Patient safety in primary health care : a systematic review

The aim of this study was to identify methodologies to evaluate incidents in primary health care, types of incidents, contributing factors, and solutions to make primary care safer. A systematic literature review was performed in the following databases: PubMed, Scopus, LILACS, SciELO, and Capes, from 2007 to 2012, in Portuguese, English, and Spanish. Thirty-three articles were selected: 26% on retrospective studies, 44% on prospective studies, including focus groups, questionnaires, and interviews, and 30% on cross-sectional studies. The most frequently used method was incident analysis from incident reporting systems (45%). The most frequent types of incidents in primary care were related to medication and diagnosis. The most relevant contributing factors were communication failures among member of the healthcare team. Research methods on patient safety in primary care are adequate and replicable, and they will likely be used more widely, thereby providing better knowledge on safety in this setting. Patient Safety; Primary Health Care; Quality of Health Care REVISÃO REVIEW


Abstract
The aim of this study was to identify methodologies to evaluate incidents in primary health care, types of incidents, contributing factors, and solutions to make primary care safer.A systematic literature review was performed in the following databases: PubMed, Scopus, LILACS, SciELO, and Capes, from 2007 to 2012, in Portuguese, English, and Spanish.Thirty-three articles were selected: 26% on retrospective studies, 44% on prospective studies, including focus groups, questionnaires, and interviews, and 30% on cross-sectional studies.The most frequently used method was incident analysis from incident reporting systems (45%).The most frequent types of incidents in primary care were related to medication and diagnosis.The most relevant contributing factors were communication failures among member of the healthcare team.Research methods on patient safety in primary care are adequate and replicable, and they will likely be used more widely, thereby providing better knowledge on safety in this setting.
Patient Safety; Primary Health Care; Quality of Health Care REVISÃO REVIEW

Introduction
The report by the U.S. Institute of Medicine entitled To Err is Human: Building a Safer Health System 1 defined patient safety as a central issue on the agendas of many countries.The publication was a milestone for patient safety and issued an alert against errors in health care and harm to patients.
Concern with patient safety led the World Health Organization (WHO) to create the program called The World Alliance for Patient Safety in 2004 2 , aimed at developing global policies to improve patient care in health services.The program's initiatives featured the attempt to define issues involved in patient safety.The International Classification for Patient Safety was developed, in which incident is defined as any event or circumstance that could have resulted or did result in unnecessary harm to the patient 2 .
The current study defines adverse event as an incident that results in harm to the patient 3 , while contributing factors are circumstances, actions, or influences that are believed to have played a role in the origin or development of an incident, or that increase the risk of an incident occurring 3 .As defined in this study, incident types involve the origin: due to medication; lack, delay, or error in diagnosis; or treatment or procedure not related to medication 4 .In 2006, the European Committee on Patient Safety acknowledged the need to consider patient safety as a dimension of health quality at all levels of care, from health promotion to treatment of the disease 5 .
Although most care is provided at the primary level, research on patient safety has focused on hospitals.Hospital care is more complex, and the hospital setting thus naturally provides the main focus of such research.
In 2012, the WHO established a group to study the issues involved in safety in primary care 5 , the aim of which is to expand knowledge on risks to patients in primary care and the magnitude and nature of adverse events due to unsafe practices.
Various methods have been adopted to evaluate errors and adverse events.Each method's weaknesses and strengths are discussed in order to choose the most appropriate one for intended measurement.However, such methods are used for research in hospitals.A systematic review from 1966 to 2007 showed that the study of patient safety in primary care was just beginning 6 .Most adverse events in hospitals are associated with surgery and medication, while the most frequent adverse events in primary care are associated with medication and diagnosis 7 .Most hospital studies use retrospective review of pa-tient files 7 , while the most widely used method in studies on primary care is the analysis of incident reporting by health professionals or patients 6 .In studies conducted in hospitals, the mean number of adverse events per 100 inpatients was 9.2, and the mean proportion of avoidable adverse events was 43.5% 7 .Estimates of incidents in primary care vary greatly, from 0.004 to 240.0 per 1,000 consultations, and estimates of avoidable errors vary from 45% to 76%, depending on the method used in the study 6 .
The objectives of this study were to identify the methodologies used to evaluate incidents in primary care, types, severity, contributing factors, and solutions to make primary care safer.

Methodology
A literature review was conducted to achieve the objectives.The following databases were consulted: MEDLINE (via PubMed), Embase, Scopus, LILACS, SciELO, and the thesis database of the Federal Agency for Support and Evaluation of Graduate Education (Capes), from 2007 to November 2012.The search strategy was the same for all the databases (MEDLINE, Embase, Scopus, LILACS, SciELO, and Capes).The key words for searches were in Portuguese, English, and Spanish, as shown in Table 1.
The starting point for the review was set at 2007 due to the existence of another systematic review 6 that had used a similar search strategy in the MEDLINE, CINAHL, and Embase databases from 1966 to 2007.
Article selection followed the following inclusion criteria: (i) articles related to patient safety in primary care and (ii) articles in Portuguese, English, and Spanish.The following studies were excluded: (i) in the format of letters, editorials, news, professional commentaries, case studies, and reviews; (ii) without available abstracts; (iii) focusing on a specific process of care at the primary level; (iv) on hospital incidents; (v) on a specific type of disease or incident; or (vi) published in languages other than Portuguese, English, or Spanish.
The two authors independently performed an initial search for article titles; articles not excluded in the first stage proceeded to independent evaluation of the abstracts, after excluding duplicate articles and those without available abstracts; and the articles not excluded were read by independent reviewers.After independent reading of the full texts, the articles were finally selected.Data were extracted based on information about the author, title, and year of publication and the study characteristics, such as objectives, methods, findings, limitations as described, and relevant observations.The quality of the selected studies was evaluated using the tool Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), adapted to Portuguese, which has a 22-item checklist called the STROBE Statement 8 .

Results
The initial database search took place from May to November 2012 and identified 1,956 relevant article titles for the review.Figure 1 shows the flowchart for the study selection.
Various data sources were used.Some studies used administrative data from incident reporting systems fed by health professionals 9,13,14,15,18,19,37,38 or by health professionals and patients and family members 32 .Data were also obtained from focus groups with physicians and other health professionals 23 , or with health professionals and patients and family members 20 .Some studies used interviews to obtain data, either with physicians 25,33,39 or with physicians and other health professionals 24 .Questionnaires were also used by some authors to extract data, and were answered by physicians 22,40 , physicians and other health professionals 10,16,28,34 , or patients and family members 26,27 .Other studies used a combination of methods for data sources: incident reporting systems, direct observation, and focus groups 35 ; incident reporting systems, direct observation, and interviews 11 ; direct observation with audio recording 29 ; direct observation and expert consensus 36 ; incident reporting systems, patient file review, and interviews 41 ; incident reporting systems and patient file review 21 ; incident reporting systems, interviews, and questionnaires 30 ; expert consensus, questionnaires for patients, and focus groups 31 ; incident reporting systems, patient file review, and questionnaires 41 (Table 2).Six studies 12,17,21,30,31,41 used a combination of data sources.Reporting system were the most frequent data source: 15 studies (45%) 9,11,12,13,14,15,18,19,21,30,32,35,37,38,41 .
Cad. Saúde Pública, Rio de Janeiro, 30(9):1815-1835, set, 2014 The definition of adverse events differed, while the great majority of studies did not present a definition for these events.Four studies 26,31,38,39 defined adverse event related to the existence of harm to the patient caused by care.In four other studies 15,17,21,37 adverse event did not necessarily express harm to the patient as a result of care.In two studies 16,33 , patient safety culture was defined similarly as individual and/or group values, attitudes, perceptions, and behavioral patterns that led to a safety management team or organizational commitment (Table 2).
Contributing factors for incidents reported in the various studies included: failures in communication between professionals and with the patient; administrative failures: lack of medical and surgical supplies and medicines, professionals pressured to be more productive in less time, flaws in patient files, flaws in patient reception, inadequate floor plan or infrastructure in the health service, inadequate waste disposal by the health service, overworked staff, and failures in care.There were various forms of failures in care: failures in drug treatment (mainly prescription errors); diagnostic failure; delay in performing diagnosis; delay in obtaining information and interpreting laboratory findings; failure to recognize the urgency of the disease or its complications; deficient professional knowledge.
Studies with the objective of identifying the types and severity of adverse events in primary care and their contributing factors Eight studies 13,14,15,17,21,27,32,34 evaluated the types and severity of adverse events in primary care and their contributing factors (Table 3).Only two 27,32 defined the adverse event by relating it to the harm caused by the patient's care.Four studies 14,15,21,34 did not relate the adverse event to the harm, but presented the incident's impact and/ or severity in the patient.These four studies did not distinguish between incidents that did nor         did not cause harm.One study 13 distinguished between incidents that did or did not affect the patient and whether some intervention was necessary (monitoring, clinical follow-up, including hospitalization).Only one study 17 , which evaluated contributing factors, did not define adverse event or present the incident's impact and/or severity.
The studies that presented the impact and/ or severity of harm caused to the patient by care failed to specify how the impact and/or severity were assessed, and no scale was used.The way the impact and/or severity were presented varied from study to study.Various terms were used, such as harm (minor, moderate, or severe), complication, impact (none, slight, moderate, or severe).Some studies classified incidents based on how they reached the patient (did not reach, reached but without harm, reached and required some intervention), ranging as far as death.One study 14 distinguished between emotional and physical harm.One study 15 approached the consequences of the harm, whether temporary or permanent.Most of the incidents evaluated in the studies did not reach the patient, and when they did, the severity was limited (frequency of incidents varied from 50 to 83%).
Some studies chose to present the types of adverse events.Medication was the most frequent type of adverse event in primary care according to the selected studies.One study 13 specifically investigated the types of medication errors.Diagnostic incidents were also frequent (Table 3).
Other studies 14,15,17,2127,34 presented the contributing factors to adverse events.Administrative procedures, communication between professionals and with patients, and documentation were the principal contributing factors.As in the majority of studies on hospital care, the most frequent contributing factor in primary care was also communication.
Studies that suggested solutions to make primary care safer for patients Nineteen studies 9,10,11,16,18,19,20,22,23,24,25,26,29,30,33,35,37,39,40 suggested solutions to improve patient safety.Communication among health staff members or between health professionals and patients were considered the main contributing factor to tackle in order to improve safety, according to five studies 23,24,33,39,40 .Information exchange between family physicians and specialists, reinforcement of team work, regular clinical case discussion meetings, and dissemination of safe practices were recommend-ed as solutions to improve inter-professional communication.
In studies 10,18,20,24,25,37,39,40 that exclusively heard the opinions of health professionals, factors contributing to incidents were: pressure to decrease time in individual patient care; lack of supplies, including medicines; incorrect communication of test results; delays in test results; problems with medication, mainly in prescription, incorrect medication or dosage, wrong patient; malfunctioning equipment; tired, stressed, or ill nurses; failure to identify emergency cases in triage; uncertainty in patient diagnosis; communication problems; inadequate information systems; administrative decisions made without participation by the healthcare team; inadequate medical records.
These contributing factors were related to various solutions, such as: disseminating safe practice; adjusting infrastructure; training health team professionals; improving inter-professional communication; improving health services management, allowing patients and professionals to recognize and manage adverse events; training health professionals to share team changes to identify and act on risk situations; motivating health professionals to act for patient safety; health professionals' participating in management decisions; creating physician performance evaluation systems.The studies classified in this section as suggesting solutions to make patient care safer did not always precisely define this objective.The solution was often implicit in the evaluation of contributing factors.
In one study 35 , the main barriers to the implementation of safe practices in primary care services were related to cultural barriers due to the heterogeneity of local practices; management barriers, with problems in the infrastructure and for a safer environment; and limited awarenessraising on safe practices, due to communication difficulties in the health team.Health professionals' difficulty with teamwork was attributed to various factors, but especially to their type of academic training.
The study 9 that analyzed data from incident reporting systems showed that 80.1% of reports also suggested solutions to improve clinical practice.According to another study 19 , reporting incidents can be a useful practice for improving health service performance.This same study showed how cascades of errors can be interrupted before reaching patients.
Both patients and physicians are capable of identifying physician errors.In one study 26 , some 15% of patients reported some type of physician error.In another 40 , physicians described lessons learned from diagnostic errors and reported that few studies have documented personal lessons learned from errors, such as: always listening to the patient; attempting to explain all the diagnostic findings to the patient more than once; always performing a complete examination of the patient; expanding differential diagnosis; and reassessing and repeating the clinical evaluation if the patient fails to respond to the treatment as expected.
Two studies 16,33 that measured safety culture showed that health professionals were willing to learn, based on the detected failures, adapting their work practices to make them safer.Group meetings were suggested to facilitate inter-professional communication, consisting of health professionals, managers, and administrative staff, in order to capture their perceptions through a multidisciplinary approach 33 .
Studies that evaluated tools to improve patient safety in primary care Six studies 12,28,31,36,38,41 aimed to evaluate tools for improving patient safety in primary care.The objective of these studies focused on application in health services.None of the selected studies evaluated research instruments on patient safety culture.
Three selected studies tracked events or circumstances involving risks that could lead to an incident.Bowie et al. 38 aimed to demonstrate the convenience of trackers in electronic patient files to identify risks that could lead to adverse events in primary care.Avery et al. 36 presented a set of safety trackers to detect potential incidents in medical prescription in electronic patient files, for physicians to select those most capable of evaluating safety in medical prescription in primary care.Wessell et al. 31 aimed to select patient safety trackers for medical prescription in primary care in electronic patient files.
Hickner et al. 28 used the Medication Error and Adverse Drug Event Reporting System (MEADERS) to identify specific medication errors in primary care through reporting.The authors concluded that the system allows evaluating medication errors, but that time pressure and punitive culture were the main barriers to reporting medication errors.
Singh et al. 12 showed that communicating abnormal imaging test results can be improved by using a system for recording the result in the electronic patient file, in the specific context of primary care.The same author published another article in 2012 41 on the same issue of communicating test results, but this time consulting health professionals in an attempt to understand their difficulties in reporting results to patients, even with the existing resources in the electronic patient file.The author concluded that despite the electronic patient file with resources, there are social and technical challenges for guaranteeing the recording of results for professionals and patients.

Discussion
The theme of patient safety in primary care has grown in importance in the main international health organizations 16,22 .Primary care is a key area for studies on patient safety, since most health care takes place at the primary level.The current review used search terms that were similar to those in the review study by Makeham et al. 6 .Unlike the latter, in which 65% of studies aimed to identify the frequency and types of adverse events, the studies in our review aimed mainly to understand causes and identify solutions to make primary care safer for patients (58%).
The most common types of incidents in primary care involved medication errors and diagnostic errors, both in the review by Makeham et al. 6 and in the current review.Frequency of incidents associated with drug therapy in the studies varied from 12.4% to 83% 13,26,32,34 , while in the review by Makeham et al. 6 , incidents ranged from 7% to 52%.According to Ely et al. 40 , diagnostic errors are also common, since clinical practice in the elaboration of patient diagnosis is a lonely task and thus more prone to errors.
The harm caused by care can be emotional or physical and incapacitating, with permanent sequelae, increasing the cost of care, extending the length of hospital stay, and even leading to premature death 2 .In the review by Makeham et al. 6 , the actual harm caused by incidents varied from 17% to 39%, with potential harm ranging from 70% to 76%.In the current review, some studies 34,37 estimated the proportion of avoidable incidents among all incidents assessed (42% to 60%).In Makeham et al. 6 , 45% to 76% of all incidents were avoidable.Some studies evaluated not only the types and severity of adverse events in primary care, but their contributing factors.The factors that most contributed to incidents were failures in communication, either among professionals or between professionals and patients (5% to 41%) 14,15,17,21,27 .Another relevant group of contributing factors involved management (41.4% to 47%) 14,34 .In relation to communication failures, Makeham et al. 6 found rates ranging from 9% to 56%, compared to 5% to 72% involving management.Risks in the physical environment, professional training, and geographic barriers were mentioned as other contributing factors.
The majority of studies indicated solutions to make care safer for patients in primary care (58%).Improvement in communication was the most common solution for mitigating incidents 16,19,23,33,39 .Other solutions were presented, such as: allowing patients and professionals to recognize and manage adverse events, shared capacity in team changes, and motivation to act for patient safety through working groups 23 .
Kuo et al. 13 suggested solutions to reduce medication errors, including the implementation of electronic patient files in primary care services, analysis of incidents from the error reporting system, and collaborative practices between pharmacists and physicians.
A group of studies (19%) evaluated the tools for improving patient safety in primary care.As technology advances, especially information technology, the tools have evolved and improved, adapted to the reality of primary care, replicable, contributing to the improvement of risk management for incidents in primary care and to harm reduction.
Reporting systems for adverse events were the most common data source in the studies in our review (45%), exceeding the rate found in the systematic review by Makeham et al. 6 (23%).Focus groups were the method that contributed the least data to studies (9%).Data capture by reporting systems for adverse events has the practical advantage of data availability, speed in obtaining information, and low study cost.However, the disadvantages include lack of incident reporting culture among health professionals, especially if the system does not guarantee anonymity for person reporting the incident 12,37 .Wetsels et al. 17 showed that general practitioners (GPs) were the professionals that were most averse to reporting incidents.The GPs that were interviewed claimed lack of time to interrupt their clinical work and record the incident, while denying any feeling of mistrust towards the reporting system.
Given the concern over learning more about the causes of incidents, the qualitative methodologies that evaluated the opinions of health professionals and patients (questionnaires, interviews, and focus groups) were the most widely used.
Studies 26,27,28,40 with questionnaires had the advantages of reaching a wide range of health professionals and/or patients, guaranteed anonymity, and low study cost.When they used open questions, one limitation was that in some cases the answers were rather superficial.Kistler et al. 26 described the method's acceptability when applied to patients to explore their perceptions of errors occurring in health care.
Studies 24,33,39 that used interview methods highlighted the interviewee's proximity as a positive point (whether it was a health professional or patient), allowing impact analysis of a direct or indirect event or experience.Several limitations were cited in this method, including geographic barriers, reliability 27 , and sampling 39 .Balla et al. 39 described the method's importance in environmental risk analysis for patient safety.
Cad. Saúde Pública, Rio de Janeiro, 30(9):1815-1835, set, 2014 Some studies 16,19,27,32,33 aimed to assess safety culture in primary care using questionnaires, interviews, and/or focus groups, since the approach to health professionals was more direct and simple, valuing the informant's subjectivity and allowing the study to explore sensitive issues for professionals in the psychological and affective dimensions, such as: anxiety 11,20,25,39 , blame for incidents 11 , uncertainty in clinical diagnosis 25,29,39 , pressure related to work organization 11,16,20,23,35,39 , professional competence 22,35 , and team motivation 23 .Wallis et al. 33 reported that the discussion on safety culture in primary care has expanded to facilitate communication, the most frequent factor contributing to errors.
Of the 33 selected studies, 14 were conducted in the United States, followed by the United Kingdom.The predominance of studies in these two countries was due to the existence of established institutional programs in the field of patient safety in primary care.As in the review by Makeham et al. 6 , the studies took place mainly in the USA and UK.Neither review identified any articles on patient safety in primary care in developing countries.
A limitation to the study by Makeham et al. 6 was that the review only searched for studies published in English, which could partially explain the lack of publications in developing countries.The current review included Spanish and Portuguese in the searches, but even so, no articles were found on this subject in developing countries, even in Brazil, where the government model for primary care is based on the Family Health Strategy.Primary care has made quantitative progress in Brazil but is still considered a faulty model, with great room for quality improvement 42 .According to the preliminary results of the Brazilian Program for the Evaluation of Improvement in Access and Quality in Primary Care 43 , 62% of health professionals fail to use the recommended protocols for performing initial clinical evaluation in patients, thus suggesting room for improvement in safe practices.The National Program for Patient Safety 44 launched by the Brazilian Ministry of Health in 2013 included primary care as a prime area for developing improved patient safety measures.
Important potential limitations to the current review include: (i) difficulty in generalizing results, considering the conceptual variation in the theme of patient safety in primary care, due to the multiple countries involved and differences in clinical practice and primary care; (ii) the fact that the review was conducted in English, Portuguese, and Spanish, which led to the exclusion of 35 articles; (iii) the use of a similar search strategy, limited to the MEDLINE, CINAHL, and Embase databases, excluding other databases such as Web of Science and the "gray literature"; (iv) non-inclusion in the search strategy of such terms as "safety management", "risk management", and "adverse drug reaction"; (v) lack of a meta-analysis in the review; and (vi) use of the STROBE Statement methodology 8 to evaluate the quality of the studies.

Conclusion
There are gaps in knowledge on patient safety in primary care especially in developing countries and countries in transition, thus leaving room for expanding research in this area.Better understanding and knowledge are needed on the epidemiology of incidents and contributing factors, as well as the impact on health and the effectiveness of preventive methods 45 .
The research methods analyzed and tested in studies on patient safety in primary care are known and replicable, and it is thus likely that they be used more widely, providing greater knowledge on this type of safety.
The current study highlighted the need for expanding safety culture in primary care in order to prepare patients and health professionals to identify and manage adverse events, while raising awareness concerning their shared capacity for change, thereby reducing errors in primary care and tensions between health professionals and the population.
More in-depth studies can assist health care managers in conducting the planning and development of organizational strategies with the aim of improving quality of primary care.

Table 1
Search strategy in electronic databases.
negligencia OR de la cultura de seguridad OR cerca de fracaso OR método de seguridad del paciente OR el indicador de la seguridad del paciente OR medida de seguridad de los pacientes OR el informe de seguridad del paciente OR el informe de eventos de seguridad[Spanish]

Table 2
Characteristics of the selected studies.

Table 2
AAFP: American Academy of Family Physicians; AEs: adverse events; GPs: general practitioners.

Table 3
Studies with the objective of identifying types and/or contributing factors and severity of adverse events (AEs) in primary health care.