Features of the independent data collection systems for incidents, adverse events and complaints used in this study
| Incident reporting | Adverse event reporting | Patient complaints handling | |
| Targeted information | Process problems (regardless of patient harm) | Patient harm (regardless of process problems) | Patients’ negative experiences with healthcare or hospital services |
| Local implementation | Implemented in 2008, and required for all Dutch hospitals since 2016 | Implemented in 1997,17 and a governmental quality indicator since 2004* | Has long been in place, but a complaints officer is required since 2016 |
| Reporters | All medical staff but mostly nurses | Physicians, residents or physician assistants | Patients and their families |
| Nature of reports | Short stories that describe how a process problem happened (eg, medication error) | Medical term (eg, surgical site infection) and severity score reflecting consequences for patients | Short or longer letters explaining why patients are unsatisfied (eg, felt not taken seriously) |
| Data storage | Reported into, and stored in, a hospital-wide digital database (on paper until mid-2011), and reviewed by a dedicated committee | Reporting 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 limitations | Unique 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.