To what extent are adverse events found in patient records reported by patients and healthcare professionals via complaints, claims and incident reports?(Research article)(Report)

Authors: Ingrid Christiaans-Dingelhoff (corresponding author) [1]; Marleen Smits [2]; Laura Zwaan [1]; Sanne Lubberding [2]; Gerrit van der Wal [1]; Cordula Wagner [1,2]

Background

For hospital managers and healthcare providers involved in patient safety issues it is important to have access to patient safety data to facilitate decisions on interventions aimed at improving the quality and safety of hospital care. Ideally there is real-time information about patient safety, capturing incidents that reflect actual or potential risks of adverse events. An adverse event is commonly defined as an unintended injury that results in temporary or permanent disability, death, or prolonged hospital stay and is caused by healthcare management rather than by the patient's underlying disease process [1].

Many countries have performed retrospective patient record review studies to identify adverse events in their hospitals [2, 3, 4, 5, 6, 7, 8, 9]. Patient record review is believed to be the most useful method for estimating the rate of adverse events among hospitalised patients [10]. However, the method has some practical disadvantages: it is time-consuming, labour intensive and expensive [11]. Moreover, retrospective record review does not provide real-time information. It is often not possible to gain additional information about the events from the people involved.

Hospitals would benefit from reporting sources, which can provide information on patient safety periodically and on demand. The value of incident reporting by healthcare professionals has been widely recognised. Moreover, it is increasingly believed that patients (or their relatives, hereafter together named "patients") can play an important role in signalling safety issues. In the report of the UK Department of Health "An organisation with a memory" [12], the importance of both sources is stressed.

So far there is little knowledge about the comprehensiveness of incident reporting systems in hospitals. A general weakness that is often mentioned in literature about incident reporting by healthcare providers is that incidents are considerably under-reported [13, 14]. A few studies compared results from record review with either incident reports or patient complaints in small scale study designs [13, 15, 16]. They found little overlap in events detected by the methods they compared and concluded that incident reporting or patient complaints alone do not provide an adequate assessment of adverse events. As far as we know, no earlier studies have reported on the completeness of both incident reporting by healthcare professionals and reporting by patients (complaints as well as claims) in regard of detecting adverse events.

The aim of our study is to get insight into the extent in which four hospital reporting systems of incidents reported by healthcare professionals and complaints and claims reported by patients cover adverse events that were identified by patient record review. We want to know if the diverse reporting systems, which are already implemented in Dutch hospitals, are individually or cumulatively useful as a method for identifying adverse events (see Box 1 for some background information about incident reporting by healthcare professionals and the procedures for complaints/claims by patients in the Netherlands).

Moreover, we are interested whether adverse events with a higher preventability and severity of consequences have a larger likelihood of being reported. It is our assumption that highly preventable adverse events might be reported relatively often, because the persons involved feel the hospital can learn from these events to prevent them in the future. Severe adverse events might have an increased chance of being reported, because of their visibility and impact on the patient. When highly preventable and severe adverse events are regularly reported in one or more reporting systems, the issue of under-reporting is less worrying than is stated in literature.

Our study has four specific research questions: 1) How many adverse events established by patient record review are also identified in one or more reporting systems of incident reports, complaints and claims? 2) What is the amount of overlap in the detection of adverse events between the reporting systems? 3) Is the degree of preventability and severity of adverse events related to the likelihood they are reported? 4) What is the sensitivity and specificity of reports for adverse events?

Incident reporting, complaints and claims in Dutch hospitals

In the Netherlands, healthcare professionals have been increasingly stimulated to report incidents or near misses within their own hospital. For the healthcare professional in 2004 reporting incidents (especially adverse events and calamities) was not mandatory by law but a consequence of healthcare quality and patients' rights legislation. It often was mandatory by employment contract. The incident reporting system is by definition meant for all incidents, including adverse events. An incident can be defined as "Any deviation from usual medical care that causes an injury to the patient or poses a risk of harm. Includes errors, preventable adverse events, and hazards." A near miss is defined as "Serious error or mishap that has the potential to cause an adverse event but fails to do so because of chance or because it is intercepted." [17]. This means that an adverse event is always an incident but an incident does not has to be an adverse event. After an incident/near miss has happened, it can be reported by filling out an electronic or paper-based report form containing, among other things, a description of the event, the time and place of occurrence and the people involved. The incident reporting committee will register …