better Health Care (ABHC). It was officially “off the record,” so I won’t quote anybody, but it’s safe to say that there was strong consensus among the diverse panel on several important issues.

ABHC, a multi-stakeholder group that promotes comparative effectiveness research (CER) addressed several issues, including CER’s role in addressing disparities, integrating CER into clinician workflow and health plan activities, and the employer perspective on CER.

Several issues relating to consumers emerged from the discussion. First, CER is critically important to filling information gaps for clinicians and patients. Second, if we want to CER to truly help patients, they need to be at the table in CER design to identify priorities and ask research questions. Third, CER findings need to be broadly disseminated, including to consumers, which means that they need to be translated into a way that makes CER findings meaningful to consumers.

Finally, CER dissemination is not enough to ensure the consumer engagement in care that is so critical to better, more efficient health care. We need to come up with creative strategies — like information therapy (Ix) — to ensure that CER findings are well integrated into the care delivery process in a way that supports shared decision making (SDM) and participatory medicine.

I also attended a meeting the eHealth Initiative (eHI) Privacy Workgroup hosted yesterday with staff from the Government Accountability Office (GAO) that are studying privacy issues related to health information technology (HIT) implementation. GAO is examining privacy practices in health information exchange (HIE) organizations and other provider networks that exchange clinical patient data.

CareEntrust is unusual among HIEs in that it decided to develop the consumer application first, which it rolled out in May 2007. Consumers in Kansas City can now access through a secure portal a wide range of personal data on medications, lab results, visits, procedures, immunization, vital signs, demographics, and allergies. It turns that, thus far, about 18% of consumers now use these data — certainly better than the general population, but still a lot of room for improvement.

Also from the meeting, I heard that the operational HIEs with opt-out policies report very few (far less than 1%) of consumers are opting out of participation in the HIE. Interesting note, however, about what both Kansas City & Memphis HIEs say about the few that do opt out. I’m not sure exactly what it means, but it turns out that most of these opting-out consumers come from the IT industry. Is that funny or scary?

A final interesting point of discussion: Data related to discharge and care coordination have been defined as “operations” data (I gather through HIPAA). In many cases, however, there’s a strong argument to be made for it to be redefined as “treatment” data in order to facilitate greater continuity of care and what the Institute of Medicine recommends in terms of “continuous healing relationships.”