Assessing the Evidence for Context-Sensitive Effectiveness and Safety of Patient Safety Practices

The emergence of new kinds of interventions to improve health care quality and safety has led to a rethinking of traditional health services and clinical research. Interventions intended to improve quality and safety are often complex sociotechnical interventions whose targets may be entire health care organizations or groups of providers, and they may be targeted at extremely rare events. As such, evaluation of patient safety practices (PSPs) must be evaluated along two dimensions: the evidence regarding the outcomes of the safe practices and the contextual factors influencing the practices' use and effectiveness. The methodological criteria for assessing the quality of clinical intervention research and evaluation studies may be insufficient for studies of the effectiveness of organizational and behavioral change required to implement a safety practice. Indeed, researchers of PSPs often have to assess, as clinical researchers do, whether an intervention works. They also, as organizational and behavioral researchers do, need to determine whether such practices will work in their own settings, (i.e., will they benefit patients in their own organization with its unique attributes). In addition to questions of effectiveness (whether, how, and why interventions work), it is also important to consider unintended adverse consequences of implementing the safety practice. In other words, like medications, quality improvement (QI) and safety interventions can have side effects, which must be anticipated and measured.