Table 1

Challenges that distinguish quality improvement (QI) from traditional clinical research

	Typical clinical research	Typical QI
‘Messier problems’ in QI Outcomes and goals less well defined, settings less controlled	In the highly controlled setting of a clinical trial, what effect do drugs A, B and C have on X, Y and Z well-defined outcomes in the following highly selected patient population?	In the setting of routine care, does reorganising the following A, B and C aspects of care delivery significantly improve X, Y and Z outcomes related to quality of care (usually not nearly as easily defined or measured as standard clinical outcome) in an unselected population?
Complex interventions QI interventions require much more description to understand and to permit replication Who performed what functions in the ‘multidisciplinary team’? What exactly did the electronic registry do? Who were the ‘project champions’ and how were they selected?	Patients in the intervention group received drugs A, B and C at such-and-such doses over the specified time period; the control group received placebo	Intervention included multidisciplinary teams, an electronic patient registry to track key aspects of disease management and generate reminders to patients and providers, project champions to help engage clinicians and educational conferences held. Control group received usual care, which consisted of x, y and z processes of care
Context plays a crucial role What motivated the intervention? What institutional features provided direct or indirect support for the intervention? What internal and external incentives might have affected the behaviours of participating clinicians and patients?	The intervention took place in a teaching hospital with N beds and access to such-and-such support services and technologies	The intervention was developed after a critical incident resulted in a patient death and received attention in local news media Senior management supports the intervention through periodic messages and facilitating necessary changes in the clinic's information systems A national system for public reporting of institutional performance included outcomes affected by this intervention