Key points
- Clinical equipoise will become more common in orthopaedics
- When treatment outcomes are subjective and have large heterogeneity, shared decision making should be used
Clinical equipoise means a situation when there is no objective superiority between two choices. The lack of superiority may be due to complete lack of data or evidence about certain conditions or due to facts that advantages of other choice are associated with equal disadvantages.
Clinical equipoise is becoming more and more common situation in orthopaedic surgery and orthopaedic traumatology. Treatment of humeral shaft fractures, Achilles tendon ruptures and clavicle fractures are great examples which show clinical equipoise between operative and nonoperative treatments. Here are simplified aspects in these conditions:
- Humeral shaft fracture: Surgery (plate fixation) greatly reduces the risk of nonunion but surgery is associated with complications such as a radial nerve injury.
- Achilles tendon rupture: Operative treatment may reduce the risk of re-rupture but is outweighed by surgery related complications, like sural nerve injury and deep infection.
- Midshaft clavicle fractures: Surgery (plating) greatly reduces the risk of nonunion but no advantage is gained in functional outcome.
There is of course many other outcome measures at play, but those give some idea what clinical equipoise means.
Some authors have proposed, however, an objective hierarchy in outcome measures. One model applied to orthopaedics was published by Lubbeke in EOR [1].
Mortality is a hard outcome and naturally above all others. But mortality very rarely is an outcome which would be feasible to include in shared decision making (SDM) process when considering clavicle fractures or Achilles tendon ruptures. Patient who is able to participate in SDM rarely are in condition in which a mortality would be deemed as a relevant risk or outcome.
Outcome measure hierarchy includes “surgery related complications” under category “Survival in Health status achieved or retained” and “time to return to work” under category “Process of recovery“. I am not sure whether this hierarchy somehow prioritizes these but I am absolutely positive that there is very large variability how these outcome are valued by our patients. Some patient may be ready to have a risk of nerve injury to achieve fast return to work and some patients may want to avoid all possible complications regardless of return to work. These are all related to patient values, preferences and expectations. Treating physicians or surgeons can´t values these but we should go to our patients and ask and find out their perspective to these.
In a case of clinical equipoise we must proceed to SDM when making treatment decisions. This will become more and more important in future in orthopaedics. My view is that the higher the number of possible outcomes, greater the heterogeneity or subjectivity of these outcomes, the higher is the need for SDM. Below I have also described the components of SDM [2].
References
1. Lubbeke A. Research methodology for orthopaedic surgeons, with a focus on outcome. https://doi.org/10.1302/2058-5241.3.170064
2. Bomhof-Roordink H et al. Key components of shared decision making models: a systematic review. http://dx.doi.org/10.1136/bmjopen-2019-031763