Global research priorities to better understand the burden of iatrogenic harm in primary care: an international Delphi exercise.

Using a modified Delphi exercise, Aziz Sheikh and colleagues identify research priorities for patient safety research in primary care contexts. Please see later in the article for the Editors' Summary.

Impact of a national multimodal intervention to prevent catheter-related bloodstream infection in the ICU: the Spanish experience.

OBJECTIVE: Prevention of catheter-related bloodstream infection is a basic objective to optimize patient safety in the ICU. Building on the early success of a patient safety unit-based comprehensive intervention (the Keystone ICU project in Michigan), the Bacteremia Zero project aimed to assess its effectiveness after contextual adaptation at large-scale implementation in Spanish ICUs. DESIGN: Prospective time series. SETTING: A total of 192 ICUs throughout Spain. PATIENTS: All patients admitted to the participating ICUs during the study period (baseline April 1 to June 30, 2008; intervention period from January 1, 2009, to June 30, 2010). INTERVENTION: Engagement, education, execution, and evaluation were key program features. Main components of the intervention included a bundle of evidence-based clinical practices during insertion and maintenance of catheters and a unit-based safety program (including patient safety training and identification and analysis of errors through patient safety rounds) to improve the safety culture. MEASUREMENTS AND MAIN RESULTS: The number of catheter-related bloodstream infections was expressed as median and interquartile range. Poisson distribution was used to calculate incidence rates and risk estimates. The participating ICUs accounted for 68% of all ICUs in Spain. Catheter-related bloodstream infection was reduced after 16-18 months of participation (median 3.07 vs 1.12 episodes per 1,000 catheter-days, p<0.001). The adjusted incidence rate of bacteremia showed a 50% risk reduction (95% CI, 0.39-0.63) at the end of the follow-up period compared with baseline. The reduction was independent of hospital size and type. CONCLUSIONS: Results of the Bacteremia Zero project confirmed that the intervention significantly reduced catheter-related bloodstream infection after large-scale implementation in Spanish ICUs. This study suggests that the intervention can also be effective in different socioeconomic contexts even with decentralized health systems.

Case studies of patient safety research classics to build research capacity in low- and middle-income countries.

BACKGROUND: Strengthening research capacity is a key priority and rate-limiting step for conducting patient safety research, particularly in low- and middle-income countries, but also in other settings where such research is currently limited. Case studies of classic publications in patient safety research were therefore developed as part of a larger strategy aimed at increasing the knowledge base and building the research capacity required for making health care safer and reducing harm to patients. METHODS: A multistep method was used to develop the case studies, which involved developing a theoretical framework for classifying patient safety research articles; purposively selecting articles to illustrate a range of research methods and study designs; and involving the articles' lead authors to provide context, review the summaries, and offer advice to future patient safety researchers. RESULTS: The series of patient safety research case studies used 17 examples to illustrate how different research methods and study designs can be used to answer different types of research questions across five stages of the research cycle: (1) measuring harm, (2) understanding causes, (3) identifying solutions, (4) evaluating impact, and (5) translating evidence into safer care. No single study design or research method is better in all circumstances. Choosing the most appropriate method and study design depends on the stage in the research cycle, the objectives, the research question, the subject area, the setting, and the resources available. CONCLUSIONS: Beyond serving as didactic tools in assisting future leaders in patient safety research to build up their own competencies, the case studies help to illuminate the burgeoning field of patient safety research as a an important vehicle for reducing patient harm and improving health outcomes worldwide.

How safe is primary care? A systematic review.

IMPORTANCE: Improving patient safety is at the forefront of policy and practice. While considerable progress has been made in understanding the frequency, causes and consequences of error in hospitals, less is known about the safety of primary care. OBJECTIVE: We investigated how often patient safety incidents occur in primary care and how often these were associated with patient harm. EVIDENCE REVIEW: We searched 18 databases and contacted international experts to identify published and unpublished studies available between 1 January 1980 and 31 July 2014. Patient safety incidents of any type were eligible. Eligible studies were critically appraised using validated instruments and data were descriptively and narratively synthesised. FINDINGS: Nine systematic reviews and 100 primary studies were included. Studies reported between <1 and 24 patient safety incidents per 100 consultations. The median from population-based record review studies was 2-3 incidents for every 100 consultations/records reviewed. It was estimated that around 4% of these incidents may be associated with severe harm, defined as significantly impacting on a patient's well-being, including long-term physical or psychological issues or death (range <1% to 44% of incidents). Incidents relating to diagnosis and prescribing were most likely to result in severe harm. CONCLUSIONS AND RELEVANCE: Millions of people throughout the world use primary care services on any given day. This review suggests that safety incidents are relatively common, but most do not result in serious harm that reaches the patient. Diagnostic and prescribing incidents are the most likely to result in avoidable harm. SYSTEMATIC REVIEW REGISTRATION: This systematic review is registered with the International Prospective Register of Systematic Reviews (PROSPERO CRD42012002304).

WHO Efforts to Promote Reporting of Adverse Events and Global Learning.

Despite the importance of reporting systems to learn about the casual chain and consequences of patient safety incidents, this is an area that requires of further conceptual and technical developments to conduce reporting to effective learning. The World Health Organization, through its Patient Safety Programme, adopted as a priority the objective to facilitate and stimulate global learning through enhanced reporting of patient safety incidents. Landmark developments were the WHO Draft Guidelines for Adverse Event Reporting and Learning Systems, and the Conceptual Framework for the International Classification for Patient Safety, as well as the Global Community of Practice for Reporting and Learning Systems. WHO is currently working with a range of scientists, medical informatics specialists and healthcare officials from various countries around the world, to arrive at a Minimal Information Model that could serve as a basis to structure the core of reporting systems in a comparable manner across the world. Undoubtedly, there is much need for additional scientific developments in this challenging and innovative area. For effective reporting systems and enhanced global learning, other key contextual factors are essential for reporting to serve to the needs of clinicians, patients and the healthcare system at large. Moreover, the new data challenges and needs of organizations must be assessed as the era of big data comes to heath care. These considerations delineate a broad agenda for action, which offer an ambitious challenge for WHO and their partners interested in strengthening learning for improving through reporting and communicating about patient safety incidents. Significance for public healthUnderstanding the causes and consequences of incidents is cornerstone for patient safety improvement. Likewise, setting up systems to facilitate such understanding and communicate the learning across all healthcare actors is crucial. Over the past decade, the World Health Organization has convened an area of work, with the support of a growing number of collaborating agencies, institutions and experts worldwide to facilitate the identification of global directions aiming to facilitate the development and management of patient safety incident reporting systems as well as the extraction and communication of useful learning. Exchange and sharing of best practices and experiences has been at the essence of this work. This paper describes such efforts and also reflects on other areas of work which are essential to enhance patient safety by learning from the failures of the health care.

The global burden of unsafe medical care: analytic modelling of observational studies.

OBJECTIVE: To contextualise the degree of harm that comes from unsafe medical care compared with individual health conditions using the global burden of disease (GBD), a metric to determine how much suffering is caused by individual diseases. DESIGN: Analytic modelling of observational studies investigating unsafe medical care in countries' inpatient care settings, stratified by national income, to identify incidence of seven adverse events for GBD modelling. Observational studies were generated through a comprehensive search of over 16 000 articles written in English after 1976, of which over 4000 were appropriate for full text review. RESULTS: The incidence, clinical outcomes, demographics and costs for each of the seven adverse events were collected from each publication when available. We used disability-adjusted life years (DALYs) lost as a standardised metric to measure morbidity and mortality due to specific adverse events. We estimate that there are 421 million hospitalisations in the world annually, and approximately 42.7 million adverse events. These adverse events result in 23 million DALYs lost per year. Approximately two-thirds of all adverse events, and the DALYs lost from them, occurred in low-income and middle-income countries. CONCLUSIONS: This study provides early evidence that adverse events due to medical care represent a major source of morbidity and mortality globally. Though suffering related to the lack of access to care in many countries remains, these findings suggest the importance of critically evaluating the quality and safety of the care provided once a person accesses health services. While further refinements of the estimates are needed, these data should be a call to global health policymakers to make patient safety an international priority.

[Impact of collective violence on health status. Results of the ISAVIC study in the Basque Region (Spain)]. / Impacto de la violencia colectiva en la salud. Resultados del estudio ISAVIC en el País Vasco.

OBJECTIVES: Despite the ubiquity of violence and its possible impact on individual and collective health, the role and causal pathways of this phenomenon as a health determinant have not been widely studied. The present study was conducted between 2005 and 2008 in the Basque Region of Spain and aimed to estimate the health effects of collective violence on its primary victims. METHODS: A purposive sample of 33 primary victims (direct victims of collective violence and the first degree relatives of murder victims) was matched (1:5 ratio) with a random selection of persons drawn from a representative sample of the population aged more than 16 years old living in the Basque Region. Matching criteria were age, sex, educational level and province of residence. All participants completed a questionnaire that included health status measures (WHO-DAS-II-12, GHQ-12, SF-12, loneliness and stigma scales) and other potentially mediating variables such as social support and emotional climate. The results were assessed by regression analysis conditional to exposure to collective violence. RESULTS: The odds of perceiving worse physical and emotional health were 4 to 7 times higher among primary victims than among the general population and were 8 times higher for experiencing functional disability. Primary victims also perceived more loneliness and stigma and negatively valued their social support and emotional climate. No significant impact was found among the general population with some experience of interpersonal violence. CONCLUSIONS: These results suggest that collective violence is associated with substantial impairment in health status. More specific studies to assess the health effects of collective violence in the general population are warranted.

[Sequelae of collective violence: victims' voices in the ISAVIC study]. / Secuelas de la violencia colectiva: hablan las víctimas del estudio ISAVIC.

OBJECTIVE: Despite the significant influence of collective violence on the health status of its victims, there are still many gaps in our understanding of the nature of the functional limitations this violence produces and its impact on victims' wellbeing and quality of life. The ISAVIC study was carried out in the autonomous region of the Basque Country from 2005-2008 to estimate the effects of collective violence on health. The assessment included victims' perceptions of these sequelae and their impact on health. METHODS: A purposive sample of 36 primary victims was selected through contact networks and mediators. The victims' perceptions were collected through semi-structured in-depth interviews, which were later analyzed according to the study's conceptual framework. RESULTS: The victims' testimony suggests that they were profoundly traumatized by the collective violence experienced, which was often not yet completely overcome and significantly impaired their quality of life. The main functional, physical, emotional and social limitations described by the victims were identified. CONCLUSIONS: The qualitative results of this study are coherent with those obtained through the parametric phase of the ISAVIC study and provide a more complete overview of the nature of the sequelae of collective violence and its impact on quality of life. These results should be verified in larger studies and the influence of the social context on the relationship between collective violence and health should be analyzed in greater depth.

Core competencies for patient safety research: a cornerstone for global capacity strengthening.

BACKGROUND: Tens of millions of patients worldwide suffer disabling injuries or death every year due to unsafe medical care. Nonetheless, there is a scarcity of research evidence on how to tackle this global health priority. The shortage of trained researchers is a major limitation, particularly in developing and transitional countries. OBJECTIVES: As a first step to strengthen capacity in this area, the authors developed a set of internationally agreed core competencies for patient safety research worldwide. METHODS: A multistage process involved developing an initial framework, reviewing the existing literature relating to competencies in patient safety research, conducting a series of consultations with potential end users and international experts in the field from over 35 countries and finally convening a global consensus conference. RESULTS: An initial draft list of competencies was grouped into three themes: patient safety, research methods and knowledge translation. The competencies were considered by the WHO Patient Safety task force, by potential end users in developing and transitional countries and by international experts in the field to be relevant, comprehensive, clear, easily adaptable to local contexts and useful for training patient safety researchers internationally. CONCLUSIONS: Reducing patient harm worldwide will require long-term sustained efforts to build capacity to enable practical research that addresses local problems and improves patient safety. The first edition of Competencies for Patient Safety Researchers is proposed by WHO Patient Safety as a foundation for strengthening research capacity by guiding the development of training programmes for researchers in the area of patient safety, particularly in developing and transitional countries, where such research is urgently needed.

[How does collective violence shape the health status of its victims? Conceptual model and design of the ISAVIC study]. / ¿Cómo influye la violencia colectiva en la salud? Modelo conceptual y diseño del estudio ISAVIC.

OBJECTIVES: Epidemiologic research on collective violence (violence exerted by and within groups in pursuit of political, social or economic goals) is very scarce despite its growing recognition as a major public health issue. This paper describes the conceptual model and design of one of the first research studies conducted in Spain aiming to assess the impact of collective violence in the health status of its victims (study known as ISAVIC, based on its Spanish title Impacto en la SAlud de la VIolencia Colectiva). METHODS: Starting with a comprehensive but non-systematic review of the literature, the authors describe the sequelae likely produced by collective violence and propose a conceptual model to explain the nature of the relationships between collective violence and health status. The conceptual model informed the ISAVIC study design and its measurement instruments. RESULTS: The possible sequelae of collective violence, in the physical, emotional and social dimensions of health, are described. Also, the review distinguishes the likely impact in primary and secondary victims, as well as the interplay with the social environment. The mixed methodological design of the ISAVIC study supports the coherence of the conceptual model described. CONCLUSIONS: The ISAVIC study suggests that collective violence may affect the main dimensions of the health status of its victims, in intimate relation to the societal factors where it operates. It is necessary to validate these results with new studies.

Tracing the foundations of a conceptual framework for a patient safety ontology.

BACKGROUND: In work for the World Alliance for Patient Safety on research methods and measures and on defining key concepts for an International Patient Safety Classification (ICPS), it became apparent that there was a need to try to understand how the meaning of patient safety and underlying concepts relate to the existing safety and quality frameworks commonly used in healthcare. OBJECTIVES: To unfold the concept of patient safety and how it relates to safety and quality frameworks commonly used in healthcare and to trace the evolution of the ICPS framework as a basis of the electronic capture of the component elements of patient safety. CONCLUSION: The ICPS conceptual framework for patient safety has its origins in existing frameworks and an international consultation process. Although its 10 classes and their semantic relationships may be used as a reference model for different disciplines, it must remain dynamic in the ever-changing world of healthcare. By expanding the ICPS by examining data from all available sources, and ensuring rigorous compliance with the latest principles of informatics, a deeper interdisciplinary approach will progressively be developed to address the complex, refractory problem of reducing healthcare-associated harm.

[Violence is also a public health issue]. / La violencia también es un problema de salud pública.

In 1996, the World Health Organization declared violence a major and growing public health problem across the world. In Spain, despite the growing incidence of reports of deaths and abuse due to intimate partners violence; the emergent data on school-based violence among children and adolescents; the persisting political violence and the tragic experience of the 11-M attacks in Madrid; a clear positioning over the role of the public health structures in the study and intervention of violence has not taken place. This article provides a characterization of the impact of violence in the health of its victims, as derived from a non-systematic review of the clinical, psychological and social literature. It also includes some prevalence data from Spanish studies. Special emphasis is given to violence against women, and political violence. The article highlights the scarcity of epidemiological data, which hinders the assessment of the health impact of violence in Spain. It brings, instead, the opinions of a number of public health professionals over the role of the Spanish communities of epidemiology and public health in this matter. The article concludes with a call to public health professionals, including the Spanish scientific societies involved in public health, to facilitate the public debate leading to the definition of the role of the Spanish public health in the understanding and reduction of the impact of violence on the health of its victims.