To The Editor:
The article "Nonoperative Treatment Compared with Plate Fixation of
Displaced Mid-shaft Clavicular Fractures. A Multicenter, Randomized Clinical
Trial" (2007;89:1-10), by the Canadian Orthopaedic Trauma Society, is an
excellent, well-conceived, and well-executed prospective randomized trial on a
question of current clinical interest. The authors deserve our congratulations
and our gratitude.
I have only one small complaint with the conclusion, namely, the authors'
claim that the study "supports primary plate fixation of completely
displaced midshaft clavicular fractures in active adult patients."
In fact, the study does no such thing. This study provides outcomes data to
guide the surgeon and the patient regarding the management of a particular
case at hand. Even if "operative fixation of a displaced fracture of the
clavicular shaft results in improved functional outcome and a lower rate of
malunion and nonunion compared with nonoperative treatment at one year of
follow-up," not all patients should select this option as, for some
patients, the costs might still outweigh these benefits.
As we knew even before this study was undertaken, operative fixation is to
be chosen if, and only if, the balance of personal costs and benefits given
the anticipated results tilts in that direction. This study helps us to make
that decision with greater confidence, but it does not "support"
one treatment or another: after all, a study can be said to
"support" a particular treatment approach over another only when
the two treatments are completely identical in terms of cost and risk, and one
offers a superior outcome. In all other cases, the study merely offers grist
for the decision analytic mill.
(I should add parenthetically that when I cite this study in my discussions
with patients—and I will—I intend to tell them three things: [1]
that the reported surgical outcomes in it in all likelihood represent an upper
bound on the expected results, as this study was conducted at trauma centers;
[2] that because there was no patient blinding, the datum regarding the
patients' perceived satisfaction is potentially biased to the point of
meaninglessness by cognitive dissonance—i.e., patients who subject
themselves to surgery are psychologically inclined, and indeed will convince
themselves, to believe that the surgery has helped; and [3] that the absence
of major surgical complications in this particular study does not mean that
their risk is zero.)
One might say that I am like the man in the cliché, given an inch
and now demanding a yard. I hope my comments are taken not in that spirit, as
I am truly impressed with this work. Yet this excellent report serves to
illustrate a glaring deficit in our literature: we have not grappled with (let
alone solved) the problem of integrating outcomes data into a decision
analytic model of patient preferences. Within the rubric of evidence-based
medicine, this paper is probably the first, and not the last, word on how to
manage clavicular fractures.