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Comparative effectiveness research (CER) in patient care

Kent Bottles, MD
Policy
August 14, 2010
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Recently, I was lucky to be invited to a New England Healthcare Institute discussion entitled “From Evidence to Practice: Making CER Findings Work for Providers and Patients” in Washington, DC.

How to disseminate and implement Comparative Effectiveness Research (CER) so that patient care is really improved was the first topic tackled by the expert panel and the moderator, Clifford Goodman of The Lewin Group.

The target audiences for CER findings include: patients, disabled patients, providers, policy makers, health plans, medical device companies, pharmaceutical companies, hospital administrators, academic researchers, community physicians, professional societies, and regulators.

Michael McGinnis, MD, of the Institute of Medicine, offered clusters as a way to organize these different targets: Cluster 1 (patients, providers, policy makers), Cluster 2 (control levers like payers, purchasers, system managers, professional societies, regulators) and Cluster 3 (researchers and those concerned with methodology).

Seth Frazier, Vice President of Transformation at Geisinger, was the first of many to point out the gap between the academic literature of CER and what patients and providers need at the point of care. He noted that providers need actionable recommendations that can be integrated into the flow of the clinic and hospital and that much of the evidence-based medicine product is not usable in this practical way.

This observation reminded me of the gap between the public and the health care experts that Drew Altman of the Kaiser Family Foundation documented so effectively and the Kristen Carmen Health Affairs survey that said patients regard evidence-based medicine as a barrier to what they want.

Aanand D. Nail, MD of the Michael E. DeBakey VA Medical Center, spoke about this gap by making the observation that CER is provider-centric and that it should be patient-centric in order to reach the key audience. He likened it to redesigning the user interface and admitted that he did not understand computers, but the computer user interface was simple enough that he could function. Jean Slutsky of AHRQ said that patients do not understand the language of CER and that a uniform vocabulary was needed to make sure the different groups could communicate with each other.

Lyn Paget of the Foundation for Informed Medical Decision Making offered a way to decrease the gap between CER experts and the public by describing FIMDM’s two-pronged approach of scientific evidence and focus groups of patients who have experienced the disease. Goodman mused that this window into the patient experience could be informed by patient stories, focus groups, and the evidence itself.

The only panel member to mention social media in passing was Kathleen Buto of Johnson & Johnson. I was surprised that the panel did not talk about the many Health 2.0 tools that patients are using to share knowledge and even conduct their own research without the help of the CER experts. Inclusion of PatientsLikeMe, DiabetesMine, Sophia’s Garden, or CureTogether would have emphasized the point that the Internet would be an excellent window into patients and an ideal dissemination tool for CER.

Perhaps they should have invited Clay Shirky (NYU professor and author of Here Comes Everybody and Cognitive Surplus) to be the expert to talk about how amateurs are now able to perform functions using professional tools, or Craig Newmark of CraigsList to talk about how newspapers are having trouble with their business model.

Dan Leonard of the National Pharmaceutical Council and a former TV journalist did make the important point that communication in the real world is using a shrinking platform. The 90-second TV segment is being replaced by an even shorter sound bite or Tweet. (It was perhaps revealing when the panel did not know that Twitter is 140 character long messages; they said it was 120 characters long).

McGinnis of the IOM offered a useful classification of four dimensions of translation of CER findings: quality of the study, applicability of the study, limitations of the study, and clinical decision to be made by the doctor and patient. The discussion added two more useful dimensions: the political context and the accountability of the CER community.

The last two additions to the McGinnis classification were needed because of the discussion around the public outcry over the mammogram recommendations. Sam Nussbaum of WellPoint was not surprised by the public uproar because we had been telling women for two decades to make sure they scheduled their mammograms. Many used this discussion to emphasize the point that the public will never understand the levels of uncertainty in science and that need for a redesigned user interface.

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Paget said the entire mammogram affair was “a cry for shared decision making.” A very helpful discussion ensued where it was noted that shared decision making is different in screening settings, surgical settings, emergency settings, primary prevention settings, and end of life settings.

Kay Dickersin of the US Cochrane Center noted that the health care community does not hold its members accountable when they neglect what is best for the patient and lobby for their own special interest.

Two stories nicely captured the challenge of bridging the gap between the CER community and the public. Steve Pearson of the Institute for Clinical and Economic Review described a seizure medication study that was zeroing in on how many seizures a child had a week. A parent of one of the subjects noted that the drug that prevented the most seizures also made her child “a zombie” who could not stay awake in school.

The study would have been better if the patients and their families were involved as early as possible to identify questions that matter to the patient, not the researcher. Nussbaum described a Mayo Clinic Proceedings study of 56,000 children where the conventional wisdom that the asthma patients needed to use their inhaled steroids more to avoid ER visits and admissions was upset by the finding that oral therapies were better at avoiding ER visits. What the providers considered a second line therapy was moved to a front line therapy in the real world.

I came away from the conference excited about both the challenges and potential of CER. It looks like the consolidation of health care providers, hospitals, health plans, pharma, and medical device companies will create a real need for aggregators that can make sure that the shared decision making tools are shared throughout American and not just in the islands of excellence like the Mayo Clinic, Intermountain, Geisinger, and other leaders in the field.

Kent Bottles is President of the Institute for Clinical Systems Improvement and blogs at the ICSI Health Care Blog.

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Comparative effectiveness research (CER) in patient care
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