Can continuous quality improvement be assessed using randomized trials? [see comment].
OBJECTIVE
Continuous quality improvement (CQI) has been implemented at least to some degree in many health care settings, yet randomized controlled trials (RCTs) of CQI are rare. We ask whether, when, and how RCTs of CQI might be designed.


METHODS
We consider two applications of CQI: as a general philosophy of management and (by analogy with the use of conceptual models from the behavioral sciences) as a conceptual model for developing specific interventions. The example of warfarin therapy for stroke prevention among patients with atrial fibrillation is used throughout.


RESULTS
While it is impractical to use RCTs to study CQI as a general management philosophy, RCT methodology is appropriate for studying CQI as a conceptual model for generating interventions. RCTs of CQI might be considered when the process change under consideration is very large, its implications (e.g., in terms of cost, outcomes of care, etc.) are very great, and the best approach is uncertain. When designing RCTs of CQI, critical decisions include (1) the unit of randomization; (2) whether the focus is on CQI as a method for generating interventions or, instead, is on specific interventions in and of themselves; and (3) the flexibility available to local personnel to modify the intervention's operational details.


CONCLUSIONS
RCTs of CQI as a conceptual model for generating interventions are feasible.
Samsa
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Center for Clinical Health Policy Research, Duke University School of Medicine, Durham, NC 27705, USA.
Matchar
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D
D000925:Anticoagulants / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy; D006302:Health Services Research / Q000379:methods*; D006801:Humans; D010346:Patient Care Management; D017064:Process Assessment, Health Care; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D012107:Research Design; D012648:Self Care; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D017749:Total Quality Management; D014481:United States; D014859:Warfarin / Q000627:therapeutic use
D000925:Anticoagulants; D014859:Warfarin