La seguridad del paciente en la atención primaria: una revisión sistemática

Marchon, Simone Grativol; Mendes Junior, Walter Vieira

doi:10.1590/0102-311X00114113

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REVIEW • Cad. Saúde Pública 30 (9) • Set 2014 • https://doi.org/10.1590/0102-311X00114113 copiar

La seguridad del paciente en la atención primaria: una revisión sistemática

Autoría SCIMAGO INSTITUTIONS RANKINGS

El objetivo fue identificar las metodologías para revisar incidentes en la atención primaria de salud, los tipos, los factores que contribuyen y soluciones para una atención primaria de salud más segura. Se realizó una revisión sistemática de la literatura sobre bases de datos bibliográficas como: PubMed, Scopus, LILACS, SciELO y Capes, desde 2007 hasta 2012, en portugués, inglés y español. Treinta y tres artículos fueron seleccionados: un 26% en relación a estudios retrospectivos; un 44% de estudios prospectivos, incluyendo grupos de discusión, cuestionarios y entrevistas y un 30% de estudios transversales. El método más común utilizado en los estudios fue el análisis de los incidentes en los informes de incidencias (45%) de los sistemas. Los tipos de incidentes se encuentran más comúnmente en la atención primaria de salud y están asociados a la medicación y diagnóstico. El factor de contribución más significativo fue la falta de comunicación entre los miembros del equipo de atención médica. Los métodos de investigación empleados en la investigación sobre la seguridad del paciente en la atención primaria de salud son adecuadas y replicables.

Seguridad del Paciente; Atención Primaria de Salud; Calidad de la Atención de Salud

Strategy	Key words
#1	Family practice OR primary care OR primary health care OR general practice [English] Cuidados primários OR cuidados primários de saúde OR atenção primária OR médico de família OR clínico geral [Portuguese] La atención primaria OR de atención primaria OR médico de familia OR médico general [Spanish]
#2	Medical error OR medication error OR diagnostic error OR iatrogenic disease OR malpractice OR safety culture OR near failure OR near miss OR patient safety method OR patient safety indicator OR patient safety measure OR patient safety report OR safety event report [English] Erro médico OR erro de medicamentos OR erro de diagnóstico OR doença iatrogênica OR imperícia OR cultura de segurança OR método segurança do paciente OR indicador segurança do paciente OR medida de segurança do paciente OR relatório de segurança do paciente OR relatório de eventos de segurança [Portuguese] El error médico OR error de medicamento OR error de diagnóstico OR de enfermedad iatrogénica OR 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]
#3	#1 AND #2

Reference (year)	Local	Study design/ Data source/ Study population	Relevant definitions	Study results and relevant conclusions by authors	Items not fully covered by the STROBE instrument
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

Reference (year)	Impact/Severity of AEs	Types/Contributing factors for AEs
AE defined in studies as incident with harm due to care
Wallis & Dovey ³² (2011)	Minor harm (83%); moderate harm (12%); severe harm (4%), half of which were deaths	Types of AEs were related to delay in diagnosis (16%), medication (38%), dental treatment (16%), injections and vaccines (10%), and others (20%)
Mira et al. ²⁷ (2010)	Without treatment complications (80.4%); with complications (19.6%)	The most frequent contributing factors for errors related to physician-patient communication (17.3%)
AE defined in studies as an incident with or without harm due to care
Kuo et al. ¹³ (2008)	Did not reach patient (41%); reached patient, but did not require follow-up (35%); reached patients and follow-up was necessary (8%); reached patients and intervention was necessary (13%); resulted in hospitalization (3%); no deaths	Medication errors related to: prescription (70%), administration (10%), recording (10%), dispensing (7 %), and others (3%)
Graham et al. ¹⁴ (2008)	Did not reach patient – without harm (40.3%); reached patient – without harm (20.7%); reached patient – without harm, but action was necessary (11.6%); reached patient with emotional harm (8.0%); reached patient with physical harm (19.4%)	The most frequent contributing factors for errors were related to communication and administrative procedures
Hickner et al. ¹⁵ (2008)	Did not cause harm (54%); unknown (28%); caused harm (18%); emotional harm (6%); physical harm (70%); temporary physical harm (90%); temporary physical harm requiring hospitalization (3%); permanent harm (7%)	The most frequent contributing factors for errors were related to communication of test results to the physician (24.6%), administrative procedures (17.6%), ordering tests (12.9%), and others (44.9%)
O’Beirne et al. ³⁴ (2011)	Without impact on patient (57%); slight impact (24%); moderate or severe impact ( 9%); incidents with permanent duration (1%); no deaths	The types and/or contributing factors for AEs were related to documentation (41.4%), medication (29.7%), and administrative procedures (29.3%)
Wetzels et al. ²¹ (2009)	Did not cause harm (50%); aggravation of symptoms (40%); led to unplanned hospitalization (4%); irreversible disability (6%); no deaths	The types and/or contributing factors for AEs were related to administrative procedures (31%), diagnosis (20%), treatment (23%), and communication (26%)
Wetzels et al. ¹⁷ (2008)	Severity not mentioned	The types and/or contributing factors for AEs were related to administrative procedures (24%), diagnosis (19%), treatment (30%), and communication (27%)

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[1] Correspondence S. G. Marchon. Departamento de Administração e Planejamento em Saúde, Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz. Rua Senador Pompeu 208, Araruama, RJ 28970-000, Brasil. simonemarchon@gmail.com