Chapter 1

Implementation of the Helsinki Declaration on patient safety in anaesthesiology: past activities, current European perspectives and future opportunities (Ffrench-O’Carroll, Smith)

The Helsinki Declaration on patient safety in anaesthesiology

The Helsinki Declaration on Patient Safety in Anaesthesiology (hereafter ‘the Declaration’) was launched in 2010 by the EBA/UEMS in close co-operation with the ESA.¹ It set out a vision for patient safety in anaesthesiology, together with recommendations for specific activities which could improve safety. It has four distinct elements: standards for clinical care; protocols for the management of clinical crises in anaesthesiology; critical incident reporting; and an exhortation to engage in audit and the compilation of annual reports about local patient safety as well as morbidity and mortality, to reap the benefits of measurement to improve safety.

The Declaration was signed by all the European societies attending its launch in Helsinki and also by the European Patients’ Forum. A number of implementation activities were undertaken to promote the use of the Declaration in practice. A joint EBA/ESA Patient Safety Task Force was set up, and every year this produced materials and resources that were made freely available to every delegate at the Euroanaesthesia Congress. In 2011, a special edition of the journal Best Practice and Research in Clinical Anaesthesiology devoted to patient safety was given out.¹⁴ A survey on syringe labelling and a template for the annual safety report (available from http://html.esahq.org/patientsafetykit/resources/basics.html) were published in 2012.¹⁷ The following year, a manual of algorithms for managing clinical crises in anaesthesiology was issued (available from http://html.esahq.org/patientsafetykit/resources/downloads/05_Checklists/Emergency_CL/Emergency_Checklists.pdf). A ‘Patient Safety Starter Kit’ on a data stick, containing recorded lectures and other resources, was distributed to participants at the ESA’s Euroanaesthesia meeting in June 2014 (available from http://html.esahq.org/patientsafetykit/resources/index.html). Many lectures and presentations were given at anaesthesiology conferences within Europe and beyond and such was the appeal of the Declaration that it has now been signed by approximately three-quarters of national societies worldwide. Despite the widespread endorsement of the Declaration’s principles, and the promotional activities described above, there remains some uncertainty regarding its usage and influence in practice, with limited studies performed assessing its impact.¹⁸

To address this gap, the ESA’s PSQC has started a project designed to assess, understand and improve the translation of the Declaration’s principles and requirements into clinical practice. As part of this project, the ESA recently commissioned one of us (AFS) to undertake a three-phase investigation (details available from https://www.esahq.org/patient-safety/hd-follow-up-project/) to assess the uptake and use of the Declaration. (The study was funded by ESA, supported by the following industry partners of ESA: Philips Healthcare, Masimo International, Fresenius Kabi and Nihon Kohden Europe. These companies played no role in data collection, analysis or writing of the article.) Phase I OF the project consisted of an online survey of ESA members to determine what aspects of the Declaration had been adopted.¹⁹ Respondents were also asked to express their opinions on the Declaration, its impact on patient safety, and limitations and barriers to embedding its recommendations in daily practice. Phase II sought to learn about patient safety practices and the Declaration’s impact in greater detail, by conducting telephone interviews with national leaders in anaesthesiology in a number of European countries. Interviews were semistructured and the resulting qualitative data underwent thematic analysis, with themes developed inductively.²⁰ Phase III involves site visits to hospitals throughout Europe, to examine patient safety practice ‘on the ground’. The three phases thus each aimed to address anaesthesiology practice at various levels (Fig. 1). While the third phase is still continuing at the time of writing (September 2019), the combination of methods used is innovative and has not previously been described in the exploration of patient safety. This chapter thus aims to outline the methodology of this phase of the project, report on the current state of implementation of the Declaration, outline possible future measures for improving its uptake, and reflect on possible implementation approaches that have been, or could be adopted.

Methodology of site visits

From the beginning of the project, it was clear that, to illuminate the subject properly, the inquiry needed to extend beyond a simple assessment of whether or not the Declaration had been adopted to a broader attempt to set it in the practice context of European anaesthesiology.^21–23 We adopted a case study methodology and a broadly positive stance implying a ‘Safety II’ framework (i.e., a framework which aims to understand why things go right in health care most of the time) complementing a traditional ‘Safety I’ framework (i.e., a framework which involves learning from errors).^24–28 Our approach was essentially ethnographic, aiming to build up a picture of safety as practised which was both scientifically rigorous but which also ‘made sense’ to those under study, recognising the time constraints imposed by the short visit schedule.^29–32

Country and hospital selection

Six European countries were chosen to reflect varying healthcare systems across Europe. Selection of countries was influenced by practicality and the presence of a ‘project champion’ (a high-level sponsor, often within the national anaesthesiology society) and a local collaborator, often a senior anaesthesiology trainee or a local consultant with expertise in patient safety. Typically, AFS conducts the first couple of visits in a country with the local collaborator, with subsequent visits being performed by the local collaborator. There are plans for the local contacts to perform visits outside of their home country to gain experience and also share their own experience of visits in different health care settings.

Four or five hospital sites were selected in each country. Methods of selection of these hospitals varied between countries. Generally, a list of hospitals in the target country was identified, then a computer-generated random number sequence was used to identify hospitals, and departments of anaesthesia were contacted. If the first department contacted did not wish to take part, then the next hospital on the list was contacted, and so on. In other countries, the hospitals were selected by the local sponsor or collaborator. Hospitals were chosen to represent a mix, both in terms of geographical spread and care provision (district general vs. university vs. private hospitals). Following agreement from the relevant anaesthetic departments, several steps were taken before the visit: included contacting local ethics boards to gain ethical approval and establishing local rules for data sharing and confidentiality.

Data collection

The data collection process was designed to explore themes which emerged from earlier phases of the project. These included pre-operative assessment; checklists (in particular the WHO Safe Surgery Checklist; WHO SSC); patient experience; anaesthesiologists’ working conditions and wellbeing the role of protocols; documentation and medication prescribing; postoperative care and critical incident reporting. The streams of data sought are set out in the hospital visit schedule shown in Table 1.

 

The first, documentary data were collated by the local contact for the project, who completed the annual safety report using the ESA’s template mentioned above, and also collected any relevant safety protocols. On the day of the visit, the investigators reviewed the departmental protocols and guidelines with staff anaesthesiologists. Second, we invited members of participating anaesthesiology departments to fill in a questionnaire measuring workplace safety culture. This, the University of Texas Safety Attitudes Questionnaire (SAQ), gauges staff attitudes across six patient safety-related domains and provides a snapshot of safety climate.³³ The local contact person was asked to distribute these among at least 20 anaesthesiologists and theatre nurses prior to the visit. SAQs measure staff attitudes across the domains of teamwork, safety climate, job satisfaction, stress recognition, perceptions of unit management, perceptions of hospital management and working conditions. The questionnaire is a widely used tool, which can be used to measure staff’s attitudes to safety at a particular time point, prompt discussion about safety and the introduction of safety interventions, and act as a comparison tool with other organisations.^33–35 The third stream of data was obtained from observation. We undertook a ‘walk-through’ of the operating theatre department, noting facilities such as drug cupboards, emergency drugs, airway management, other equipment and optional monitoring modalities [apart from ECG, pulse oximetry, noninvasive blood pressure (NIBP)]. Such ‘safety walk-rounds’ provided the opportunity to engage staff in the project, discuss safety concerns and notable safety practices and help towards promoting a safety culture.^36,37 Furthermore, we observed several practices to gain further information around safety, namely WHO Safer Surgery ‘time out’ procedures, handover between anaesthesiologists and recovery staff, and sometimes drug and equipment checking.³⁸ The fourth stream of data came from several semistructured interviews. The open-ended guide questions used in the interviews are shown in Table 2. Questions were developed to explore themes mentioned above which emerged from phases I and II of the project, incorporating previous work on patient safety assessment, but also to allow discussion of local safety practices and opinions.³⁹ Typically two consultant anaesthesiologists (one with a responsibility for safety in the department), one trainee anaesthesiologist and one anaesthetic nurse were interviewed. The interviews were tape recorded, with the respondents’ consent.

Follow-up

Following the visit, the investigators prepared a report on their findings. This was sent to the anaesthetic department but not shared more widely, either with other participating departments or the project funder. The report included: a summary of the annual safety report; discussion of organisation and staffing issues; analysis of monitoring standards; discussion of departmental policies and protocols; an analysis of the results of the SAQs; qualitative themes from interviews; a list of recent safety initiatives and notable safety practices and notes on areas for consideration for improvement or change. Within the report appendices, there were also links for safety resources and examples of notable safety practices from other institutions, which the department might choose to adopt. We also invited participating hospitals to provide feedback on the visit process by completing an evaluation questionnaire after receiving the report.

Results

Material from online and interview studies

Results from phases I and II of our project provide an insight into current and future implementation of the Declaration (full results from phases I and II have already been published in this journal).^19,20 In summary, the Declaration is perceived variously as a force for good, a standardisation framework and a catalyst for change. It benefits from being broad in scope, with knowledge of the themes of the Declaration being better known than the more specific details. National leaders interviewed felt that it acts as a tool to help advance patient safety, both politically and scientifically. It could be argued too that the Declaration is also an improvement intervention with 44.5% of ESA members surveyed agreeing that it had improved safety. This was felt to be largely through promoting the use of checklists in the areas of pre-operative preparation, and the management of crises during anaesthesia.¹⁹

Our results suggest that the Declaration’s impact is influenced by national practice context and local safety culture. Many respondents commented that safety practices such as monitoring standards have exceeded those set out in the Declaration for many years, especially in Northern Europe. It is possible that the high levels of monitoring as recommended by WHO/World Federation of Societies of Anaesthesiology (WFSA) standards (pulse oximetry: 99.6%, BP: 99.4%, ECG: 98.1% and capnography: 96.0% throughout Europe), would have come about without the Declaration.⁴⁰ Thus the potential benefit of the Declaration in enabling change and improvement is greatest in areas where safety practices are less well established (such as in the use of data for improvement, whether they are routinely collected or reporting adverse incidents). The Declaration’s impact has also been influenced by recent changes in anaesthesia, with anaesthesiologists throughout Europe reporting greater workloads, more complex patients, and pressures to cut down on pre-operative preparation. This, along with financial austerity and staff shortages (with workforce migration reported by many) have resulted in a perception that more time is spent reacting to patient safety threats as opposed to progressing safety practices.²⁰ Other factors, namely an organisation’s safety culture and staffing issues, have influenced the uptake of the Declaration: for example in the production of annual safety reports and running morbidity and mortality meetings.¹⁹ The hospital visit process described above aimed to explore many of these contextual factors identified in the first two phases of the project.

Survey and interview data suggested that future changes to the Declaration could take account of the challenges mentioned above, as well as the increased role of simulation, human factors and multidisciplinary training in anaesthesiology. But many respondents advocated greater adherence to the existing Declaration rather than changes to the Declaration itself. This could be brought about by introducing a formal checklist of items in the Declaration to guide day-to-day practice, and greater publicity. Efforts could be focused on areas that are less well implemented, such as annual safety reports. The Helsinki Declaration on Patient Safety in Anaesthesiology could be revitalised, by inviting signatories to confirm their continuing commitment on the Declaration’s 10-year anniversary in 2020. The existing Declaration could also be translated into languages other than English where this has not already been done. Further safety suggestions stemming from our study results are outlined in Table 3.

Practical aspects of the visits and our experiences

Having performed several site visits at the time of writing, we can now reflect on some of the factors required for a successful visit, some of the difficulties we have experienced and the benefits to host departments.

The visits require considerable organisation and planning. Early work involves contacting anaesthesiology departments and requesting their participation. Many departments contacted raised concerns that the visit was an ‘inspection’, or that data collected might result in negative publicity for the organisation. It was important at this stage to stress that the project is an attempt to learn about safety in everyday anaesthesiology work (especially what is done well) and how the Declaration fits into this, rather than an assessment of compliance with any particular standard. A successful visit depends on close liaison with the local contact person, who will be required to gather protocols, fill out the safety report, distribute the SAQs and inform relevant staff in the hospital of the visit. We are extremely grateful for the enthusiasm and time dedicated by our local hosts.

We found that providing an open education session to the host anaesthesiology department about the project (on the morning of the visit) was useful in engaging staff, many of whom were later keen to chat to us during our theatre walk-through. Ideally this meeting should be multiprofessional, including anaesthesia nurses and theatre managers.

Early feedback suggests several immediate benefits to hospitals from taking part in the project. Staff reported promotion of a safety culture through the planning and execution of the visit. Multidisciplinary staff were keen to complete SAQs, although for some the questionnaires were seen more as an opportunity to express their opinions on problems with the organisation. Anaesthesiology departments learnt much about their safety systems; for example, they identified protocols that needed updating or revision, and they reviewed their position with regard to contributing to national audits of practice. In some cases, the visit provided an impetus to commence new safety projects. The report distributed to departments after the visit contained several recommendations, useful safety references and suggestions from other hospitals. We hope this will serve as a useful tool for departments.

Performing the visit was also a valuable learning experience for the investigators. Trainees taking part gained greater understanding of recommended safety standards, safety culture and research methods; arranging the visits called for a level of communication, leadership and organisation more than is usually necessary in everyday clinical practice.

Discussion

As we mark the 10th anniversary of the launch of the Declaration, we have, with hindsight, an opportunity to ask some fundamental conceptual questions which have not been previously asked but which are relevant to any consideration of the Declaration’s impact. The first is, what was (is) the Declaration exactly? Is it a statement of vision or intent, similar, for instance, to a resolution from the United Nations or WHO? Is it a standard of care (it certainly refers to published international standards and invites compliance)? Is it a guideline? (This is more contested perhaps, as the word ‘guideline’ can encompass care standards too and there are different challenges to uptake).⁴¹ Is it in some sense a care ‘bundle’ (a set of interventions implemented together for a synergistic effect on outcomes)?^42,43 These questions may seem theoretical, but are important, because how the Declaration is framed will affect how we perceive it, our expectations of what it can achieve, and how it should be evaluated. What is clear, both from the initial documentation at the time of the launch, and from the interview responses and visits so far, is that the Declaration is not explicitly seen as a quality/safety improvement intervention. Maybe this is because it is complex (it has a broad focus and includes drug, equipment, individual and organisational elements). Alternatively, it may simply be that those who met and drafted it did not refer to quality improvement science, although it must be said that this science was neither so well developed, nor so widely applied, as it is today.⁴⁴ This is not just conceptually important; viewing the Declaration as an intervention allows us to invoke the science of implementation referred to above, both as an analytical framework but also to enhance future uptake into practice. The text of the original Declaration shows little evidence of planning as to outcomes, timelines or accountability, and only vaguely deals with what change is desired, though even this lacks any prediction of the effect any change might be expected to have.⁴⁴

There is a note that ‘we’ (not explicitly defined, but possibly the three organisations represented by the signatories in the printed version of the Declaration) would reconvene annually to review progress. This apparent lack of specificity in setting out a framework for evaluation is not necessarily a problem, especially if the Declaration is conceived as a ‘vision statement’. However, if it is seen as a quality improvement tool greater attention to the design of the intervention at the start of its ‘lifetime’ can help avoid disappointing results later.

The second question is, to what extent can changes in practice be attributed to the Declaration? It is clear from the various streams of data collected during the project that there have been many changes since 2010, and it is not possible to establish fully which have come about as a result of the Declaration and which were happening anyway. (The interview data refer to the latter phenomenon, known in quality improvement science as a ‘maturation’ effect.⁴⁴) Selection bias in respondents in all three phases of this project could have coloured the data we hold, and this is inevitable. Evidence for maturation could have been captured by repeated measurements over time (an ‘interrupted time series design’), had an implementation and evaluation plan for the Declaration been conceived as part of its launch.⁴⁴ (A further analytical approach to uptake and coverage of the Declaration, drawing on the basic foundational categories of implementation science, might also be fruitful in the future.⁴⁵) In any case, there was variation in uptake, both of the same elements between countries, but also of different elements of the Declaration. Compliance with essential monitoring standards was very high throughout Europe though there was variable use of other modalities such as bispectral index and neuromonitoring.^46,47 Protocols for pre-operative assessment and preparation were more widely used than those for the management of postoperative pain, but sedation remains problematic.^{19,40,48–52} Both ‘human factors’ elements such as communication, and critical incident reporting were recognised as important throughout Europe, but the degree to which they featured in practice and training varied.^53,54

The third question deals with the nature of the project we have conducted. Right from the start it was clear to the investigating team that, although the impetus for the ESA was to establish the uptake and impact of the Helsinki Declaration, a wider reaching enquiry was preferable, for two main reasons. Despite the ESA’s efforts, we knew that some anaesthesiologists had not heard of the Declaration, and many were not familiar with its contents. Further, any safety initiative needs to fit into the practice context for which it is intended, if it is to be adopted and used.⁵⁵ Asking closed questions such as ‘does this department of anaesthesiology comply with the Declaration?’ yields some information, but less than asking ‘why?’ (if they do) or ‘why not?’ (if they do not). Thus the project has been more an attempt to understand the context (or indeed, multiple contexts) of safety in anaesthesiology in Europe.²² Methodologically, we designed it too as ‘action research’ right at the beginning (indeed, this is in the title of the project as presented to its funders and various research governance bodies). This entails not only discovering new knowledge and understanding specific problems, but also facilitating action and generating knowledge about that action.⁵⁶ This implied a mixed methods approach drawing on both quantitative and qualitative data, which has allowed us to construct an account of patient safety in anaesthesiology, which reflects participants’ perceptions of, and meanings attributed to patient safety within the social context of anaesthesiology practice.⁵⁷ We believe that this is one of the main strengths of our approach, which falls broadly within the emerging field of sociology of healthcare safety and quality as recently delineated by Allen at al.⁵⁵ It was argued that patient safety is not simply about individual or team psychology, but is subject to the sociocultural and political context of healthcare work. According to them, ‘a sociological perspective … reveals how these problems might be managed and by whom, as well as the everyday – and often invisible – situated practices through which quality and safety are accomplished’.⁵⁵

A further point on our data collection approach deals with how we conceptualised and presented the project. We did not see it (especially for the hospital site visits) as an ‘inspection’ in the sense that we were directly assessing ‘compliance’ with the Declaration’s standards (as noted above, there is more to it than this is any case). We introduced it, both in our initial contact with potential sites, and during the briefing at the start of the visit, as an attempt to understand how safety is ‘created’ in day to day anaesthesiology work, as above, and gauge the role played by the Declaration within this. Patient safety can easily be overshadowed by a strong ‘normative’ element, with negative moral overtones and intimations of blame and recrimination.²⁶ Adopting the more positive note of ‘Safety II’, with its emphasis on understanding how and why things usually go right in safety terms, and seeing safety as a natural part of the anaesthesiologist’s professional identity complement this.^27,58

The action research approach described above also implies that those participating are not simply passive providers of data but are also being facilitated in further action in the name of promoting patient safety. The project could be said to have had a ‘transformative’ goal from its inception.⁴⁵ Scientific purists might label this ‘contamination’ or invoke the Hawthorne effect, but as the ultimate aim of the Declaration and its associated activities is to promote patient safety, we do not see this as a shortcoming. We believe that it was possible to find out what was happening but also at the same time to stimulate interest and activity in safety and raise awareness of the Declaration. The project (especially phase III) has indeed promoted the Declaration and patient safety; our initial informal intelligence (supported by the initial postvisit evaluation questionnaires completed by our local contacts) suggests that the mere fact of taking part in the visits has heightened departments’ awareness of patient safety. Sharing of safety practices between hospitals will probably also benefit sites and in the future, we hope that departments may be able to use the visit schedule we have described to perform their own self-assessment of their safety practices. Establishing a network of safety peer-reviewers, who could then potentially cover more sites, as more anaesthesiologists within the network gain experience and confidence with the visit tool, could provide the benefit of having an external view. We hope that such activities will help implement the Declaration in themselves.

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