1 Boring Old Man

^{So Insel’s NIMH has been a directed research agency, jumping on the Translational Medicine ideas of the NIH – research focused on a speedy move to clinical application. And it was more focused than that. There were any number of programs that announced topics of interest. My fantasy is that instead of sitting under an apple tree waiting for an inspiring bump on the head, researchers spend their time surfing through the NIMH web-site looking for what’s getting funded this cycle. Besides directed research, there was much ado about partnering with industry. And waves of Clinical Drug Trials – STAR*D, CO-MED, CATIE, TADS, TORDIA, etc. Rather than a funding source for creative scientists, NIMH has been pointing the way. And Insel’s NIMH has been fad-driven. Something that fits comes along, and he’s talking about it in his next blog. Pretty soon, it’s a new direction, a new program.}

From Practice to Research
NIMH Director’s Blog
By Thomas Insel
November 15, 2012

^{…Recently, there has been a lot of hand wringing about the low efficiency of clinical trials, especially in mental health. They can be slow and expensive, and may not even produce actionable findings. Even when successful, there is a distressing delay in moving an important research finding from the research clinic into practice. In fact, we usually hear that there is a 17-year lag from research to practice. That is not always the case. The polio vaccine was implemented within days of the first report of success, and new AIDS medicines have been disseminated quickly. But for mental disorders and other chronic diseases like hypertension, there does seem to be a persistent gap between what we know from research and what we do in practice. At a meeting last week at NIMH, I heard how one group is working to close this gap. Greg Simon and his colleagues in the Mental Health Research Network [MHRN] presented a new approach – we need to stop thinking about moving research to practice and start thinking about moving practice to research. That’s what MHRN does. MHRN is a network of 11 research organizations affiliated with non-profit health care systems serving 12 million patients. It is the largest research network for people with mental disorders in the nation. The idea is simple: understand what works in the real world of practice by using scientific methods, like randomization and statistical comparisons, to create a learning health care system. By linking health information databases and creating an efficient process for assessing outcomes, MHRN is working to transform the world of health care practice into a laboratory for research…}

^{Recently, the NIH Common Fund launched a broad version of this approach through its Healthcare Systems Collaboratory project with practical trials on hypertension, dialysis, cancer, and suicide prevention. This project is catching the interest of large providers and payers who need answers about what works in the real world. There is a well-described "voltage drop," or decrease in efficacy, when we move treatments from the research setting to real world practice. But efforts like MHRN and the Collaboratory, which are bringing real- world practice to research, should help to reduce this problem. These large research-based practice settings can also serve as a dashboard for monitoring the changing needs of the population or the effects of changes in health policy. For mental health, as we face an historic confluence of insurance parity and health care reform, the questions facing patients and providers are urgent. How should we deal with complex, comorbid health conditions? How can we reduce early mortality? How can we ensure fidelity of the best psychosocial treatments? What is the best strategy to personalize care? These are all pressing questions that can be answered rigorously in large practice networks with a solid infrastructure for conducting research…}

^{MHRN is based in the HMO Research Network, a consortium of 19 public-domain research centers based in not-for-profit health care systems… MHRN centers have a greater chance of efficiently answering questions that involve real-world patients and providers through joining forces and combining resources. Initial funding for the MHRN is through a 3-year cooperative agreement with the National Institute of Mental Health [U19 MH092201 “Mental Health Research Network: A Population-Based Approach to Transform Research” with total costs of $8,999,198] and through a supplement from NIMH to the existing Cancer Research Network funded by the National Cancer Institute [with total costs of $1,499,873]. This initial funding cycle supports development of a core infrastructure for collaborative research as well as four developmental research projects to test and leverage that infrastructure in specific clinical areas.}

• Practice Variation in high- and low-value care for mood disorders – At five sites, electronic records will be used to examine how patient, provider, and health system factors influence use of both proven effective treatments and treatments that increase costs without improving outcomes. This work will advance knowledge regarding variation in mental health care and develop methods for future effectiveness studies.
• Feasibility of behavioral activation therapy for perinatal depression – Across four sites, 200 pregnant women with depression detected by screening will be randomly assigned to receive structured Behavioral Activation therapy [delivered via telephone and in-person] or care as usual. This project will both evaluate feasibility of an innovative intervention and test new methods to increase the efficiency of future effectiveness trials.
• A geographically and ethnically diverse autism registry for effectiveness studies – At five sites, computerized records will be used to create a population-based registry of children with autism spectrum diagnoses. Methodologic research will examine accuracy of records-based diagnoses. A sample of affected families will be surveyed regarding costs and perceived effectiveness of treatments and will be asked to contribute biospecimens for future research. This project will both advance knowledge regarding diagnosis and treatment of autism and establish a registry and specimen repository to support effectiveness research.
• Longitudinal analysis of SSRI warnings and suicide in youth – At eleven sites, computerized records will be used to examine the effect of the FDA advisory regarding suicidality during antidepressant treatment on rates of antidepressant use and suicide attempts. This study will both help clarify the relationship between antidepressant use and suicide risk and develop methods for future policy and implementation research.

From my perspective, the deeper I looked, the worse it got. I’m not really the person to evaluate something like treating depressed pregnant women with a token-based behavior-mod regimen. My negative reaction is visceral rather than rational. But I’m a little better placed to look at treating depressed adolescents with SSRIs, because I treat them and have given a few of them SSRIs [with big time warnings]. I’ve seen occasional suicidal akithisia. I’ve had some successes. But mostly I’ve seen no effect. I spent a long session Friday with a 15 year old girl I’ve known for a while whose boyfriend had been put on an SSRI by his primary care physician recently. The kids had all watched him withdraw and become hostile in the days before he shot himself in the head several weeks ago. His friends all say, "It was the antidepressant" [recall that I live in rural Appalachia and they aren’t reading that in our weekly paper]. My patient was wearing the boyfriend’s sweater the day I saw her, and had intrusive thoughts of joining him. She has taken ADD medicine for about two years [for good reason with good results], but she stopped after her boyfriend killed himself. She wants nothing to do with medication. So that story may be a little too fresh in my mind for me to claim objectivity – but I’ll continue with that as my conflict of interest statement.