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Table 2 Study characteristics of included studies

From: Factors that influence the recognition, reporting and resolution of incidents related to medical devices and other healthcare technologies: a systematic review

First author; country; year Number of centres; number of participants (errors); sponsor Study objective(s) (verbatim) Study design and duration; clinical category(ies)
Wong et al. [25]; UK; 2013 1 ophthalmic facility; 579 incidents; no funding sources To examine the impact of patient safety incident reporting on errors during vitreoretinal surgery Descriptive; January 1997 to December 2009; vitreoretinal surgery
Anderson et al. [26]; UK; 2012 2 large, teaching hospitals; 62 healthcare practitioners (for example, doctors, nurses and managers); government To examine the perceived effectiveness of incident reporting in improving safety in mental health and acute hospital settings Documentary analysis and semi-structured interviews; NR; mental health and acute care
Flotta et al. [37]; Italy; 2012 Hospitals across 20 Italian regions; 696 physicians; none To investigate physicians’ knowledge about evidence-based patient safety practices, their attitudes on preventing and managing medical errors and to explore physicians’ behaviour when facing medical errors Survey; NR; general medicine, general surgery, medical specialities, ICU/ED
Hartnell et al. [34]; Canada; 2012 4 community hospitals; 30 participants (pharmacists, physicians, nurses); government 1. To identify incentives barriers and facilitators to encourage medication error reporting as perceived by front-line hospital staff Key informant interviews and focus groups; NR; NR
2. To understand why certain factors serve as barriers
3. To explore how some hospitals have successfully removed barriers
Heard et al. [30]; Australia; 2012 The Australian and New Zealand College of Anaesthetists; 327 consultant anaesthesiologists and 103 anaesthesia residents, NR To explore the attitudes and barriers of anaesthesiologists to reporting adverse events and errors Anonymous, self-administered survey; NR; anesthesiology
Hwang et al. [39]; Korea; 2012 42 general hospitals; 42 nurses; government To explore the barriers to and factors facilitating the operation of patient safety incident reporting systems Interviews and emails; July 2010 to April 2011; NR
Albolino et al. [38]; Italy; 2010 14 hospitals; 820 healthcare workers; government To assess workers’ experience of patient safety incidents and their expectations on incident reporting Written survey; April/May 2006 to January 2007; surgery, medicine, obstetrics and gynaecology, intensive care, radiology and laboratory, rehabilitation and other
Bodur and Filiz [41]; Turkey; 2010 1 general hospital, 1 teaching hospital, and 1 university hospital; 309 participants (physicians and nurses); NR 1. To determine the validity and reliability of the Hospital Survey on Patient Safety Culture Cross-sectional survey; not specified
2. To evaluate physicians’ and nurses’ perceptions of patient safety in Turkish hospitals
3. To compare the findings with US hospital settings
Chien et al. [42]; China; 2010 1 2,300-bed university hospital; NR; NR To present information framework to build and to enhance the CED on the medical equipment management capabilities with an example for portable physiological monitors used in nursing department Descriptive; NR; NR
Espin et al. [36]; Canada; 2010 3 hospitals (1 urban academic tertiary hospital, 1 community hospital, 1 academic paediatric hospital); 37 nurses; government and academic To explore emergent factors influencing nurse’ error reporting preferences, scenarios were developed to probe reporting situations in the ICU Semi-structured interviews; NR; ICU
Henneman et al. [17]; US; 2010 2 urban university medical centres and 2 community hospitals; 20 nurses; non-profit organization To describe error-recovery strategies used by critical care nurses Focus groups; NR; critical care units
Loren et al. [16]; US; 2010 NR; 1,673 healthcare facility-based risk managers; government and academic To conduct a national survey of risk managers’ attitudes regarding patient safety and error disclosure and to compare the results with a previously published survey of medical physicians Survey; November 2004 to March 2005; NR
Malik et al. [43]; Pakistan; 2010 600- bed tertiary care facility; 114 doctors 103 and nurses; NR To determine the attitudes and perceived barriers towards incident reporting tertiary care health professionals in Pakistan Survey; NR; medicine (non-surgical), ICU, surgery, anaesthesia, gynaecology and obstetrics, paediatrics, ER and others
Smits et al. [45]; Netherlands; 2010 21 hospitals (4 university, 6 tertiary teaching, and 11 hospitals); 744 AEs identified in 7,926 patient records and 55 physicians reviewed patient records; government To gain more insight into Retrospective patient record review; August 2005 to October 2006; excluded admissions of psychiatry, obstetrics and children <1 year old
 1. The causes of AEs
 2. The relationship between the causes of AEs and the preventability and health consequences of the AEs
 3. Potential prevention strategies to prevent AEs and
 4. The relevance of the prevention strategies for each main causal factor type
Kreckler et al. [27]; UK; 2009 General surgical department in teaching hospital; 55 doctors and 82 nurses; NR To evaluate the process of incident reporting in a surgical setting. In particular, the influence of event outcome on reporting behaviour; staff perception of surgical complications as reportable events Anonymous web-based questionnaire survey; January to March 2007; general surgery
Hohenhaus [24]; US; 2008 2 US states; 173 nurses; government To evaluate current practice of reporting medical error among nurses in the emergency department Survey; April to June 2005; emergency medicine
Kroll et al. [28]; UK; 2008 10 hospitals; 38 junior doctors; none To investigate experiences of and responses to medical error amongst junior doctors and to examine challenges junior doctors face and the support they receive Semi-structured interviews; NR; NR
Bognár et al. [18]; US; 2007 3 academic hospitals; 61 PCS team members; non-profit organization To explore the impact of real and potential medical errors on PCS team members Survey; NR; paediatric cardiac surgery
Cooke et al. [35]; Canada; 2007 1 academic cancer care centre; 125 radiotherapists, nurses, dosimetrists, doctors and other staff To motivate improvements in an organizational system by measuring staff perceptions of the organization’s ability to learn from incidents and by analysing their personal experience of incidents Survey, NR; oncology
Evans et al. [31]; Australia; 2007 2 regional hospitals; 14 doctors and 19 nurses; government To assess the effectiveness of an intervention package comprising intense education, a range of reporting options, changes in report management and enhanced feedback, in order to improve incident-reporting rates and change the types of incidents reported Non-equivalent group controlled clinical trial (ten intervention and ten control units); June to August 2003; medical units, surgical units, ICUs, EDs, neurology, cardiology and gastrointestinal surgery
Kim et al. [40]; Korea; 2007 8 university hospitals; 886 nurses; government 1. To describe the frequency of error reporting for near misses and harmless but potentially harmful errors Survey; NR; internal medicine, ICU, surgical unit, ER, OR, obstetrics unit and other
2. To describe nurses’ perceptions of patient safety culture in their working unit and hospital, their supervisors’ attitudes towards patient safety issues, communication channels, and processes regarding patient safety
3. To examine whether nurses’s perceptions were significantly associated with their work experience, work position, type of unit, age and working hours
Evans et al. [33]; Australia; 2006 3 principle referral hospitals, 1 major referral hospital, and two major rural base hospitals; 773 participants (physicians and nurses); NR To investigate by profession Cross sectional survey; November 2001 and June 2003; NR
 1. Awareness and use of current incident reporting system
 2. The types of incidents staff are more likely to report and believe should be reported
 3. The barriers to reporting
Schectman and Plews-Ogan [19]; US; 2006 1 academic medical centre; 120 physicians; NR To assess the safety reporting behaviour and witnessed AEs or near misses Anonymous survey; spring 2005; internal medicine
Ursprung et al. [20]; US; 2005 20-bed tertiary care medical-surgical NICU; 338 errors; government To conduct a pilot study to determine the feasibility (whether audits were completed each day they were attempted and whether staff disclosed errors during routine daily work) and utility (whether the safety questions audited detected important errors) of 36-item real-time safety auditing during routine clinical work in the ICU Descriptive; 28 January to 4 March 2003; NICU
Cohen et al. [22]; US; 2004 489-bed non-teaching suburban community hospital; NR; NR To determine comprehensive patient safety programme’s impact on two specific putative measures of the safety culture: event-reporting rates and surveys of staff opinion Survey; January 2000 to March 2003 in three phases; NR
Demiris et al. [21]; US; 2004 8 rural hospitals in Missouri; 30 participants (administrators, physicians and nurses); NR 1. To investigate rural healthcare providers’ and administrators’ attitudes towards patient safety and their attitudes towards and expectations of an adverse event reporting system Interviews; NR; NR
2. To provide insight into the organizational culture and level of readiness as well as to identify critical issues pertaining to the rural context that needs to inform the design of such strategies
Jeffe et al. [23]; US; 2004 20 academic and community hospitals; 49 staff nurses, 10 nurse managers, 30 physicians; government To gain insight into workers’ perspectives about key concepts and issues regarding medical error reporting in hospitals Focus groups; May to June 2002; NR
Kingston et al. [32]; Australia; 2004 5 units across 3 tertiary metropolitan public hospitals; 33 participants (medical and nursing staff; NR 1. To examine attitudes of medical and nursing staff towards reporting incidents Focus groups; March 21 to 22, 2002; NR
2. To identify measures to facilitate incident reporting
Mazeau et al. [44]; France; 2004 2 hospitals; 216 participants (physicians paid on hourly basis, head nurses, nurses, other caregivers, and administrative personnel); NR 1. To evaluate staff knowledge of hospital medical device surveillances and to describe potential determining factors of this knowledge Cross-sectional survey; 3 December 2001 to 15 January 2002; NR
2. To design a method suitable for any evaluation of hospital staff knowledge about what must be indisputably known by a large part of the staff
Waring [29]; UK; 2004 1 medium-sized district general hospital; 28 interviews with 3 senior medical representatives and 25 specialist physicians; NR The attitudes of medical physicians towards adverse incident reporting in health care, with particular focus on the inhibiting factors or barriers to participation are explored Interviews; 2001 to 2003; anaesthesia, acute medicine, obstetrics, rehabilitation and surgery
  1. AE, adverse event; AMDE, adverse medical device event; ED, emergency department; ER, emergency department; ICD, International Classification of Diseases; ICU, intensive care unit; NA, not applicable; NICU, neonatal intensive care unit; NR, not reported; OR, operating room; PCS, paediatric surgical team; UK, United Kingdom.