Table 1

Features of the independent data collection systems for incidents, adverse events and complaints used in this study

Incident reportingAdverse event reportingPatient complaints handling
Targeted informationProcess problems (regardless of patient harm)Patient harm (regardless of process problems)Patients’ negative experiences with healthcare or hospital services
Local implementationImplemented in 2008, and required for all Dutch hospitals since 2016Implemented in 1997,17 and a governmental quality indicator since 2004*Has long been in place, but a complaints officer is required since 2016
ReportersAll medical staff but mostly nursesPhysicians, residents or physician assistantsPatients and their families
Nature of reportsShort stories that describe how a process problem happened (eg, medication error)Medical term (eg, surgical site infection) and severity score reflecting consequences for patientsShort or longer letters explaining why patients are unsatisfied (eg, felt not taken seriously)
Data storageReported into, and stored in, a hospital-wide digital database (on paper until mid-2011), and reviewed by a dedicated committeeReporting system is integrated in electronic medical records (on paper until mid-2011), and data are stored in a digital format.Archived in binders rather than in digital databases by complaints handling office22 with copies sent to departments involved
Strengths and limitationsUnique in revealing hazards before harm is inflicted, but unfit for monitoring due to risk of under-reporting and unknown number of patients at risk (denominator)Useful for benchmarking and to inform patients on adverse event risks, but risk of under-reporting and lacks of contextual information (eg, whether preventative measures were taken)Unique information from the patient perspective to reveal issues not captured elsewhere, but unstructured data of low and unreliable volume22
  • * In 2004, at least 75% of the Dutch hospitals had adverse event registries for interventional specialties, such as surgery, gynaecology and orthopaedics.