Adverse events case record review

Studying adverse events using case record review... 

Woloshynowych, M., Neale, G. and Vincent, C. (2003) Case record review of adverse events a new approach. Quality and Safety in Health Care, 12(6), 411 15. 

Reporting systems in healthcare were established in response to the scale of harm revealed by case record review studies. The studies had shown the underlying problem reporting systems were meant to provide information about adverse events on an ongoing basis. Do reporting systems actually capture adverse events successfully A number of studies have now examined this issue, coming to broadly similar conclusions (Stanhope et al., 1999 Sari et al, 2007 Blais et al, 2008). As an example, we will consider the study... 

The basic record review process is as follows. In phase I, nurses or experienced record clerks are trained to identify case records that satisfy one or more of 18 well-defined screening criteria - such as death, transfer to a special care unit or re-admission to hospital within 12 months. These have been shown to be associated with an increased likelihood of an adverse event (Neale and Woloshynowych, 2003). In phase II, trained doctors analyse positively screened records in detail to determine whether or not they contain evidence of an adverse event using a standard set of questions. The basic method has been followed in all the major national studies, though modifications of the review form and data capture have been developed (Woloshynowych, Neale and Vincent, 2003). In France, Phillipe Michel used prospeaive review, in the sense that record review is carried out close to the time of discharge on a... 

Case note review is sometimes viewed as time consuming and comparatively expensive. Nevertheless, with experience and refinement and the development of training packages (Olsen et al 2007), it can be carried out relatively inexpensively, producing systematic, detailed analyses. A few organizations, such as Royal North Shore in Sydney (Harrison, personal communication) carry out formal, annual case note reviews and use these as the basis of their quality assurance and improvement systems. Record reviews could be repeated over time, and trends studied, particularly as we would now be able to define and monitor specific types of adverse events rather than just assess the overall rates. Reliability and validity of judgement of adverse events is not as good as we would wish but could certainly be improved if specific definitions of particular classes of adverse events were developed. 

Record review revealed a by now familiar finding 11 % of patients suffered an adverse event, with about a tenth (11 cases) of these being serious and preventable. However, 23% of patients reported an adverse event and there was little concordance between the two methods. Patient reports revealed an additional 21 serious and preventable events (Table 15.1), in addition to the 11 found in medical records, thus tripling the rate revealed by record review. The true rate of incidents potentially reportable by patients may be higher still, as some interviews took place several months after discharge and patients who died or were very sick post discharge were excluded from the study. As the examples show, many of the incidents reported by patients were serious untoward events that should have been described in the medical record. 

The risk of intussusception and other adverse events temporally connected with the administration of bovine-derived rotavirus vaccine (RotaTeq, manufactured by Merck) from May 2006 to May 2008 (see also SEDA-33, 662) has been studied in children aged 4-48 weeks [23 ]. Adverse events over the next 30 days were ascertained from in-patient, out-patient, and emergency department files cases of intussusception were validated by reviewing the medical records. The study population received 207621 doses of RotaTeq , of which 42% were first doses. Five children had computerized diagnosis codes for intussusception, and 6.75 cases were expected based on historical rates (RR = 0.74). There was no increased risk of intussusception or any other adverse event. Two of five children with suspected intussusception based on diagnosis codes met the case criteria after review of their medical records. The authors concluded that RotaTeq is not associated with an increased risk of intussusception. 

A retrospective review of 1633 propofol procedural sedation records administered by paediatric hospitalists for diagnostic imaging in children between January 2005 and September 2009 were reviewed [73. The safety and efficacy of propofol procedural sedation by non-anaesthesiologists is again confirmed with a 99% case completion rate and low incidence of adverse events reported. 

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