Case record review of adverse events: a new approach

The use of case record review to identify adverse events has been important in the drive to improve patient safety. ^{1, 2} The Harvard Medical Practice study ³ carried out in New York in the mid 1980s provided powerful evidence of the scale of harm to patients in hospital. These initial findings were substantiated in further studies in the United States, ⁴ in Australia, ⁵ the UK, ⁶ Denmark, ⁷ and New Zealand, ⁸ and there are ongoing studies in other countries.

The basic methodology was developed in the early 1970s for the Californian Insurance Feasibility Study. ⁹ Retrospective case record review studies are carried out in two stages. First, using Review Form 1 (RF1), medical records are screened according to 18 predefined criteria (for example, unexpected death, hospital acquired infection/sepsis, unplanned return to the operating theatre) to identify records of patients more likely to have suffered an adverse event. Records meeting one or more of the screening criteria are forwarded for clinical review using Review Form 2 (RF2). In this second stage trained clinicians examine each case record in detail to determine whether or not an adverse event has occurred and to extract information about the nature and causes of adverse events. Each research group ^{4- 8} made minor modifications to the RF2, adding or subtracting specific questions, but the basic format used in the Harvard study ³ was maintained.

The methodology of case record review has considerable strengths. It has provided a more complete indication of the incidence of adverse events or critical incidents than reporting systems, even when they are backed by additional monitoring by a dedicated risk manager. ¹⁰ Familiarity and other biases are reduced when external independent assessors are used to conduct the review. The review forms provide a standardised method of recording and data collection which is robust when used on a random sample of case records. The epidemiological data obtained are potentially useful for comparative studies, although any comparisons need to take account of variations in methodology, particularly with the definition and inclusion criteria.

Readers are invited to respond to the three questions listed at the end of the accompanying commentary by Ross Wilson on page 402 by using the rapid response function http://qhc.bmjjournals.com/cgi/eletter-submit/12/6/402 .

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