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).

Comments

[Patrick McGrath]

The Child Behavior Checklist is the dominant North American instrument but the Strengths and Difficulties Questionnaire, www.sdqinfo.coma freeware instrument, is becoming very widely used, especially outside of North America. As the developer of a currently copyright set of distance treatment modules for child mental health, Strongest Families, we have wrestled with the issue of copyright or freeware models. There are two issues with freeware. The first is insuring the proper use of an instrument of any sort that can be freely used, the second is how to fund the ongoing development of the material.

[Eric]

I think the biggest issue with the MMSE is the 3 decades of benign neglect in which a market opened up for its use. Once the MMSE dominated the market, the copyright holders decided it was time to cash in. Why did the market open up for the MMSE? Because clinicians, researchers, and educators emphasized its ease of use, including the ability to use it for free. As these no longer hold true, I have made a point to boycott the MMSE.

[Brad F]

Bill,
Three points:

1) Given most clinical instruments are developed by academics or folks working for institutions accepting govt dollars, the involvement of public funding is virtually assured. The finer points of how one deduces salary underwriting is beyond me, but one wonders whether 5, 10, or 30% of public dollar contribution changes "ownership," or not.

2) Inertia plays a role re: your example of CBCL above. Interestingly, clinicians are inculcated with the use of UptoDate and ePocrates. Most folks are familiar with the tools or at least the brands. Even when institutions offer free alternatives, some better, migration is slow. Its the first one out of the gate theory. Once your hooked...

My guess is the issue, while important in the piece, will resemble illegal MP3 downloading. Clinicians speak the language of MMSE, so for the greater good, we justify poaching. I am not saying its right, but there is always an altruistic tinge if activity involves patient care--thus, we "steal" with a clean conscience. It will continue, to the detriment of the creators--better or worse.

Great pick up and thanks for posting this. I am making a mental note.

Brad

[Bill Gardner]

Brad,
Sorry for being slow to respond. Agree with your points. In your experience, what is the best way to get clinicians to try a new instrument?

[Brad F]

Surprisingly, free trials dont seem to generate success (I am thinking of big ticket apps and online resources). As we know from behavioral economics, and docs are no different, trust, comfort, and hassle avoidance keeps us using the same tools. This assumes that the old ones are kept up to date and are not faulty.

Thinking about non-proprietary instruments that are common in my world, its slow adoption and recurrent mentions in influential journals that move folks. A few big trials in NEJM, JAMA, or high end specialty journals that demonstrate superior operating characteristics and equivalent or better bedside application, and it will happen. Intuitive though, and its the better mousetrap thing.

MMSE is so ingrained however, its like the beta vs VHS thing (VHS won, but should not have). MMSE is really sticky, as we all know the scoring, ie, 24 cut point, etc. It will take major publications and dissemination of instrument in a few big AMCs to move th needle I think.

I liked this review, delirum (not dementia), and it gives you an idea whats out there, and choice architecture. Too much choice.
http://jama.ama-assn.org/content/304/7/779.abstract?sid=7dbe4022-6452-4cde-9ea3-de6b662d6fa0

(notice the inclusion of the MMSE)
Brad