Risk, safety, and the dark side of quality.

Clinical risk management was initially considered a means of controlling medical negligence litigation. Gradually, however, the need systematically to examine the underlying clinical problems became apparent, together with the need to care for injured patients rather than simply treating them as potential litigants.1 Though driven by anxiety about litigation, risk management has the potential to act as a gateway into a more important problem, which current quality initiatives have not adequately addressed: injury to patients. Can care that is actually harmful be encompassed in traditional frameworks of quality, such as Maxwell's dimensions of effectiveness, efficiency, appropriateness, acceptability, access, and equity?2 Certainly harmful treatment will be ineffective, inappropriate, and unacceptable but these terms imply an absence of quality rather than actual danger or harm. Maxwell's dimensions are important, but, in the positive way they have been interpreted, have perhaps directed attention away from quality's darker side. Iatrogenic effects of drugs and other treatments have been recorded in many studies, but only recently has the scale of injury to patients become apparent. The Harvard study found that patients were unintentionally harmed by treatment in almost 4% of admissions in New York state. For 70% of patients the resulting disability was slight or temporary, but in 7% it was permanent and 14% of patients died partly as a result of their treatment.3 Serious harm therefore came to about 1% of patients admitted to hospital. Similar findings were reported from Colorado and Utah in 1992 (personal communication, T Brennan). A …