Yet more health IT articles based on functionalist and determinist assumptions of the general format “what is the impact of technology X on outcome Y"

The article "Tensions and Paradoxes in Electronic Patient Record Research: A Systematic Literature Review Using the Meta-narrative Method" by Greenhalgh, Potts, Wong, Bark and Swinglehurst at University College London appeared in the Dec. 2009 Milbank Quarterly. I wrote about it extensively and quoted it at this post. A key statement:

... This review has also identified some areas where more research does not appear to be needed ... [including] simplified experimental studies based on functionalist and determinist assumptions of the general format “what is the impact of technology X on outcome Y?” or variations thereof ... the circumstances in which they add value are more limited than is often assumed.

We [also] believe that surveys of attitudes of patients or staff towards ‘the EPR’ or ‘computerization’ which are not adequately contextualized have almost no enduring value.

So guess what was just published in the NEJM?

An article based on functionalist and determinist assumptions of the general format “what is the impact of technology X on outcome Y."

In a special article entitled "Electronic Health Records and Quality of Diabetes Care", NEJM August 31, 2011 (link), a study was performed in which the researchers:

... compared EHRs with paper-based records in a long-term regional collaborative that seeks to improve care and outcomes for patients with chronic conditions.

They found that:

... EHR sites were associated with higher levels of achievement of and improvement in regionally vetted standards for diabetes care and outcomes. Our findings focus on composite standards, although the results were similar for virtually all component standards.

This is not really news. I had the same results in a more limited EHR data-based study of diabetics ... in 1997.

As I've often written, health IT can be of great benefit...but only if done well. (I have to frequently repeat that there is massive, perhaps wicked complexity behind those simple two words "done well.") When not done well, disaster can strike.

There are no statistics in in the NEJM article regarding complications, "close calls", patient injuries, or patient deaths due to the implementation of health IT. I sincerely doubt the incidence was zero. Their dismissal or lack of mention is common in the medical and health IT literature and seems to reflect an amoral, pervasive paternalism in medicine. The amoral paternalism in turn seems to be a repeat of the attitudes towards experimentation that led to the many human subjects protections that apply everywhere else in biomedicine (link) - except computing - e.g.:

45 CFR 46 Protection Of Human Subjects

Guidelines for Conduct of Research Involving Human Subjects at NIH (Gray Booklet) (pdf file)

The Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research

Nuremberg Code Directives for Human Experimentation

World Medical Association Declaration Of Helsinki

To their credit, the NEJM authors did issue several caveats:

... we compared sites that had sophisticated EHR systems with paper-based organizations that, as safety-net practices, care for a vulnerable patient population and may have fewer quality-related resources than other paper-based practices ... Our results, showing accelerated improvement in care and outcomes, should encourage those concerned that the quality of ambulatory care may fail to improve with increased adoption of EHRs [per numerous past studies - ed.] ... our study did not determine changes in achievement after the conversion from paper to electronic records, which would provide more compelling evidence of the benefits of EHRs.

One might wonder how the tens or hundreds of millions of dollars spent on EMR's might compare, with regard to disease management, with the results achieved by hundreds of dedicated people who could be hired for that purpose for far less money. In other words, the ROI issues of the health IT investment vs. alternatives are not addressed (they rarely are), and truly robust RCT's were not performed comparing the two alternatives.

Greenhalgh et al. also wrote in the aforementioned Milbank article:

... as a cross-cutting theme in all the above areas, the realpolitik of EPR projects within and between organizations and interest groups should be more explicitly explored ... Orlikowski and Yates have called for more research on the “messy, dynamic, contested, contingent, negotiated, improvised, heterogeneous, and multi-level character of ICTs [information & communications technologies - ed.] in organizations” (page 132) (Orlikowski and Yates 2006).

We suggest that sponsors and publishers eschew sanitized accounts of successful projects and instead invite studies of the EPR in organizations that “tell it like it is” – perhaps using the critical fiction technique to ensure anonymity (Winter 1986).

There's no trace of that in the new NEJM article. Where health IT is concerned, that's where the money is (no pun intended) in learning how to "do health IT well."

-- SS

Millions for tribute, but not one cent for defense: If hospitals cannot afford to legally defend EMR mishaps, should they be investing in them?

Imagine an airline going out and buying new multimillion-dollar jets with increased fuel efficiency and that produce less pollution. However, they knowingly buy them under conditions of not being able to afford to perform complete diagnostics/forensics for the FAA when something goes awry and a plane malfunctions or crashes.

Absurd?

Apparently not in the domain of healthcare IT.

The hospital where my mother was injured (now of blessed memory as a result) has still refused to substantively answer EMR-related questions, after a motion by my mother's attorney to compel discovery.

As part of their legally sworn-truthful response they write:

"The burden and expense of more detailed responses would put a substantial drain on the hospital's limited resources."

If this is true, perhaps hospitals (which generally do have limited resources) should not be spending tens or hundreds of millions of dollars on electronic medical records, a still-experimental technology (link).

It also causes concern about the maintenance state of the current technology.

The general point of which this is a specific example is this:

If hospitals cannot afford to defend/produce forensics for the technology when mishaps inevitably occur (such as in the Feb. 2010 FDA internal memorandum on health IT related mishaps, link, which the director of CDRH states are likely the "tip of the iceberg, link), then perhaps hospitals need to rethink the initial investment and ongoing maintenance/upgrading costs until the technology is more mature.

Should the motto of hospitals be "Millions for IT tribute, but not one cent for defense?"

Finally, in the same brief claiming poverty, I, now representing my deceased mother was referred to as a "self-described expert in computerized medical records" and "critic of use of computerized medical records in hospitals" (as opposed to the reality of my being a critic of misuse of computerized medical records, especially deficient ones, in hospitals).

Just to further nail that point down as to my being a health IT amateur and Luddite, they also included as an attachment to their brief my entire CV and publications history -- 17 pages long - as retrieved from http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=about, picture included. (Perhaps I should send the hospital a thank-you note for introducing me to the judge, without my having to lift a finger.)

Also issued were subpoenas for another fifteen or so doctors and practices that saw my mother, in addition to many others in past subpoenas. These records, mostly paper, will need to be reviewed. This will likely be a very profitable piece of work with many billable hours for the retained defense firm's lawyers.

All this was more than one month after the state's Medicare Quality Improvement Organization found my mother's care "did not meet applicable professionally accepted standards of healthcare", and the deficiencies led to the catastrophic "subsequent medical complications" that she filed a complaint about while still lucid. Medicare also set up a monitoring program at the facility "for several quarters" as a result. (This was not mentioned in the defendant's brief to the court.)

In effect, for probably $300+ per hour for legal services in the attempt to defend a case Medicare itself found not to have met applicable professionally accepted standards of healthcare, the hospital seems to have plenty of money.

Again, the general point here is this:

I believe this type of behavior is not atypical for hospitals today, and is likely another unfortunate manifestation of the medical leadership deficiencies and ethical gaps (e.g., at link, link) commonly noted on this blog.

-- SS