One of the most influential trials in cardiology over the past 25 years was the GISSI 1 study, which demonstrated the beneficial effects of administering a medication called streptokinase after a heart attack.2 GISSI involved more than 11,000 patients in 176 coronary care units over 17 months. Its total cost was less than $500,000. And the time it took to be disseminated from research to practice? Merely months.
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.3 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.
Of course, not all research questions can be addressed in a practice environment. For instance, this approach may not be the best way to develop biomarkers for mental illness or test out a novel medication. But some important questions are being addressed already-in a way that is faster, cheaper and potentially better-than they might have been addressed using more conventional research approaches. Currently through MHRN, trials are being conducted to study a behavioral therapy to treat perinatal depression and a preventive suicide intervention.
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.4 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 still developing. But the MHRN team has already built a data warehouse to manage information, created standard definitions of mental health events, and developed a standard toolkit of mental health assessments. An active advisory board of stakeholders is guiding their work. And, much more will be done to harness the research power of large healthcare practices - just imagine the questions that can be answered with potential access to 12 million patients. MHRN is providing an important new model for a learning health care system, one which does not need 17 years or even 17 months to bring research to better patient care.
- Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico (GISSI).
- GISSI . Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Lancet 1986 Feb 22;1(8478):397-402. PMID: 2868337
- Balas, E. A., & Boren, S. A. Yearbook of Medical Informatics: Managing Clinical Knowledge for Health Care Improvement. Stuttgart, Germany: Schattauer Verlagsgesellschaft mbH; 2000. pp 65-70.
- Matthews S. New NIH effort seeks to find ways to make trials run smoother. Nat Med. 2012 Nov;18(11):1598. PMID: 23135498