Cautionary Tale: How to Read (and Not Read) a Study Dotted with Asterisks
One of the more interesting moments, for me, at the HIMSS Conference last month in Orlando, came during the impromptu press briefing that Karen DeSalvo, M.D., the National Coordinator for Health IT gave, on Thursday, Feb. 27. It was her first, and Dr. DeSalvo appeared slightly nervous; but she handled the grilling from an eager-to-grill press corps with aplomb.
The first question, though, came absolutely out of left field. One of the 20-some journalists gathered at the press briefing gave a very long-winded introduction to her question, and then essentially challenged Dr. DeSalvo to justify or explain the findings of a study published just the day before in the Journal of the American Medical Association. Dr. DeSalvo very politely responded that, of course, she hadn’t had time to read or review the JAMA article yet, but did address the broader implied question.
Here was the question: “Given the results of the JAMA study, Dr. DeSalvo, would you say that the patient-centered medical home [PCMH] model should be considered a failure?” Okay, then. Well, let’s plunge into the JAMA article and consider why the question was truly absurd, and what the implications are when people rush to judgment based on one narrowly focused study of specific aspects of a very broad, complex phenomenon—and then I’ll share what Dr. DeSalvo said in response to the question.
The article, designated as an “Original Investigation,” bore the title, “Association Between Participation in a Multipayer Home Intervention and Changes in Quality, Utilization, and Costs of Care,” and was written by Mark W. Friedberg, M.D., MPP; Eric C. Schneider, M.D., MSc; Meredith B. Rosenthal, Ph.D.; Kevin G. Volpp, M.D., Ph.D.; and Rachel M. Werner, M.D., Ph.D. Those authors performed a very detailed statistical study, with the objective being “To measure associations between participation in the Southeastern Pennsylvania Chronic Care Initiative, one of the earliest and largest multi-payer medical home pilots conducted in the United States, and changes in the quality, utilization, and costs of care.” (The study was sponsored and funded by the Commonwealth Fund and Aetna.)
Essentially, what Dr. Friedberg and his colleagues did was to identify and recruit participant leaders from 32 primary care practices participating in the Pennsylvania Chronic Care Initiative (PCCI), a statewide multi-payer medical home pilot, and compare their outcomes data around changes in quality, utilization, and costs, with data from 29 practices not participating in the PCCI program. Among the 11 clinical outcomes studied were changes in hemoglobin a1c testing, changes in normal/abnormal hemoglobin a1c status, and the execution of nephropathy monitoring, breast cancer screening, and colorectal cancer screening. Hospitalizations, emergency department (ED) visits, and ambulatory care visits were analyzed with regard to utilization. And “propensity-weighted and –adjusted costs and utilization” were analyzed for differences between patients in the two different groups, after three years of participation in the PCCI program, on the part of the participating medical groups.
So what happened? Broadly speaking, there was very little positive difference in outcomes or in cost reduction among patients cared for by the pilot-participating medical groups, versus those cared for by non-participating medical groups. Indeed, some patients cared for by non-participating medical groups actually fared slightly better in some of the outcomes categories.
The authors’ conclusion? “Despite widespread enthusiasm for the medical home concept, few peer-reviewed publications have found that transforming primary care practices into medical homes (as defined by common recognition tools and in typical practice settings) produces measurable improvements in the quality and efficiency of care. The southeast region of the PACCI, which featured relatively generous financial support from six commercial and Medicaid health plans, is to our knowledge the first multi-payer pilot in the nation to report results over a three-year period of transformation,” the authors wrote. “We found that practices participating in the PACCI pilot adopted new structural capabilities and received NCQA certification as medical homes. Our evaluation also suggests,” they added, “that the quality of diabetes care improved, but we found few statistically significant results and no robust associations with utilization or costs.”
And now come all the asterisks. First, the study’s authors freely admit that they studied primary care practices whose physicians, while participating in the PCCI pilot program, were not enmeshed in programs sponsored by large integrated health systems. These are and were smaller primary care practices. Second, as the authors note, “This pilot—the first of the PACCI regions—was focused on quality improvement for chronic conditions and featured early financial rewards for NCQA recognition, possibly distracting from other activities intended to improve the quality and efficiency of care. In subsequent regions,” the authors noted, “PACCI organizers placed less emphasis on early NCQA recognition so that practices could focus more fully on learning collaborative participation.”
In other words, for all the rigor of their statistical analysis, Dr. Friedberg and his co-authors concede that their study was limited by a number of fact ors, including the characteristics of the medical groups participating in the PACCI pilot project, the incentives built into the program being studied, the specific model of medical group organization being studied, and a host of other factors.
Yet this study, having appeared in JAMA, has received a very significant amount of attention, and frankly, it is precisely the kind of study whose findings led themselves to misunderstanding and easily overbroad interpretation.
So Dr. DeSalvo was exactly right in saying that, while she hadn’t yet read the JAMA article, the reality is that the patient-centered medical home is complex both in its conception and its execution. And now I’ll add the final part of the question from the journalist at the HIMSS press briefing. That journalist said, “If the patient-centered medical home were a drug, and a study were published in JAMA finding its efficacy questionable, wouldn’t that be ringing alarm bells everywhere?” Appropriately enough, Dr. DeSalvo immediately rejoindered that the patient-centered medical home is far from complex than any medication, and that we have a long road ahead of us as we as a healthcare system and society evaluate phenomena as complex as the PCMH.
In short, I’m with Dr. DeSalvo on this one. Let’s be very careful as we perform the first statistical studies in areas like the patient-centered medical home, lest we leap to conclusions that really will require at least a decade of development and then study, to allow leaping to. PCMHs like those involved in the PACCI pilot project are the equivalent of healthcare delivery model infants. Can we at least give them the benefit of the doubt until they mature to becoming the equivalent of teenagers? Oh, and watch out for all those scholarly asterisks along the way.