Major accidents occurred frequently in the road transportation industry, and the resulting harm to drivers, property loss, and traffic interruption are very serious. This study investigated 11 particularly major accidents involving commercial vehicles in China, and performed analysis on accident characteristics regarding the time, location, types of vehicles, and accident causation at different levels based on the 24Model. Large buses and dangerous goods vehicles were involved in 10 accidents and they all occurred on a freeway. The months from May to August, especially during the time periods of 2:00–4:00 and 14:00–16:00 every day, were the most prone to accidents. The driver’s speeding and fatigued driving, and vehicle failure were the direct causes of most of the accidents. The defects in organizational safety management involved 12 system elements, such as safety accountability, education and training, etc. Procedures are of no use if they were not followed, and there was often no effective process to assess the implementation of procedures in many organizations. The weaknesses in organizational safety culture were the source of accidents, which was mainly manifested in members’ inadequate cognition of key elements in the aspects of safety importance, safety commitment, safety management system, etc. Understanding the characteristics and root causes of accidents can help to prevent the recurrence of similar mistakes and strengthen preventative measures in road transportation enterprises. Road traffic accidents posing a serious hazard to modern societies, as they result in injuries, disabilities and even loss of lives, along with significant economic and social consequences. Globally, the number of deaths on the world’s roads remains unacceptably high, with around 1.35 million people dying each year . The impIn the context of road traffic safety, studying the factors that affect accidents and the associations between causal factors, especially those behind particularly major accidents, is very necessary. Many studies have applied safety analysis to explain the occurrence of road traffic accidents. The following stand out among the predictors of road traffic accidents due to their consistency in the literature: environmental factors such as the climate, weather and road infrastructure; mechanical factors such as the model, age and breakdowns of vehicles ,5; and iSpecifically, human factors and unsafe conditions are the primary causes of accidents. A previous study showed that human errors accounted for 95% of the causes of 5519 road traffic accidents in China from 2008 to 2012 . AccidenDespite previous studies on the frequency of road traffic accidents and its related causal factors, there is limited research about major or particularly major commercial vehicle accidents  exploring the relationship between different types of causes. In China, commercial vehicles must be operated by an enterprise and are supervised by multiple external organizations. As a result, the causes of commercial vehicle accidents are more complex, and usually involve multiple organizations and deep causes at the organizational level . ResearcWhat are the key points we should remember and how to avoid similar mistakes is of vital importance within the industry and for the whole world. Therefore, it is significant to create understanding about the nature of fatal traffic crashes, by identifying different salient factors that may influence the occurrence of accidents. The burden of most of these attributes can be reduced through effective interventions, which will result in a significant decrease in the burden of road transportation accidents. For that reason, this study aimed to provide a broad exploratory analysis for commercial vehicle accidents in China. Considering the typicality of the accident and the completeness of the investigation report, this paper mainly selected commercial vehicle accidents with relatively serious consequences for study.Accidents can be explained differently, depending on various accident analytical methods. In the last few decades, several typical accident models, such as the Domino accident model , Swiss CAccident analysis/investigation is widely recognized as an important part of a comprehensive and efficient safety management . InvestiFor every fatal accident, the basic information in the aspects of the time, location, vehicle, crash type, etc. was extracted from the investigation report, and then Excel software was used to carry out data statistics and presentation  for the trend or characteristics of the accident. In addition, graphic presentation techniques, such as fishbone diagrams and accident causation models were utilized in the analysis of the causes. Especially, the accident causation model played an important role in this work as it could demonstrate the logical relationships among different causal factors and help people better understand and remember the key lessons .In this study, an improved causation model—24Model—which was established by our research team based on the domino accident theory and Swiss Cheese Mode (SCM) ,37,38,39When utilizing the 24Model to analyze an accident, the first step is to find out the organization in which the accident occurred, and the following analysis begins from the bad outcomes , to the identification of unsafe behaviors and unsafe conditions, to the mining of organizational defects regarding the safety management system and safety culture based on the individual factors, and finally to the external causes outside the organization.The domino accident theory indicated that unsafe acts and unsafe conditions were the immediate causes of an accident ,31; furtSafety culture, which reflects the belief, vision, value, or attitude shared by the staff related to safety, guides the establishment and implementation of the safety management system ; thus, bThis section carried out the process anatomy and cause identification for the 11 particularly major accident cases listed above. The common characteristics of these accidents in the aspects of vehicles, time, locations and crash types were analyzed and discussed, and various factors that led to accidents are identified, classified and displayed based on fishbone diagrams and 24Model.Commercial vehicles are used to carry passengers and/or goods for profit. In China, commercial vehicles mainly include vehicles for ordinary goods, vehicles for dangerous goods, large buses, small taxis, etc. They must belong to an organization and are subject to safety supervision by the enterprise and the government. The particularly major accidents in this study involved three kinds of vehicles, including light goods vehicles, heavy semi-trailer tower vehicles and large buses, and two crashes also involved small private cars. Additionally, the crash forms of the vehicles include collision with central or roadside guardrail, rear-end collision and head-on collision, among of which, seven collisions further caused severe fires or explosions, and two vehicles rolled over and fell off the cliff.From The time series trend for particularly major accidents related to commercial vehicles clearly revealed the pattern of variable frequencies for different hours, months and seasons. In In addition, with the arrival of several holidays, more people travelling and the operation of bus business, the accident rate increased. Furthermore, schools were closed for summer season and many students and residents spent time indoors or leave the country for holiday. This increased the business of the commercial buses and led to significantly severe injuries and deaths during the summer season.There were nine crashes that occurred on freeways. As we know, the traffic flow on the freeway is relatively large and the speed of vehicles is very fast, which is more dangerous than those ordinary low-speed urban and rural highways. Briefly, the freeway is the frequent area of major and particularly major road traffic accidents.Four crashes occurred in areas of with steep bends and sloping roads on the freeway, and another two occurred at the entrance of a tunnel see . The linGenerally, large-scale accidents occurred due to unexpected interactions among multiple failures. Based on the analysis of the accident characteristics, there was a nested collection of causal factors that triggered the crash. These causes ranged from straightforward ones in the aspects of drivers or vehicles to more fundamental roots such as managerial flaws or poor safety culture in the organization.The road transportation system is composed of several important factors like the individual, vehicle, road, environment and organization. If there are defects in these sub-systems, accidental events will be easily triggered. Combined with the accident causation theory, the key causal factors of those particularly major traffic accidents related to commercial vehicles are extracted and classified in detail.In order to illustrate the role played by all causal factors, the fishbone diagram has been adopted for the accident causation analysis. The fishbone diagram is also called a cause and effect diagram and was often used to summarize the causes that create or contribute to a specific effect ,43. WithThe further analysis and discussion regarding the sub-causes under the individual, road, vehicle, goods, environment, and organization categories will be carried out in the following section.Through the investigation, all particularly major crashes in this study were classified as the “accountability accident”, namely human error accidents. This section has identified the individual’s unsafe acts leading to the accident and the flaws of the individual’s abilities in the aspects of the knowledge, awareness, habit, physiology and psychology that lead to the unsafe acts.Ten categories of unsafe acts have been summarized from the accident report, as shown in Almost all unsafe acts were violations of regulations, involving different frontline workers like the drivers, passengers, and dynamic supervisors for vehicles. Additionally, unsafe decisions such as the inadequate safety training and poor safety inspection organized by the management had great impacts on frontline workers’ acts, which were usually considered as the potential causes of the accident. These causal factors will be discussed as the deficiencies at the organizational level in the following section.In Inadequate safety knowledge: Drivers in several accidents lacked emergency driving experience, especially when facing bad road conditions on the freeway. In addition, some drivers and management did not know the characteristics of some hazardous chemicals loaded in the vehicle and did not know how to handle the leaks after the crash.Poor safety awareness: Some drivers were not aware of the serious consequences of speeding on the freeway and overloaded vehicles, and did not realize the risk of illegal transportation of hazardous chemicals. They failed to attach great importance on the implementation of rules or regulations regarding the traffic on the freeway.Poor safety habits: Some drivers had developed bad driving behaviors  in their daily work. Violations of regulations appeared very frequently in the driving as accidental events did not occur in the past and the organization did not remind or punish the drivers.Poor psychological status: Many drivers in accidents had unstable moods or bad psychology, such as the quick temper, low energy psychology , fluke mind, herd mentality, and some were almost not competent to do transportation work, as they were the main reason of unsafe acts in the driving.Poor physiological status: Fatigue is considered as one of the great taboos in the driving. Many drivers in accidents were very tired and distracted after the long-time driving and had a bad emergency capacity when facing a danger on the freeway.Unsafe conditions are also the important factors causing the commercial vehicle accidents. In the Fishbone diagram above, unsafe conditions regarding this kind of accident mainly involved the defects of the vehicle, goods, road, and environment. Vehicles and goods are usually managed and supervised by the transportation enterprises, and their unsafe conditions are determined as the internal factors according to the 24Model; while the management and maintenance of freeway and road facilities come from other organizations, and their unsafe states were usually classified as the external factors. The specific unsafe conditions leading to the commercial vehicle accidents are shown in Defects related to commercial vehicles appeared the most in these accident cases. The brake malfunction was very dangerous condition and it will easily lead to the severe crash once the vehicle encountered bad road conditions or environment. For vehicle overload (both goods and passengers), and defects of vehicle-mounted emergency facilities, both not only had indirect impact on the occurrence of the accident, but also led to the expansion of the accident scale and the casualties. Indeed, most of the unsafe conditions are directly or indirectly caused by unsafe acts; therefore, an effective way to eliminate unsafe conditions is to strengthen the control of the individual behaviors.The Chinese government has attached great importance to the safety supervision of commercial vehicles, especially for the large buses and dangerous goods vehicles. The daily operation of commercial vehicles is supervised jointly by multiple organizations. Commercial vehicles must rely on an enterprise to carry out transportation activities and the organization is responsible for the dispatching, inspection and maintenance of vehicles, as well as the online supervision of drivers. In addition, the transportation enterprises must apply for a legal production safety license and accept the supervision from different government agencies . Thus, the occurrence of a commercial vehicle accident was often involved in factors from multiple organizations. The safety management defect within the organization is the root cause of the accident, while the safety supervision and improper decision-making outside the organization directly affect the safety work of the enterprise, which has important indirect impacts on the accident.Considering the directness of the enterprise’s safety management to commercial vehicles and employees, this study focuses on the analysis of the shortcomings of safety work within the organization. Based on the 24Model, the deficiencies in the construction of organizational safety management system and safety culture elements have been identified from the accident report, which can reflect the weaknesses in the safety supervision of related government agencies.Deficiencies in the safety management systemOrganizational safety management determines individual behaviors ,37. AccoIndeed, the deficiencies in the organization’s safety policy and safety objective were not easy to be identified from the accident report, but it can be inferred that the safety policy of those accident enterprises failed to properly reflect the importance attached to safety. Although the organization may set its own safety goal, it failed to formulate effective measures to accomplish the goal. As a result, the risk identification and rectification rate, safety education and training rate, the number of emergency drills and other aspects did not meet the requirements of relevant laws and regulations.Deficiencies in the safety cultureSafety culture is considered as the guiding ideology  for the enterprise’s safety management. The weaknesses in organizational safety culture were the source of accidents, which is mainly manifested in members’ inadequate understanding and cognition for safety culture elements, thus failing to form good safety climate in the organization. Based on the above analysis of accident causation at different levels, the weaknesses in the construction of safety culture in accident organizations are identified, and five categories regarding the elements are summarized as follows:(1)Recognition for safety importanceThe management and drivers did not attach great importance to safety, did not put safety work in the first place, did not integrate safety work into the normal management of the enterprise, and believed that safety was only input and could not produce economic benefits. Members in these business units did not reach a consensus on safety beliefs such as “safety is the first priority”, “economic benefit of safety”, “integration of safety and management”, “treatments for safety performance”.(2)Recognition for safety commitmentThe top managers, middle management, line management and front-line operators of the enterprise failed to realize and understand their own post responsibilities, and did not well fulfill their safety responsibilities and commitments signed level by level. Members in these business units did not reach a consensus on safety beliefs such as “primary responsibility for safety”, “safety responsibility of the management”, “role of the safety department”, “responsibilities of line management departments”.(3)Recognition for safety management systemThe organization did not realize the important influence of safety management system on individual unsafe behaviors. The members did not write the safety work into procedures in accordance with the requirement of laws and regulations, and the implementation of the systems were not completely recorded, which failed to realize the whole process management of enterprise safety including pre-prevention, in-process emergency response and post-investigation and analysis. Members in these business units did not reach a consensus on “role of safety laws and regulations”, “role of safety management system”, “emergency capability”.(4)Recognition for safety practiceIt is meaningless if safety rules and regulations only remain on paper. The organization shall ensure the safety investment of human resources and capitals in production according to the specific requirement of laws and regulations, formulate effective execution measures regarding the procedure documents, and especially, strengthen the assessment and feedback of the implementation effect. Members in these business units did not reach a consensus on “demand of safety education and training”, “satisfaction for facilities and workplace”, “safety performance and human resources”, “types of safety inspections”.This study performed an analysis on 11 particularly major commercial vehicle accidents, focusing more on the identification and presentation of common characteristics and causes at different levels. The 24Model which was improved from different accident models was used in the accident analysis, and especially, the causal factors at the organizational level regarding the safety management system and safety culture were newly summarized for the identification of latent causes. Thus, several important findings were summarized and they can provide a basis for the development of accident prevention measures for the government and enterprise.The basic accident information in the aspects of the time, location, vehicle, crash type, etc. was extracted from the investigation report, and the trends or characteristics were summarized and discussed. Large buses and dangerous goods vehicles were involved in 10 accidents and should be supervised strictly by the government. The months from May to August, especially at the time of 2:00–4:00, 14:00–16:00 every day, were most prone for driver accidents. Freeways is the frequent location of particularly major road traffic accidents.Unsafe acts and unsafe conditions were the immediate causes of the accidents, moreover, almost all unsafe acts were violations of existing driving regulations. Speeding occurred most frequently, which was one of the most direct causes of the accidents. In addition, drivers’ fatigued driving and improper operation in an emergency had great impact on the occurrence of the crashes. Unsafe conditions related to commercial vehicle maintenance such as malfunction of the brake system and overloading of vehicles appeared the most of the accident cases.More efforts should be taken on the root causes at the organizational level. Common problems in safety management system mainly involved the elements such as the organizational structure and personnel allocation, safety commitment or responsibility, safety training, etc. Procedures are of no use if they were not followed, and there was often no effective process to assess the implementation of safety procedures in many accident organizations. The weaknesses in organizational safety culture were the source of accidents, which was mainly manifested in members’ inadequate cognition for elements in the aspects of safety importance, safety commitment, safety management system and safety practice.The object of this study is particularly major commercial vehicle accidents, so there have been few cases in recent years, and the laws of some research results, especially the statistics of accident characteristics, are not obvious. Therefore, it is necessary to carry out further research using a larger sample of general commercial vehicle accidents, and to make a comparative analysis with the present results. In addition, this study focused more on the characteristics and causes of the accidents, while the corresponding accident prevention measures in the aspects of the government, enterprises and individuals were less involved, which will also be the focus of the next research.


The number of chemicals in our society and in our daily lives continues to increase. Accompanying this is an increasing risk of human exposure to and injury from hazardous substances. Performing regular, structured surveillance of chemical incidents allows a greater awareness of the types of chemical hazards causing injury and the frequency of their occurrence, as well as providing a better understanding of exposures.The objective of performing event-based surveillance (EBS) and capturing chemical incidents is to use this information to increase the situational awareness of chemical incidents, improve the management of these incidents and to inform measures to protect public health.This paper describes a method for EBS for chemical incidents, including the sources used, storing the gathered information and subsequent analysis of potential trends in the data.We describe trends in the type of incidents that have been detected, the chemicals involved in these incidents and the health effects caused, in different geographic regions of the world.The methodology presented here provides a rapid and simple means of identifying chemical incidents that can be set up rapidly and with minimal cost, the outputs of which can be used to identify emerging risks and inform preparedness planning, response and training for chemical incidents. Given the ever-increasing number and variety of chemicals manufactured, transported and used globally in all aspects of modern life , the risIn order to strengthen preparedness for chemical incidents, surveillance is a key activity required under the International Health Regulations core capacities  and the EU decision on cross-border health threats (Dec 1082/2013/EU – currently under review) , 7. As oEvent-based surveillance (EBS) is a functional component of the early warning and response process and encompasses the organised collection, monitoring, assessment and interpretation of mainly unstructured information  regarding chemical incidents or hazards, which may represent an acute risk to human health . EBS canThe benefits of using EBS for the surveillance, reporting and responding to chemical threats include its speed and cost-effectiveness, as few resources are required to perform EBS and ease of access to information  can sometimes provide more information from those on the ground than in official reports on the incident. More credible media sources usually provide accurate information and these are readily accessible via the internet . The useHowever, there are some obvious caveats to this approach, the reports captured from websites may often not be verifiable, may include opinions or observations rather than established facts and may change over time as the incident unfolds, e.g., number of injuries and deaths. Sometimes when an incident is reported, the information does not include the identity of the chemical agent involved. Particularly when an incident occurs in countries with fewer public health resources and reduced analytical laboratory capacity, the identity is often not elucidated at all. Incidents may be reported for being newsworthy rather than an accurate depiction of its risk or impact to public health, e.g., when an explosion or release occurs but actually poses little risk to the public. In addition, when the media in a country is restricted or controlled, conflicting reports of the incident can arise  or may not be reported at all. Despite these caveats, the rapidity at which this information is available allows the alerting of other partners/agencies and drafting of an initial risk assessment of the incident. This latter point is important when considering cross-border chemical health threats, as an initial risk assessment provides public health organisations in other countries with an early warning so that measures can be put into place earlier to limit the threat to public health .EBS heightens the awareness of the individuals and organisations performing surveillance, this information could assist in identifying trends in chemical incidents and go on to inform public health interventions. Sharing this information with colleagues, collaborators and other stakeholders (in different organisations and countries) could lead to strengthening of preparedness and response activities nationally and internationally ; in addiThis paper describes the EBS methodology led by Public Health England that has been developed over a number of years through various international projects and involved a number of people in an international network from different organisations. The EBS strategy was originally initiated to detect chemical incidents within the EU or with the potential to affect EU citizens. Once detected, these could be posted to the EU Rapid Alerting System for CHEMicals (RASCHEM) for information sharing and awareness raising for incidents that may cross borders, under the EU ECHEMNET project . The scoEBS has contributed to surveillance activities and supports provisions within EU Decision 1082/2013 and IHR (2005). EBS also contributes to improving the process of detecting, analysing and notifying others of serious chemical health threats, including those that have the potential to cross international borders, which require a joined-up approach from multiple sectors and countries.In 2014, the initial EBS strategy was undertaken to capture incidents that were cross-border  in nature within the EU; however, the strategy was also able to detect chemical incidents from around the globe and those were also recorded in the database. Incidents that meet the criteria outlined in the methods are logged in a Microsoft Access database (see below for details). The websites used to perform EBS searches are detailed in Table EBS captures the impact of chemical incidents on public health, including chemical exposures, releases, explosions and poisonings. The strategy focuses on incidents that result in injury or death, rather than incidents that result in near misses, property damage or environmental pollution, i.e., the focus is on the effects of these incidents to public health, rather than risks that do not result in injury . It should be noted that this method did not take into account mental health, which can also be affected by exposure to chemical incidents and can occur even if physical injury was not sustained. However, the lengthy follow-up required for diagnosis and treatment of mental health issues is out of the scope of EBS. For this database, injuries were recorded when someone was exposed to a chemical. All chemical incidents resulting in injury or death are collected and distributed to colleagues and stakeholders within PHE, from around Europe and globally. The collected incidents form a valuable resource of past incidents for lessons learned and for monitoring that area or type of incident for similar occurrences.An unexpected chemical incident including a release, explosion, contamination, fire involving chemicalsAny incident involving chemicals that caused mortalityAny incident involving chemicals that caused significant injury Cross-border determination; is the incident near rivers/ports, near borders?Any incident involving chemicals that may ‘spread’—leading to additional cases of mortality or injuryBased on the criteria below, incidents detected with the websites listed in Table Those who would be notified, depending on the incident type/chemical agent/incident location, include PHE staff involved in responding to chemical incidents in the UK, interested individuals from European Poison Centres and public health agencies, WHO International/WHO Europe staff involved in chemical incident response and the EU Scientific Committee for Health, Environment and Emerging Risks (SCHEER) that coordinates response to cross-border chemical incidents in the EU. These stakeholders are notified in case a chemical incident is of interest, may affect their country  or they may have previous experience of such an event which would be valuable to share.While initially the detected incidents were listed in an Excel spreadsheet, the increasing numbers of incidents required a more robust system to cope with the amounts of data stored. As such, a Microsoft (MS) Access database was written for Office 365. Initially, the data were stored in MS Access but now exists as SharePoint Lists to enhance performance, with Access remaining as the user interface. The design of the database was straightforward and consists of four main entities: Incidents, Agents, References and Categories.An incident can also be tagged with multiple categories, which help describe the incident. Detected incidents are copied into emails that are distributed internally for review after every search (three times per week), to provide an opportunity to discuss the incidents to see if notification or follow-up is required. These emails are imported, from MS Outlook, into a database table where the individual stories are then separated and parsed. Longitude and latitude of the location of the chemical incident are also recorded, allowing the creation of maps to show the global distribution of the detected incidents, their health effects and types of chemical agent.The recorded incidents presented in these results relate to the period between November 2014 and June 2020, covering the global EBS strategy. As of the end of June 2020, the database contains 1592 recorded chemical incidents in 121 countries, involving 252 unique chemical agents. The original purpose of performing EBS was to identify incidents that had the potential to be cross-border in nature, some of these incidents were then forwarded to RASCHEM and to colleagues from around Europe within the ECHEMNET network , this waAs well as sharing these incidents with RASCHEM, EU colleagues, WHO and the European Monitoring Centre for Drugs and Drug Addiction, the collected incidents provided a useful source of information about the types of incidents which occur, their location, the agents involved and some of the health effects caused.The top 5 countries with the highest number of incidents detected, comprising over half of the detected incidents, include USA, with 322 (20.2%), India with 225 (14.1%), UK with 130 (8.2%), China with 117 (7.3%) and Russia with 55 (3.5%) detected incidents, respectively. These figures may not necessarily represent countries where the highest number of incidents is occurring; it could be that some countries have more advanced reporting systems than others. This can lead to all incidents being reported in some countries, whereas only the most serious ones being widely reported in other countries. For example, the incidents detected in the USA are associated with 117 deaths and 6497 injuries, while those detected in India are associated with 989 deaths and 6749 injuries. The number of injuries is comparable, while the number of deaths is far higher in India. While this is not a rigorous analysis, it shows that chemical incidents detected in India give rise to more deaths than in the USA.To highlight where the different incidents are detected, the incidents detected from the last 12 months have been compiled along with their source website. Table While 45% of the detected incidents have come from two websites (RSOE EDIS and InformationAware), the spread of all the incidents shows the value of having a variety of sources, as many more incidents would be missed with a reduced number of sources. Using just one of the source websites would preclude the detection of many other relevant chemical incidents. There may be other reasons for this distribution between sources, e.g., the two most common sources, RSOE EDIS and InformationAware, are map-based and allow incidents to be picked up by eye much easier than GPHIN, e.g., which requires reading through hundreds of summaries to find relevant chemical incidents. There are some regions  that are consistently underrepresented in the chemical incidents detected, this could be due to a number of reasons, for instance, a general lack of reporting in the region(s), an under-reporting of less serious incidents or the incidents not being reported in English and hence not picked up by the sites used by EBS.From the detected incidents, around two-thirds of these incidents gave the identity of the chemical involved. Of these, the most commonly identified chemicals are chlorine, involved in 105 detected incidents (6.6%), ammonia, involved in 89 incidents (5.6%), methanol, involved in 86 incidents (5.4%) and carbon monoxide, involved in 47 incidents (3.0%). Often when incidents are detected, the chemical agent is actually unknown and this accounts for 525 of these incidents . This may be explained by the reporting of incidents soon after they have occurred and before the agent is known, and frequently the unknown agent is not elucidated. However, while the exact agent is sometimes unidentified, the type of agent is usually given, e.g., the incident may involve an unknown gas, fuel or pesticide.To give an overview of the detected chemical incidents, Table In terms of the health effects of the most commonly identified chemicals, ‘unknown’ incidents  accounted for 1421 deaths  and 11,563 injuries . Of the incidents where the causative agent was identified, methanol has caused the highest number of deaths and injuries at 2090  and 9381 , respectively. As methanol was not the most common chemical agent, it highlights the severe health impacts methanol incidents can cause.The next most common agents involved in incidents leading to high loss of life include petrochemicals (petrol/diesel/kerosene and liquefied petroleum gas) at 608 (10.1%), explosives (including munitions and fireworks) at 388 (6.5%) and chlorine at 122 (2.0%). When looking at the number of injuries caused, the agents involved are slightly different. Other than methanol and unknown agents, the next highest number of injuries from the detected chemical incidents involves benzene with 3425 injuries (6.4%), synthetic cannabinoids with 2943 injuries (5.8%) and ammonia with 2888 recorded injuries (5.7%).Methanol poisoning is responsible for most of the deaths and injuries detected through EBS. The problem is so widespread that it affects almost all the regions in the world; there is also a high mortality rate associated with these incidents as 92% of the detected incidents involve at least one or more deaths. The number of deaths and injuries tend to be higher in countries where alcohol is either not widely sold or is prohibitively expensive for most residents. While some of these are due to intentional ingestion of methanol, the majority of the detected incidents are due to outbreaks of people unknowingly consuming methanol-contaminated alcohol. Figure Over half (54%) of reported methanol incidents occur in South and South East Asia, this could be for a variety of reasons including: poorer regulation on spirit production and distribution, reduced access to legitimate alcohol products, affordability of legitimate products versus bootlegged or locally manufactured alcohol, religious considerations . Of course, it is not possible to draw definitive conclusions from this overview of the data, these are merely suggestions to try to explain the trend in methanol incidents.Some recent methanol incidents have been related to the coronavirus pandemic, as it is believed by some that drinking alcohol offers protection from the virus. This has prompted an increased demand for alcohol that did not previously exist. In some countries where alcohol is more difficult to find, e.g., Iran, the demand has caused an increase in the availability of adulterated alcohol. In an ongoing incident, first detected in April, over 700 Iranians have died and more than 5000 have been injured due to methanol poisoning .This paper has provided a description of the EBS activities undertaken, the main advantages and disadvantages of this strategy, examples of the data analysis carried out and some broad trends identified from this work. EBS was originally established to identify chemical incidents occurring in the EU that could be posted to RASCHEM, as required under the EU decision 1082/2013 when it came into force. Some of the incidents detected by this method were, or had the potential to be, cross-border incidents and were posted to RASCHEM and shared with the EU . Performing regular EBS can be used to heighten situational awareness and be used to provide advice in the event of cross-border incidents to appropriate organisations and relevant agencies . The data have been used to contribute to awareness raising of chemical incidents through the creation of case studies and exercise scenarios, used in training courses, workshops and exercises on chemical incident preparedness and response. Reports on a specific region or a specific time period are also created, which identify trends in the type of agents involved in incidents, the health effects common to a region or caused by a particular agent. Under previous EU projects  a wThis EBS method is not designed, and never was intended to, follow-up on the detected incidents. Aside from the fact that following-up on each incident would take a prohibitive amount of time, it was not in the scope of why EBS was initiated. While the original scope of EBS was to detect and report potential cross-border chemical incidents, with the aim of highlighting these issues for countries to take action if they deemed it appropriate, the scope was later broadened to include the rest of the world and WHO, so that they could liaise with the affected country if required. This increase in detected events allowed for the monitoring of certain broad trends, including the distribution of detected incidents by country/world region, the agents involved and the health burden (injuries/deaths) caused by these incidents. Trends in the types of incidents identified and chemical agents involved have also been found, highlighting methanol as one of the most commonly detected chemical incidents with the greatest health burden (deaths and injuries). In addition, details on which sources provide the most detected incidents, as well as the type of incident, have also been reported. The countries that were identified as having the highest number of detected incidents include USA, India, UK, China and Russia. The number of incidents detected in these countries is not necessarily a direct reflection of the number of incidents that occur but may reflect a difference in capacity for reporting incidents. As this methodology includes only cases with reported death and injuries, further work would be required to assess the public health impact and burden of disease associated with these events. In general, the USA and UK often report chemical incidents with fewer health effects whereas in India and China, the incidents that are detected tend to have more serious health effects , while more minor incidents  are generally less reported or detected through EBS.A general observation is that while EBS tends to focus on picking up large-scale acute chemical incidents  that may affect multiple countries, these actually account for a small proportion of the health effects recorded. The majority of the health burden is due to frequent, smaller-scale incidents, such as outbreaks of methanol poisoning. Further data analysis is required to better understand and provide evidence for any potential trends identified from the EBS data. For example, linking methanol incident data with existing data from national poison centres would validate information on the health effects of the incident .Comparison of this overall EBS strategy with just one of the sources used  shows that the number of detected incidents using this EBS system is far higher  . As commAn example of where chemical and communicable disease surveillance can overlap is through syndromic surveillance, which searches for symptoms exhibited by exposed individuals, rather than confirmed incidents. While this is primarily used for communicable disease surveillance, adding symptoms of chemical exposure to the list of symptoms of communicable diseases is a straightforward way of enabling the detection of chemical exposures as well. Some European Poison Centres have specific syndromic surveillance for known chemicals of concern, enhancing this process for chemical incidents . This meGreater integration with other sources of data would allow a more unified, comprehensive surveillance system as described in the JEE Tool  and IHR The EBS process outlined in this paper has identified some trends (as well as caveats and limitations), such as the locations where more incidents are detected, the different health burden of the agents causing the detected incidents, the identification of methanol incidents as having the most significant health burden (even when it is not the most common causative agent in the detected incidents) and differences in the sources of incidents that have been used. The limitations of this method include: the details from the reports may be unreliable and the difficulty in verifying or confirming information from the initial detected reports. While it is possible to search for updates on specific incidents, e.g., for the most recent/accurate casualty information, it is not feasible to do this routinely, but can be a useful tool to increase awareness of the type and range of events, and alert public health agencies to potential cross-border health incidents. One way to address this would be to link with, e.g., hospital data to provide reliable figures on those injured from chemical incidents. However, this is not really in the scope of EBS, a system that is designed to detect incidents soon after they have occurred, to enable the early warning and notification of others involved in the response to such incidents.More could to be done to improve the sustainability of this type of surveillance activity, both at a national and international level, e.g., across the EU. For example, more in-depth data analysis, follow-up of chemical incidents to gather further information and track recovery from these incidents, notifying/alerting relevant stakeholders on a more routine basis (currently it is done ad hoc) and linking the data with other surveillance systems or existing databases of chemical incidents. An additional improvement would be the increased automation of the system, as it requires a significant number of person-hours to routinely look through the sources, evaluate each incident, cross-check the information and manually enter incidents into the database. Google Alerts and automated updates from other sources used  already detect potentially relevant incidents but this would need to be applied to all sources, to reduce time spent on manually scanning and detecting incidents. There is also the possibility of linking with other surveillance systems nationally and internationally. At first this could include other surveillance systems for chemical incidents, but could be incorporated into an all-hazard surveillance approach.Previously there was a network in place for utilising the incidents detected through EBS, as under the ECHEMNET project, incidents were forwarded to network colleagues in EU countries, Poison Centres and posted to RASCHEM if there was potential for the incident to become cross-border . As the


Medication reconciliation (MedRec), a process to reduce medication error at care transitions, is labour- and resource-intensive and time-consuming. Use of Personal Electronic Records of Medications (PERMs) in health information systems to support MedRec have proven challenging. Relatively little is known about the design, use or implementation of PERMs at care transitions that impacts on MedRec in the ‘real world’. To respond to this gap in knowledge we undertook a rapid realist review (RRR). The aim was to develop theories to explain how, why, when, where and for whom PERMs are designed, implemented or used in practice at care transitions that impacts on MedRec.We used realist methodology and undertook the RRR between August 2020 and February 2021. We collaborated with experts in the field to identify key themes. Articles were sourced from four databases  to contribute to the theory development. Quality assessment, screening and data extraction using NVivo was completed. Contexts, mechanisms and outcomes configurations were identified and synthesised. The experts considered these theories for relevance and practicality and suggested refinements.Ten provisional theories were identified from 19 articles. Some theories relate to the design , some relate to the implementation , some relate to use (T6 Support and on-demand training) and others relate iteratively to all stages of the process .This RRR has allowed additional valuable data to be extracted from existing primary research, with minimal resources, that may impact positively on future developments in this area. The theories are interdependent to a greater or lesser extent; several or all of the theories may need to be in play to collectively impact on the design, implementation or use of PERMs for MedRec at care transitions. These theories should now be incorporated into an intervention and evaluated to further test their validity.The online version contains supplementary material available at 10.1186/s12911-021-01659-8. Medication reconciliation (MedRec), a process to reduce medication error whenever patients transfer between care settings, is labour- and resource- intensive and time-consuming. MedRec has proven challenging to implement . Lack ofWhilst evidence is emerging regarding the positive impact of PERMs implemented in research environments, relatively little is known about the design, use or implementation of PERMs at care transitions that impacts on MedRec in the ‘real world’ , 10. We Medication Reconciliation (MedRec) relates to any opportunity taken to collect a medication history, check for any differences with current medication and communicate about any differences, thus creating a current accurate list; Care Transition relates to any movement between care settings or change in responsibility of care of a patient; PERMs relate to any digital record, partial or complete, of information regarding an individual’s medications (past or current) prescribed, dispensed or used by a patient; Users relates to any person, including healthcare workers, administrators or patients and carers, using PERMs.We used the following definitions of the key terms: Controlled trials generally determine what effect an intervention has when a number of static variables are applied but may not always identify how and why it worked . In the Other researchers have examined the effectiveness of using PERMs to improve MedRec at care transition –15. RealA realist approach is suited to the synthesis of evidence about complex, multifaceted interventions because it explores how the underlying contexts and mechanisms configure to generate an outcome . RealistA RRR is a more focused and accelerated version of a full realist review which aims to produce theories in a time-sensitive way and that is useful to a specific audience about emerging issues, while preserving the core elements of realist methodology .Interventions are influenced by an endless source of contexts which can, for convenience, be grouped under the four I’s as outlined by Pawson et al. ; (1) Indcontexts represent conditions and examples include, but are not limited to, issues such as work environment, resources , governance, policies and standards, interoperability, sources of information, accuracy, reliability, security, user interface, user access, user (computer) skills and frequency of use of PERMs, user workload and readiness to change, patient consent, implementation, evaluation and audit.For this RRR, mechanisms are about individuals’ or organisations’ beliefs / feelings about PERMs and related contexts (as listed above). Examples of positive mechanisms include, but are not limited to; being enabled, engaged, involved, trusting, satisfied, contented, valued, proud, determined, confident, supportive, ready, motivated, aware, skilled, incentivised or efficient. A similar range of negative mechanisms may also be at play.In this RRR, outcomes for this RRR will include anything that has impacted positively or negatively on the use of PERMs for medication reconciliation at care transitions. Examples of outcome topics might include but are not limited to: workflow, communication, frequency of use, relationship between stakeholders , efficiency, errors, adherence to medications, patient’s awareness of medications and reasons for use.The The approach is guided by methodological guidance, publication standards and training materials for realist and meta-narrative reviews: Realist And Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES), which have been followed in this review .This rapid realist review was undertaken over a seven-month period from August 2020 to February 2021. The protocol for the RRR was registered with Prospero in September 2020 , and experts in the field from around the world (the Expert Panel) who ensure we reflect the most current thinking on the topic. For this RRR the Reference Panel was made up of thirteen key stakeholders, providing insight from clinicians, safety science, informatics, human factors expertise, e-health, governance, policy, research and academia. The Expert Panel comprised five key researchers in the area, from the USA, Ireland, Sweden and UK.At the beginning of the RRR both panels were asked to provide key articles on the topics of interest. The Reference Panel was also asked to collaborate in identifying the challenges and facilitators for introducing PERMs for MedRec at care transition. The information provided was reviewed for emerging themes, which assisted the research team to develop the research questions, which sought to identify the types of medication data sources used, the contexts and mechanisms that impact on the outcomes relating to the design, implementation and use of PERMs for MedRec, with the intention of identifying in what circumstances the use of PERMs for MedRec in care transitions are most likely to be effective.st of September 2020.Firstly, we used search terms based on those used for a systematic review of MedRec at care transitions completed by a member of this research team in 2018  and we sPurposeful searching, particularly for qualitative reports, interviews or surveys and reports of negative findings continued throughout the review. We also considered relevant articles suggested by the Reference and Expert Panels. All article types were eligible for inclusion, for example, policy documents, newspaper articles and opinion pieces, no study designs were excluded. The reference lists of relevant articles were considered (chaining) and snowballing was also carried out to a small extent. The protocol outlined that relevant review articles would be searched for relevant articles not already included, if numbers are low, this however was not required.We piloted the screening of title and abstracts, which resulted in some amendments and clarifications of the inclusion and exclusion criteria  of realist data is considered under the headings of relevance, rigour and richness , 26. RicRelevance was assessed by determining if the article had information of value to the review. Rigour was assessed based on whether the sources or methods used to generate the relevant data were credible and trustworthy. We scored the relevance and rigour of the included articles using the following ratings: 0 = very poor, 1 = poor, 2 = good, 3 = very good.Richness, a term coined by Booth et al., relates to the level of theoretical and conceptual development detail provided in the articles, and used as a means to identify articles of most value in a realist review. We assessed it by scoring the articles in relation to the richness relative to the research questions. To score highly an article should provide sufficient details in relation to how the approach used was expected to work; documenting the process and explaining contextual factors that influenced implementation and/or outcomes . We rateNodes based on the themes.The data extraction process took place between September and December 2020 following a brainstorming session to finalise the list of themes identified by the conceptual HIT systems framework developed by Burns , the refA pilot extraction of data from three articles was undertaken in stages by three team members independently. After the data extraction was completed for the first article, we discussed the findings and how the NVivo set up was working. We then completed the data extraction independently for the two remaining articles and made final refinements to the process. The data from the remaining 16 articles was extracted by one team member. The NVivo nodes developed iteratively over the extraction process, the final NVivo codebook used is in Additional file We also extracted additional data—including the authors, year and country the study was carried out, the research questions or objectives, the formal outcomes, study conclusions, any theory/concept outlined or inferred, the software in use, the setting  and personnel involved and any citations of interest. We reassessed the quality assessment ratings during the extraction process and recorded them. This was based on individual sections of extracted data rather than the overall article, as per RAMESES guidelines . We usedWe analysed the extracted data to find and align evidence to demonstrate that particular mechanisms influence particular outcomes in particular contexts, i.e. CMOCs which form the basis of provisional theories  Additio.Juxtaposing—where evidence about mechanisms in one source enables insights into outcome patterns of another source.Reconciling—finding explanations for different outcomes by uncovering contextual differences.Adjudication—explaining opposing study outcomes on the basis of methodological strengths and weaknesses.Consolidation—where outcomes differ in particular contexts and explanations can be constructed of how and why these differences occurred.Situating—describing which mechanisms were activated in which context.The analytical processes used to make sense of the CMOCs being developed followed a process outlined by Pawson :JuxtaposThe result is a series of theories based on the literature examined which describe what is it about how, why, when, where and for whom PERMS are designed, used or implemented in practice at care transitions that impacts on medical reconciliation.understood each theory, the relevance of the theory and the feasibility to apply the theory in practice. Comments or suggestions to improve theory clarity and focus were invited.A survey to determine the reference panel’s feedback on the provisional theories was piloted and revised. The expert and reference panels were then provided with a brief introduction to realist methodology and the purpose of the RRR  or national PERMs (n = 8). Of the remaining four articles, two reported on patients use of PERMS, one on an electronic discharge system and one on the use of an e-messaging system.The users of the PERMs were predominately hospital-based staff which included doctors, nurses, hospital pharmacists and technicians, administrators and IT staff. Of the fifteen articles involving hospital-based staff, seven involved hospital staff only. The other eight also involved GPs (n = 4), community pharmacists (n = 3), nursing home staff (n = 2), system designers (n = 1) and patients (n = 4). The remaining four articles involved a mixture of users who were patients and/or their families/carers (n = 3), GPs (n = 2), community pharmacists, (n = 1), or nursing home nurses (n = 1).The location of PERMs use was influenced by who the users were, and so was mainly in hospitals only (n = 9), jointly in GP practices and community pharmacies (n = 4), jointly in hospitals and nursing homes (n = 2), jointly in hospitals and GP practices (n = 1) or jointly in all of these settings (n = 1). Use of PERMs by patients in their own home was reported in two articles.The identified CMOCs from the 19 articles, allowed us to develop ten theories in relation to what is it about how, why, when, where and for whom PERMs are designed, implemented or used in practice at care transitions that impacts on medical reconciliation.The panels’ feedback (88% response rate) Fig.  indicatePanellists’ feedback comments related to clarifying that no one theory was the solution, the need for a good MedRec process should precede the introduction of PERMs to support it and highlighting the importance of evaluating the implementation and use of PERMs so that unintended effects and problems could be identified to improve the PERMs. Several panellists commented positively on the methodology used, their satisfaction with the range of theories developed and the ease at which they were able to provide their feedback. The panellists’ engagement facilitated our revision of the theories improving their clarity and intention: seven theories were revised and the remaining three required no change. None of the theories were considered irrelevant or totally impractical, although the challenge of implementing some of them was acknowledged.Engage stakeholders—If stakeholders including all user groups are given the opportunity to provide input, and both give and receive feedback at all stages of the design, implementation and use of PERMs, they will feel engaged, be supportive and understand the challenges, they will then accept and feel confident about using PERMs to complete MedRec at care transitions.Inclusive design—If PERMs are designed with user input and employing user-centered design & usability principles then users will feel heard and supported, thus fostering successful collaboration, acceptance and increased use of PERMs to complete MedRec at care transitions.PERMs complement existing good processes—If PERMs complement MedRec cognitive and workflow processes or forms that are already in existence in a setting and have been shown to work well, then PERMs will feel familiar and consistent, users will feel confident using them and PERMs will become embedded more easily into normal work practices, allowing a smooth transition to PERMs to improve MedRec at care transitions.Build trust—If users are aware and understand how they and others access and use PERMs, the integrity of the PERMs data sources and the data protection controls, their trust and confidence in the PERMs design and use will increase, they will then be more likely to value and use it at care transitions to improve MedRec and patient safety.Tailored training—If training is provided to users that takes into account their existing MedRec knowledge and skills, their computer skills and their role at care transitions, and the training outlines the clear benefits, usefulness and usability of PERMs, users will then feel less anxious and be more engaged and confident in relation to the introduction of PERMs in their setting.Support and on-demand training—If support and training on PERMs is available on demand to cater for new staff or those needing additional support, at times or in formats that suit all users, with the opportunity for users to give feedback on the training, then the users will feel supported and enabled to use PERMs consistently thereby improving MedRec at care transitions.Interoperability—If the data sources are technically interoperable with PERMs, allowing integration of data from multiple sources, then users will find that PERMs align with or improve the MedRec process flow, thereby increasing their use of PERMs for MedRec at care transitions impacting positively on patient safety.Resource investment—If the increased effort, volume and quality of data gathered when using PERMs for MedRec at care transitions, providing opportunities for risk identification, management and analysis, is recognised by leaders/ management from the outset then they will understand the need for additional resourcing to support the use of PERMs to improve MedRec at care transitions and patient safety.Positive impact of legislation or governance—If the introduction of PERMs or standards for the MedRec process are supported by relevant legislation, governance or policies then organisational participation and engagement is increased impacting positively on individual users' engagement with the introduction of PERMs to improve MedRec at care transitions.Patients as users of PERMs—If patients are supported to use PERMs to understand and record their medication use and share their medication information, they will feel enabled, empowered and organised in helping to maintain an accurate medication record, be more informed and have improved likelihood of adherence to their medications.The ten provisional and final theories and a data synthesis summary for each theory is presented in Table The theories are all interdependent to a greater or lesser extent. It is likely that several or all of the CMOCs inherent in the theories would need to be in play in order for them to collectively impact on the design, implementation or use of PERMs for MedRec at care transitions in a positive way.Some of the theories relate to the design , some relate to the implementation , some relate to use (T6 Support and on-demand training) and many relate iteratively to all stages of the process  :Consideration should be given to the individual user’s levels of confidence, trust, engagement and acceptance of PERMs. Users may have differing needs in relation to the amount, flexibility and format of training throughout the development and implementation life-cycle and therefore need differing levels of on-demand support in relation to both the MedRec process itself and the function and purpose of PERMs to support that process. Identification and comprehension of the user’s existing cognitive and decision-making processes and level of application of these to PERMs are important. For example, displaying pre-admission and in-hospital medication lists side by side on the screen reduces the cognitive burden and facilitates the task to compare these medication lists. An awareness of the changing roles of individuals undertaking MedRec is also important. For example, the expanding roles of the pharmacist and pharmacist technician.Interpersonal relationships (the stakeholder relationships that carry the intervention):The level of inclusive engagement of all stakeholders, including the individual users, in the design and implementation of PERMs; the level of awareness and respect for each other’s roles in the processes; and the level of clarity around who is responsible for the various stages of the MedRec processes, may all influence the successful introduction of PERMs.Institutional settings :The quality of the MedRec processes in place, the quality and complementarity of PERMs to support it and the complexity of the contexts in which PERMs will be used will influence success.Infrastructure :The level of interoperability of systems supporting PERMs; the level of existing and future legislation and governance supporting MedRec and use of PERMs; the quality of the sources of data for MedRec; and the extent of resourcing including budgetary and human resources, required to allow PERMs to achieve their full potential, will influence success.Rahimi et al.  in theirMany of the theories, if the term PERM was removed, could be applicable to any electronic system, including in a healthcare setting, where multiple users are using the system for different purposes.However, focusing specifically on PERMs for MedRec at care transitions, Theory 3 states that for PERMs to become embedded into normal work practices they should complement an existing MedRec process. Some examples from the studies of the elements that could be complemented were: organisation and display of information following the natural order of events in a patient encounter; supporting workflow and accreditation requirements; medication information ordered by clinical importance; access to the history of a person’s previous medication use; inclusion of a function to prompt the user to record medication changes and reason for starting or stopping medications; inclusion of a field to capture details identified about a person’s medication adherence, allergies, or posologies; date of initiation of prescription and first prescriber; access to the prescribers’ or other HCPs’ contact details and the ability to produce a discharge summary and/or patient friendly print out.Elements of PERMs, identified in the studies, that were expected to improve the frequency and integrity of MedRec, cognitive burden and decision making were: use of generic drug names thereby reducing confusion and duplication, organisation of information from different sources with the ability to see several lists at the same time facilitating rapid comparisons, information displays tailored to the needs of different users, ease of identifying medication changes, alerts i.e. drug-drug interactions or drug-disease interactions, reasonable balance of alerts, checks or warnings, action buttons , edit, sort (i.e. by therapeutic intent), drag and drop, or on-demand and additional information options, 24 h access to information, smooth processes to get patient consent to access their information. Barriers included number of clicks needed, too much text, unclear icons and lack of understanding or training in relation to how PERMs worked.In relation to Theory 7, the quality of the data sources and level of interoperability between them, allowing safe and accurate sharing of information, was determined to be crucial to the successful introduction of PERMs.Theory 8 identified that in order for the full potential of MedRec using PERMs to be realised, proper investment in the technology and sources of information must be provided, ensuring interoperability and access to accurate information for MedRec. For this to occur, increased patient safety and decreased hospital readmission rates and preventable events must be sufficiently valued.A number of systematic reviews have examined the use of electronic MedRec at care transitions , 53–55.The scoping review by Monkman et al. examined both the contextual and human factors perspectives of using PERMs for MedRec and had several findings similar to those found in Bassi’s , Marien’Comparing this review to the general health information technology (HIT) literature, Ammenwerth et al.’s framework focused on what they described as the “fit” of three key elements; individuals, task and technology (FITT framework) . They idYen et al. considered how HIT implementation is evaluated. They suggest including evaluation of technology acceptance, communication and collaboration, work productivity, training and competency, leadership, existing policy, the organisational culture, the level of social support provided and the idiosyncrasies across contexts . Marien Shachak et al. described what the provided support for PERMs should look like, describing it under three headings; functional support: e.g. assistance in learning how to use the various features of the system; data support: e.g. activities intended to ensure the completeness, accuracy and consistency of data input and finally; training and education support, which they combined and stressed was an essential part of end-user support . Such reThe HIT literature features many of the contexts identified in this review as impacting on the design, implementation and use of PERMs and supports the validity of evaluating outcomes under the four I groupings referred to earlier as outlined by Pawson et al.; the individuals, interpersonal relationships, institutional settings and infrastructure , 56–58.’s [Acknowledging the associated human and financial resources required to deal with the increased effort, volume and quality of data gathered and generated when using PERMs for MedRec was identified in this review as being important. This finding was unique in the literature. The increased data potentially available provides opportunities for risk identification, management, and analysis; if the value of these opportunities is recognised by leaders/ management from the outset then they will understand the need for additional resources. (Theory 8. Resource investment). However, consistent with Sevick et al.’s  finding ’s .A RRR, by its nature does not include all relevant literature on the topic of interest, however, we strived to include the richest data in this review, and the reviewers feel that saturation for each of the theories was achieved. If time allowed, a specific search through the remaining 32 articles included in the full text reading for other potential contexts and mechanisms identified by the panels during the review of the final theories, but lacking evidence in the 19 included articles, could have provided enough evidence to support the development of additional theories. Examples of such contexts include organisational culture or level of reliance on PERMs. We recommend this as a future study.The quality assessment of realist data, using relevance, rigour and richness, could be considered a subjective assessment of the quality of the data within the articles included. However, the research team have extensive knowledge and experience in the field under review allowing expert assessment of these elements. We followed the RAMESES guidelines for the quality assessment process by providing a transparent procedure for the rating systems used to appraise the evidence used within the review; the real quality has been determined within the act of synthesis . The iteThis RRR has allowed additional valuable data to be extracted from existing primary research, with minimal resources, that may impact positively on the future design, implementation and use of PERMs at care transitions for MedRec and of research in this area. The main outcomes formally considered in the included articles focused on either the impact on patient safety or the user’s experiences during implementation or use of a PERM. The use of realist methods has generated data to support identification of additional outcomes from the articles which were not formally identified by the authors in their aims and objectives. The additional outcomes included changes to interprofessional relationships, changes to awareness of others’ roles, changes to the users’ cognitive burden, changes to the consent process when sharing patient information, changes to the level of interaction with patients, changes to the patients level of awareness regarding the need for their consent, their opinions in relation to the benefits of interoperability/sharing their information and their level of engagement with PERMs. Consideration of this evidence has added richness to the knowledge identified in the systematic reviews referred to earlier, validating our chosen methodology. Future research should include appraisal of these socio-technical outcomes.The product of realist reviews are theories, developed from evidence extracted from the literature and the input of experts in the field. These theories should subsequently be incorporated into an intervention or mapped to existing interventions and evaluated to further test their validity and refined or rejected based on that evaluation.The use of realist methodology to investigate what is it about how, why, when, where and for whom PERMs are designed, implemented or used in practice at care transitions that impacts on medical reconciliation, has proved efficient and effective. We developed ten theories that identified the contexts and mechanism that may impact on the successful introduction of PERMs at care transitions for MedRec. Engaging all stakeholders; allowing a free flow of ideas and feedback; building trust in relation to the accuracy, safety and security of the data; providing sufficient resources for the full potential of PERMs to be realised; considering interoperability; and the value of patients having a role in using PERMs for MedRec, were considered important elements at all stages of the process.Further research to assess the application of these theories in practice is now required. Future research in this area must also include evaluation of all aspects and at all stages of the process of introducing PERMs, including sociotechnical factors and cost analysis. Further realist reviews could be undertaken to examine other elements that may impact on the use of MedRec at care transitions that this RRR did not cover, such as organisational culture and level of reliance on PERMs.Additional file 1. Protocol.Additional file 2. Search terms.Additional file 3. Inclusion and exclusion criteria.Additional file 4. Themes identified by the Reference Panel.Additional file 5. NVIVO codebook.Additional file 6. Template for summary of study document.Additional file 7. The supporting contexts, mechanisms and outcomes configurations.Additional file 8. Introduction for expert and reference panels.Additional file 9. Feedback survey.Additional file 10. List of included studies.Additional file 11. Feedback responses.Additional file 12. Full data synthesis.


The challenges faced by healthcare personnel in relation to dengue prevention and control are perennial but noticeably unexplored. It is often difficult to translate policies and decision making by the elite into astute management in consonance with the needs of rank-and-file personnel. In this study, we assess the impact of governance on dengue prevention and control activities in Malaysia as narrated by the elite.A qualitative study using a case-study approach was conducted between January 2019 and November 2019 in the districts of Gombak and Klang, where the relevant key informants were located. Nineteen interviews were conducted among elite healthcare personnel from different divisions: management, vector, laboratory, inspectorate, health promotion and entomology. Semi-structured interviews were conducted. The sample size was determined through saturation point criteria. Purposive sampling techniques were used to recruit the participants. The interviews were audio recorded, and the transcribed text was analysed with deductive thematic analysis.Data analysis led to the development of 5 themes and 13 categories. The major principles of governance were embodied in a milieu of predicament, linked to constraints but also opportunities. The constraints resulted from inherent determinants of dengue outbreaks, the serviceability of governing policies and the macro-economics of budget allocation. The opportunities to sustain governance at the local operating level stem from a prevalent supportive internal management system, collaborative efforts among corresponding external government agencies and willingness to innovate and embrace novel technology.Elites are influential, often well-informed personnel tasked with making decisions that can reverberate across an organisation, impacting future plans and strategic policies. Political arrangements at higher levels will reflect in advance the tone of how governance in dengue prevention and control is operationalised by entities and individuals at lower levels of the health system. The prevailing centralised structure in the Malaysian health system will continue to entrench the position of the elite and intertwine it with governance and its predicaments.The online version contains supplementary material available at 10.1186/s12889-021-10917-3. Governance matters, as it is concerned with how different stakeholders in the world function and operate as well as the rationale for each decision-making process . The subAccording to the Commission of Global Governance, there are four core principles of good governance . First, The Malaysian government has named nine principles per the circulation by the chief secretary to the federal government , 10. TheGovernance in healthcare is increasingly being regarded as a salient theme in healthcare development and delivery. Previous reviews have highlighted the positive impact of good governance on the healthcare sector, directly or indirectly through its impact on income , 14. TheThe healthcare sector, specifically public health and the associated healthcare delivery system, is one context in which there is a scarcity of research based on interviews with elite healthcare personnel –19. The Malaysia’s healthcare system is a structured system under the responsibility of the Ministry of Health. Administratively, it consists of the central headquarters at the national level, state health departments and district health offices. Health policies are developed at the central level and passed down to the intermediate (state) and peripheral (district) levels for implementation.Elites may wear different hats based on their expertise or talent as policy makers, inner-sanctum decision makers or simply division heads in the process of developing policies or building frameworks for rank-and-file personnel in the Ministry of Health , 24. HowMalaysia is situated in Southeast Asia; it is a former British colony with various inherited legacies, including the Malaysian health system, which is modelled after the National Health Service of the United Kingdom . This stThe primary objective of this study was to explore the predicament of governance in dengue prevention and control along with possible solutions. In part, this study also explored the methodological approach of a novice interviewing the elite.The qualitative study used a case-study approach. We aimed to interview elite healthcare personnel individually, face-to-face, to obtain their views on the governance of dengue prevention and control. Purposive sampling of elite healthcare personnel  was conducted based on selected domain expertise. The respondent(s) were selected based on purposive sampling with a minimum of one healthcare representative from each unit, as shown in Fig. A semi-structured format was used for the interviews . There were instances when we found ourselves being asked questions and assessed by the interviewee. Hence, it was important to project a positive impression, constantly gauge the mise-en-scène of the interview and adjust behaviour, intonation, and mannerisms accordingly to gain the interviewees’ respect. This was important not only to gain respect but also to increase the likelihood of elite members providing access to other interview opportunities through personal recommendations , 27, 28.NTR conducted all of the interviews between January 2019 and November 2019. They lasted 32–68 min. The interviews were conducted face-to-face at a location designated by the interviewee or the interviewee’s workplace, depending on the interviewee’s preference. The interviews were digitally recorded and transcribed verbatim. To facilitate unvarnished discussion, the interviewees’ confidentiality was assured by obtaining their consent.This study was approved by the Ethics Committee for Research Involving Human Subjects of Universiti Putra Malaysia (JKEUPM), the Medical Research and Ethics Committee of Ministry of Health (MOH) and the Selangor State Health Department Quality Unit. Written consent was obtained from the participants. The names of the respondents were not disclosed in the study, and the audio recordings were saved on a password-protected computer.All qualitative data collected were analysed using NVivo version 11. We conducted a deductive thematic analysis aimed at identifying the themes associated with principles of good governance derived from the expressed narrative. The interviews were conducted mostly in English and Malay, which is the official language of Malaysia. Field notes were made by NTR promptly after the interviews. However, some of the audio-recorded interviews contained code mixing and/or code switching. Accounting for the latter issue presented a unique challenge, and the audio recordings had to be listened to several times before they fit the verbatim transcriptions compiled by NTR. The transcripts were carefully translated into English by NTR, and the forward-backward translation method was applied to five of the transcripts (20%) to check the accuracy of the data. The researchers studied the translations repeatedly to familiarise themselves with the data.RAM then reviewed the translated transcripts of the interviews. Manual coding was performed by NTR and RAM. Codes that emerged from the first few translated interviews formed the basis of the codebook that was used to assess the subsequent translated transcripts. The initial coding process was expanded into focused coding. In focused coding, the association between different initial codes was explored on the basis of frequency, sequence, correspondence, and similarity. The other investigator (SRS) independently repeated this process iteratively for all of the transcripts based on the codebook. RAM and SRS then discussed the focused coding choices in detail. The final deductive codes were grouped into meaningful categories. AM assisted in reviewing and proofreading the transcripts. The sub-themes were generated by blending several categories together under the guidance of the main principles of existing governance theory, namely, corporate governance theory. The research team held regular meetings and discussions to cross-check the generated categories based on the objectives of the study. In case of any conflict or disagreement, the final decision rested upon RAM, who is a senior academician with vast experience in mixed-methods research.Patients and the public were not involved in the planning or conduct of this study.This study did not examine factors among the elites involved in dengue prevention and control activities who were not employed by the Ministry of Health; hence, the exclusion of many stakeholders was necessary to weave an inclusive framework of good governance.While many of the elites interviewed for this study were willing to share their experiences and reflections, some of the interviewees appeared hesitant and had reservations about expressing their thoughts, especially those related to accountability, operational effectiveness and discrepancies related to dengue prevention and control.A total of 19 elite healthcare personnel were interviewed  . The proThe elites widely agreed that for good governance to thrive at the district health offices, the well-being of healthcare personnel needs to be prioritised and safeguarded. Most, if not all, healthcare personnel are resilient and dedicated in their pursuit of providing high-quality service; however, operating in a less-than-optimal environment can gradually undermine their performance. The interviewees felt that this problem could be solved by competent leaders spearheading programmes and filling governance training gaps.Eight of the elites mentioned that regulatory constraints were a perceived governance impediment. Without a proper regulatory framework, the establishment of trust, flexibility of work processes and stability needed for medium- and long-term planning in dengue prevention and control programmes are likely to deteriorate, according to the interviewees. However, facilitating harmony among the various stakeholders and promoting governance in the regulatory ecosystem are challenges in themselves, according to the elites. One of the interviewees described the multi-faceted layers of regulation and work procedures at the district health offices, ranging from active to passive surveillance to offsite and onsite enforcement of regulations Table .Table 4More than half of the elites identified the lack of a good governance framework for healthcare personnel in the course of dengue prevention and control engagement with the communities. One of the interviewees bluntly remarked that counterproductive actions such as issuing summonses or compounds in a community would likely backfire in terms of cultivating goodwill, since the law is discriminatory when applied injudiciously.In summary, the majority of the elites felt that for good governance to expand at the district health office level, healthcare personnel need to be refreshed on how laws and regulations function at the point of their initiation into civil service and every so often afterwards. Healthcare personnel should be reminded of the external consequences of infringement when engaging with the community in dengue prevention and control activities, the internal consequences of violating the code of practice, and the risk of being reprimanded by the department’s whip for noncompliance with protocols.A recurring theme of the elite supported the assumption that positive reciprocity from the community can no longer be expected when public policies are delivered merely as an afterthought. Most of the participants noted that public health programmes delivered successfully at the district level require good governance, co-production and involvement and rapport with the community initiated by healthcare personnel.The majority of the interviewees felt that for good governance to expand to district health offices, community participation was essential. However, the elites identified that first, the underlying needs and concern of the community must be identified, and when these levels have been determined, then specific interventions can be tailored in accordance with the local needs and requirements of the community Table .Table 5The elites agreed that coordination and diffusion of responsibility for public health initiatives throughout government and society can be improved with genuine collaboration. One of the participants stated that health has become critical macro-economic and political fodder for certain actors in the current state of affairs, especially when governments, communities and citizens are increasingly engaged in governance for health, whether as state or nonstate stakeholders Table .Table 6The majority of the elites felt that for good governance to expand at the district health office level, the underlying complexity of the dengue prevention and control programme needs to be acknowledged and particularised. Notwithstanding their frustration, the interviewees sensed that the multifarious complexity necessitates decision makers and stakeholders clarifying and collaborating with better-informed entities regarding how to implement a strategic framework for healthcare personnel to control and prevent dengue outbreaks.Governance is about power, relationships, and accountability—who has influence, who decides, how citizens and other stakeholders have their say, and how decision makers are held accountable . In thisIn this study, the elites agreed that the state health department and health district offices continuously endeavour to galvanise and improve the capacities of dengue prevention and control programmes among healthcare personnel. Nonetheless, the management of public health activities is particularly challenging because, unlike in the private sector, where feedback on performance is demonstrated via clear metrics, the performance and impact of public health programmes such as dengue prevention and control activities are very often difficult to track in real time . For heaMost of the elites identified the need to enhance the current regulatory framework for healthcare personnel. A fortified rule of law will contribute to the establishment of trust, flexibility of the work process and stability needed for medium- and long-term planning in the dengue prevention and control programme. However, the archaic work process does not bode well for the changing landscape, in which the general public demands more accountability from public servants and healthcare personnel . Hence, The elites frequently spoke about how public health services at the local district level should also leverage existing key units, i.e., surveillance, entomology, and enforcement in other agencies, for better decision making and efficient use of resources. In addition, better support from relevant agencies for public health advocacy can be realised if public health and urban planners collaborate in the creation of a non-conducive environment that can hamper potential vector breeding sites. This study also suggests that wider engagement with other agencies and groups, i.e., district education offices, local law and enforcement units, and the corresponding municipal councils of Gombak District, could be beneficial.To pool resources, there needs to be a more participatory approach at the local level pivoting around common interests. Hence, healthcare personnel who are key decision makers need to forge partnerships with community leaders to generate more constructive communication and collaboration by empowering them to participate in dengue control and prevention activities . A well-There were a number of challenges in interviewing people in positions of power, such as the interviewer-interviewee relationship, gaining access and unnecessary distraction. Elites are used to taking the initiative, issuing directions, leading strategic planning, and asserting themselves in relation to those with whom they work. Such a demeanour can lead to an imbalance between a novice interviewer and an assertive interviewee, resulting in the interviewer being unable to be parrhesiastic in his conduct. This issue of power is a significant determinant in interviewing elites and has attracted a substantial literature , 27, 28.The process of gaining access to the elites occurred largely through referrals. In this context, starting the interviews with ultra-elites from the eagle’s perch facilitated unceremonious access to other elites via referrals. Setting the appointments was a challenge, but patience and perseverance were rewarded once the elites agreed to be interviewed. To prevent distraction, the designated location for conducting interviews should be situated away from the elite office or workstation. This strategy will lessen interruptions from unannounced walk-ins by personnel seeking engagement with the interviewee for various reasons.Political arrangements at the national level will establish the tone of how governance practice will be operationalised by entities and individuals at lower levels of the health system. Giving too much attention to the infallibility of the elite risks side-lining the expression of rank-and-file personnel. Based on the current intergovernmental structure that constitutes federalism, the trajectory is unlikely to deviate, as are the predicaments. This study advocates the development of a good governance framework for the dengue prevention and control programme that integrates the core principles of good governance across multiple levels of healthcare delivery. The framework will serve as a guideline and epitomise a model for other districts where the burden of dengue places significant constraints on healthcare personnel to deliver health services in tandem with good governance.Additional file 1. Semi Structured Interview Guide – the list of questions and probes used during the interview.