Wallis & Dovey 32 (2011) |
New Zealand |
Retrospective, descriptive observational study; analysis of data systems for incident reporting by physicians, family members, and patients |
There were no relevant definitions for the study |
83% of reports showed less serious harms and 12% showed more serious harms. Medication was the type of care with greatest risk to the patient |
Study limitations; interpretation of findings |
McKay et al. 19 (2009) |
United Kingdom |
Retrospective, descriptive observational study; analysis of data from systems for incident reporting by GPs |
The study used the term error resulting from care with or without harm to the patient |
32.5% of reports involved diagnostic errors (most frequent), 25.1% with harm to the patient. 80.1% of the AE reports suggested measures to improve clinical practice, e.g.: dissemination of protocols for safe practices; training health teams; programs to improve physician/patient communication |
None |
Gaal et al. 22 (2010) |
Europe |
Retrospective, descriptive observational study; questionnaire applied in 10 European countries |
There were no relevant definitions for the study |
Analyzed 10 dimensions of patient safety, where medication and safety in physical infrastructure showed the strongest association with patient safety |
Financing |
Parnes et al. 9 (2007) |
United States |
Retrospective, descriptive observational study; analysis of data from systems for incident reporting by physicians and staff |
The study used the term medication error with or without harm to the patient |
Of the 754 reported events, in 60 there was an interruption in the error cascade before reaching patients in primary care. In one participant it was possible to interrupt progression of the event before reaching or affecting the patient. Despite many individual and systematic methods to avoid errors, a system to avoid all potential errors is not feasible |
Study limitations; interpretation of findings |
Kuo et al. 13 (2008) |
United States |
Retrospective, descriptive observational study; analysis of data from systems for reporting medication errors recorded by family physicians and other health professionals |
The study used the term error resulting from care with or without harm to the patient |
70% of medication errors involved prescription, 10% errors in administration of medication, 10% errors in patient documentation, 10% errors in distribution and control of the medicine. 24% of errors reached patients. The study concluded that involvement by physicians, multidisciplinary teams, and patients combined with technology improve the process of managing medicines, reducing medication errors |
Outcome |
Graham et al. 14 (2008) |
United States |
Retrospective, descriptive observational study; analysis of data from incident reporting systems; 8 AAFP clinics |
There were no relevant definitions for the study |
25% of errors showed evidence of mitigation; these mitigated errors resulted in less frequent and less serious harm to patients. Training physicians and other health professionals and developing protocols are the best measures for reducing AEs |
None |
Hickner et al. 15 (2008) |
United States |
Retrospective, descriptive observational study; analysis of data from incident reporting systems; 243 physicians and administrative staff from eight AAFP services |
The study did not specify whether the AE harmed the patient |
In 18% there was some harm. Losses were financial and lost time (22%), delays in care (24%), pain/suffering (11%), and adverse clinical consequences (2%). AE reports should be integrated into electronic patient files |
None |
Bowie et al. 38 (2012) |
United Kingdom |
Retrospective, descriptive observational study; analysis of data from systems for reporting errors |
The study used the term AE to mean an injury resulting from care |
The method used in the study was unable to identify risks of errors in care, highly relevant for GPs. Important to conduct new studies in this area |
Participants |
Buetow et al. 23 (2010) |
New Zealand |
Prospective, descriptive observational study; focus group; 11 homogeneous groups of 5-9 persons, including 8 groups of patients and 3 groups of health professionals in the North of New Zealand |
The study used the term error resulting from care with or without harm to the patient |
Four patient safety issues were identified: improve inter-professional relations, allow patients and health professionals to recognize and manage AEs, shared capacity for team changes, and motivation to act in defense of patient safety. This methodology can help reduce tension between health professionals and the patient in the work process and reduce errors in health care |
None |
Manwellet al. 20 (2009) |
United States |
Prospective, descriptive observational study; focus group; 9 focus groups with 32 family physicians and GPs from 5 areas in the Midwest United States and New York City |
There were no relevant definitions for the study |
Physicians described factors that affect patient safety in primary care: patients are clinically and psychosocially complex; pressure from health plans; communication is complicated due to different languages; time pressure in patient care; inadequate information systems; lack of supplies; lack of medicines; slow diagnostic tests; principal administrative decisions made without participation |
Context/Justification for method |
Wallis et al. 33 (2011) |
New Zealand |
Prospective, descriptive observational study; interviews with 12 family physicians |
Safety culture was defined as shared values, attitudes, perceptions, skills, and individual or collective behaviors |
The adapted Manchester Patient Safety Framework was tested and can be used to evaluate safety culture in primary care in New Zealand |
None |
Balla et al. 39 (2012) |
United Kingdom |
Prospective, descriptive observational study; interviews with 21 GPs |
The study used the term AE to mean an injury resulting from care |
GPs described risk factors for patient safety: uncertainty in patient diagnosis and time pressure at work. Improvements in primary care could be achieved with feedback between GPs and specialists. The authors recommend regular meetings for clinical case discussions |
Context/Justification for method |
Gaal et al. 24 (2010) |
Netherlands |
Prospective, descriptive observational study; semi-structured interviews with 29 physicians and nurses |
The definitions were given by the interviewed health professionals |
Primary care physicians and nurses cited problems with medication as the most important safety issue. Some professionals quoted “not harming the patient” as a brief definition for patient safety |
None |
Gaalet al. 25 (2010) |
Netherlands |
Prospective, descriptive observational study; semi-structured interviews with 68 GPs |
There were no relevant definitions for the study |
GPs listed the following risk factors for patient safety: medical records and prescriptions. Of the 10 clinical cases presented to the GP, 5 were considered unsafe (50%) |
None |
Ely et al. 40 (2012) |
United States |
Prospective, descriptive observational study; questionnaire sent to a random sample of 600 family physicians, GPs, and pediatricians |
The study used the term diagnostic error with or without harm to the patient |
Physicians described 254 lessons learned from diagnostic errors. The three patient complaints most frequently associated with diagnostic errors were abdominal pain (13%), fever (9%), and fatigue (7%). Patient diagnosis is a lonely task, more prone to error. The authors recommend reinforcing teamwork |
None |
De Wet et al. 16 (2008) |
Scotland |
Prospective, descriptive observational study; questionnaire sent to 49 primary health teams |
Safety culture was defined as shared values, attitudes, perceptions, skills, and individual or collective behaviors that determine a team or organizational commitment to safety management |
Safety culture measure by primary care teams identified the following contributing factors for incidents: professional training, professional experience, communication. The data only provided a superficial and partial description of conditions at a given moment. Capturing the complexity and more in-depth aspects of safety culture requires more studies |
None |
Kistler et al. 26 (2010) |
United States |
Prospective, descriptive observational study; questionnaire in a sample of 1,697 patients |
There were no relevant definitions for the study |
Patients reported having perceived a medical error (15.6%); erroneous diagnosis (13.4%); incorrect treatment (12.4%); having changed physicians because of an error (14.1%). 8% reported “one or more” serious perceived harms, for diagnostic and treatment errors |
Context/Justification for method |
Mira et al. 27 (2010) |
Spain |
Prospective, descriptive observational study; questionnaire for 15,282 patients treated at 21 primary health care centers in Spain |
The study used the term AE to mean an injury resulting from care |
For most participants, the increase in frequency of AEs is related to communication between physicians and patients. Factors like duration of the consultation and work style of GPs influence the result. Protocols for information provided to patients should be reviewed |
Limitations |
Singh et al. 10 (2007) |
United States |
Prospective, descriptive observational study; questionnaire to 45 rural primary health care professionals |
There were no relevant definitions for the study |
Type of errors and contributing factors, according to interviewees: emergency cases not identified in triage; incorrect medication / wrong dose; wrong patient; incorrect reading of test results; delay in test results; incorrect communication of results; malfunctioning equipment; nurse tired, stressed, ill, and/or rushed |
Context/Justification for method |
Hickner et al. 28 (2010) |
United States |
Prospective, descriptive observational study; questionnaire to 220 physicians and other health professionals |
The study used the term medication error with or without harm to the patient |
Seventy per cent included medication errors, 27% involved AEs, and 2.4% both. Most frequent contributing factors for drug-related AEs were communication problems (41%) and insufficient knowledge (22%). 1.6% of the reported events led to hospitalization. Time pressure and punitive culture were the main barriers to reporting medication errors. The authors suggested an online system to facilitate reporting medication errors |
None |
O’Beirne et al. 34 (2011) |
Canada |
Prospective, descriptive observational study; questionnaire for 958 health professionals in Calgary |
The study used the term incident to mean with or without harm resulting from care |
Physicians and nurses were more likely than administrative personnel to report incidents. 50% of incidents were associated with harm. Most reported incidents were avoidable and with limited severity. Only 1% of the incidents had a serious impact. The main types of reported incidents involved: documentation (41.4%), medication (29.7%), management (18.7%), and clinical process (17.5%) |
None |
Cañada et al. 35 (2011) |
Spain |
Descriptive observational study; analysis of data from incident reporting systems; analysis based on direct observation of safe practices; focus groups; 21 health centers in Madrid |
There were no definitions |
42 safe practices were identified and recommended for application in primary care. The main barriers to implementation of safe practices in primary care services related to training of health teams, culture, leadership and management, and limited awareness-raising about safe practices |
Context/ Justification for method |
Kostopoulouet et al. 11 (2007) |
United Kingdom |
Mixed descriptive observational study; analysis of data from incident reporting systems; analysis based on direct observation of patient safety events and interviews with 5 GPs |
The study used the term error resulting from care with or without harm to the patient |
78 reports pertained to patient safety, of which 27% with AEs and 64% with “near misses”. 16.7% had serious consequences for the patient, including one death. Only 60% of reports contained sufficient information for cognitive analysis. Most reports of AEs were related to work organization, which included overwork (47%) and fragmentation of the service (28%). The authors recommend more studies to improve information in electronic records on AEs |
None |
Weiner et al. 29 (2010) |
United States |
Experimental study with audio taping of simulated medical consultations; 8 actor-patients approached 152 physicians from 14 health services |
The study used the term error resulting from care with or without harm to the patient |
81% of physicians believed they were seeing a real patient during the visit. Physicians investigated less contextual information (51%) than biomedical information (63%). Lack of attention to contextual information, such as patient’s transportation needs, economic status, or caregiver’s responsibilities can lead to error, which is not measured in physician performance assessment |
Study limitations and financing |
Avery et al. 36 (2011) |
United Kingdom |
Descriptive observational study; analysis based on direct observation; expert consensus method (12 GPs) to identify quality assessment indicators for medical prescriptions |
There were no relevant definitions for the study |
34 safety indicators were considered appropriate for evaluating prescription safety |
Context/Justification for method |
Singh et al. 41 (2012) |
United States |
Descriptive observational study; analysis of data from incident reporting systems; review of patient charts; interviews with patients in Houston, Texas |
The study used the term error resulting from care with or without harm to the patient |
The authors identified diagnostic errors in 141 records out of 674 detected as potentially positive for diagnostic errors. None of the evaluation methods for diagnostic errors was considered reliable |
Participants |
Wetzels et al. 21 (2009) |
New Zealand |
Mixed descriptive observational study; analysis of data from incident reporting systems with primary care physicians; review of patient charts; total of 8,000 patients from 5 family physicians in Nijmegen |
The study used the term AEs as potentially causing harm to the patient |
Some 50% of the events had no health consequences, but 33% led to worsening of symptoms resulting in unplanned hospitalization, 75% of the incidents with potential harm to health. The authors recommended that patient safety programs not concentrate only on harms |
Participants |
Wetzels et al. 17 (2008) |
New Zealand |
Descriptive observational study that used 5 different data sources to evaluate primary care (Nijmegen) |
The study used the term AEs as potentially causing harm to the patient |
Studies with reports by patients showed more AEs than those with reports by pharmacists, with the lowest number. In the evaluation of patient charts, analysis of errors featured treatment and communication. There were 1.5 events per 10 deaths. None of the methods proved better for identifying de AEs |
Participants |
Harmsen et al. 30 (2010) |
Netherlands |
Retrospective, descriptive observational study; analysis of data from incident reporting systems; prospective study of incidents using interviews; questionnaire on management |
The study used the term incident to mean with or without injury resulting from care |
Difficulties in estimating frequency of incidents in primary care, which depends on accuracy of patient files; lack of professional consensus on recognition of incidents. The study showed that in primary care there is virtually no system for recording or reporting incidents. There is a need to implement an electronic AE recording system in primary care |
Other analyses of the results and financing |
Wessell et al. 31 (2010) |
United States |
Descriptive observational study; consensus method with 94 experts to select indicators for medication errors; questionnaires sent to patients; focus group; study in 14 States of the USA |
The study used the term AEs as harm due to the use of medicines |
Thirty indicators were selected for medication safety: inadequate treatment, drug-drug interactions, and drug-illness interactions were adequate in 84%, 98%, and 86% of the eligible prescriptions in the databank, respectively. Identifying errors is a difficult task, but crucial for improving medication safety |
None |
Singh et al. 12 (2007) |
United States |
Descriptive observational study; analysis of data from reporting systems on diagnostic errors; blinded patient chart review by 2 independent reviewers, determining presence or absence of diagnostic error; questionnaires for patients |
The study used the term diagnostic error with or without harm to the patient |
The system’s error rate was 4%. Most common errors in the diagnostic process were: insufficiency or delay in obtaining and interpreting information in the visit. Most common secondary errors were failure to recognize the urgency of the disease or its complications |
Participants |
Makeham et al. 18 (2008) |
Australia |
Retrospective, descriptive observational study; analysis of data from incident reporting systems with 84 GPs |
The study used the term error resulting from care with or without harm to the patient |
Seventy percent of reported errors were due to problems in care without evidence of deficiencies in knowledge or professional skills. The study indicated that patients with chronic diseases are more susceptible to AEs |
Context/Justification for method |
Gordon & Dunham 37 (2011) |
United States |
Retrospective, descriptive observational study; analysis of data from incident reporting systems with physicians and primary care professionals |
The study used the term AE to mean with or without harm resulting from care |
326 AE reports in the system by GPs were related to the environment (63), laboratory (49), and patient flow and scheduling (38). Patients with chronic health problems may be more vulnerable to AEs. Self-reporting was rare, suggesting that individuals could be reluctant to admit errors |
None |