Prospective methods for identifying perioperative risk-assessment methods for patient safety over 20 years: a systematic review.

BACKGROUND: Serious preventable surgical events still occur despite considerable efforts to improve patient safety. In addition to learning from retrospective analyses, prospective risk-assessment methods may help to decrease preventable events further by targeting perioperative hazards. The aim of this systematic review was to assess the methods used to identify perioperative patient safety risks prospectively, and to describe the risk areas targeted, the quality characteristics and feasibility of methods. METHODS: MEDLINE, Embase, CINAHL and Cochrane databases were searched, adhering to PRISMA guidelines. All studies describing the development and results of prospective methods to identify perioperative patient safety risks were included and assessed on methodological quality. Exclusion criteria were interventional studies, studies targeting one specific issue, studies reporting on structural factors relating to fundamental hospital items, and non-original or case studies. RESULTS: The electronic search resulted in 16 708 publications, but only 20 were included for final analysis, describing five prospective risk-assessment methods. Direct observation was used in most studies, often in combination. Direct (16 studies) and indirect (4 studies) observations identified (potential) adverse events (P)AEs, process flow disruptions, poor protocol compliance and poor practice performance. (Modified) Healthcare Failure Mode and Effect Analysis (HFMEA™) (5 studies) targeted potential process flow disruption failures, and direct (P)AE surveillance (3 studies) identified (P)AEs prospectively. Questionnaires (3 studies) identified poor protocol compliance, surgical flow disturbances and patients' willingness to ask questions about their care. Overall, quality characteristics and feasibility of the methods were poorly reported. CONCLUSION: The direct (in-person) observation appears to be the primary prospective risk-assessment method that currently may best help to target perioperative hazards. This is a reliable method and covers a broad spectrum of perioperative risk areas.

ANTECEDENTES: A pesar de los esfuerzos considerables para mejorar la seguridad del paciente, aún se producen complicaciones quirúrgicas graves prevenibles. Además de adquirir conocimientos a través de los análisis retrospectivos, los métodos de evaluación de riesgos prospectivos por su enfoque en los riesgos perioperatorios, pueden ayudar a disminuir aún más los efectos adversos prevenibles. Esta revisión sistemática tiene como objetivo evaluar los métodos utilizados para identificar de forma prospectiva los riesgos perioperatorios de seguridad del paciente, describiendo las áreas de riesgo y las características de calidad y viabilidad de los métodos. MÉTODOS: Se realizaron búsquedas en las bases de datos MEDLINE, EMBASE, CINAHL y Cochrane siguiendo las recomendaciones PRISMA. Se incluyeron todos los estudios que describían el desarrollo y los resultados de métodos prospectivos para identificar los riesgos perioperatorios de seguridad del paciente y se evaluó su calidad metodológica. Se excluyeron los estudios de intervención, aquellos estudios dirigidos a un tema específico, los estudios enfocados a factores estructurales relacionados con elementos hospitalarios clave, y los estudios no originales o series de casos. RESULTADOS: La búsqueda electrónica identificó 16.708 publicaciones, pero solamente se incluyeron 20 publicaciones en las que se describían 5 métodos prospectivos de evaluación de riesgos. La observación directa fue el método utilizado en la mayoría de los estudios, a menudo en combinación con métodos indirectos. Las observaciones directas (80%) e indirectas (20%) identificaron efectos adversos potenciales (potential adverse events, (P)AEs), disrupciones en el flujo de los procesos, baja adherencia a los protocolos y prácticas deficientes. El análisis (modificado) de fallo de la atención sanitaria por modo y efecto (Healthcare-Failure-Mode-and-Effect Analysis) (25%) enfocado a fallos potenciales de disrupción de los procesos y la vigilancia directa de los (P)AEs (16%) identificaron (P)AEs de forma prospectiva. Los cuestionarios (15%) identificaron una baja adherencia a los protocolos, alteraciones en el flujo del proceso quirúrgico y la disposición de los pacientes para hacer preguntas sobre su atención. En general, las características de calidad y la viabilidad de los métodos se describían de manera deficiente. CONCLUSIÓN: La observación directa (en persona) es el principal método prospectivo de evaluación de riesgos que actualmente podría ser el mejor método para el enfoque en los riesgos perioperatorios. Es un método confiable y cubre un amplio espectro de áreas de riesgo perioperatorio.

Development and validation of a Self-assessment Instrument for Perioperative Patient Safety (SIPPS).

BACKGROUND: Patient safety is a fundamental value of healthcare to avoid patient harm. Non-compliance with patient safety standards may result in patient harm and is therefore a global concern. A Self-assessment Instrument for Perioperative Patient Safety (SIPPS) monitoring and benchmarking compliance to safety standards was validated in a multicentre pilot study. METHODS: A preliminary questionnaire, based on the Dutch perioperative patient safety guidelines and covering international patient safety goals, was evaluated in a first digital RAND Delphi round. The results were used to optimize the questionnaire and design the SIPPS. For measurement and benchmarking purposes, SIPPS was categorized into seven main patient safety domains concerning all care episode phases of the perioperative trajectory. After consensus was reached in a face-to-face Delphi round, SIPPS was pilot-tested in five hospitals for five characteristics: measurability, applicability, improvement potential, discriminatory capacity and feasibility. RESULTS: The results of the first Delphi round showed moderate feasibility for the preliminary questionnaire (81·6 per cent). The pilot test showed good measurability for SIPPS: 99·8 per cent of requested information was assessable. Some 99·9 per cent of SIPPS questions were applicable to the selected respondents. With SIPPS, room for improvement in perioperative patient safety compliance was demonstrated for all hospitals, concerning all safety domains and all care episode phases of the perioperative trajectory (compliance 76·1 per cent). SIPPS showed mixed results for discriminatory capacity. SIPPS showed good feasibility for all items (range 91·9-95·7 per cent). CONCLUSION: A self-assessment instrument for measuring perioperative patient safety (SIPPS) compliance meeting international standards was validated. With SIPPS, improvement areas for perioperative patient safety and best practices across hospitals could be identified.

Development of the Surgical Patient safety Observation Tool (SPOT).

BACKGROUND: A Surgical Patient safety Observation Tool (SPOT) was developed and tested in a multicentre observational pilot study. The tool enables monitoring and benchmarking perioperative safety performance across departments and hospitals, covering international patient safety goals. METHODS: Nineteen perioperative patient safety observation topics were selected from Dutch perioperative patient safety guidelines, which also cover international patient safety goals. All items that measured these selected topics were then extracted from available local observation checklists of the participating hospitals. Experts individually prioritized the best measurement items per topic in an initial written Delphi round. The second (face to face) Delphi round resulted in consensus on the content of SPOT, after which the measurable elements (MEs) per topic were defined. Finally, the tool was piloted in eight hospitals for measurability, applicability, improvement potential, discriminatory capacity and feasibility. RESULTS: The pilot test showed good measurability for all 19 patient safety topics (range of 8-291 MEs among topics), with good applicability (median 97 (range 11·8-100) per cent). The overall improvement potential appeared to be good (median 89 (range 72·5-100) per cent), and at topic level the tool showed good discriminatory capacity (variation 27·5 per cent, range in compliance 72·5-100 per cent). Overall scores showed relatively little variation between the participating hospitals (variation 13 per cent, range in compliance 83-96 per cent). All eight auditors considered SPOT a straightforward and easy-to-use tracer tool. CONCLUSION: A comprehensive tool to measure safety of care was developed and validated using a systematic, stepwise method, enabling hospitals to monitor, benchmark and improve perioperative safety performance.

Development and measurement of perioperative patient safety indicators.

BACKGROUND: To improve perioperative patient safety, hospitals are implementing evidence-based perioperative safety guidelines. To facilitate this process, it is important to provide insight into current practice. For this purpose, we aimed to develop patient safety indicators. METHODS: The RAND-modified Delphi method was used to develop a set of patient safety indicators based on the perioperative guidelines. First, a core group of experts systematically selected recommendations from the guidelines. Then, an expert panel of representative professionals appraised the recommendations against safety criteria, prioritized them and reached consensus about 11 patient safety indicators. Measurability, applicability, improvement potential (based on current practice) and discriminatory capacity of each indicator were pilot tested in eight hospitals. RESULTS: Seven structure, two process and two outcome indicators were developed covering the entire perioperative care process. Most indicators showed good applicability (N=11), improvement potential (N=6) and discriminatory capacity (N=7). Four indicators were difficult to measure. Improvement opportunities concerned the use of perioperative stops, timely administration of antibiotics, availability of protocols on perioperative anticoagulants and on prospective risk analysis of medical equipment, presence of a surveillance system for postoperative wound infections, and a morbidity and mortality registration. CONCLUSIONS: Using a systematic, stepwise method 11 patient safety indicators were developed for internal assessment, monitoring and improvement of the perioperative care process. There was large variation in guideline adherence between and within hospitals, identifying opportunities for improvement in the quality of perioperative care.

Meta-analysis of operative mortality and complications in patients from minority ethnic groups.

BACKGROUND: Insight into the effects of ethnic disparities on patients' perioperative safety is necessary for the development of tailored improvement strategies. The aim of this study was to review the literature on safety differences between patients from minority ethnic groups and those from the ethnic majority undergoing surgery. METHODS: PubMed, CINAHL, the Cochrane Library and Embase were searched using predefined inclusion criteria for available studies from January 1990 to January 2013. After quality assessment, the study data were organized on the basis of outcome, statistical significance and the direction of the observed effects. Relative risks for mortality were calculated. RESULTS: After screening 3105 studies, 26 studies were identified. Nine of these 26 studies showed statistically significant higher mortality rates for patients from minority ethnic groups. Meta-analysis demonstrated a greater risk of mortality for these patients compared with patients from the Caucasian majority in studies performed both in North America (risk ratio 1·22, 95 per cent confidence interval 1·05 to 1·42) and outside (risk ratio 2·25, 1·40 to 3·62). For patients from minority groups, the length of hospital or intensive care unit stay was significantly longer in five studies, and complication rates were significantly higher in ten. Methods used to identify patient ethnicity were not described in 14 studies. CONCLUSION: Patients from minority ethnic groups, in North America and elsewhere, have an increased risk of perioperative death and complications. More insight is needed into the causes of ethnic disparities to pursue safer perioperative care for patients of minority ethnicity.