The aim of this study was to explore the range and nature of influences on safety in decision-making by ambulance service staff (paramedics). A qualitative approach was adopted using a range of complementary methods. The study has provided insights on the types of decisions that staff engage in on a day-to-day basis. It has also identified a range of system risk factors influencing decisions about patient care. Although this was a relatively small-scale exploratory study, confidence in the generalisability of the headline findings is enhanced by the high level of consistency in the findings, obtained using multiple methods, and the notable consensus among participants.
The seven predominant system influences identified should not be considered discrete but as overlapping and complementary issues. They also embody a range of subthemes that represent topics for future research and/or intervention.
The apparently high level of consistency across the participating trusts suggests that the issues identified may be generic and relevant to other ambulance service trusts.
In view of the remit of this study, aspects relating to system weaknesses and potential threats to patient safety dominate in the account of findings. However, it should be noted that respondent accounts also provided examples of systems that were said to be working well, for example specific care management pathways, local roles and ways of working and technological initiatives such as IBIS and the ePRF.
Implications for health care
The NHS system within which the ambulance service operates is characterised in our study as fragmented and inconsistent. For ambulance service staff the extent of variation across the geographical areas in which they work is problematic in terms of knowing what services are available and being able to access them. The lack of standardisation in practice guidelines, pathways and protocols across services and between areas makes it particularly challenging for staff to keep up to date with requirements in different parts of their own trust locations and when crossing trust boundaries. Although a degree of consistency across the network is likely to improve the situation, it is also desirable to have sufficient flexibility to accommodate the needs of specific local populations. There was some concern over the potential for further fragmentation with the increased number of CCGs.
Ambulance services are increasingly under pressure to focus on reducing conveyance rates to A&E; this arguably intensifies the need to ensure that crews are appropriately skilled to be able to make effective decisions over the need to convey or not to convey if associated risks to patients are to be minimised. Our findings highlight the challenges of developing staff and ensuring that their skills are utilised where they are most needed within the context of organisational resource constraints and operational demands. Decisions over non-conveyance to A&E are moderated by the availability of alternative care pathways and providers. There were widespread claims of local variability in this respect. Staff training and development, and access to alternatives to A&E, were identified as priorities for attention by workshop attendees.
One of the difficulties for ambulance services is that they operate as a 24/7 service within a wider urgent and emergency care network that, beyond A&E, operates a more restricted working day. The study findings identify this as problematic for two reasons. First, it fuels demand for ambulance service care as a route to timely treatment, when alternatives may involve delay. Second, it contributes to inappropriate conveyance to A&E because more appropriate options are unavailable or limited during out-of-hours periods. Ultimately, this restricts the scope for ensuring that patients are getting the right level of care at the right time and place. Study participants identified some patient populations as particularly poorly served in terms of alternatives to A&E (e.g. those with mental health issues, those at the end of life, older patients and those with chronic conditions).
The effectiveness of the paramedic role in facilitating access to appropriate care pathways hinges on relationships with other care providers (e.g. primary care, acute care, mental health care, community health care). An important element relates to the cultural profile of paramedics in the NHS, specifically, the extent to which other health professionals and care providers consider the clinical judgements/decisions made by paramedics as credible and actionable. Staff identified this as a barrier to access where the ambulance service is still viewed primarily as a transport service. Consideration could be given to ways of improving effective teamworking and communication across service and professional boundaries.
Although paramedics acknowledged the difficulties of telephone triage, they also identified how the limitations of this system impact on them. Over-triage at the initial call-handling stage places considerable demands on both staff and vehicle resources. A related concern is the limited information conveyed to crews following triage. Initial triage was suggested as an area that warrants attention to improve resource allocation.
The findings highlight the challenges faced by front-line ambulance service staff. It was apparent that the extent and nature of the demand for ambulance conveyance represents a notable source of strain and tension for individuals and at an organisational level. For example, there were widespread claims that meeting operational demands for ambulance services limits the time available for training and professional development, with this potentially representing a risk for patients and for staff. Staff perceptions of risk relating to patient safety extend to issues of secondary risk management, that is, personal and institutional liabilities, in particular risks associated with loss of professional registration. The belief that they are more likely to be blamed than supported by their organisation in the event of an incident was cited by staff as a source of additional anxiety when making more complex decisions. This perceived vulnerability can provoke excessively risk-averse decisions. These issues merit further attention to examine the workforce implication of service delivery changes, including how to ensure that staff are appropriately equipped and supported to deal effectively with the demands of their role.
Paramedics identified a degree of progress in relation to the profile of patient safety within their organisations but the apparent desire within trusts to prioritise safety improvement was felt to be constrained by service demands and available resources. Attempts to prioritise patient safety appear to focus on ensuring that formal systems are in place (e.g. reporting and communication). Concerns were expressed over how well these systems function to support improvement, for example how incident reports are responded to and whether lessons learned are communicated to ambulance staff within and between trusts. Consideration could be given to identifying ways of supporting ambulance service trusts to develop the safety culture within their organisation.
Service users attributed the increased demand for ambulance services to difficulties in identifying and accessing alternatives. They were receptive to non-conveyance options but felt that lack of awareness of staff roles and skills may cause concern when patients expect conveyance to A&E.
Recommendations for research
The workshop attendees identified a range of areas for attention in relation to intervention and research, which are provided in Chapter 6 (see Suggestions for potential interventions and research). The following recommendations for research are based on the study findings:
Limited and variable access to services in the wider health and social care system is a significant barrier to reducing inappropriate conveyance to A&E. More research is needed to identify effective ways of improving the delivery of care across service boundaries, particularly for patients with limited options at present (e.g. those with mental health issues, those at the end of life and older patients). Research should address structural and attitudinal barriers and how these might be overcome.
Ambulance services are increasingly focused on reducing conveyance to A&E and they need to ensure that there is an appropriately skilled workforce to minimise the potential risk. The evidence points to at least two issues: (1) training and skills and (2) the cultural profile of paramedics in the NHS, that is, whether others view their decisions as credible. Research could explore the impact of enhanced skills on patient care and on staff, for example the impact of increased training in urgent rather than emergency care. This would also need to address potential cultural barriers to the effective use of new skills.
Research to explore the impact of different aspects of safety culture on ambulance service staff and the delivery of patient care (e.g. incident reporting, communication, teamworking, and training) could include comparisons across different staff groups and the identification of areas for improvement, as well as interventions that could potentially be tested.
The increased breadth of decision-making by ambulance service crews with advanced skills includes more diagnostics; therefore, there is a need to look at the diagnostic process and potential causes of error in this environment.
There is a need to explore whether there are efficient and safe ways of improving telephone triage decisions to reduce over-triage, particularly in relation to calls requiring an 8-minute response. This could include examining training and staffing levels, a higher level of clinician involvement or other forms of decision support.
There is a need to explore public awareness of, attitudes towards, beliefs about and expectations of the ambulance service and the wider urgent and emergency care network and the scope for behaviour change interventions, for example communication of information about access to and use of services; empowering the public through equipping them with the skills to directly access the services that best meet their needs; and informing the public about the self-management of chronic conditions.
A number of performance measures were identified engendering perverse motivations leading to suboptimal resource utilisation. An ongoing NIHR Programme Grant for Applied Research (RP-PG-0609–10195; ‘Pre-hospital Outcomes for Evidence-Based Evaluation’) aims to develop new ways of measuring ambulance service performance. It is important that evaluations of new performance metrics or other innovations (e.g. Make Ready ambulances, potential telehealth technologies or decision-support tools) address their potential impact on patient safety.
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4 Conclusions and Recommendations INTRODUCTION The results of the survey provide some of the first empirical data about the perceptions of a sample of U.S. life scientists of the potential risks of misuse of legitimate scientific research for malicious purposes. The survey obtained information from a diverse group of academic, gov- ernment, and industry researchers. The survey data provide evidence about how the respondents perceive the sources of risk related to dual use research, the actions that some scientists are taking to reduce the risk of misuse of science, and the prospects for acceptance of various policy proposals aimed at reducing the risks of misuse of legitimate life science research. While useful, the results of the survey must be viewed with caution because of the low response rate and possible response bias. Scientists who may be involved in biodefense or select agent research, for example, may be more aware of the dual use dilemma and thus more likely to have responded to the survey. In addition, a few of the questions could have been interpreted in multiple ways. Despite the limitations, which are discussed in detail in Chapter 2, the committee believes that the data obtained in this study offer valuable insights and new information. Overall, the survey findings suggest that there is considerable support for models of oversight that rely on the responsible conduct of research and self-governance by the scientific community. The responses also sug- gest, however, that there is a critical need to clarify the scope of research activities of high concern and to determine the appropriate actions that 115
116 DUAL USE RESEARCH IN THE LIFE SCIENCES members of the life sciences community can take to reduce the risk of misuse of science for bioweapons development or bioterrorism. The rest of the chapter provides a summary of the survey findings. Following a brief summary of the perceptions of risks of the scientists who responded to the survey, three key areas of current and potential activities and policies are highlighted: actions that life scientists have already taken to address dual use concerns, mechanisms for the oversight of research, and issues related to education and outreach. The chapter closes with the committeeâs recommendations for furthering education and outreach activities that are based on the findings of the survey and its own judg- ments and analysis. PERCEPTIONS OF RISK The findings suggest that, on average, the scientists who responded to the survey perceive a potential, but not overwhelming, risk of bioter- rorism and that the risk is greater outside the United States. On average, the respondents believed that there is a 51 percent chance that there will be an act of bioterrorism somewhere in the world in the next 5 years and a 35 percent chance that there will be an act of bioterrorism in the United States in the next 5 years. Three-quarters of the respondents believe that a preference for other means of attack is the primary reason why there have been only a few acts of bioterrorism to date; overwhelmingly, 87 percent of respondents said that they believe that terrorists are not deterred by the threat of being caught and punished. Fewer scientists considered a lack of knowledge (46 percent) or access to equipment (51 percent) or agents (36 percent) to be significant barriers. It may be that oneâs perceived risk of such an attack is related to oneâs support for taking measures to reduce the risks that life sciences research might be misused. With regard to the chance that the knowledge, tools, or techniques from dual use research will facilitate bioterrorism, the respondents per- ceive a 28 percent chance, on average, of such a bioterror attack within the next 5 years. Half of the respondents thought that if someone wanted to create a harmful biological agent, the Internet would be the most likely place to provide sufficient information for life scientists with college- level training. Other sources of informationâarticles in scientific journals (40 percent), personal communications (38 percent), and presentations at professional meetings (18 percent)âwere considered relatively less likely sources, although on average 45 percent of respondents answered âDonât Knowâ to these questions.
CONCLUSIONS AND RECOMMENDATIONS 117 ACTIONS TAKEN BY LIFE SCIENTISTS IN RESPONSE TO DUAL USE CONCERNS Although the responses to the survey indicate that bioterrorism prob- ably is not perceived to present a serious immediate risk to U.S. or global security, the survey results also indicate that there is already concern about dual use issues among some of the life scientists who responded. Fifteen percent of the respondents (260 individuals out of 1,744) indicated that they are so concerned about dual use research that they have taken actions, even in the absence of guidelines or mandatory regulations from the U.S. government. Some respondents reported that they had broken collaborations, not conducted some research projects, or not commu- nicated research results. The results indicate that more scientists have modified their research activities than some members of the committee expected on the basis of previous reports of manuscripts that have been modified or not published because of dual use concerns. Interestingly, many of the actions that the respondents reported tak- ing to mitigate concerns occurred before the publication stage; much of the behavior change occurred during the research design, collaboration, and early communication stages. Of particular interest and concern to the committee, a few respondents commented on their concerns about for- eigners as potential security risks, which may be reflected in the reported avoidance of some collaborations. The survey results suggest that: (1) some life scientists in the United States may be willing to consider self-governance aimed at the respon- sible scientific conduct for dual use research, and (2) some life scientists in the United States are already acting, even in the absence of govern- ment regulations and guidance, to protect against the perceived risk of misuse of dual use research. OVERSIGHT MECHANISMS With a proposed oversight framework for dual use research of concern proposed by NSABB in June 2007 now under consideration within the U.S. government, the survey was an opportunity to assess scientistsâ atti- tudes toward specific policy options. Many of the respondents indicated that they believe that personal responsibility, including measures such as codes of conduct, could foster a positive culture within the scientific com- munity to evaluate the potential consequences of their research for public safety and national security. They also indicated that they believe that individual researchers, professional scientific societies, institutions, and scientific journals should be responsible for evaluating dual use potential of research and/or fostering the culture of scientific responsibility. A majority of those who responded to the survey favored self-gov-
118 DUAL USE RESEARCH IN THE LIFE SCIENCES ernance mechanisms for dealing with dual use research of concern, such as those proposed by the Fink report (NRC 2004a), rather than addi- tional mandatory government regulations. In addition to the low level of support for greater federal oversight (26 percent), the individual com- ments indicated a belief that increased government oversight of dual use research would be counterproductive by inhibiting the research needed to combat emerging infectious diseases and bioterrorism as well as being potentially harmful to the scientific enterprise more generally. The survey suggests that most of the respondents (82 percent) favor their professional societiesâ prescribing a code of responsible conduct to help prevent misuse of life sciences research. However, many respondents (66 percent) did not know whether the societies to which they belonged already had codes that address dual use issues, and some of the societies most frequently cited do not in fact have a code. There was substantially less support (38 percent agree or strongly agree) for a Hippocratic-style oath. The results also indicate potential support for journals having bios- ecurity policies. Yet, most of the respondents did not know if any of the journals in which they have published or to which they have submitted manuscripts have those policies. Moreover, more than half of those who responded to the survey strongly disagreed or disagreed with restrictions on personal communication, altering or removing methods or findings from scientific publications, or limiting publication itself. The survey points to a likely preference for self-governance measures to provide oversight of dual use research. There was substantially less support for mandatory measures that might be imposed by regulation, although the results varied for different policy measures. The results indicate that there may be greater support for restrictions on access to biological agents (just under 50 percent of the respondents said they agree or strongly agree) and certifications of researchers (just over 40 percent of the respondents said they agree or strongly agree) than for any control of scientific knowledge generated from the research or through informa- tion exchange (only 20 to 30 percent of respondents supported these measures). Table 4-1 provides a list of the level of support for the various measures addressed in the survey. The survey results suggest there is support for: 1. Greater oversight that is not federally mandated, 2. Self-governance mechanisms as an approach for preventing misuse of life science research and knowledge, 3. Professional and scientific societies adopting codes of conduct that include dual use research as suggested in the Fink report (NRC 2004a), 4. Establishing and implementing policies for authors and reviewers
CONCLUSIONS AND RECOMMENDATIONS 119 TABLE 4-1â Summary of Results Regarding Support for Measures of Personal and Institutional Responsibility Strongly Agree or Agree Measures of Personal or Institutional Responsibility (or Respond Yes*) (%) Principal investigators should be responsible for the 87 initial evaluation of the dual use potential of their life sciences research. Principal investigators should be responsible for training 86 lab staff, students, and visiting scientists about dual use research. Should professional science societies have codes for the 82* responsible conduct of dual use life sciences research? University and college students should receive 68 educational lectures and materials on dual use life sciences research. Scientists should provide formal assurance to their 67 institution that they are assessing their work for dual use potential. Funding agencies should require grantees to attest on 60 grant applications that they have considered dual use implications of their proposed research. Should scientific journals have policies regarding 57* publication of dual use research? Institutions should provide mandatory training for 55 scientists regarding dual use life sciences research. Greater restrictions should be placed on access to specific 47 biological agents or toxins. Researchers conducting dual use research should be 42 certified. All grant proposals for life sciences research with dual 41 use potential should be reviewed by a researcherâs institution prior to submission for funding. Scientists conducting or managing research should take 38 an oath. Research findings should be classified based on their dual 28 use potential. Dual use research needs greater federal oversight. 26 Certain experimental methods or findings should be 22 altered or removed prior to publication or presentation. Certain biological equipment that is commonly used in 21 life science research should be licensed. There should be restrictions on disclosure of details 21 about the research or its findings through personal communication. There should be restrictions on publication of findings 21 based on their dual use potential. SOURCE: NRC/AAAS Survey of Life Scientists; data analysis by staff.
120 DUAL USE RESEARCH IN THE LIFE SCIENCES to consider the dual use potential of research manuscripts submitted to journals. The survey results suggest there is opposition to: 1. Mandatory government regulations to govern the conduct of dual use research and the communication of knowledge from that research; 2. Other mandatory oversight actions, such as oaths or licensing of scientists. Based on the survey results and its own analysis, the committee believes that a basis of support exists within the U.S. scientific commu- nity for measures that, taken together, could lead to the development of a system of self-governance for the oversight of key aspects of dual use research. EDUCATION AND OUTREACH A major reason for conducting the survey was to inform efforts for education and awareness-raising about dual use research by providing empirical data on the attitudes of a sample of the life sciences community. In general, the respondents to this survey would likely support educa- tional and outreach activities aimed at raising awareness of the dual use dilemma. The respondents indicated that they supported educational materials and lectures on dual use research for students. They also sup- ported mandatory training by institutions for practicing life scientists regarding dual use research of concern. The survey results also highlight the need to better define the scope of dual use research of concern. Fewer than half of the respondents who indicated that they were carrying out dual use research activities felt that their research fell into one of the seven categories of research of concern specified by the NSABB. The dual use experiments of concern as listed in the Fink report (NRC 2004a) and by the NSABB are all based on microbial research, but other relevant research, such as theoretical research, scenario development, or applied research (e.g., pharmaceutical formulations or neuroscience research) can be of dual use concern. In their individual comments, a number of respondents stressed the difficulties of defining dual use, as did participants in the focus groups used to develop the survey. Clearly a better understanding of the scope of dual use research of real concern would help any educational or outreach activities aimed at raising the awareness of life scientists so that appropriate actions can be taken.
CONCLUSIONS AND RECOMMENDATIONS 121 Based on the survey results and its own analysis, the committee believes that there is support for mandatory education and training about dual use issues, most likely as part of ethics and responsible conduct of research training. RECOMMENDATIONS The committee believes that the survey raises several hypotheses that merit further research about the views of life scientists about oversight policies and education and outreach efforts to address concerns about dual use issues in the life sciences. In particular, based on the survey results and its own deliberations, the committee offers the following recommendations: Oversight, Education, and Outreach 1. Explore how to continue and to expand the dialogue within the life sciences community about dual use research of concern. 2. Explore ways to provide guidance to the life sciences community about appropriate actions that can be taken to protect against the misuse of dual use research. 3. Seek to better define the scope of knowledge in the life sciences that may be at greatest risk for misuse and to provide the life sciences community with criteria for recognizing dual use research of concern. 4. Encourage journals that have biosecurity policies or plan to adopt them in the future and the professional and scientific societies that have or plan to develop codes of conduct to communicate those policies more effectively. Further Research 1. Examine the effectiveness of existing educational programs and how they can be enhanced and focused. 2. Seek to extend educational and awareness-raising efforts being conducted in the United States to the broad international scientific community. 3. Examine how education and outreach activities can be developed to guide the life science communityâs response to concerns about dual use research so as to ensure that actions taken by the community are appro- priate and contribute to advancing scientific knowledge while protecting national security. 4. Conduct additional surveys, interviews, or focus groups of U.S. life scientists that better represent the full community, with higher response
122 DUAL USE RESEARCH IN THE LIFE SCIENCES rates than the current study was able to achieve, and the ability to assess potential bias, in order to gain i.â a better understanding of the awareness of a broader range of U.S. life scientists about dual use research of concern and the measure that they would support to reduce the threat that research in the life sciences could be subverted to do harm; ii.â a better understanding of the types of behavioral changes being made in response to dual use concerns to determine if actions by life scientists are contributing to national security or harming scientific research; such research is critical given the actions that the current survey suggests are being taken; iii.â more detailed information about the types of changes scientists are making or scientistsâ thoughts about dual use issues, experiments of concern, and select agents; iv.â a better understanding of scientistsâ experiences with educa- tion on this topic and their views about the content and delivery of educational and training materials. 5. Conduct additional surveys of life scientists outside the United States that would enable comparisons of attitudes toward dual use research of concern and inform educational and outreach programs so that they can be effective on a global scale. Such knowledge could also facilitate international discussions of potential measures to address dual use concerns.