Second-hand Smoke (SHS) exposure is a significant public health problem that may be responsible for serious health hazards for child. This study aimed to examine the exposure status of SHS and the factors associated with SHS avoidance behavior among the mothers of pre-school children.A cross-sectional study was used to obtain a sample of the mothers of pre-school children  in 30 registered kindergartens in eastern Taiwan. Overall, 919 (a response rate of 90%) completed the questionnaires. Regression models were used to identify factors with respect to the avoidance behavior of SHS.The prevalence of exposure to SHS was 70% and 50% for the mothers and their children, respectively. After adjusting for other variables, mothers who were current smokers , had spouses who smoked , SHS exposure , and/or children with exposure to SHS  were found to be less likely to avoid SHS, whereas mothers with a high knowledge score about SHS , positive attitudes  and a high self-efficacy level in regard to the avoidance of SHS  were observed to be more likely to avoid SHS. Regression analyses confirmed that the significantly factors associated with the avoidance behavior of SHS were self-efficacy, being a current smoker, and the attitude toward the avoidance of SHS to be that of 55.5% of the total variance explained (p < 0.001).The high prevalence rate of exposure to SHS for mothers and their children suggests that a well-designed future intervention program should be implemented in regard to pre-school children's mothers in order to prevent these mothers and their children from SHS exposure hazards, more particularly, to strengthen the knowledge base, to enhance self-efficacy and to foster a more positive attitude toward the avoidance of SHS in the mothers. Exposure to Second-hand Smoke (SHS), also called Environmental Tobacco Smoke, is a serious health hazard for children and causes substantial morbidity , includiAccording to the 2002 Taiwan National Health KAP Interview Survey, the smoking population was 4.89 million, with 50% of males and 5.8% of females found to smoke . In 2004Moreover, the SHS exposure of non-smoking American women appears to be comparatively low, that is, 13.2% , whereasSmoking among fathers is another concern of particular interest , as the Mothers' avoidance behavior of SHS plays a critical role in the exposure of children to SHS. If mothers do not take adequate precautions to avoid exposure to such SHS hazards, they and their children may be susceptible to a series of negative health effects ,18. In TData on the SHS avoidance behavior by the mothers of Taiwanese kindergarten attending/aged children was obtained from the Smoke-free Home Survey Project in eastern Taiwan in 2006. The survey was originally constructed to collect data related to SHS avoidance behavior as well as its potential determinants among schoolchildren and their mothers. Sixty-two of the registered kindergarten schools are located in Hualien County, the largest county in eastern Taiwan, with 10 located in this county's central region, 40 in the northern part, and 12 in the southern part. The participants were invited to take part in this study by means of the issuance of formal letters from the Hualien County Bureau of Health. A total number of 30 kindergarten schools agreed to participate in this study between March and June of 2006. Among these schools is: 5 are located in this county's central region, 19 in the northern part, and 6 in the southern. Non-significant difference was found between mothers of the kindergartens who agree and who disagreed to participate in our study.A total of 1,020 eligible mothers met the inclusion criteria for this study, and these women received additional information about the study as well as consent forms. Overall, 919 of these mothers (a response rate of 90%) consented to take part in this study and completed the questionnaires sent to them. All of the participants in this survey voluntarily filled out the questionnaires and were assured of retaining their anonymity.The kindergarten teachers were invited to act as questionnaire facilitators in this study. A one-day training program was provided to all of these facilitators in order to ensure that they could properly explain and administer the questionnaire survey according to standardized study protocol. The survey instruments were constructed based on a conceptual framework that was developed after a comprehensive literature review. They were examined for face and content validity by five local experts in tobacco hazard prevention and public health, as well as by researchers and scholars in order to determine the validity of the questionnaires in terms of accuracy, appropriateness and adequacy. Modifications were made to enhance the content validity of the questionnaire. To assure that the content was well understood by our participants, the questionnaire was piloted in a convenience sample of 68 children's mothers from two kindergartens in Hualien County. Items were revised as needed according to the results of this pilot test. Analysis of the pilot data showed excellent internal consistency.An avoidance SHS scale adapted from Martinelli  was usedParticipant demographics: these consisted of age, educational level, the monthly income of the household, the smoking status of participant, the smoking status of the spouse ("non-smoker"/"current-smoker"). As in national Behavioral Risk Factor Surveillance System (BRFSS) surveys, a current-smoker was defined as a person who had smoked more than 100 cigarettes in their entire life and who currently smoked on all or some of the days in a month [ a month .SHS exposure: Participants reported whether or not they were exposed to second-hand smoke for the past 7 days in the home and/or in other places.Knowledge of the SHS scale: The following 12-item scale developed by the authors was used to assess the participants' knowledge about the adverse health effects of SHS exposure as well as in regard to ways to avoid SHS: "Second-hand smoke is generated by the side-stream (the burning end) of a cigarette or by the exhaled mainstream (the smoke puffed out by smokers) of cigarettes"; "As long as I do not smoke, long-term exposure to second-hand smoke will not be harmful to my health"; "A smoldering cigarette is more toxic than smoke exhaled by a smoker"; "If not actively smoking, one does not have to worry about damage to one's health from second-hand smoke"; "If one is a current smoker, one's spouse has a higher risk of developing lung cancer"; "If the husband is a current smoker, the wife has a higher risk of developing cervical cancer"; "A lit cigarette burning in an ashtray will not affect the health of people nearby"; "Long-term second-hand smoke exposure during pregnancy contributes to adverse infant health outcomes, including particularly low birth weight and prematurity"; "Long-term second-hand smoke decreases lung function but does not affect the incidence of cardiovascular disease"; "Long-term second-hand smoke contributes to a high incidence of lung cancer in non-smokers"; "Only train and airplane passengers cannot smoke, but car passengers can smoke"; and "Second-hand smoke is a toxic cocktail consisting of carcinogens". Possible responses here included "true," "false" or "unknown" with possible scores ranging from 0 to 12, with higher scores indicating a better degree of knowledge about SHS. In this study, a 0.69 Kuder-Richardson 20 reliability scale level was deemed acceptable.Attitudes toward the avoidance of the SHS scale: Attitudes toward the avoidance of the SHS scale were based on Ajzen's Theory of Planning Behavior [Behavior . The queThe self-efficacy of avoiding SHS scale: Items were adapted from Bandura's self-efficacy theory [y theory , which iThis study was reviewed by and later granted permission to be conducted by the Bureau of Health in Hualien County, Taiwan. Each questionnaire was prefaced with a letter that described the purpose, time spent, reward for completion, and as to the voluntary nature of this study, which assured the respondents of the anonymity and confidentiality of their responses.p > .05), while a Cook's Distances was performed to indicate if there were no outliers (less than 1). The independent variables were sequentially entered into the regression models to determine the significant variable of a mother's avoidance behavior of SHS.SPSS for Windows 15.0 was used for the descriptive and inferential statistical analysis here. Descriptive analyses were carried out to examine the independent and dependent variables. Univariate analysis and Pearson product-moment correlation coefficients examined the relationships observed. The variance inflation factor (VIF) values were less than 10, indicating no multi-collinearity. A Kolmogorv-Smirnov test was performed to test for normality of the distribution , whose spouses are current smokers , who have SHS exposure time , in regard to a child's SHS exposure time , and that a participant's self-efficacy , attitude toward avoiding SHS , and that their level of knowledge  were all found to be significantly associated with SHS avoidance behavior. These variables can explain 55.5% of the total variance in behavior as to the avoidance of SHS . This is slightly higher than that seen in another study conducted on Taiwanese children in 2004, which concluded that there was a 44.9% SHS exposure rate.Furthermore, 69.7% of the mothers in our study reported that they had been exposed to SHS, a number that is much higher than the results found in the Taiwan National Health Interview Survey in 2001, which found a 58% SHS exposure rate in similar age groups. The resFor more than two decades, Taiwan has worked hard to control the hazard of tobacco intake. This effort has been carried out in an in depth manner in public spaces, workplaces, schools, and homes. In order to prevent SHS and to arouse people's awareness of the dangers of SHS, this has included the banning of smoking in public places. Until January of 2009, a new tobacco control act was included with the aim of preventing second-hand smoke in public places in Taiwan. Although SHS problems have not been limited to homes and other private quarters, as of 2009 such Taiwanese governmental legislative protection has not been enforceable in individual living environments, which remain the primary source of SHS exposure for women and children ,13.With respect to the eastern Taiwanese population, a high rate of smoking prevalence and smoking behavior has been found. The Bureau of Health Promotion reported a 50.2% current smoking rate among male adults in eastern Taiwan, indicating a relatively high prevalence of smoking there as compared to in other areas in Taiwan . MoreoveThe present study explored factors that are predicted to be significant with respect to a mother's avoidance of SHS. In this study, self-efficacy was the strongest factor associated with such behavior, explaining 19.9% of the variance. In the past, self-efficacy has been an important issue in health practice promotion research. Evidence has indicated that health practices that promote self-efficacy have a significant effect on behavior performance -28. ThisFrom the standpoint of social cognition theory, self-efficacy functions as a mediator that promotes action when an individual applies knowledge and executes it. As suchMeanwhile, this study sheds light on the body of knowledge about the SHS association to the avoidance of SHS among mothers. The results of this study are similar to those found by Kurtz et al . In addiIn this study, mothers who were current smokers were less likely to adopt SHS avoidance behavior. Being a current smoker was significantly associated with the avoidance of SHS. Mothers who were current smokers were less likely to refuse to enter an environment where SHS was present, to control passive exposure by requesting smokers to stop smoking, or to attenuate exposure when unable to fully withdraw from SHS. Since it was possible to increase their and their child's SHS exposure rates, in order to better protect the health of children, further campaigns against SHS should be developed and implemented that increase the degree of a mother's smoking cessation. Furthermore, mothers should be made aware of the necessity of adopting SHS avoidance behaviors and encouraged to make their households more smoke-free at the very least .This study demonstrates that spouses who smoke had an inverse effect on and were significantly associated to the degree of avoidance behavior in regard to SHS. Similarly, prior studies have found that the odds of SHS avoidance were lower among women who had a current partner that smokes . Our stuThis study has been found to have several limitations. Firstly, since this was a cross-sectional study, evidence of any associations should be interpreted carefully before a causal relationship can be claimed. Second, since both the avoidance behavior of SHS and other independent variables included in the analysis were based on self-reported information; such data were subject to report bias. Third, since the currently decreased acceptance of SHS in a smoke-free society may have led these mothers to under-report the child's actual prevalence of SHS exposure, a social desirability bias is an important concern when interpreting these results. Notwithstanding, since all of the participants in this survey were assured of their anonymity, the threat of social desirability bias is likely to be limited here. Fourth, our findings are potentially limited by the selection of participants on more of a convenience basis, leading the results from perhaps being as readily generalized to other populations in Taiwan.The high prevalence rate of exposure to SHS in mothers and their children is quite troubling. If such a high rate of SHS exposure continues unchecked, SHS exposure will be responsible for the increased risk of mothers and their children's health consequences as a result of tobacco exposure. Self-efficacy and current smoker avoidance in regard to SHS has reached a significant degree of predictability in terms of a mother's taking SHS avoidance action. The findings further suggest the need for a well-designed intervention program to be implemented to assist pre-school children's mothers to avoid SHS exposure hazards, more specifically, the need to strengthen such a population's knowledge, to enhance their self-efficacy levels and their positive attitude in dealing with such issues.In conclusion, theoretically directed and empirically evidence based tobacco control intervention designed programs should be quickly and carefully provided in order to encourage mothers to prevent themselves and their family members from the hazards associated with SHS exposure.The authors declare that they have no competing interests.PLL and HMH conceived of this study, participated in its design, developed the measure instruments, collected the data and coordinated as well as revised the manuscript. PLL and HLH performed statistical analysis, interpretation of the data, and were involved in the drafting and revision of this manuscript. KYL, TC, WTL and CHL were involved in the drafting and revision of this manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/10/606/prepub


Road traffic injuries (RTIs) are a major public health problem, especially in low- and middle-income countries. Among middle-income countries, Iran has one of the highest mortality rates from RTIs. Action is critical to combat this major public health problem. Stakeholders involved in RTI control are of key importance and their perceptions of barriers and facilitators are a vital source of knowledge. The aim of this study was to explore barriers to the prevention of RTIs and provide appropriate suggestions for prevention, based on the perceptions of stakeholders, victims and road-users as regards RTIs.Thirty-eight semi-structured interviews were conducted with informants in the field of RTI prevention including: police officers; public health professionals; experts from the road administrators; representatives from the General Governor, the car industry, firefighters; experts from Emergency Medical Service and the Red Crescent; and some motorcyclists and car drivers as well as victims of RTIs. A qualitative approach using grounded theory method was employed to analyze the material gathered.The core variable was identified as "The lack of a system approach to road-user safety". The following barriers in relation to RTI prevention were identified as: human factors; transportation system; and organizational coordination. Suggestions for improvement included education , more effective legislation, more rigorous law enforcement, improved engineering in road infrastructure, and an integrated organization to supervise and coordinate preventive activities.The major barriers identified in this study were human factors and efforts to change human behaviour were suggested by means of public education campaigns and stricter law enforcement. However, the lack of a system approach to RTI prevention was also an important concern. There is an urgent need for both an integrated system to coordinate RTI activities and prevention and a major change in stakeholders' attitudes towards RTI prevention. The focus of all activities should take place on road users' safety. Road traffic injuries (RTIs) are a major global public health problem, requiring concerted efforts . WithoutIn order to make a road traffic system safer, understanding the system as a whole and the interaction between its elements  is important. It is also crucial to identify where there is potential for intervention . In LMICData from the World Health Organization (WHO) reveal that Iran has one of the highest mortality rates from RTIs in the world . In ordeThus, in order to find the essence of the phenomena, it was found fruitful, as one important step, to explore the phenomena in more depth. The present article therefore was designed to explore informants' perceptions on the factors obstructing RTI prevention and to identify facilitators that could lead to greater road-user safety in Iran.The study was performed using grounded theory method. Grounded theory is a suitable method when researchers wish to explore a known area from a fresh perspective -29. ThisThis study was conducted in 2007 among informants in West Azarbaijan Province and at the national level in Iran, interviewing those involved in RTI control, other road-users and victims of RTIs. In Iran there are several organizations involved in RTI prevention (See below).The principal investigator, who has work experience in the country in post-crash issues , took responsibility to contact eligible key persons in different organizations. Accordingly, stakeholders who have experience and knowledge, representing their perspectives on RTIs, were approached for interviews. A few victims and road-users were also interviewed because of the unique perspective they could add on what takes place in the field. The thirty-eight participants included: six police officers; five public health professionals; two experts from the Ministry of Road; and four experts from the Road & Transportation Office; three representatives of the General Governor of West Azarbaijan Province, the car industry and firefighters; seven staff from the Emergency Medical Services; and two from Red Crescent; four road-users including two motorcyclists and two car drivers; and five victims of RTIs. The number of participants was determined based on saturation principles. Their ages ranged between 20 and 65, and their education ranged from nine-year intermediate school to professional education in the field of medicine.Semi-structured interviews in Persian were used for data collection. We were looking to gather informants' perspectives from different groups and organizations and this procedure felt far more suitable. They began with simple and general questions, gradually progressing to more specific ones. Probing was performed according to the reflections of each participant, concerning experiences of RTIs, the barriers to RTI prevention, opinions about barriers related to transport system, perceptions about road-users' behaviour as well as planning and organizational coordination. Interviews lasted between 45 and 80 minutes. Theoretical sampling was also used to contact other key informants; those who weren't considered initially as participants in order to saturate data and all generated concepts. By theoretical sampling, we refer to a sampling procedure of high value in qualitative research, especially in the grounded theory . The goaAll interviews were recorded, transcribed verbatim and then analyzed according to recommendations by Strauss and Corbin ,28, i.e.The study was approved by the National Ethics Committee of Iran . Study p"The lack of a system approach to road-user safety" was the core variable. Barriers in relation to RTI prevention were identified as: human factors (divided into two concepts of traffic safety culture and enforcement); transportation system (divided into two concepts of vehicle safety and infrastructure); and organizational coordination. Suggestions for improvement included education , more effective legislation, more rigorous law enforcement, improved engineering in road infrastructure, and an integrated organization to supervise and coordinate preventive activities. Table All participants pointed out that the current traffic culture of road-users and their safety behaviour are the most important barriers to RTI prevention. Undeveloped traffic culture was particularly pronounced among people who lived in the countryside. Traffic culture was regarded as "knowledge, values and beliefs about safety behaviour and compliance with traffic safety rules".(P3) Bad driving is a problem in our country. Most car drivers like to drive fast without attention to safety behaviour. (P7) While helmet wearing and seat belt use are compulsory in the country, most motorcyclists don't wear a helmet and it seems they don't believe it....Most participants pointed out that there is a lack of compliance with traffic law among road-users. Accordingly, some parameters identified in undeveloped traffic safety culture related to: a lack of knowledge of and confidence in traffic law; a sense of urgency in most road-users, which is reflected in their driving behaviour. Moreover, a high volume of trips by private cars were regarded as other barriers affecting road-user safety.(P2) Most people, especially those living in the countryside, don't know about traffic regulations and they don't have enough information about traffic rules... (P9) young motorcyclists usually don't wear a helmet and some of them don't have a driving licence...Concerning improving road-users' behaviour, most participants were of the opinion that education is the key to RTI prevention. As they pointed out, this should take the form of campaigns directed at the general public and training targeted at specific groups. The focus of this education should be on changing people's behaviour. A number of suggestions came up e.g.: encouraging calmness and patience among all road-users, increasing knowledge in road-user safety, and introducing traffic calming measures including more and lower speed limits. The mass media, especially television, should be used to achieve many of these goals. However, some professional in the health sectors pointed out that the importance of improvements to the infrastructure rather than simply a focus on road-user behaviour changes could be more effective. On the other hand, target group training was also recommended. This included a more comprehensive training course including road safety training prior to the driving test that needs to be followed up by continuous training, especially for professional drivers and those drivers who are illiterate.(P16) Traffic safety culture is a problem in the country in relation to road traffic accidents...the best way for its prevention is public education campaigns using mass media, especially television...According to participants, lack of enforcement was the other important obstacle to safe behaviour among motorized road-users. Moreover, some participants pointed out that traffic violations in Iran are usually punished by imposing fines. For dangerous behaviour, vehicles can be confiscated or driving licenses revoked; however in practice this is difficult. Accordingly, they mainly focus on imposing fines, which however, are relatively low. All participants felt this problem could be addressed by strengthening the legislation, law enforcement and providing modern equipment for traffic police monitoring.(P4) We believe that the current authority for law enforcement is not adequate and it is difficult for us to punish traffic offences. Since revoking a driving license is a very difficult process, we prefer to not do that...Most participants pointed to the lack of detailed instructions given by traffic police; old-fashioned police monitoring of traffic behaviour on interurban roads; and a lack of adequate public cooperation with the traffic police as other concerns. Moreover, as expressed by most participants, the legislation needs to be strengthened, the level of fines and other sanctions should be increased, and the issuing of driver's licenses should be more restricted with a greater focus on driving training and skills. However, participants in police office pointed out that during the recent new policy has led to the traffic police being more restrictive in the issuing of driving licenses.(P14) The current station-based police monitoring of traffic management is out of date and old fashioned; the laws should provide greater authority for police. The main form of punishment for traffic offences is fines which are too low... (P24) It is necessary to install more speed cameras for traffic monitoring.As pointed out by a number of participants, two important obstacles related to vehicles were identified. Firstly, there is insufficient attention to car fleet safety; there is a lack of standards as regards the safety and crashworthiness of vehicles in the car industries. Secondly, there has been an over-production of vehicles in recent years with insufficient attention to crashworthiness and design safety. As expressed by all participants, a large number of old, even less safe vehicles that are incompatible in terms of speed with newer cars, was another important barrier.(P2) In recent years a new loan-to-buy system has been implemented, making it much easier to buy a car and resulting in a dramatic increase in both the passenger car fleet and motorized two wheeled vehicles.According to most participants, some other concerns related to vehicles were the shortcomings in public transport, and a lack of well-designed seat belts and child car seats. Most professional participants pointed out that a lack of air bags and anti-block braking systems (ABS) in most vehicles, very poor safety standards in motorcycles as well as a lack of safety equipment were the other obstacles to vehicle safety. These factors, hand in hand with very cheap petrol and a high volume of trips by private cars, could indirectly make the situation worse.(P12) In the car industry we think of everything, but little on safety. Petrol is cheaper than water! Which makes the situation even worse...Suggestions to deal with vehicle safety, expressed by professional participants, included vehicle safety improvements in the car industry and the implementation of research activity for vehicle safety indicators. The participants also suggested that the removal of old vehicles from the roads needs to be more facilitated and periodic vehicle inspection needs to be more rigorous.(P23) An old car fleet is one important problem. Not only they are unsafe themselves but they are also a danger to other vehicles on the road and we should provide more incentives to remove them from the vehicle fleet...According to all participants, a large number of problems in relation to the transport system and its safety came up, mainly relating to the one way streets, inadequate road lighting, a lack of special roads for low-speed vehicles, a lack of enough roadside protection, lack of sufficient traffic signs on the roads, a poor overall level of road maintenance and repair as well as a large number of accident black spots. Moreover, a lack of safe routes for pedestrians and cyclists, and incompatibility of high- and low-speed vehicles were other obstacles. As expressed by participants, more traffic signs, quicker road repairs, installation of speed bumps in heavily populated areas and crash barriers in high-risk areas, and more alternative road junctions will all help to reduce crashes at black spots in both the short and the long term. Furthermore, most participants in road administration office and police officers as well as EMS pointed out that a better urban infrastructure including splitting roads up into different lanes, making them wider, and reserving special lanes for emergency services would also help matters.(P17) There are many accident black spots on the roads throughout the country ... (P21) Traffic police have made substantial efforts to improve road safety, however, due to poor vehicle and road safety design, the number of accident and casualties is still high...Most participants raised the issue of inadequate communication and coordination between organizations in relation to road safety activities, which was one of the most important obstacles to RTI prevention. As participants pointed out, there are currently several organizations working in the road safety field but they are poorly coordinated. Accordingly, there is no single agency with overall authority and responsibility to make decisions and arrange road safety activities. Some other examples of the lack of coordination, expressed by participants were: the same task being carried out by two organizations; lack of a clear allocation of responsibility for some activities; lack of sustainable planning with regard to road safety activities among sectors. Moreover, participants in health sectors and road administration office as well as police office pointed out that there is no comprehensive information system to register motoring offences in Iran as whole, resulting in no distinction being made between traffic offenders and law-abiding citizens.Most participants pointed out that the most important factor to decrease RTIs would be a "National Decision", whereby all sectors and road-users would decide to tackle this major national problem. As expressed by participants, it would be possible to devise a future plan and activities. Moreover, according to the participants, road-user safety could be improved by integrating safety activities and research.(P19) Currently different organizations have responsibility in road safety, but there is no defined organization to coordinate and follow these activities. This problem can result parallel activities for some duties and lack of responsibilities for some others...This study, the first of its kind in Iran, describes the major barriers to RTI prevention and the related recommendations of facilitators in the field based on stakeholders' perceptions. The participants in our study believed that the greatest gains would be achieved by changing road-users' behaviour by means of information, education campaigns and the more rigorous enforcement of regulations. Barriers related to the transportation system and the need for its development were also commented on but were given less emphasis.In terms of RTI prevention, the areas for potential intervention in all society can be included: environmental modification of the infrastructure, greater attention to safety in vehicle manufacture as well as the promotion of safe behaviours through social marketing, legislation and law enforcement .The perception of the current traffic safety culture as one major barrier was pronounced by most participants in this study. The forms of behaviour, as commented on by participants, could be due to: a lack of safety knowledge and traffic rules; a sense of urgency among most road-users; inadequate driver training and testing; insufficient enforcement of traffic and transport regulations, which together make the situation far worse. While safe road-user behaviour is one important component, however, changing such behaviour should not simply focus on education and enforcement. This idea is supported by a systematic review indicating that education programmes alone, in the case of child pedestrians safety, does not reduce the risk of motor vehicle collisions . ConcernThe manner of enforcement in Iran however is important. A lack of strengthened traffic legislation, a tendency for people to expect extremely lenient treatment from the traffic police, a low level of fines for traffic violations and a lack of long-term sustainable planning are important obstacles. These situations can lead a lack of effective enforcement. It is interesting to note that experience from high-income countries shows that if road-users had greater respect for road traffic legislation, the number of road crash fatalities could be almost halved . AccordiExperience in Sweden reveals that changing road-user behaviour by means of environmental changes rather than education campaigns or police enforcement is more effective. In this area, an observational study revealed that seat belt reminders in the vehicle led to a significant difference in seat belt use in the cars with and without seat belt reminders ,36. The Participants in this study pointed out that an over-production of new cars combined with a lack of emphasis on safety in their design was an important obstacle. It is well known that as motorization increases, specially in LMICs, there will also be a rapid increase in the number of crashes and injuries . Iran cuIn general, there are two different approaches to RTI prevention: the individual and the system approach ,40. TherAs expressed by most participants in this study, lack of organizational coordination was another important obstacle. According to WHO, prevention of RTIs is a shared responsibility and needs multisectoral collaboration ,9. CollaPolicy intervention including both short- and long-term strategies should be considered by the authorities. In the long-term strategies, traffic system development needs to be considered as regards both car manufacturers and the road system. Road safety development can include taking action regarding accident black spots as well as the improvement of vehicle safety standards with a focus on crashworthiness and research. Short-term interventions include: increasing penalties and tougher enforcement for dangerous driving behaviours, speed management (with high priority) and the more installation of traffic-monitoring cameras. Safety education programmes should focus on defining the behaviour and changing the attitude of all road-users.This interview-based study gathered the opinions of various actors, including road-users and victims of RTIs, relating to the barriers to and possible facilitators of RTI prevention. As such, it is one of the few studies adopting a qualitative approach to highlight ways of improving the current situation. The results point to a number of crucial areas in need of improvement, and for which some strategies have been proposed.As is the case in qualitative studies, the number of participants was relatively small, but all participants were experienced and knowledgeable and saturation was reached for all concepts. The data were even validated using constant comparison analysis, which means returning to the data in order to verify and develop the categories further. This method requires the researcher to take one piece of data and compare it to all other data in terms of similarity and difference . In the Iran ranks as one of countries with the highest rate of fatal RTIs in the world and there is currently a gap in the knowledge of and attitude towards RTIs among participants that needs to be addressed through educational campaigns and more research in the field of road-user safety. The attitude among stakeholders in relation to road safety activities needs to change. As other RTI prevention models have shown, instead of an individual component approach, there is a critical need for a system approach to RTI prevention considering the interaction between road-users, the road infrastructure and vehicles as well as integrated organizational coordination in Iran. Although the current educational campaign is an important step in behaviour changes, most focus should be placed on environmental changes. The focus of all activities should take place on road users' safety.The authors declare that they have no competing interests.DKZ has made substantial contributions to the conception and design of the study, and taken responsibility for and coordinated the acquisition of data, which he gathered and analyzed. He took an active part in the analysis of the data, in its abstraction and in the writing-up of the manuscript. HRK and LL contributed to the conception and design of the study. HRK was involved in the data collection process and took part in the data analysis. LL also took part in the writing-up and finalization of the manuscript. RM, AB and BH contributed to the study design, data acquisition, results interpretation and writing-up of the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2458/9/486/prepub


In order to reduce maternal mortality, the Indian government has increased its commitment to institutional deliveries. We assess the determinants of home, private and public sector utilization for a delivery in a Western state.Cross sectional analyses of the National Family Health Survey – 2 dataset.Maharashtra state. The dataset had a sample size of 5391 ever-married females between the ages of 15 to 49 years. Data were abstracted for the most recent birth (n = 1510) and these were used in the analyses. Conceptual framework was the Andersen Behavioral Model. Multinomial logistic regression analyses was conducted to assess the association of predisposing, enabling and need factors on use of home, public or private sector for delivery.A majority delivered at home ; with private and public facility deliveries accounting for 32% (n = 493) and 31% (n = 454) respectively. For the choice set of home delivery versus public facility, women with higher birth order and those living in rural areas had greater odds of delivering at home, while increasing maternal age, greater media exposure, and more then three antenatal visits were associated with greater odds of delivery in a public facility. Maternal and paternal education, scheduled caste/tribe status, and media exposure were statistically significant predictors of the choice of public versus private facility delivery.As India's economy continues to grow, the private sector will continue to expand. Given the high household expenditures on health, the government needs to facilitate insurance schemes or provide grants to prevent impoverishment. It also needs to strengthen the public sector so that it can return to its mission of being the safety net. Despite the Registrar General reporting recently that the maternal mortality rate in India declined to 301 per 100,00 live births, India still accounts for the largest contribution to maternal deaths worldwide, related directly to or exacerbated by pregnancy.  One straThe choice of delivery locations in India can be broadly be classified into three mutually exclusive categories. A woman can deliver her baby at home, with or without the presence of a birth attendant, who may be trained or untrained. Home delivery is usually the cheapest option, but is associated with attendant risks of infection and lack of available equipment should complications occur. Institutional deliveries can occur at private or public facilities. Public facilities are usually owned and financed by the government, and while costs are usually minimal, available amenities often leave much to be desired. Although private facilities are the most expensive, they are often perceived as having the best amenities and offering the best standard of care in India.Most research has focused on understanding the determinants of home vs. institutional deliveries. -8 With rThe purpose of the present study is to understand the determinants of delivery location  in one state of India (Maharashtra), using data from the Second National Family Health Survey (NFHS-2).What are the determinants of delivery location  the state of Maharashtra?The study was a cross sectional analyses of the National Family Health Survey – 2 (NFHS – 2) dataset.The NFHS – 2 is a house-to-house interview survey conducted in 1998–99 across 26 states of India. It interviewed a nationally representative sample of approximately 91,000 women. The survThe Maharashtra sample of the NFHS-2 data had a sample size of 5391 ever-married females between the ages of 15 to 49. We abstracted data from the most recent birth (n = 1510).predisposing factors, demographic characteristics  reflect the propensity of individuals to use services. Social structure  measures the ability of the individual to cope with the problem, the resources available in the community, and the state of the physical environment. Health beliefs are values and knowledge about health and the health care system that influence utilization, and these include general attitudes towards medical care, physicians, and disease.[Andersen's Behavioral Model of Health Services Utilization was used as the conceptual framework. This mod disease.Enabling factors, both personal and organizational, must be present for service utilization, and these represent the actual ability of the individual to obtain health services. Personal enabling factors include income, health insurance, regular source of care, and travel and waiting times; organizational enabling factors include the availability of health care providers and their spatial distribution.[need. This judgment about need can be made by the individual himself or family caregivers (perceived need), and can be estimated by a self assessment of health status, symptoms experienced during a period of time, or number of symptoms during a period of time. Need can also be defined through a professional evaluation ; for example, physician severity ratings for an episode of illness.[ribution. The most illness.A categorical dependent variable was created based on the location of the most recent live birth. It was categorized as 'home' if the mother reported that the most recent live birth occurred at home; 'public' if the most recent live birth occurred in a government hospital, government dispensary, urban health center, urban family welfare clinic, community health center or primary health center, and 'private' if the birth occurred at a private hospital, private clinic, and non-governmental organizations (NGO) or trust hospital. NGO and trust hospitals were included in the private sector category and could not be classified as a separate entity due to their small numbers.The predisposing variables included in the model were birth order of the baby for which care was sought, sociodemographics of the mother and father . Given the emphasis placed till the recent past on the two child per family policy, we dichotomized birth order (two or less and more than two). Maternal age was a three level categorical variable . Based on the highest level of education completed, the mother's and father's education were categorized into three levels . Religion was coded into three categories, viz. Hindu, Muslim and others. To assess the effect of caste on the health services utilization, the NFHS – 2 variable classifying the population into scheduled caste/tribe (SC/ST) and non-SC/ST was used.The enabling variables were household standard of living, media exposure, health care decision-maker, number of antenatal visits and location. The household standard of living is provided in the NFHS – 2 dataset, and is calculated based on the family assets and possessions. It is indicative of the economic status of the family, and is coded as low, medium and high. Media exNeed was based on the past history of stillbirths or abortions. If the woman reported having had a stillbirth, induced or spontaneous abortion in the past, she was categorized has having a 'high' need, if she did not have any of these, she was categorized as having a 'low' need.Data analysis was carried out using Stata SE, Version 10. The unitOf the 1,510 women who sought delivery care among the 5,391 women interviewed in Maharashtra in the NFHS-2, a majority delivered at home ; with private and public facility deliveries accounting for 32% (n = 493) and 31% (n = 454) respectively. Table Among the enabling variables, a higher standard of living, greater media exposure, and greater number of antenatal visits were associated with use of private facilities for delivery. When the mother was the healthcare decision maker, the delivery was more likely to occur in a private facility. Respondents living in rural areas were more likely to deliver at home. Need was not statistically significantly associated with place of delivery.Table Maternal and paternal education, scheduled caste/tribe status, and media exposure were statistically significant predictors of the choice of public versus private facility delivery. Compared to women with primary education or less, women who had up to secondary level education had 41% lower odds of using a public facility, while women who had more than secondary education had 66% lesser odds of using a public facility. A similar trend was noted for paternal education – fathers with than secondary education had 60% lesser odds of using a public facility. Respondents belonging to scheduled caste/tribes were 80% more likely to deliver in public facilities; and women belonging to households with a high standard of living had 45% lower odds of using public facilities compared to women belonging to households with low standard of living.The National Population Policy provides "a policy framework for advancing goals and prioritizing strategies during the next decade, to meet the reproductive and child health needs of the population of India". The straIndia spends approximately 5% of its GDP on health care. Despite There is increasing concern regarding the unmet need for care, especially among the destitute and the rural population. Consequently, the dependence on private sector for health care is increasing, more by default rather than by design. This is reflected in the fact that households in Maharashtra account for 73.3% of all health care spending, and the government accounted for 22.1% – percentages that mimic the all-India averages.[The 63% institutional delivery rate in Maharashtra is much higher than the all India average for institutional deliveries, which is around a third.,10 Of thOur analyses show that among the predisposing factors, birth order, maternal education and religion affect the choice between home and public/private deliveries. It is plausible that after the uneventful birth of the first child at home, subsequent deliveries are perceived to be of low risk, thus increasing the likelihood of delivering subsequent babies at home. Increasing maternal age may, on the other hand, may increase the perception of risk, thus increasing the likelihood of institutional (public or private) delivery. Further research is need to understand why Muslims are less likely than Hindus' to deliver at home in Maharashtra.Maternal and paternal education, and scheduled caste status are the predisposing factors that determine the choice between private facilities and public/home deliveries. The direction of the education effect is in the expected direction – increasing education leading to increased probability of using private facilities. Education leads to better health awareness, and this may sensitize the family to the quality of health care provided at various facilities.,23 It isAmong the enabling factors, media exposure, number of antenatal visits and location affected the choice between home and private/public facilities, while a higher standard of living affected the choice between private and home/public facilities. The rich have the wherewithal to pay for the price of private care, and given the perception of better quality at private facilities, it is no surprise that they utilize them.We did not find need to be a significant determinant of public versus private sector use. The Andersen Model posits that need is the most proximate determinant of health services utilization. Need can be conceptualized as perceived  or evaluated ; our construction of need is more evaluative than perceived. It is possible that perceived need may be the appropriate variable to use, however, the NFHS-2 lacks sufficient data to construct such a variable.Policy recommendations from our analyses are threefold. First, given the preponderance of home deliveries in the state, especially in the rural areas, every attempt should be made to ensure that these are attended to by a trained birth attendant. Efforts should also be made to ensure that every pregnant women receives at least 3 antenatal visits, with each visit being used as an educational opportunity. This requires strengthening the public health and outreach components of the publicly funded health care system.Second, private sector health care delivery system is a fact of life in Maharashtra. As the India's economy continues to grow, its effects will filter down to all levels of society, thus raising the household income. As this occurs, the likelihood of increased utilization of the private sector will increase, leading to a further expansion of this sector. If we take the importance of education and standard of living as determinants of private sector use, we need to set up mechanisms that will prevent impoverishment of families as they seek care from this sector. Given the percentage of household expenditures devoted to health care, it is important that insurance schemes be set up to financially protect the consumers. This is already happening in the country, and needs to be strengthened more.Third, quality of care in the public sector should be improved, so that it becomes an attractive place to obtain care. This is especially important for households of low and middle income, who maybe using the private sector due to a perceived lack of quality, and may reach financial distress quicker than households with higher standards to living. In other words, the public sector needs to return to its mission of being the safety net for the vulnerable. The government has recognized the limitations of its Family Welfare program in providing services, and has implemented a new Reproductive and Child health program to deliver and even wider range of services. The NatiA few caveats should be kept in mind regarding our study. It is limited to Maharashtra, and may not be generalizable to other states in the country, especially poorer states such as Bihar, where the context and environment may be quite different. Our analytic model does not take into account factors such as distance and travel time, which may affect the decision to use a particular facility. We do not explicitly control for the perceived quality of care in our model. Lastly, we categorize all private and all public providers into one category each, when in fact each group encompasses a heterogeneous range of providers, each of which may have distinct clientele.In conclusion, our study deepens our understanding of delivery location in one state of India, but further research is needed to be able to generalize the results to the rest of the country.The author(s) declare that they have no competing interests.AT was responsible for conceptualizing the research question, data acquisition and analyses, and drafting the manuscript. AM assisted in data analysis and manuscript drafting. KB assisted in data analyses and provided contextual and policy input. FH contributed to study design and help in manuscript drafting. All authors read and approved the final document.The pre-publication history for this paper can be accessed here:


The use of complementary and alternative medicine (CAM) has become more common in Western developed countries in recent years, as has media reporting on CAM and related issues. Correspondingly, media reports are a primary information source regarding decisions to use CAM. Research on CAM related media reports is becoming increasingly relevant and important; however, identifying key concepts to guide future research is problematic due to the dispersed nature of completed research in this field. A scoping review was conducted to: 1) determine the amount, focus and nature of research on CAM and the mass media; and 2) summarize and disseminate related research results.The main phases were: 1) searching for relevant studies; 2) selecting studies based on pre-defined inclusion criteria; 3) extracting data; and 4) collating, summarizing and reporting the results.Of 4,454 studies identified through various search strategies, 16 were relevant to our objectives and included in a final sample. CAM and media research has focused primarily on print media coverage of a range of CAM therapies, although only a few studies articulated differences within the range of therapies surveyed. Research has been developed through a variety of disciplinary perspectives, with a focus on representation research. The research reviewed suggests that journalists draw on a range of sources to prepare media reports, although most commonly they cite conventional (versus CAM) sources and personal anecdotes. The tone of media reports appears generally positive, which may be related to a lack of reporting on issues related to risk and safety. Finally, a variety of discourses within media representations of CAM are apparent that each appeal to a specific audience through resonance with their specific concerns.Research on CAM and the mass media spans multiple disciplines and strategies of inquiry; however, despite the diversity in approach, it is clear that issues related to production and reception of media content are in need of research attention. To address the varied issues in a comprehensive manner, future research needs to be collaborative, involving researchers across disciplines, journalists and CAM users. At the same time as approximately one-half of the population in Western developed countries uses some form of complementary and alternative medicine (CAM) -4, CAM rMedia research is commonly categorized into three main areas: production, representation and reception by audiences . ResearcOf course, all research related to CAM and the mass media needs to be theoretically informed, which includes a comprehensive knowledge of the current body of research literature. Identifying relevant research, however, is somewhat problematic as–by its nature–the field is multi-disciplinary, crossing the disciplines of health care, communication, sociology, cultural studies and others. Researchers tend to be comfortable with the literature in only one or a few of these disciplines but a narrow review focused on only a few disciplines is likely to exclude important evidence on this topic.The purpose of a scoping review is to identify, retrieve and summarize literature relevant to a particular topic for the purpose of identifying the key concepts underpinning a research area and the main sources and types of evidence available . ScopingA scoping review of research on CAM and the mass media was conducted with the objectives to: 1) describe the scope  of research activity in this field; and 2) summarize and disseminate research results.Scoping reviews follow many of the same methodological steps as systematic reviews -15, as tWe operationalized CAM as a set of examples from a core list of CAM products and therapies presented by the International Society for Complementary Medicine Research . For exaWe defined media as various communication channels capable of reaching broad and heterogeneous audiences; but, we limited our review to the traditional "mass" media of radio, television, newspapers and magazines. We excluded the Internet and other specialized media, primarily as a means to focus our review but also due to some fundamental differences between these media types. Audiences tend to engage with these media types in a more interactive, versus unidirectional, manner than traditional mass media . FurtherReferences to original research in the field of CAM and the traditional mass media were sought by searching electronic databases , contacting authors and researchers in the field, distributing an email to over 150 members of the International Society for Complementary Medicine Research, and screening reference lists of identified articles ,14,21.For each database searched, we worked with a librarian from the primary discipline to develop a list of relevant keywords. In the case of some non-medically oriented databases, no CAM specific keywords were available and so we developed a set of terms applicable to general health care  media type of television, radio, newspapers or magazines; 2) CAM product or therapy on the ISCMR core list; and 3) English language publication. No exclusion criteria were defined based on study design or publication type , as longThe list of article titles resulting from the various searches was scanned by two reviewers, who each assigned a value of "include", "exclude" or "maybe" to each reference. In cases where it was impossible to make a decision based on the title alone, the full article was retrieved.We used a standard coding template to extract data from each original research article that would enable us to describe the amount, focus and nature (i.e. the scope) of research related to CAM and the mass media, as well as to summarize and disseminate the results of published research. To describe the amount of research in this field, we recorded the year of publication of each article. To describe the focus of the research, we extracted data regarding the media type, country of media origin as well as the disease and type of CAM product or therapy that were the subject of the research. To describe the nature of the research, we extracted data regarding the researchers' disciplinary background, the type of article, the research approach, characteristics related to methodological reporting and assessment, and the type of media research . In addition to extracting descriptive information, we extracted statements from each article that indicated original research results, being careful to distinguish results from the researchers' original data, results presented from different research studies in the form of discussion as well as researchers' discussion of their own findings .Each author independently extracted the data from each article and entered them into an Excel database.We used a qualitative descriptive approach  to summaFigure Inter-rater reliability of the study selection and data extraction processes was high. In regards to study selection, there were 41 discrepancies representing 0.92% of the total. Each discrepancy was a case of one reviewer coding an article as "maybe" with the other coding it as "include" or "exclude". In all cases, the full article was retrieved and read by both reviewers to resolve the discrepancy. Inter-rater reliability of the descriptive data extraction process was 100% agreement.We located 16 articles that described research on CAM and mass media. All articles were published in 1998 or later with a maximum of three articles published in any year , five from the United States (US) and four from Canada.Most of the studies did not analyze media content related to a specific disease (n = 12); however, two studies focused on representations of CAM treatment for cancer, one focused on menopause, and one on Alzheimer's disease.The majority of articles (n = 9) described media coverage of a range of CAM therapies, with some of these articles articulating differences within the range of therapies surveyed  and the majority described content analyses (n = 11), with discourse analyses also being common (n = 4). One half of all articles we reviewed excluded a discussion of reliability in sampling and measurement, definitions for subjective outcomes or discussion of analytic approach . In addition to multi-disciplinary research relationships, collaborative relationships between journalists and researchers and researchers and CAM users should be established. Such relationships will help ensure research is informed by media practice as well as the context in which individuals use media information, and also that media practice is informed by research. Further, the differences we suggest are inherent between media published in different countries and between media types has important implications for future research sampling decisions. It also seems important that researchers recognize the many differences between the variety of products and therapies that are typically labelled "CAM". For example, it is reasonable to assume that different issues  may emerge as important related to media coverage of acupuncture or massage, as opposed to NHPs. Researching CAM as a unified concept is useful in the sense that CAM tends to represent that which is not in the culturally dominant position of biomedicine and therefore serves as the basis of resistance or opposition; however, as we learn more about the intricacies of this varied group of products and therapies researching CAM as a unified concept becomes less meaningful. We also recommend that researchers fully report their methodological approach, so that given differing conceptions of research quality research users can make their own judgements whether study results are useful to them.Our review suggests unequal attention to the different areas of media research and different media types. Representation research was by far the most common, and it almost exclusively focused on the print media. The same focus has been observed with regards to conventional medicine related media research ,37 and tA scoping review of research on CAM and the mass media has identified a wide range of research and research approaches. However, despite the diversity in approach the review has highlighted some key concepts that should be considered when designing and reporting future research. Specifically, issues related to production and reception are in need of research attention, and focused studies that examine radio and television broadcasts are needed. Most importantly, however, future research needs to be collaborative, involving researchers across disciplines, journalists and CAM users so that issues related to production, representation and reception can be studied in a rigorous and comprehensive manner.The authors declare that they have no competing interests.LCW conceived of the study, designed the research protocol, conducted the literature search, participated in data collection and analysis and prepared a first draft of the manuscript. TS assisted with data collection, analysis and interpretation and assisted with drafting the manuscript. Both authors have read and approved the final manuscript.The pre-publication history for this paper can be accessed here:Search strategy used to identify CAM related media research articles. outlines in table format the search strategy and results of the search strategy used in the scoping review. It includes search terms, databases searched and number of articles retrieved from each source.Click here for fileDescriptive summary of research on CAM and the mass media. summarizes in table format various qualities of the research we reviewed on CAM and the mass media, including: author of research, year of research publication, author's home discipline, article type, study design, type of media, type of media research, country of media origin, and the disease and CAM focus of the reviewed research.Click here for file


Many simulation studies in biomedicine are based on a similar sequence of processing steps, starting from images and running through geometric model generation, assignment of tissue properties, numerical simulation and visualization of the results—a process known as image-based geometric modelling and simulation. We present an overview of software systems for implementing such a sequence both within highly integrated problem-solving environments and in the form of loosely integrated pipelines. Loose integration in this case indicates that individual programs function largely independently but communicate through files of a common format and support simple scripting, so as to automate multiple executions wherever possible. We then describe three specific applications of such pipelines to translational biomedical research in electrophysiology. Many simulation studies in biomedicine are based on a similar sequence that starts from images and runs through geometric model generation, assigning tissue properties, numerical simulation and visualization of the results. The images, often sets of images that combine to describe volumes, come from many modalities and the task then becomes to identify structures of interest and describe those structures in a form suitable for the numerical solution of equations that describe the function of these structures. Thus, one can define a pipeline for image-based model generation and simulation that, once created, can find use in many different fields of biomedical (or other) science and engineering. The desire for such models has, in turn, created a pressing need for software tools that extract anatomy and tissue characteristics from the images, create computational meshes and allow assignment of relevant parameters to the resulting geometric model.Unfortunately, another trait common to many areas of biomedical simulation is the lack of available software, especially those in the public domain, to carry out all the steps of this pipeline. A major goal of our research and development is to address this need and we have created a set of software tools that support simulation pipelines in at least a few application domains. Wherever possible, we have maintained a high level of generality in the software and the algorithms they combine; however, we propose that, in many situations, there are substantial benefits to adapting software to a particular application that outweighs the resulting inevitable loss of generality. Moreover, by striking a suitable balance between the generality of the simulation pipeline and the specific requirements of a problem domain, our experience suggests that one can achieve another major objective of contemporary biomedical simulation, which is creating subject-specific implementations of clinically relevant numerical simulations. We will describe examples of subject-specific models that we have developed, as well as highlight a few of the outstanding challenges that arise in this setting.Interest in image-based modelling is based on the growing access of biomedical scientists to three- (and even four-) dimensional imaging that allows the creation of simulation models that, in some cases, include explicit and individualized anatomical information from the objects under study. Where previous models have used highly simplified representations of biological tissues based on simple shapes , it is now possible to acquire sets of images of all manner of cells, tissues and organs using modalities such as microscopy , X-rays (e.g. biplanar fluoroscopy or computed tomography (CT)), nuclear medicine (e.g. single photon emission computed tomography (SPECT), positron emission tomography (PET)), magnetic resonance  or ultrasound. These images then provide a means to create models that are highly realistic and even subject- (or patient-) specific in their anatomical or geometric aspects.image acquisition and processing for a tissue, organ or region of interest (imaging and image processing),identification of structures, tissues, cells or organelles within the images (image processing and segmentation),fitting of geometric surfaces to the boundaries between structures and regions (geometric modelling),generation of three-dimensional volume mesh from hexahedra or tetrahedra (meshing), andapplication of tissue parameters and boundary conditions and computation of spatial distribution of scalar, vector or tensor quantities of interest (simulation).Naturally, there are variations possible at each step in the pipeline depending on, for example, the imaging modalities that are relevant and available, the physical scale of the problem domain or the mathematical equations and their numerical approximations. The arrows in There are different approaches to addressing any multifaceted software project and the choice of the structure of the software is critical to the success of the project. The need for careful design is especially critical when the software is to serve a diverse community of domain-specific experts. Decisive factors include ease of use, flexibility to adapt to a wide range of data sources and applications, robustness, efficiency and support for multiple platforms. It is also desirable to have a certain degree of integration among different aspects of the software so that users see a similar interface and use familiar terms across each step in the workflow. An additional factor in the design of a large-scale software system is whether to employ a ‘top-down’ design or to iterate from specific to general solutions through a ‘bottom-up’ design that starts with elemental solutions tailored to specific applications and then seeks to integrate them.There are numerous open-source software systems for biomedical simulation and one can organize them according to their degree of coverage from both their technical capabilities and the breadth of their application domain. One category of such software achieves broad technical coverage across a very general application domain. Others, by contrast, target a particular application domain and provide comprehensive and/or integrated solutions within that domain. A third category includes programs that are very specific in their technical coverage but are generalized in terms of the application domain. The final category is the programs that are focused in terms of both technical capacity and breadth of application. The list of open-source examples below, organized by these criteria, is meant to be representative and not comprehensive, and we apologize for inevitable omissions. We have limited the list to our first-hand knowledge, thus have also omitted commercial software.software.sci.utah.edu/scirun) is our own example of a general purpose, problem-solving environment that has found extremely broad application both within biomedicine (SCIRun (medicine .www.cmiss.org) also has a very broad technical scope and application domain  is a newly emerging software system from the NIH-funded Center for Physics-based Simulation of Biological Structures  is a multi-platform, open-source set of tools for visualization and image computing. It is also from an NIH NCBC Center, the National Alliance for Medical Image Computing  problems.Brainstorm (neuroimage.usc.edu/brainstorm) is an integrated toolkit dedicated to visualization and processing of data recorded from magnetoencephalography (MEG) and electroencephalography (EEG). Brainstorm provides a comprehensive set of tools for researchers interested in MEG/EEG (SimBio and NeuroFEM (www.simbio.de and www.neurofem.com) are a combination of programs directed at source localization in the brain using patient-specific finite-element models with multiple conductivities and even anisotropic conductivity (Continuity (www.continuity.ucsd.edu) is a problem-solving environment for multiscale modelling in bioengineering and physiology with special emphasis on cardiac biomechanics, transport and electrophysiology.nv (www.cellml.org/downloads/pcenv) is the Physiome CellML Environment, an integrated software that provides an interface to the cell simulation models of the CellML project.PCEVirtual Cell (www.nrcam.uchc.edu) is a software system for a wide range of scientists, from experimental cell biologists to theoretical biophysicists, who wish to create models of cellular structure and chemical, electrical or mechanical function.Neuron  is a simulation environment for modelling individual neurons and networks of neurons, which is especially well suited to comparisons with experimental data. It has a very user-friendly interface that provides tools for building, managing and using models in a way that is numerically sound and computationally efficient.Genesis (www.genesis-sim.org) has a very similar application domain to Neuron as a general purpose simulation platform to simulate neural systems ranging from subcellular organelles and biochemical reactions to complex models of single neurons, large networks and system-level models.Software systems that provide comprehensive technical support for a specific application area in biomedicine.TetGen (tetgen.berlios.de) creates tetrahedral volume meshes from volume data made from triangulated surfaces for solving partial differential equations by finite-element or finite-volume methods. TetGen is an integrated component in some of the modelling pipelines described here.Insight toolkit  is a comprehensive set of software functions to perform image processing or analysis. ITK is the basis of many other tools (e.g. SCIRun and Seg3D) as they lack a graphical user interface (GUI) and exist only as a C++ class library , which consists of an extensive library for visualization functions, is a component in many larger systems, e.g. 3D Slicer  is a program that computes the body surface potentials from the heart and allows the user to make changes in the electrical characteristics of the cells in any region of the heart. Its goal is not only to provide an educational tool but also a way to study the relationship between the electrical activity of the ventricular myocardium and the resulting potentials on the thorax under both normal and pathological conditions.ECGSLabHeart (www.labheart.org) is primarily a teaching tool that simulates the cardiac action potential, including the individual ionic currents and the fluctuations in intracellular calcium concentration.iCell is an internet-based simulation program that allows the user to generate action potentials from a wide range of cell types , which provide volume rendering and segmentation capabilities, respectively. ImageVis3D is based on our own volume rendering capabilities , which is part of the NA-MIC kit  format and the associated TEEM toolkit for accessing and writing NRRD files.In some applications, we have also used a second segmentation tool,  kit see . AlthougTetGen (tetgen.berlios.de), at the moment the most effective and robust open-source tetrahedral mesh generation program, especially for cases with multiple embedded surfaces. It is this ability to deal effectively with the internal boundaries between regions of different characteristics  and to maintain the integrity of outer boundaries, especially when they are concave, which are essential and challenging requirements for applications in biomedicine.Another component of all our tetrahedral mesh generation pipelines is BioMesh3D, which includes support for both hexahedral and tetrahedral mesh elements  in a scripting environment  and SCIRun . The mesh was composed of 179 643 nodes and 1 067 541 tetrahedral elements and the preliminary simulation was carried out with a dipole source in the right posterior region. Future improvements here will focus mainly on the incorporation of diffusion tensors and then the inverse computation to identify bioelectric sources in patients with epilepsy.The goal of the second example was to create subject-specific models of the heart for use in simulating myocardial ischaemia, a condition in which the blood supply to the heart does not match the demand, which represents the physiological basis of a heart attack. The goal of the simulations was to mimic the results of experiments in which reduced blood flow to the heart in an animal model produced ischaemia that we measured electrically with high-resolution mapping systems .For this simulation, we selected the modelling approach known as the bidomain , in whicTo implement the bidomain solution for ischaemia requires an accurate discrete model of the heart that includes values for conductivity in both the intracellular and interstitial spaces. Because cardiac tissue is highly anisotropic in structure . Within un modules and also performed diffusion tensor magnetic resonance imaging (MRI) of hearts from animal experiments using post-mortem scans on a dedicated, 7 T, small animal MRI system. Subject-specific segmentation on each heart was performed within a few hours using Seg3D and then modules in SCIRun performed all additional steps, including alignment, preprocessing of fibre orientations, meshing of the myocardium, assigning the ischaemic zone interactively and solving the potentials. Figure 5c,d illustrates initial results from these studies, including volume renderings of the coronary circulation and perfusion bed of the individual hearts.More recently, we have converted the code of the original ischaemia simulations into SCIRThe goal of these simulations was to calculate the electric potentials in the body, and especially in the fibrillating heart, which arise during a shock from an implantable cardiac defibrillator (ICD), over 90 000 of which are implanted annually in the USA alone. Of special interest was the use of such devices in children, who are both much smaller in size than adults and almost uniformly have some form of anatomical abnormality that makes patient-specific modelling essential.We have developed a complete pipeline for the patient-specific simulation of defibrillation fields from ICDs, starting from CT or MRI image volumes and creating hexahedral meshes of the entire torso with heterogeneous mesh density in order to achieve acceptable computation times . Then additional modules in SCIRun computed the resulting electric field throughout the torso and visualized the results, also showing the details of the potentials at the heart and deriving from the simulations a defibrillation threshold value . We have also carried out initial validation of the complete system by comparing computed with measured defibrillation thresholds and obtained encouraging results  models, suggesting that patient-specific modelling may not be needed , a dedicated and reasonably computer literate biomedical scientists or physicians can and do use SCIRun  or even Photoshop  to perform customized manipulations or analyses, further adding to the flexibility of the overall system. With some expertise, it is also possible to gather such a set of individual programs into a scriptable, and thus automated, workflow. BioMesh3D is just such a system, driven by scripts written in Python that call individual programs, pass the data files and provide interactive control and feedback to the user.Many of the obstacles that come from the inertia and enforced consistency of large systems are reduced dramatically in software systems that are built from small, largely independent programs that interface through files. Each program can use data structures, memory management and event management suited only for one task. The result can be smaller programs that are easier and faster to create and maintain and which can be re-engineered quickly when the inevitable knowledge that comes with widespread use of software in real-world applications motivates a major reorganization of the program. From the user perspective, because the results of each step in such a pipeline are captured as files, it is also easier to create or use additional third-party programs such as Matlab , In summary, image-based modelling and simulation appear to be paradigms with growing implications and opportunities for biomedical research and software systems to support the resulting pipeline that are bound to continue to grow and become more robust and useful for biomedical scientists. The question of which software architecture offers the most effective infrastructure for the development of such systems remains open. We have shown biomedical examples using both strategies and will continue to explore the benefits of both, driven always by the close collaborations with biomedical scientists that motivate the development and ultimately determine its success.


Improved quality of care is a policy objective of health care systems around the world. Implementation research is the scientific study of methods to promote the systematic uptake of clinical research findings into routine clinical practice, and hence to reduce inappropriate care. It includes the study of influences on healthcare professionals' behaviour and methods to enable them to use research findings more effectively. Cluster randomized trials represent the optimal design for evaluating the effectiveness of implementation strategies. Various codes of medical ethics, such as the Nuremberg Code and the Declaration of Helsinki inform medical research, but their relevance to cluster randomised trials in implementation research is unclear. This paper discusses the applicability of various ethical codes to obtaining consent in cluster trials in implementation research.The appropriate application of biomedical codes to implementation research is not obvious. Discussion of the nature and practice of informed consent in implementation research cluster trials must consider the levels at which consent can be sought, and for what purpose it can be sought. The level at which an intervention is delivered can render the idea of patient level consent meaningless. Careful consideration of the ownership of information, and rights of access to and exploitation of data is required. For health care professionals and organizations, there is a balance between clinical freedom and responsibility to participate in research.While ethical justification for clinical trials relies heavily on individual consent, for implementation research aspects of distributive justice, economics, and political philosophy underlie the debate. Societies may need to trade off decisions on the choice between individualized consent and valid implementation research. We suggest that social sciences codes could usefully inform the consideration of implementation research by members of Research Ethics Committees. Improved quality of care is a policy objective of health care systems around the world. Research findings are sometimes implemented by helping professionals to acquire skills or knowledge, sometimes by making systems changes within health care organisations, and sometimes by legislation which restricts or controls practice. Over the past decade, health care systems have invested heavily in the development of clinical practice guidelines and associated quality improvement interventions . HoweverImplementation research is the scientific study of methods to promote the systematic uptake of clinical research findings into routine clinical practice, and hence to reduce inappropriate care . It incl1. Voluntary consent of the human subject is absolutely essential. Ascertaining the quality of the consent rests upon each individual: responsibility which may not be delegated.2. The experiment should ... yield fruitful results for the good of society.3. Anticipated results must be justified by background knowledge.4. Avoid all unnecessary physical and mental suffering and injury.5. Not conducted if a priori reason to believe death or disability will occur.6. Degree of risk taken to be balanced by the humanitarian importance.7. Proper preparations should be made to protect the experimental subject.8. Only conducted by scientifically qualified persons.9. Subject should be at liberty to end the experiment.10. Early stopping of experiment if risk of injury, disability, death.The primary ethical requirement of consent  raisThis study evaluated the effectiveness of audit and feedback and educational reminder messages to implement the UK Royal College of Radiologists' guidelines for lumber spine and knee x-ray in UK general practices. The study was undertaken in six radiology departments and the 247 general practices that they served. The study design was a before-and-after pragmatic cluster randomised controlled trial using a 2 × 2 factorial design. A randomly chosen subset of general practice patient records (paper and computerised) were examined to assess concordance with criteria derived from the guidelines. The effect of educational reminder messages  was an absolute change of -1.53  lumbar spine requests and of 1.61  knee x-ray requests, relative reductions of approximately 20%. Similarly, the effect of audit and feedback was an absolute change of -0.07  lumbar spine x-rays requests and an absolute change of -0.04  for knee x-rays requests, relative reductions of about 1%. None of the differences in concordance between groups were statistically significant.This was a before-and-after cluster randomised controlled trial, which used a two by two incomplete block design to evaluate the use of computerised decision support (CDSS) to implement clinical guidelines for the primary care management of two conditions: asthma in adults and angina. Practices eligible to participate in the study were those with one of two computing systems, and with at least 50% of the general practitioners reporting use of their practice computer system to view clinical data and for acute prescribing. Process of care data were collected in two ways: by electronic retrieval from the computerised medical record and by abstraction from paper medical records.  Patient-based outcomes were assessed by postal surveys using a range of generic and condition specific measures administered at three points in time: approximately a year before the intervention; just before the intervention and approximately a year after the intervention. There were no significant effects of CDSS on consultation rates, process of care measures (including prescribing) or any quality of life domain for either condition. Levels of use of the CDSS were low.This was an evaluation of the effectiveness and efficiency of an area-wide 'extended' computerised diabetes register, which incorporated a full structured recall and management system, actively involved patients, and included clinical management prompts to primary care clinicians based on locally-adapted evidence based guidelines. The trial, in 58 general practices in three Primary Care Trusts in the northeast of England, was a pragmatic cluster randomised controlled trial with the general practice as the unit of randomisation. The computerised structured recall and management system improved care for people with diabetes. Patients in intervention practices were more likely to have at least one diabetes appointment recorded , to have a recording of a foot check , have a recording of receiving dietary advice , and have a recording of blood pressure (BP) . There was no difference in mean HbA1c or BP levels, but the mean cholesterol level in patients from intervention practices was significantly lower . There were no differences in patient-reported outcomes, or in patient-reported use of drugs or uptake of health services. NHS investigation and treatment costs, and costs to patients were not significantly increased by the intervention; there were administrative costs and there may have been an impact of the intervention on costs within general practice.The conduct of cluster randomized trials in implementation research raise a series of questions: What is consent, and who should give it? What does the freedom to withdraw from an experiment mean in implementation research? Indeed, should implementation research be considered 'biomedical research' for ethical purposes? Although the use of medical records in research is considered by the Council for International Organizations of Medical Sciences , these gIs consent necessary for cluster randomized trials in implementation research? Seeking consent poses potential problems, such as causing bias or distress ,17. In tIt may also be legitimate to consider whether consent is necessary if the risks to the individual patient are minimal ,18. It cOur experiences in implementation research in the early 1990s suggested that some ethics committees were confused about this. On at least one occasion, an ethics committee argued that a cluster randomized implementation research trial did not need to be formally considered by an ethics committee. However, as implementation research does incur potential risks for patients and health care professionals, and as implementation researchers might not be well-placed to judge these risks, we believe that formal ethics review should be required. A review of a cluster randomized trial in implementation research should decide whether the quality of the design and the study team are adequate , as wellIn a patient randomized trial of a treatment, patients are asked whether they are willing to consent to randomization to the treatment or control, and willing to participate in all other aspects of a trial, such as regular review visits with their physician, or completion of outcome questionnaires. For cluster randomised trials in implementation research, it is useful to make distinctions that are often not explicit in ordinary randomised controlled trials of treatments. In particular, we consider consent to randomization and consent for other aspects of the trial at the level of the cluster and patient separately.Consent might be sought from those who are the focus of an intervention. Professionals will usually be the primary subjects, and one might seek consent for an intervention intended to affect them. However, if a health care professional chooses not to participate in a study, they are in effect denying their patients the potential benefits of participation. Health care providers ought to do the best for their patients, and have an obligation to improve their skills and knowledge. This might suggest that they should have a high threshold for opting out of implementation research studies. Opting out could be based on the belief that there are significant risks for their patients, or that the opportunity costs of participation are substantial and will be to the detriment of the care of other patients. We  have used different approaches to consenting health care professionals, often for pragmatic reasons. In the NEXUS trial , we succThe level at which an intervention is delivered may determine whether patients can opt in or out . For intConsent might be sought for the use of routinely held data or for the collection of additional data, with or without invasive procedures. For patients who are not directly the subjects of an intervention, one might seek consent to extract data from their medical records ,24. Conse.g., COGENT used this method) and thus be consented during this process. Return of a survey implies implicit consent to provide data, but in order to post a questionnaire, access to clinical data is needed to judge eligibility, and a contact address is required. The patient's clinician could be responsible for this, but it is a substantial additional task. For use of routine administrative data in a tightly controlled research environment across a large population, individual patient consent might be waived [Studies might require subjects to opt-in, or allow them to opt-out. The potential implications for study feasibility of requiring individual patient consent for data collection may be substantial. A quarter of total research funds were spent on consent processes in one study that achieved only 50% participation . We belie waived .Patients are sometimes deemed incompetent and other people, designated proxies, are allowed to give consent on their behalf. A proxy is usually the next of kin or a legally authorised representative . Proxy cOne might rule that individual informed consent must always be obtained. Several studies have assessed the impact of such laws on participation rates and representation. Studies in family practice (USA) or general practice (UK) settings reported similar active consent rates for researchers to have access to patients' medical records: 67% and 61% respectively ,31. Of tThere are several important general theories that provide ways in which ethical questions can be approached : AristotThe dominance of informed consent in biomedical codes is consistent with a primary focus on autonomy. Comfortable, individualist societies that take the existence and reasonable quality of health care staff and facilities for granted can afford to focus on autonomy. Respect for autonomy is one principle in a popular scheme for medical ethics proposed by Beauchamp and Childress  that hasOrdinary people can recognise that informed consent can raise a problem, and that their concerns about confidentiality might be addressed by other means . The CanThe Nuremberg Code and the Declaration of Helsinki aim to protect patients: but they have limited relevance when subjects are health professionals, and the division of responsibilities between professionals, patients, and researchers must be considered. In contrast to the four principles of Beauchamp and Childress, obligations to four groups of people form the framework used by the International Statistical Institute Declaration on Professional Ethics , from whThe groups to whom obligations are owed by statisticians  are: society, funders and employers, colleagues, and subjects. No one group has priority. Social obligations require statisticians to consider conflicting interests and guard against misuse and misinterpretation of statistics, to benefit as large a community as possible, and to pursue reasonable objectivity. Hence the interests of patients, doctors, and managers in promoting the uptake of clinical research must all be recognised, and the study design must facilitate interpretation and generalisation of results. Obligations to funders or employers require clarity about roles and responsibilities; transparency of statistical methods; no pre-emption of outcomes; and safeguarding privileged information. For example, if a funder of implementation research insisted on informed consent, a statistician may have to state that she cannot ensure that there will be data relevant to the funder's chosen outcome, as well as what limitations arise from data on a biased subset of people.Greater access to well-grounded information benefits society, so implementation research, which endeavours to translate improvements in clinical research into improvements in health care, is ethically commendable. Implementation research should be guided more by the principles of social science research, with the clinical treatment of patients being governed by ordinary professional practice. Seeking individual informed consent is not merely expensive: it may be futile, as those choosing to respond will almost certainly be unrepresentative, hence the study results will be biased. In reality, societies may face a political decision between individual informed consent and implementation research.While ethical justification for clinical trials relies heavily on individual consent, for implementation research aspects of distributive justice, economics, and political philosophy underlie the debate. These ethical issues have been thoroughly debated in the social sciences. Biomedical codes focus on doctor-patient relations, whereas obligations to a variety of interest groups, ownership of information, rights of access and exploitation of data, and responsibilities for professional development are addressed in social science codes. We suggest that social sciences codes could usefully inform the consideration of implementation research by members of research ethics committees. We recommend that training on the particular features of implementation research be offered to those on research ethics committees.JLH: none declared. MPE and JMG have both submitted implementation trial protocols to ethics committees and had difficulty explaining to them the differences between implementation trials and individual patient clinical trials.JLH, ME and JMG together developed the idea for this paper. JLH led the writing. All authors commented on sequential drafts and approved the final version.