Table 2 Studies for data synthesis and analysis

1

Spigelman/Swan (2005) [10]

Interviews

–

N = 12

The Australian Incident Monitoring System (AIMS) signifies a consistent system of coding, trending, and monitoring of incident data. Added promotion of patient safety culture and awareness of system errors such as failures and risk sources. More teamwork and patient safety strategy implementation were observed. Limitations: Low rate of CI reporting by staff. Information was often too generic.

2

Anderson et al. (2013) [53]

Documentary analysis and interviews

–

N = 62 (physicians, nurses, managers)

CIRS was perceived as having a positive effect on safety due to changes in care processes, staff attitudes, and knowledge. It can be useful in the development of awareness of risks in health care practice. Limitations: In practice, utilization of incident reports to improve care is difficult.

3

Brinkrolf, Prien, and Van Aken (2013) [24]

Retrospective analysis of CI

N = 235

Distribution of CIRS reports: (i) theatre 29%, (ii) ICU 21%, (iii) other workplaces 22%. Distribution of mistakes: (i) preparation of drugs, (ii) administration of drugs 37%, (iii) delivery and storage of drugs 5%.

4

de Feijter et al. (2013) [5]

Retrospective analysis of CI

N = 736

CIRS captures only a small fraction of occurring incidents in hospitals. It should be combined with complementary data about diagnostic errors, patient complaints, and retrospective chart reviews.

5

Desikan et al. (2005) [6]

Retrospective analysis of CI

N = 1.126

–

In voluntary incident-reporting systems, there is only a low and highly variable reporting rate of adverse drug events. The reporting rate can be increased by utilization of reporting systems that focus on certain types of events (medication programs may be more suitable for adverse drug events, whereas CIRS captures error patterns and conditions).

6

Dinkel/Eiche (2005) [14]

Data analysis

N = 151

–

Distribution of CIRS reports: (i) communication problems and organization 47%, (ii) human errors 36%, (iii) technical errors 11%. CIRS is deemed as efficient and safety promoting.

7

Evans et al. (2006) [7]

Anonymous cross-sectional survey

–

N = 186 (physicians), N = 587 (nursing staff)

65% of the physicians and 89% of the clinical staff made an error report already. Reasons for non-reporting are a lack of feedback, a lack of knowledge, time pressure, and underestimation of CI.

8

Gupta et al. (2009) [19]

Retrospective analysis of CI

N = 112

–

Surveillance of CI is useful for detecting of new potential weak spots, problems, and risk factors. Identification of ‘near misses’ gives rise to learning potential and improvements.

9

Heidevel-Chevalking et al. (2014) [18]

Retrospective analysis of CI

N = 2.563

–

There is a relationship between non-compliance of perioperative SOPs and patient safety. Most of the reports are related to human errors (68%) and organizational shortcomings (23%).

10

Herzer et al. (2012) [38]

Analysis of a new concept

–

N = 57 (departments over 7 years)

Development of a “Good Catch” award that may serve as an incentive for clinical staff members. Awarded for valuable CIRS reports which give rise to more patient safety and risk minimization.

11

Hübler et al. (2006) [17]

Retrospective analysis of CI

N = 162

–

Systematic analysis of safety-related incidents based on CIRS is possible with the premise of an institutionalized error culture. Derived measures should include tailored staff training, technical modifications, improving standards, team work, and communication exercises.

12

Hutchinson et al. (2009) [8]

Analysis of trends over 18 months

–

N = 22 (nations)

A high CIRS rate correlates with a sound error and safety culture. The number of incident reports increases when CIRS is coupled with a national vigilance system. Positive association with patient safety culture.

13

Kaldijan et al. (2008) [46]

Survey

–

N = 338 (faculty and resident physicians)

Most physicians tend to report harm-causing hypothetical errors, but in reality, only a minority of the respondents have reported an error so far.

14

Khorsandi et al. (2012) [40]

Retrospective analysis of CI

N = 3142

–

In only 14.8% of the cases analysed, a vague description of the incident is given. There is an urgent need in improving the quality of CI reports, which can be achieved by appropriate staff training. Causal analysis tools such as root cause analysis (RCA) combined with reporting systems are highly recommended.

15

Chul-Hoon/Myoungsoo (2009) [21]

Retrospective analysis of CI

–

N = 75 (nursing staff)

A CIRS trial in a Korean hospital induces a more open-minded culture with respect to CIs. 77% of correspondents acted as an observer, while 23% of the correspondents were involved in the respective situation.

16

Levtzion-Korach et al. (2010) [26]

Retrospective analysis of CI

N = 8.616

–

5 distinct reporting systems were compared. Each of them captured specific although complementary patient safety issues. About half of the physicians reported adverse events via the clinical risk management, while the nursing staff used CIRS more often.

17

Moss, Embletion, and Fenton (2005) [55]

Retrospective analysis of CI

N = 562

–

Utilization of findings from CIRS in inter-hospital transfers of sick infants. Changes made as a result of CI review reduces the number of incidents caused by poor preparation and transport, clinical problems, and both ambulance delays and ambulance equipment failure.

18

Nakajima, Kurata, and Takeda (2005) [13]

Retrospective analysis of CI

N = 6.041

–

Web-based incident-reporting systems have been taken for developing patient safety programs. In conjunction with staff training and feedback, those voluntary and anonymous reporting programs can help promote an open-minded safety culture.

19

Nuckols et al. (2007) [15]

Retrospective analysis of CI

N = 1.000

–

9% of patients had suffered at least 1 reported incident but only 17 CI per 1.000 patient days have been report. Distribution of reports: (i) medication errors (29%), (ii) falls (14%), (iii) incidents during surgery (15%).

20

Orlicek (2010) [27]

Employee survey, expert interviews

–

N = 226 (employees)

37% of the respondents (UKH Graz) made at least 1 CIRS. The nursing staff used CIRS more often than other staff members, in particular physicians. Most respondents agree that CIRS is very important.

21

Panzica, Krettek, and Cartes (2011) [16]

Retrospective analysis of CI

N = 4.278

–

CIRS plays a major role in clinical risk management with respect to incident reduction in long terms. Based on CIRS data, a systematic and resource-efficient approach for minimization of risk has been recommended.

22

Ramanujam et al. (2008) [30]

Data analysis

N = 20.000

–

It is recommended that issues of patient safety must redeploy to the top level of governance (top management or strategic management in hospitals) in order to establish learning processes as a result of CIRS.

23

Reed et al. (2014) [31]

Interviews

–

6 persons in charge of CIRS from 6 European nations

With respect to anaesthesia, both national coordination by government and specialty-focused initiatives seemed to be necessary for an optimal functioning CIRS.

24

Rose/Germann (2005) [4]

Retrospective analysis of CI

N = 1.470

–

In 2004, there were 874 incident reports or 46% compared to the previous year (2003, 596). In response, the number of improvement measures increased from 83 (2003) to 120 (2004) (45%).

25

Schildmeijer et al. (2013) [20]

Retrospective analysis of patient documents

–

N = 350 (patient documents)

CIRS reports on ‘near misses’ are valuable to reveal weak spots in processes. Organizational learning relies heavily on anticipated risks and shortcomings.

26

Steyrer et al. (2013) [39]

Observations

–

N = 378 (patients), N = 57 (intensive care units (ICUs))

CIRS or any other kind of formally implemented safety procedure and policy did not work when the workload increase, i.e. a higher workload has a negative effect on safety.

27

Takeda et al. (2003) [52]

Retrospective analysis of CI

N = 1.550

–

After implementation of an electronic online incident-reporting system, the number of CIRS reports increases from 50 to 140–180 per month (+180–260%).

28

Tereanu et al. (2011) [12]

Retrospective analysis vs. CIRS reports

N = 185 (CI)

–

A test of a voluntary CIRS in Romanian and Italian hospitals showed that most adverse events occurred in diagnostics (17–28%), surgery (14%), patient falls (12–32%), nursing care (25%), and drug prescription and administration (21%). Results suggest that CIRS could be introduced on a larger scale (in Romania).

29

Valentin et al. (2009) [22]

24-h cross-sectional study

–

N = 1.328 (patients) (113 ICU)

Parenteral medication errors are identified as a serious safety problem in ICU. Error-reporting systems and routine checks can reduce the risk for such errors, especially in case of critically ill patients.

30

Wan et al. (2013) [50]

Retrospective analysis of CI

N = 2.519 CI from 75.331

–

CI reporting provides insight in the clinical system by being useful in identification of active and system errors in paediatric anaesthesia. It is also deemed as a foundation of prevention and strategy. A high and consistent reporting can be achieved by maintaining a culture that encourages reporting of CI.

31

Westbrook et al. (2015) [25]

Analysis of documents

N = 3.291

–

Reported incidents do not reflect the real number of medication errors or underlying rates. Of 12.567 prescribing errors which were identified at audit, only 1.2/1.000 errors were reported. Of 539 clinically important prescribing errors, only 218.9/1000 errors were detected by staff, but only 13.0/1000 errors were reported. New approaches such as data mining of electronic information systems were highly recommended.