A strategy must be defined which drives you to achieve a set of target outcomes. These are often expressed as a strategy map.

Hospitals can have an effective strategy for an inappropriate outcome, depending upon what they are trying to achieve. For example, consider this hospital's strategy of maximizing income received from the government, regardless of the value they delivered to their patients.

There were four key components to Dr. Berwick's 100,000 lives campaign:

• a well-defined set of evidence-based, strategic interventions that were designed to improve outcomes, and that achieved community-wide acceptance
• a set of key measurements that could be used to reinforcing the drivers for those strategic interventions, and support tracking progress towards the desired outcomes
• an operations network to collect feedback, build and track momentum across the networks of individuals and sites, and provide accountability for implementing improvements
• a focus on communications, to reinforce what the changes mean, demonstrate that feedback is being acted upon, publicize the campaign’s progress, and celebrate successes

In a recent article in the Journal of the American Medical Association, Don discusses a key difference in the 'systems approach' which IHI has employed, compared to traditional 'experimental' approaches: 

In Realistic Evaluation, Pawson and Tilley ... argue strongly for methods that go beyond the classic "successionist" format of experimental design that dominates the usual toolkit of evidence-based medicine. They use the shorthand OXO to refer to such designs: observe a system (O), introduce a perturbation (X) to some participants but not others, and then observe again (O). Properly measured, the changes in outcome are, with a calculable degree of certainty, attributable to the perturbation.

Pawson and Tilley assert boldly that when studies use the OXO paradigm to evaluate social programs (that include most system improvements in medicine), the result, in the aggregate, is almost always "a heroic failure, promising so much and yet ending up in ironic anticlimax. The underlying logic . . . seems meticulous, clear-headed and militarily precise, and yet findings seem to emerge in a typically non-cumulative, low-impact, prone-to-equivocation sort of way." Indeed, the assertion either that nothing works or that the results are inconsistent and more research is needed is a typical conclusion from classical OXO evaluations of quality-improvement efforts in health care, such as rapid response teams, chronic disease management projects, or improvement collaboratives.

Pawson and Tilley suggest an alternative evaluation model, which they call CMO, context + mechanism = outcome. They write, "Programs work (have successful ‘outcomes’) only insofar as they introduce the appropriate ideas and opportunities (‘mechanisms’) to groups in the appropriate social and cultural conditions (‘contexts’)." ...

Many have pointed out that there is, and ought to be, a strong relationship between what is studied and how it is studied. To study a linear, mechanical or natural, tightly coupled causal relationship most efficiently... an OXO design ... may be exactly correct. But with social changes—multicomponent interventions, some of which are interpersonal, all of which are nonlinear, in complex social systems—then other, richer, but equally disciplined, ways to learn (such as CMO designs) are needed:

• Use assessment techniques developed in engineering and used in quality improvement areas, such as statistical process control, time series analysis, simulations, and factorial experiments

• Reconsider thresholds for action on evidence

• Rethink views about trust and bias. Almost always, the individuals who are making changes ... know more about mechanisms and context than ... evaluators... A better plan is to equip the workforce to study the effects of their efforts, actively and objectively, as part of daily work.

• Be careful about mood, affect, and civility in evaluations. Academicians and frontline caregivers best serve patients and communities when they engage with each other on mutually respectful terms. Practitioners show respect for academic work when they put formal scientific findings into practice rapidly and appropriately. Academicians show respect for clinical work when they want to find out what practitioners know.