By Bob Wachter

(Parenthetically, this was the study, led by Genius-Award Winner Peter Pronovost, that the Feds tried to shut down over the failure to obtain informed consent, an action that caused me to blow my gasket last year. The subsequent broo-ha-ha, fueled in large part by readers of this blog, led to a change
in the federal policy regarding informed consent for quality
improvement programs. Accordingly, the new 10-state roll-out of the
CABSI program is considered “quality improvement” and thus exempted
from the need for individual consent from providers and patients,
Heaven be Praised.)

Last month’s surgical checklist study, one of the first initiatives of the WHO’s World Alliance for Patient Safety (spearheaded by the UK’s indefatigable and charismatic Chief Medical Officer, Sir Liam Donaldson) is, if anything, even more
amazing than the Hopkins/Michigan effort. Why? Instead of changing the
behavior of intensivists and ICU nurses, this one involves surgeons.
And instead of changing practices in ICUs in a single U.S. state, this
one did it in hospitals in 8 different cities around the world, ranging
from Seattle to Manila, and Auckland to Amman. It was an audacious
effort, which makes its results all-the-more-remarkable.

(In
fact, it is hard to fully explain the tremendous decrease in surgical
deaths and complications based on the nature of the intervention,
leading some to question whether the results owe to a Hawthorne effect
and are replicable. We’ll see, but for now I think the study is
impressive and the intervention is likely to work elsewhere, albeit
perhaps not quite as well as reported in the NEJM. OK, that’s enough parenthetical paragraphs for one posting.)

Gawande articulated (a particularly apt word in the case of this gifted writer) his zeal for checklists in his New Yorker article, “The Checklist.”
And Pronovost is passionate about everything – he could make you joyful
about doing your laundry. But what is so impressive about both these
superb leaders and the projects they spawned was something more wonky
than stirring: their insistence on a rigorous measurement strategy.

Which brings me to the recent wrap-up of the 5 Million Lives Campaign, the Institute for Healthcare Improvement’s (IHI) much-touted sequel to its 100,000 Lives Campaign. As you may recall, I critiqued
the earlier campaign for using fuzzy math in estimating its “lives
saved,” among other things. I worried aloud that the short-term high
that came from celebrating the 100,000 Lives Campaign’s achievements
might prove to be as ephemeral as that achieved by crack cocaine:
without measurable results, it is awfully hard to generate
sustainability, and the day-after hangover can be nasty.

And so
it was with the 5 Million Lives Campaign, which ended with a relative
whimper, sans the press hoopla that accompanied the 100,000 Lives
effort. To IHI’s credit, there was no preening this time about lives
saved, or defending of largely indefensible statistics. In fact, as the
Boston Globe reported in December after the campaign’s end,

[the
IHI] does not have numbers to measure the effect of its efforts over
the last two years, IHI vice president Joseph McCannon said… But
stories of reduced infection rates, improved medication management, and
better cardiac care have been flowing in from the more than 4,000
hospitals participating in the campaign, he said…

The
next stage, added McCannon, was the addition of three new “planks” to
the 5 Million Lives practices: linking hospitals’ patient safety
efforts to cost savings, preventing nosocomial urinary tract
infections, and promoting the WHO surgical checklist program described
above. In addition, IHI launched a tool, known as the “Improvement Map,” to help hospitals keep track of their various quality and safety initiatives.

This
is all fine, but I get the sense that the absence of results took some
wind out of the IHI’s sails. (Of course, that’ll be nothing compared to
the wind removed if – as has been reported in the blogosphere – IHI founder and CEO Don Berwick becomes head of the Centers for Medicare & Medicaid Services).

What
is the lesson in all of this? While baking rigorous measurement into
large-scale tests of quality improvement or patient safety practices
costs some time and money (doubtless the reason why IHI chose a
Nike-like, “Just Do It” implementation strategy), the choice to eschew
such measurement comes at a high cost. When the Michigan ICU study
ended in a seminal New England Journal paper, there was
tremendous momentum to do more, based largely on the unassailable
evidence of lives saved. Not only did AHRQ jump at the opportunity to
fund a rollout to 10 more states, but two private philanthropists gave
Pronovost another $2.5 million to disseminate it even more widely! We
haven’t heard the upshot of the WHO surgical checklist study yet, but
you can bet that it will spark more efforts to promote this and similar
interventions. Not just because the premise (marrying the use of
checklists with culture change) made sense or because Gawande is a
wonderful writer and a great guy, but because they demonstrably worked.

At
the end of the AHRQ meeting last month, all the advisory board members
were asked to identify the highlight of the day. Mine was this: I was
floored by the blend of passion and scientific rigor shown by Pronovost
and the other members of the project team (he’s being aided by the
American Hospital Association’s Educational/Research Trust, along with
several leaders from the Michigan effort).

Why did I focus on
this combination of passion and scientific rigor? Because too little of
the former and you can’t get projects this complex and messy off the
ground. And too little of the latter, you risk finishing the project
and not knowing whether you’ve accomplished anything of importance.

In other words, this is a Goldilocks problem and both Gawande and Pronovost, and their superb teams and funders, have gotten it just right.

Robert Wachter is widely regarded as a leading figure in the modern
patient safety
movement. Together with Dr. Lee Goldman, he coined the
term "hospitalist" in an influential 1996 essay in The New England
Journal of Medicine. His most recent book, Understanding Patient
Safety, (McGraw-Hill, 2008) examines the factors that have contributed
to what is often described as "an epidemic" facing American hospitals.
His posts appear semi-regularly on THCB and on his own blog "Wachter's World."