Something Not Unlike Research

Outcomes Measurement and Intellectual Property Rights

post by Bill Gardner

This is a message for health researchers or psychometricians who develop diagnostic instruments or patient-reported outcomes measurements, and for clinicians and health organization leaders who use them: 

Please read Newman and Feldman's article in today's NEJM on "Copyright and Open Access at the Bedside."

The authors recount the intellectual property (IP) history of the Mini-Mental State Exam (MMSE). The MMSE has been under copyright since it was developed, but was widely and freely used. The authors of the MMSE have more recently sought to profit from their IP. Moreover, they have raised copyright challenges to an alternative open access mental status exam. They are impeding the use of standardized mental status exams, and if so they may be harming patients.

Newman and Feldman argue for an extension of the open source copyleft approach to IP to instruments:

Copyleft is a general method for making a program (or other work) free, and requiring all modified and extended versions of the program to be free as well.

Most instruments have no commercial prospects and attempting to sell them will just waste your time. For most instrument developers, copyleft is simple common sense.  

There is, however, an interesting counter example. If you have anything to do with child mental health, you know about the Achenbach Child Behavior Checklist (CBCL) and its many sister instruments. Achenbach charges for his instruments and protects his IP. Nevertheless, the CBCL has been cited in thousands of research projects and is routinely used by many clinicians, even though there are competitors that can be used for free. Why has the CBCL flourished? Achenbach has consistently developed and improved the instruments. 

I believe that the future of mental health assessment and patient-reported outcomes is in computerized adaptive tests (CATs) that are continuously improved as assessment science improves and the prevalence of disorders changes. (I better believe this, since I am a PROMIS co-investigator.) To realize this future, we will need to identify the IP and business model to support an on-going non-profit organization that develops instruments and can deliver them to clinicians and patients. There is clearly much to learn from the free software movement (e.g., here or here).

The Prevention and Public Health Fund: Where is the money going?

post by Bill Gardner

Evidence-based strategies for preventing chronic diseases are essential for improving the health of current and future generations. So it is distressing to read Sarah Kliff's reporting on the political jeopardy of the Prevention and Health Fund:

Republicans have regularly attacked the $16 billion investment [over 10 years] in programs meant to reduce chronic diseases and improve Americans’ health. Wyoming Sen. Mike Enzi has quipped that the program was a “slush fund” for jungle gyms... “There’s certainly concern among the public health advocates,” says Jeff Levi, who chairs the new National Advisory Group on Prevention, Health Promotion and Integrative and Public Health “The concern is will it fall into a catch all category of things that can be cut, and that’s a challenge.” ...The White House proposed slashing its budget for the first time in its last deficit reduction proposal. House Republicans, meanwhile, would like to zero out the program’s funding in their budget...“The question is: are we funding the status quo, are we funding the stagnant quo, or are we getting an effort...that’s transformative?,” Maryland Sen. Barbara Mikulski vented at a Senate hearing on the fund last week.

Sadly, I think there is something to Sen. Mikulski's concerns. I looked at what the Fund is doing in the state of Ohio. The graph shows how much money will be spent on three types of activities in Ohio over 10 years (the vertical axis is in $1000s). The categories are:

1. Community and Clinical Prevention: Prevention activities that have been shown to be effective in reducing health care costs and promoting health and wellness. Specific activities include: a) Assisting communities with the integration of primary care services into community-based mental & behavioral health settings, b) HIV Prevention, and c) Tobacco Cessation. 
2. Public Health Infrastructure: To strengthen state and local capacity to prepare health departments to meet 21st century public health challenges and support the training of existing and next generation public health professionals. The money supports information technology, laboratories, public health training, and something called 'capacity building'.
3. Primary Care Training: Spending to expand the primary care workforce. These are training programs for (in order of increasing spending): State health care workers, physician assistants, advanced nurse practitioners, and primary care physicians.

There is an argument to be made for each of these categories of spending. But I'm concerned about the priority of infrastructure and training programs relative to actual community interventions. The latter appear to be getting less than $100,000 / year. The details will matter here. Are the Infrastructure and Primary Care Training funds being spent in ways that will generate a sustained increase in evidence-based preventive care by primary care practitioners? If so, the money could be well spent. If not, we will just have more doctors doing more of the same. I hope that the Senators push the Prevention Fund managers hard on this point.

 

 

 

eHealth technology enhances active self care, but is not a substitute for it

post by Bill Gardner

Here is a cool new eHealth technology: a bone cast with wireless telemetry of muscular activity. It is

threaded with electromyographic (EMG) sensors that track muscle activity around a fracture site. Created by Pedro Nakazato Andrade, a recent graduate of the Copenhagen Institute of Interaction Design, the cast can relay data wirelessly to physicians and physical therapists. It shows how much mobility a patient has in an affected area and how physical therapy and daily activity are affecting the area, allowing clinicians to adjust treatment accordingly.

The key thing this device does is measure "how physical therapy and daily activity are affecting the area." It is not, itself, a device with therapeutic activity. More to the point, it does nothing if you are not doing your physical therapy -- which is most of us. eHealth will fundamentally change health care only in the context of interventions that successfully engage patients in self-care. 

I've overstated the point somewhat. My motivation to adhere to my physical therapy regimin will likely increase if that I know (or at least believe) that that regimin will work. So if the smart cast makes therapy more effective, I'll be more likely to do it.

The problem is that eHealth technology is often presented as if it were a pill: you put it on and you get better. Rather, you put it on, and your self-care becomes more effective. And getting patients to effectively and consistently care for themselves is the hardest problem in chronic care. 

Jimmy Connors was once asked, what are the most effective exercises to improve your tennis?Connors: "The ones that you will actually do."

Are people ready for Personal Health Records?

post by Bill Gardner

A Personal Health Records (PHR) is a record of your medical and health data that you access and maintain yourself. In theory, PHRs should empower patients to better understand and manage their health care. Google Health, however, was unable to build up a sufficient user base to make it viable even for a very well funded and patient company. This may be one reason why:

This week, I talked with Dan Russell, a search anthropologist at Google, about the time he spends with random people studying how they search for stuff. One statistic blew my mind. 90 percent of people in their studies don't know how to use CTRL/Command + F to find a word in a document or web page! I probably use that trick 20 times per day and yet the vast majority of people don't use it at all. "90 percent of the US Internet population does not know that. This is on a sample size of thousands..." 

It may be some time before PHRs can make a significant contribution to population health.