An exploration of the implementation of open disclosure of adverse events in the UK: a scoping review and qualitative exploration.

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Chapter 1 Background

. . . there are no easy answers when it comes to making mistakes. That needs to be said outright lest someone, especially someone in training who is less experienced, think that admitting a mistake stops at quality control or sharing responsibility, and that there is then some way around the difficult task of actually taking responsibility for the mistake. Within the culture of medicine and even more broadly in modern society there seems to be a drive for finding the easy way out. In this case there is none, and it needs to be made very clear that this is a defining moment in the life of a physician with regard to integrity and professionalism

Reproduced from Medical Errors and Medical Culture. There is no Easy Way Around Taking Responsibility for Mistakes, Lyckholm L, Vol. 323, p. 570, 20011 with permission from BMJ Publishing Group Ltd.

Estimates suggest that approximately 1 in 10 patients admitted to hospital will experience some sort of unintended harm; approximately half of these cases are thought to be preventable. 2,3 In a recent review of prevalence studies, between 3% and 16% of hospitalised patients were found to have suffered harm from medical care. 4 This represents a significant proportion of patients, and the Department of Health in the UK has identified quality and safety of care as a major concern. 5 The recent publication of the Francis report has brought this into even sharper focus. 6 Internationally, other agencies are dedicated to co-ordinating improvement efforts [e.g. the Agency for Healthcare Research and Quality (AHRQ) and The Joint Commission (TJC) – formerly the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) – in the USA, and the Australian Commission on Safety and Quality in Healthcare (ACSQH)]. A central component of a just patient safety culture is thought to include the disclosure of serious medical incidents to patients who have been affected or their families, often termed open disclosure. 7 The concept of openly disclosing the details of medical incidents has been adopted by several organisations, including ones in Canada,8 New Zealand,9 the UK,10,11 the USA12 and Australia,13 which implemented a national open disclosure policy in 2003. However, it is estimated that as few as 30% of harmful errors may currently be disclosed to patients. 14

Historically, the disclosure of adverse events to patients was neglected. Prior to the 1970s there was a general acceptance of medical expertise; medical notes were rarely seen by patients or families and, if required, often had to be obtained through a legal process. Discussions recognising this as problematic appear to have emerged during the 1970s and early 1980s, when it was identified that patients suffering from ‘medical mishap’ were often unable to find out who was responsible for an error or whether or not anyone had been at fault. 15 The importance of transparency in relation to improving quality and safety in health care became increasingly discussed in the wake of seminal documents such as To Err is Human 16 in the USA and An Organisation With a Memory 17 in the UK. Standards that promote open communication with patients following events where errors have occurred are rapidly emerging in both the UK and a wider international setting. 4,17–19 Advocates of open disclosure propose that failing to communicate effectively with patients following errors could reduce patient trust in health services, perhaps with negative consequences for future care, and may increase the likelihood of litigation. Patient trust may be diminished if they consider that their health service provider has not honoured their commitment to care for patients by apologising. There is some evidence, mainly emerging from the USA, to support such concerns. 20,21

In the UK, the National Patient Safety Agency (NPSA) relaunched its Being Open framework in November 2009. 11 The framework describes Being Open as being about the way in which health-care organisations and their staff communicate with patients and/or their carers following a patient safety incident, and sets out 10 key principles that underpin the successful facilitation of this process. These include providing a genuine and timely apology for what has happened, keeping patients and/or their carers informed about the progress made with the incident investigation, reassuring patients and/or carers that the incident is being taken seriously and ensuring that measures are taken to prevent the incident from happening again.

An apology is described as different from an admission of liability, and though an apology may be referred to in legal proceedings, the NHS Litigation Authority (NHSLA) stresses that this should in no way deter those involved from providing explanations and apologies following adverse events. 22 Being Open suggests that good communication and trust are fundamental to the relationship between health-care professionals and patients, but also that it is the ethical course of action. The Being Open framework was part of a broader NPSA initiative in the UK to create an open and fair culture in the NHS. The NPSA stressed that open disclosure should be explicitly linked to systems of incident reporting and analysis in health-care organisations. 23 Reorganisation within the NHS meant that on 1 June 2012 the key functions and expertise for patient safety developed by the NPSA transferred to the NHS Commissioning Board. It was anticipated that this would ensure that patient safety remains at the heart of the NHS and builds on the learning and expertise developed by the NPSA in driving patient safety improvement. The Board will continue to use the National Reporting and Learning System (NRLS) to identify important patient safety issues at their root cause. Health-care organisations are expected to report patient safety incidents to the NRLS as previously. The approach to monitoring safety within UK NHS trusts is therefore unchanged, and the stance that disclosure should be part of safer patient care remains.

Despite limited empirical work assessing the effectiveness of implementing open disclosure policies (largely undertaken in the USA, Australia and New Zealand), a review of the available literature in 2008 revealed increasing recognition of open disclosure as an important issue for both organisations and patients. 24 The review also highlighted key debates around the ethical principles of ‘being open’ versus the legal liability and economic risk involved. The absence of investigation into non-hypothetical scenarios and individuals’ actual experiences of open disclosure was also noted. With growing acknowledgement of the challenges associated with open disclosure, the literature in this field has rapidly expanded, and there is now a need to update the synthesis undertaken in 2008 to identify a point from which to move forward, particularly in relation to the UK. Further work undertaken by Iedema et al. includes the assessment of open disclosure in terms of the impact on patients and health-care staff in Australia. 25–27 Qualitative analysis of interviews with 131 clinical staff and 23 patients/family members indicated that, despite some uncertainty surrounding the use and consequences of open disclosure, the system was strongly supported. 24 Further work has examined 119 patients’ and family members’ responses to questions about whether or not, and how, they experienced disclosure. 27

Complementary work by Gallagher et al. has conducted an investigation into patients’ and doctors’ attitudes towards the disclosure of medical errors, which highlighted the need for doctors to meet patients’ expectations of an apology following medical errors and also to provide information about the error. 28 Further work by Gallagher et al. ,29 in line with findings from other studies,30,31 has discussed the increasing need and desire for open disclosure of medical errors.

Although the ethical arguments for the open disclosure of adverse events to patients are strong, there are many stakeholders (e.g. patients and clinicians, hospital managers, health policy-makers, unions, equipment companies, insurers, legal advisers and indemnifying organisations) involved in the delivery of such a framework at a variety of levels. (Future reference to stakeholders will include the aforementioned groups, although this is not intended as an exhaustive list.) The complexities of the differing perspectives of all of these stakeholders means that implementation of any initiative is challenging. Embedding incident disclosure into national and local culture within the NHS is a substantial challenge for NHS managers, as well as for the individuals involved in direct patient care. It has been suggested that this is due to a culture that favours risk aversion over patient-centred disclosure, despite the suggestion that the latter produces better financial and relational outcomes. 32 Current barriers to disclosure, such as fear of litigation or damaged reputation, can obstruct clinicians in maintaining good relationships with patients and becoming more open to learning from error or mistakes. If such barriers are not recognised, challenged and addressed appropriately and overtly, they may cause significant problems for the implementation of a more open safety culture.

There appears to be a small but significant literature within the area of patient safety which looks at the open disclosure of adverse events, including the important area of the impact of open disclosure on the health professionals involved in the error and the link between disclosure and systems improvement. 33 However, this research is almost exclusively grounded in contexts outside of the UK, and much of the empirical work is based on training scenarios rather than in situ practice. We know little about how the policy of open disclosure is being, or might be, implemented and applied locally or nationally in the UK and how it is, or will be, aligned with current incident reporting and analysis systems in health-care organisations. As is the case with many patient safety outcomes, there is also a lack of knowledge around how open disclosure might best be evaluated and improved. In addition to examining the current breadth and quality of the literature in the area of open disclosure to date, this research will provide information about the implementation and current stakeholder perceptions of open disclosure within the UK.

Chapter 2 Methods

This study addressed the objectives via three main phases of work. A review phase and a qualitative phase directly contributed to a synthesis of the information, to address specific issues in relation to delivery of the Being Open guidance in the UK in the final phase of the study.

Chapter 3 Results

Chapter 4 Discussion

This project set out to critically evaluate and extend both the evidence base and practice in relation to the implementation of a policy of open disclosure of adverse events to patients within the UK. The findings have been presented and the implications of both reviews and the primary research will be summarised here in relation to our original purpose highlighted below. The project set out to:

• identify current areas where evidence and knowledge remain sparse

• supplement the current guidance on implementing open disclosure

• inform training and support for organisations and individuals in this area

• identify continuing barriers to the implementation of open disclosure

• identify well-developed models for open disclosure

and:

• develop a series of short and pragmatic guidelines for NHS trust managers to facilitate the implementation and evaluation of open disclosure initiatives.

The following discussion will situate the findings from the reviews and the qualitative work within our research aim. We have been able to identify current areas where evidence and knowledge remain sparse and within identified limits we are able to supplement the current guidance on implementing open disclosure. The supplementation of the guidance is reviewed in the context of findings from the work conducted within the context of this report. Similarly, we have been able to identify issues and evidence which can inform training and support for organisations and individuals in open disclosure practice.

The gaps observed in the literature in relation to open disclosure of adverse events to some extent mirror observations which have been made in relation to patient safety research in a broader sense. Although patient safety research has made progress since To Err is Human 16 and evidence of success is apparent, this largely falls in quite specific clinical areas such as decreasing catheter-related infections227 or surgical checklists. 228 Shekelle et al. ,229 in their appraisal of patient safety science, have suggested that a view that patient safety interventions have improved outcomes for patients is not entirely convincing based on a number of other reports (e.g. Landrigan et al. 230). Their view that the science behind patient safety improvement is still developing and maturing holds true for the related area of disclosure of adverse events. Shekelle et al. have made four key recommendations for improving evaluation of safety initiatives: describing the theory, describing the practice in detail, detailing the implementation process and assessing the outcomes including unintended effects. They also stress the importance of attention to context when making conclusions about successful implementation. 229 The literature reviews that we have produced have emphasised the gaps that still exist in relation to these recommendations when considering open disclosure. Although the reviews have highlighted the lack of conventional empirical studies as a means of evaluation, they have located a body of useful opinion which raises a number of issues and provides useful illustrations. However, the area is undertheorised.

The development of theory is perhaps particularly important in relation to the design and evaluation of efforts to improve communication with patients and families about safety incidents that have (or may have) affected their care. The significance of the multiplicity of value considerations at play in these situations needs to be taken seriously, and considerations of context will be both particularly difficult and particularly important for good judgement both in and of practice. In relation to the conceptualisation of open disclosure, both the literature reviews and the interviews have highlighted the challenges in conceptualising acts of disclosure as processes, because these cannot be prescribed in any simple or linearly direct way from a broader principle of openness in health care or the moral concepts that lie behind this.

The act of disclosing (Being Open) and the broader issue of openness or transparency in health-care systems more generally are often discussed interchangeably but conceptually are quite different. There is a definitional problem around the area of Being Open which is highlighted in both the literature reviews and the qualitative data. Open disclosure in relation to so-called ‘never events’ presents a picture of greater agreement in that health services are morally obliged to communicate with patients and families in a way that is somehow ‘open’. However, what exactly is required and why still seems to be open to interpretation. Events that are catastrophic, life-changing for all concerned and considered avoidable are the main focus of the Being Open guidance. However, the language of the Being Open guidance strays into a much wider domain which speaks to a broader perspective on openness. The broader principle of transparency within health care is highlighted in the content of the second Francis report6 and in the very recent report by Berwick et al. ,200 which address a broader concept of openness and duty of candour. However, the lack of distinction between moral constructs and behaviour may cause confusion for those attempting to implement the guidance in that the definitions provided within it allow for interpretation, and it is this that appears to cause tensions within our data.

An alternative approach in addressing the disclosure of adverse events is to focus on the wider problem of candour on a bigger scale and to change the emphasis from candour associated with discrete events to candour associated with health care per se. This emerged as a theme in both the literature and in our primary data. If health-care providers were generally more open with patients then openness in the aftermath of error may be easier to achieve. However, there is a lack of exploration of the impact of such a blanket promotion of general candour, and even if such a culture were promoted and existed, the reliance on interpretation would still require good judgement in the promotion of moral behaviour. Organisations need to be clear about the focus of attempts to change. It is relatively easy to capture whether or not events are disclosed but more challenging to capture a change in broader concepts of openness. This broader focus would increase patients’ confidence that all aspects of their care are being shared with them, extending from everyday decision-making about their care to a more involved consent process. This is not to say that care should be one long disclosure process but more to emphasise a culture shift which sees candour incorporated into everyday conversations in relation to care, which may in itself help with the process when things do go wrong.

There was little literature from the UK which allowed us to determine understanding, views and interpretation of a policy of open disclosure of adverse events among UK stakeholders, but the qualitative data from the wide variety of stakeholders we were able to access has provided a valuable starting point on which to base future efforts to promote both disclosure of discrete events and a wider principle of openness in care provision.

Many of our stakeholders were willing and able, in the context of anonymised individual interviews, to articulate clear examples of situations where they had made errors or had been involved in situations where errors needed to be or were disclosed. However, the reluctance of those who we approached to engage in focus group discussions highlights the considerable challenge of embedding discussion of real error and disclosure events into quality and safety improvement efforts at national and organisational level. The persistent reluctance of individual clinicians and managers to engage in reflective and reflexive processes around particular errors hampers attempts to unpick ways in which this is embedded and linked to quality and safety reporting and management in practice. This is an important finding and reflects the continued lack of confidence of individuals employed in health care that the professional and organisational systems in which they work will be supportive in managing the context in which a particular event has occurred.

The previous sections have presented the findings from the literature reviews and the primary research. The following section will discuss how the synthesis of these findings might further inform an evidence base and practice in relation to the implementation of a policy of open disclosure of adverse events to patients within the UK. Although no formal mixed-methods synthesis was applied, we have summarised the findings from both phases and presented them as a matrix (see Table 3 ) to allow simple comparisons of the evidence in relation to each of the 10 principles of Being Open. The matrix summarises areas of convergence or divergence between the reviewed papers and our primary data, and identifies where gaps in knowledge remain. This synthesis has been used to explore ways in which future research might further inform and extend current practice and implementation of open disclosure and produce a series of short and pragmatic guidelines for NHS trust managers to inform and facilitate the implementation and evaluation of open disclosure initiatives.

During the course of the work reported here there has been a fast-paced change in the landscape of the NHS. Significant challenges to the belief that the NHS presents a safe and high-quality service at point of care have been raised. The recent Francis report6 has highlighted the urgent need to address transparency and openness within the NHS, and the decision to implement a contractual duty of candour within health care from April 2013 has been challenged by Francis, with a recommendation for a statutory duty of candour. Although the debate appears to have moved from a contractual duty of candour to a statutory duty, the implications of this for organisations and individuals remains unclear. The current attention to openness within the NHS means that our examination of the existing evidence and thinking around open disclosure of unanticipated outcomes in health is not only useful but timely.

A synthesis of the literature exploring open disclosure and primary data from stakeholder interviews reveal that although knowledge around some of the concepts presented in the 10 principles of Being Open is well established, little is known about the way in which other principles feature in practice or in the perceptions of stakeholders.

This discussion will examine areas where literature exists and which are aligned with the issues raised by respondents in our primary data collection, and raises novel concepts which are highlighted in the primary data but where little literature exists. We also propose to look at the areas where little evidence was identified from either phase and begin to situate our findings within a broader theoretical perspective of safety and organisational change.

A summary of the evidence and brief synopsis of the synthesised findings is presented in Table 3 .

An abundance of literature was identified in relation to four of the principles of the Being Open guidance: acknowledgement, apology, professional support, and truthfulness, timeliness and clarity of communication. These issues were also some of the most pertinent arising in stakeholder interviews. It was apparent that these issues were perceived as critical to open disclosure by all stakeholders, but also as problematic when not implemented effectively.

The acknowledgement of an adverse event demonstrates one such example of where there was a large amount of literature and was widely discussed by respondents. There was an emphasis in the literature review on the importance of health professionals and organisations acknowledging events (e.g. Mazor et al. ,20 Gallagher et al. ,28 Wojcieszak et al. ,48 Berlinger,50 Anon.,231 Brahams232), and this belief was echoed by patients and many other stakeholders in interviews. Despite this, one of the most commonly reported features of poor or non-disclosure emerging throughout this project was the lack of consistent acknowledgement of adverse events (e.g. Pham et al. ,58 White et al. ,62 Kroll et al. ,63 Martinez and Lo,66 Garbutt et al. ,68 Gallagher et al. ,71 López et al. 111). The primary reason cited for this in our interview data seems to be the difficulty health professionals experience in defining an adverse event and the particular circumstances in which disclosure is required. Most interview respondents raised the difficulty of knowing which events should be disclosed; as the Being Open and GMC guidance both use patient harm as the determinant for whether or not disclosure is needed,11,95 respondents who were familiar with either defined the need for disclosure in these terms. The dissonance between patient or family and health professional definitions of harm shown in the review69,233 may mean that the use of patient harm to define what should be disclosed is problematic. Although one solution may be to define the types of events that warrant disclosure, it was apparent from the range of search terms required to capture all of the relevant literature (see Appendix 2 ) that numerous terms were used to describe adverse events in health care. The use of diverse terminology means that even when issuing guidance in relation to events that warrant disclosure, organisations, health professionals and patients may not always attribute the same type of event to each term.

The literature and the interviews relating to the topic of acknowledgement demonstrate the complexity of developing appropriate strategies to ensure that open disclosure occurs; at a basic level, simply recognising that an event has taken place and that disclosure is needed can be challenging. In the context of patient safety and protecting patients from harm, decisions regarding events that warrant disclosure become additionally complex as they appear to link the potential for patient harm and what may be the subjective judgements of providers. An additionally complicating aspect seems to be that the further from obvious error with apparent harm an event moves, the more opaque the decision seems to become. However, when conceptualised in the context of care quality, the complexity relating to terminology may be lessened. In providing high-quality care, health providers may need to consider whether or not a general principle of adopting an open and ongoing dialogue with patients may contribute to improvements in patients’ perceptions of quality and commitment to it; this includes discussions about everything that occurs in their care, including minor or more serious undesirable events.

Discussion of patient–provider communication featured prominently in the interview data and in the literature around the ethics of disclosure and disclosure training. This evidence relates closely to the principle of truthfulness, timeliness and clarity of communication. Data from both the reviews and interviews consistently demonstrated that most stakeholders strongly support the principle of being truthful with patients (e.g. Kohn et al. ,16 NHSLA,22 Scheirton,41 Shapiro152). This consensus about broad values sits alongside reports from practice in which interviewees describe staff withholding information from patients. The discrepancy might be variously explained by failures to reflect the key value of truthfulness appropriately in practice and/or by appropriate efforts to balance this value with other values that suggest different ways of acting in particular circumstances.

We found it striking that a number of health professionals considered it their prerogative or role to determine the type of information patients and carers needed to know, and that they used the aim of protecting patients from harm as the primary reason for withholding information. They seemed to have few reasons that might strengthen their imperative to act on considerations of truthfulness, but potential to develop these can be found in the reasoning of some of their peers who gave accounts of what seemed to be more open and truthful disclosures. The professionals who seemed to adopt more truthful practices were not neglectful of considerations of harm, but also mentioned considerations of who owned the information, and of patients’ rights to know. The language of rights and concepts of information ownership that they used might not be ideal, but could be further explored and developed for use in efforts to encourage a greater emphasis on truthfulness in relation to the discussion of safety incidents.

Similarly, the literature and patient accounts suggest that timely and clear communication are central to good disclosure, and though this view was reflected in interview data, descriptions of the complexities that prevented this happening were also described. More complex (but possibly common) scenarios in which information was missing or the discovery of an event was delayed led to uncertainty regarding when communication with the patient should take place and what this might include. There is a tension between acknowledging promptly and presenting a delayed, but more complete, picture of the implications and cause of errors. Early disclosure conversations may leave patients with uncertainty in relation to their current condition and vulnerable to delayed and unclear communication from health providers. Communication could be further hampered by dilemmas regarding who should disclose, where and how.

One of the most widely discussed barriers to truthfulness was health professionals’ fears regarding litigation. This was discussed in interviews and apparent in the literature. Concerns about litigation and studies of the impact of disclosure on litigation commonly featured in the reviews, particularly those originating from the USA (e.g. Gallagher et al. ,67,71 Studdert et al. ,79 Wu et al. 193). In relation to these, numerous articles presented disclosure as a strategy for health professionals to protect against litigation, suggesting that openness with patients may prevent legal action (e.g. Boothman et al. ,32,182 Kraman and Hamm,52 Kachalia et al. 208). However, a marked lack of any evidence to support this widely held belief was apparent from the reviews. The stakeholder interviews suggested that though health professionals were aware of the potential for litigation in relation to adverse events, this did not appear to be such a pervasive fear in our UK sample. Health-care managers discussed the possibility of litigation more than front-line staff, suggesting that this may be a more salient barrier for managers attempting to manage organisational risk than for clinicians. However, where health professionals made reference to litigation, it was generally to suggest that their fears had not been realised in their own experience, and that patients had not pursued legal action as a result of disclosure. The literature review suggests that patients often litigate to obtain information that they feel they have failed to access through other discussions and this was reinforced by the patient respondents in our sample. However, litigation may be pursued as a legitimate claim for loss of earnings or care costs even though individual patients and families are happy with explanations of error and apologies.

Professional support is identified as a principle of Being Open which can be conceptualised as support for professionals in a number of ways. Support may be in the form of support from professional organisations, the organisation that employs the health professional and managerial support. Additionally, support may be from peers and may occur within and between professional groups. Support can be enacted in ways that promote learning and inform how to disclose effectively, and as emotional and instrumental interventions for health professionals to cope with the burden of clinical work and emotional responses to adverse outcomes that may impact on their ability to disclose effectively. With regard to the former, although training was developed to accompany the Being Open guidance and support its implementation, both the review and interviews revealed a lack of awareness of its availability. No evaluation of any training specifically associated with the UK Being Open guidance was identified in the reviews. Only interviewees involved in developing or delivering the training, and senior leaders in one trust in which it was used, were aware of its existence. Those who were aware of the training package cited cost as the main barrier to wider uptake. Beyond the training that was explicitly developed in relation to the UK guidance, there was a wider absence of any evaluation of training approaches to support disclosure, although in the accounts of successful implementation of a disclosure policy, training was always featured as key to success. 150–152,154 Interview participants consistently articulated the view that professional training is imperative to support and enhance the disclosure process. Such findings suggest that while professional support and training are widely recognised as valuable, little is known about the most acceptable and effective models on which to base such interventions. Further research may help to clarify the most effective training models, the most appropriate outcomes on which to judge effectiveness and ways to support implementation. Iedema234 suggested that the promotion of reflexivity may be critical to underpinning attempts to enhance safety, and suggested methods for achieving this, such as video filming real-time clinical practice and inviting clinicians to feedback on their own film, and reflection on the knowledge and questions that patients and families have about their care and about unexpected outcomes and clinical incidents. Such methods could be used to underpin specific training in relation to disclosure conversations and encourage reflexive practice, enabling individuals and teams to reflect upon and appraise their actions in light of a range of salient values.

With reference to broader support for health professionals, interviewees recognised the lack of support available to staff to manage their experience of making an error or of being involved in an adverse event; this is reflected in a growing body of literature about the distress experienced by health professionals in these situations. This literature was not included in this review but has a growing evidence base. 235 A small number of papers referred to the belief that disclosure may help professionals involved in error to come to terms with their own associated distress; however, while this may convey empathy in some situations this may not always be the case, and we currently know little about how disclosure affects either health professional or patient well-being. Interview respondents (particularly those representing professional bodies) indicated that without the necessary support for health professionals, they may not be as willing to disclose events or may do so with low levels of commitment or skill. This belief is reflected in the broader literature (e.g. Levinson,69 Stroud et al. 73). There is a well-established literature and understanding (shown through our interview data) that broader professional support is important to enhance open disclosure, but the availability of support appears to be inconsistent and, as with training, based more on the motivation of well-intentioned institutions than evidence-based guidance. US-based accounts of providers who have implemented such support are enthusiastic152 but no evaluation data seem to be available.

Apology was one of the most widely debated issues identified in the review, spanning the medical, ethical and legal literature. Literature reporting patients’ beliefs indicated that a genuine and timely apology was one of the most important aspects of effective disclosure. 86 Policy material from the NHSLA also supported the notion that health professionals should be free to give an apology without fear of the possible impact it may have on a claim. 22 Although the value of apology was widely discussed, health professionals and managers described several dilemmas in deciding when to apologise, who should apologise and what this should include. Additionally, there is a sense that although the message seems to be that apologies are welcomed by patients, and often by professionals and their regulatory organisations, this may sometimes conflict with interpretations of that message from those involved in risk management. This can be understood as reflecting different interpretations of the concept of apology and how it relates to a range of values and consequences. For instance, the legal system in the USA in particular means that the caveats placed on apology translate to nervousness around the timing and content of apology, which may appear to convey insincerity and a lack of empathy if not handled sensitively by the individual or team making the disclosure. The absence of pragmatic guidance around apology to support professionals to translate the principle into practice was evident; however, as we have emphasised throughout this discussion, the presence of guidance that may be interpreted as a recipe for what to say is unlikely to facilitate any progress towards helping individuals in appraising their moral reasoning about apologies. In the UK, an apology is clearly articulated as not being the same as an admission of fault. There seems to be a present need, articulated in patient accounts, to distinguish between an ‘apology’ whereby a health-care provider accepts responsibility for something that happened or did not happen and apologises for this, and the situation where a provider expresses sympathy or regret at an outcome but fails to take responsibility for harm. Confusing these two situations appears to have the potential to cause more harm than good when a patient feels that failing to accept responsibility for an error fails to address the impact it has had.

Continuity of care and multidisciplinary team responsibility were primarily highlighted by our interview respondents but had a less established literature. Continuity of care may relate to the implications of disclosure for the ongoing treatment of the patient but was also conceptualised in relation to the ongoing nature of a disclosure process. Often ‘good disclosures’ or training for disclosure models were represented in the literature in terms of a single conversation between patient and provider. Interview data and a small number of written accounts suggested that conceptualising disclosure as an ongoing dialogue between patient and health-care team was of great importance for ensuring real transparency. 31,85 Only a small number of professional respondents recognised disclosure as a dialogue, suggesting that mismatched expectations of the disclosure process between patient and provider may be an issue. Preparing health professionals for a disclosure conversation may exacerbate the belief that disclosure occurs at a single point in time; therefore, defining disclosure more explicitly as an ongoing process in any guidance, but also in training and education, may be helpful.

A failure to recognise disclosure as a process over time may be part of a broader lack of recognition of patient and carer expectations about disclosure. Patient and carer expectations of communication with health professionals are referenced in broader health-care literature, particularly in relation to patient involvement and shared decision-making. However, the literature that focused on open disclosure revealed that patient and carer expectations of disclosure, and the ability of health professionals to recognise these, received little attention. In contrast, interviewees who were health-care managers and representatives of professional organisations consistently raised the need to consider and respond to patient and carer expectations. More work may be needed to establish the most effective way to support health professionals in determining patient expectations and representing these in disclosure dialogue, in order to promote responses and reactions that meet the needs of patients or carers and allow them to contribute to the disclosure discussion.

Interview data revealed a lack of consistent agreement regarding who is responsible for leading disclosure communications with patients and carers, and this appeared to contribute to inconsistency and some confusion for both clinicians and patients. Although Being Open identified multidisciplinary team responsibility as one of the 10 principles, most respondents identified the most senior doctor in the team as responsible for disclosure. Perceptions of the roles of other team members varied widely, particularly in relation to nurses and junior team members. In keeping with the limited literature that we found,99,100,168–170 nurses were not depicted as central to disclosure conversations by respondents, despite the common belief that nurses are often closer to the patient than other team members. There was divergence between interviewees regarding the degree of responsibility that should be held by junior team members. Some felt that junior staff should be protected from challenging discussions with patients, whereas others suggested that involvement in disclosure is critical to their learning and may also be helpful for the patient if the junior team member was directly involved in the incident. Interestingly, although the literature around disclosure training demonstrates that much of the training has been directed at junior medical staff, studies exploring the role of the wider multidisciplinary team in disclosures beyond the lead doctor were limited. 175 Such findings suggest that although multidisciplinary responsibility is identified as a principle of Being Open, there is a lack of clarity about what role each team member should play and how teams can work together to deliver more effective disclosures.

Reference was made to the majority of the principles in the Being Open guidance to at least some extent in both the literature and interviews, but we noted an absence of evidence from existing literature or our interviews that related explicitly to three of the principles: confidentiality, risk management and systems improvement and clinical governance.

Confidentiality around disclosure was not raised by patients or other stakeholders as a primary concern and this was reflected in the absence of literature that discussed this. Moreover, it was apparent from interviews with patients and health professionals that concerns about breaking confidentiality may be used by health-care providers as a reason for delaying or not revealing certain information to patients. Being unable to discuss an error with those directly involved seemed to be a particular frustration for families for whom this was an important part of the process of coming to terms with what had happened. In the literature, limited work made reference to the level of confidentiality offered to the health professionals involved in an incident, but it was not clear how confidentiality would be conceptualised in the context of open disclosure beyond patient confidentiality that is part of day-to-day practice. Confidentiality regarding serious adverse events was highlighted as challenging, and many respondents identified that in the case of serious errors information was often widely discussed within the organisation beyond the immediate team and risk management. Teams may wish to explore the motives around maintaining confidentiality in relation to health-care staff in their reporting of error and harm to patients, and the value of this approach in relation to both patient expectation and learning. Issues around confidentiality may be particularly challenging in the area of mental health care where patients may not wish discussion about their care to take place with family members or representatives, and this requires further exploration.

Implications of disclosure for risk management and systems improvement were discussed in the context of clinical governance by some health-care managers, but these were not addressed as distinct issues. Literature from the USA reports the role of risk managers in relation to incident disclosure to some extent, but work originating from the UK does not explore the role of this group, which may be very different from the US context. The explicit links between disclosure, risk management and clinical governance remain underinvestigated. Establishing which outcomes might link these areas requires more examination. Interview data linking disclosure with risk management, clinical governance or systems improvement were limited to the reporting of risk incidents and action taken with staff as a result. The contribution of patient perspectives was described by some interviewees as a source of information that might guide systems improvement but is currently not exploited to its full potential. This strategy relates closely to a broader literature on patient involvement,236 but respondents did not explicitly make this link. Risk management, clinical governance and systems improvement may each be critical to open disclosure and informed by open disclosure, but these principles are currently under-represented in the literature.

The recent debate on duty of candour as a contractual rather than statutory duty was contentious; however, the recent Francis report6 may mean that this is reviewed and changed to a statutory requirement. Since 1 April 2013 the new standard NHS contract has been used by all organisations commissioning NHS services, with the exception of services commissioned under primary care contracts. The contract requires all NHS and non-NHS providers of services to NHS patients to comply with the duty of candour. Unlike professional ethical duty (e.g. Good Clinical Practice), the contractual duty of candour only applies to incidents that result in moderate to severe harm or death. This will present considerable challenges for both organisations and professional bodies in terms of clinical governance and monitoring. The impact of contractual or statutory duty of candour is unknown but there seems to be a concern from practitioners that an over-reliance on measurement and reporting of open disclosure could reduce the principle of openness to numbers of disclosures, with a focus on documentation. This may result in the loss of information regarding which criteria represent a good quality disclosure. The interviews suggest that the messages from the various sources and organisations that clinicians look to for support are interpreted inconsistently and differently. In the UK, the requirement to be open about adverse events is currently disseminated as guidance, although a contractual duty of candour may mean that the pace of change is accelerated. Those in favour of statutory duty of candour feel that genuinely essential practice can only be achieved through this route. 201 NHSLA guidance emphasises openness, and the MDU and MPS have publicly advocated candour. However, the evidence in the literature and the interviews in this study demonstrates that despite this practice is often different, and more recently, A Promise to Learn 200 has called for a clearer supervisory and regulatory system, with clearer incentives which do not conflict, to ensure that individuals and organisations feel confident in being transparent.

The challenge of defining appropriate outcomes for individual trusts to allow them to demonstrate both quality and quantity of disclosure needs further clarification. The current emphasis is on championing a no-blame culture, despite a lack of evidence that this improves safety in health care. The concept of just blame is becoming increasingly discussed, but there is an enduring concern that genuine mistakes should not be punished to ensure that health professionals are confident to be open and feel supported by their organisation. This has been reinforced by Berwick et al. 200 in their recent report into the NHS, which has called for recognition that transparency is essential and that organisations, health professionals and patients should expect and insist on it. This recommendation was balanced with a clear message that blaming staff should end and that they should be trusted to do the right thing with adequate support throughout their careers.

Although this report concentrated on open disclosure, we are aware that there are a number of theoretical perspectives which might be brought to bear on any examination of the disclosure of adverse events. The area itself is undertheorised but there appear to be several useful perspectives from related fields which might be employed to progress thinking in this area and inform future research questions. Patient safety more generally draws upon a theoretical body of work around systems and behavioural change in health professionals and organisations. There is also a body of change management, transformational, entrepreneurial and ethical leadership, and organisational change literature equally relevant to this report. Although a detailed analysis of appropriate theoretical models is beyond the scope of this work, we are aware of some approaches which appear to sit well with our current analysis of the available literature but in particular with our interview findings.

In theory, the UK NHS is a collection of organisations that share, to a greater or lesser extent, a common mission and values. It is referred to as a ‘national institution’ and described by both staff and patients in a way that depicts a well-recognised brand. However, Checkland et al. 237 suggest it is more accurate to consider it as a heterogeneous and evolving organisation, which is becoming more diverse as it evolves in response to the considerable changes which have occurred in recent years. This makes it a complex adaptive system, and as such there are a number of theories through which we would be able to view the attempts to introduce greater transparency around adverse events. The purpose of the complex adaptive systems perspective is to draw attention to basic tenets or principles rather than provide hard and fast rules about what works. The recommendation of this approach is that policy should avoid elaborate checklists or specific instructions for change. The idea that health-care systems are complex adaptive systems has been established for a number of years, and several influential papers from a number of authors in mainstream medical journals are emphasising the usefulness of the complex adaptive systems lens in understanding improvement and transformation in health care. 238,239

The majority of literature on transformation in health care describes change on a relatively small scale, often by one organisation or service. 240 Generally it lacks both definition and an evidence base. 241 Best and Holmes240 define large-scale transformation in health-care interventions as change which is aimed at ‘system wide change affecting multiple organizations and care providers with the significant goal of significant improvements in the efficiency of healthcare delivery, the quality of patient care, and population-level patient outcomes’ (p. 422). Embedding a culture of openness in the NHS can, at least to some extent, be considered a large-scale transformation. Therefore, this work may be usefully employed here. Lanham et al. 242 has stressed the need to move away from top-down efforts and focus instead on the natural creativity of health professionals to adapt and develop new ways of achieving quality – a suggestion which was recently endorsed by Berwick et al. 200 in their report on the NHS. However, this can only be achieved when positive conditions allow a supportive work environment. Those working in health care need to be able to make use of relationships and skills within the system, and it may be at this point that complex adaptive systems theory is able to link into the systems theory. The focus of systems theory on just blame may complement organisational theory in terms of supporting the development of a culture where candour is able to become a more ingrained cultural norm in health care.

Work from a realist review of large system transformation (LST) in health care has identified a number of findings which may be applied to the practice of disclosure but are, as yet, largely untested outside of individual accounts. 240 Our review highlights examples where the principles of LST, which makes use of the engagement of individuals at all levels in leading change, have been applied. There are examples in practice-based literature where this need has been recognised, and where there are identified individuals leading on efforts to mobilise delivery of change in terms of disclosure. 150–154 This would suggest that each trust should have an individual lead for openness. However, engagement at the levels of policy, regulation and indemnity bodies through to risk management and patients all need to be considered. The model of more distributed responsibility may be useful and possibly more sustainable, but in the few reported examples where organisations are perceived to have adopted more transparent ways of working, they appear to have significant figureheads usually accompanied by a stakeholder, often from among relatives who have been instrumental in helping to bring about change. Distributed leadership appears to focus on practice and relationships in leadership as well as developing leadership through mentoring. Pedagogical approaches which support and model good practice to promote leadership may be useful models with effective feedback loops to further bolster learning and development. A number of recommendations for LST change have been suggested by Best and Holmes240 and are discussed below in relation to open disclosure.

Ensuring that it is valuable and safe for staff to engage in good disclosure practice is crucial to success. The need to promote the reflection of important values and principles in practice, and to provide cultural and interpretive support for those values, is likely to be important and has been highlighted in our data. When staff or patients are concerned, or suspect error, the organisation needs to be receptive and welcome reports. This would be echoed in current patient safety thinking which emphasises feedback and learning. A Promise to Learn 200 emphasises the need to engage both staff and patients in gathering information about risks and harm and the involvement of both in establishing the important information that needs to be collected. Additionally, it seems important to focus on how this might be achieved, as this will avoid measures that could potentially influence behaviours in negative and unintended ways, and employ metrics which capture things of importance to both clinicians and patients.

Clarification of concepts, and consistency and transparency of definition have also been highlighted as important. There is a pervasive problem around definitions of error and harm which are defined solely by one side (the provider) and are driven by definitions of events which are classed as moderate or severe. We would suggest that the naming of harm, beyond so-called ‘never events’ (or those that the organisation judges to have harmed the patient), appears to be open to interpretation and would benefit from such examination and consistency. This lack of clarity was conspicuous in the accounts of stakeholders in our data. Unless definitions are applied and seen to be used consistently, patients will be frustrated by such inconsistencies and report this in their accounts of instances where they seek an apology. Incentivising acting on feedback should include patient feedback but has to be sustained to avoid gaming.

Open disclosure could connect to the valued commitment to learn from previous safety problems to prevent future errors and harms. Careful analysis of events is an important step but will not predict how things might happen in the future. Analysis of events should be viewed as an opportunity for sensitive discussion and planning of how to avoid the situation or, more realistically, how to handle a situation if it happens again. Although the aspiration of the NHS may be zero harm, in the journey to this aspiration the usefulness of the approach of handling how to disclose error must not be forgotten. Broader literature on quality and safety will need to address how the aspiration of zero harm can be made to sit more comfortably with values and behaviour in relation to open disclosure where the very aspiration of a service has been challenged by the occurrence of error. It is exactly this tension which was raised by our stakeholders, and failure to address this as part of ongoing support and development is unlikely to result in changes in action.

The importance of engaging physicians and their indemnity and professional bodies in LST change has been identified. The issue of who makes decisions about disclosure and how it is done seem largely to fall in the domain of doctors, although our data do support the active participation and in some cases leadership of nursing colleagues. Transformative initiatives are often championed by nurses or non-clinical mangers (who have less power) involved in the system and the literature identified the frustration expressed by nurses in relation to their involvement in disclosure. Although doctors in the UK tend not to operate as independent practitioners (though GPs and those in private practice may be an exception to this), their collegial regulatory framework is geared towards detecting extreme examples of poor practice or unethical behaviour to protect the profession rather than monitoring quality. That gives them a great deal of power in responding to transformative events. Our interviews supported this and it was clear that professional regulatory guidance had most influence on the moral perspective articulated in practice. The influence of professional regulation was apparent during the duty of candour debate, with the medical profession objecting to a legal duty of candour on the grounds that their professional regulatory framework already meant they had a duty to be open with patients. Nurses and patient organisations, on the other hand, were supportive of regulation around openness in care which went beyond a statutory duty. As doctors often have a power of veto when other groups adopt a normative aspirational target, the engagement of the medical profession in making this a normative aspiration seems essential and the current literature and our interview data would suggest that this is currently equivocal.

The role of situated judgement in both the literature review and the interviews with stakeholders has been discussed in all sections, and the importance of attention to context in both practice (for professionals) and in evaluating practice (for those who would judge them) is clear. Context has emerged in the theoretical literature as important and is discussed separately from effectiveness of interventions. 243,244 In a systematic review of interventions, context was highlighted as poorly described and reference to the general lack of understanding that still exists in relation to context in patient safety practice interventions was made. 243

Implications for research suggested by some patient safety researchers are that there needs to be clarity about both theory and concepts in relation to any safety practice244 and this could equally apply to the broader but related value of openness in health care. Defining the events to be disclosed without due care and attention to the multiple values inherent in decisions about disclosure behaviour fails to address contextual issues and thus the effectiveness of guidance such as Being Open.

Providing care for individual patients and organisation of care for populations are related but different endeavours and this may lead to tensions, which has been highlighted by Shale245 in relation to the concept of ethical leadership. Health-care professionals and health-care organisations aspire to provide the best possible care for individuals but the reality of health care, especially in a system such as the NHS, is that this is achieved through providing shared resources at a population level. Thus, there is an inherent challenge in managing a shared resource in an ethical way which often differs from managing a resource for an individual. Therefore, managing the reputation of an organisation to maintain the trust of the larger population may conflict with disclosing information about an individual error.

Such dilemmas are apparent at all levels from the boardroom to the bedside and solutions present a constant challenge. These observations were reflected in every interview and by the differing perspectives represented in the review literature. Such work may also be useful in starting to unpick why moral values do not automatically translate into ethical action.

Shale245 also points out the importance of doing the right thing in the right way and this point is particularly salient in disclosure conversations. Training, where it exists, focuses on raising awareness of the moral and legal imperative, but occasionally also on how to have a challenging conversation. In both the literature review and our interview findings, clinicians highlight their anxiety about having disclosure conversations and patients highlight the damage that can be done by the right thing being done in the wrong way. A doctor who wishes to tell a patient that an error in his or her care has occurred is ethically correct, but blurted out in the wrong circumstances and in the wrong way, it would not be considered an action which was necessarily morally strong. So the skill involved in doing the moral thing in the right way is important. Finding the right place, having all the information and rehearsing this all underpin efforts to train people to do this well, if the ethical course of action is to be carried out in a morally appropriate way. Preferences of the family or patient need to be taken into account; therefore, the person disclosing should have good knowledge of the individual being dealt with, and this has implications for who discloses. Moral communication requires skills and these skills need to be practised and experienced. There are the real skills of expressing the situation clearly, listening and tailoring information to suit the context. However, the degree of emotional intelligence required in such situations is important in relation to managing difficult conversations; being able to express empathy, and managing anger and distress are all important in making the communication with the patient or family sensitive. Equally important are the skills enabling the professional to self-manage his or her own emotional response, as feelings of defensiveness, distress, shame and anger are often cited by professionals in relation to errors. Forgiveness may not be forthcoming from the patient and family and dealing with this response when an individual and an organisation feel they have acted with integrity can be hard to accept.

Interventions to train people in disclosure may well find the work around ethical leadership and emotional intelligence useful as a starting point for their construction. Although emotional intelligence theory would not state that managing emotions either in oneself or in others is easy, or that every individual can become skilled in such conversations, it does support the notion that skills can be developed and that levels of improvement can be measured. The simple ethical question of ‘is it the right thing to do?’ to disclose error is easily answered. An ethical perspective and our data suggest that the answer is yes, but any exploration of its enactment highlights the numerous challenges associated with action. It is both emotionally and legally sensitive and takes considerable skill that is not captured well by current guidance, which is unlikely to be able to address the complexity of decision-making underpinning disclosure of an adverse event, whether serious or associated with less or no apparent harm.

There is an inherent sense of risk for organisations in relation to disclosure and the wider principle of candour. In order to achieve an open culture they must be prepared to give up some control. Patient safety initiatives are, for the most part, aimed at exerting as much control over processes as possible, limiting the points where initiative or opinion come into play in order to prevent error, and checking the process at as many identified points as possible to reduce the likelihood of mistakes. However, disclosure requires a degree of resilience and the ability to manage uncertainty if organisations and individuals are to deal with errors and disclosure effectively. The process linking the monitoring of quality and safety is unlikely to be able to measure or quantify a sea change in openness which may be imperceptible even to those using health-care services, and so cannot be conceptualised in the same way as the majority of safety interventions. Disclosure of adverse events should be focused around informing future practice and improving quality and safety but it has wider implications for the staff and patients involved. For these reasons, sitting disclosure entirely within the current patient safety theoretical models is unlikely to fully address its challenges, and theoretical models which are able to address the complexity of values within health care and emotional intelligence in practice are also likely to be useful.

Chapter 5 Conclusion

Health-care reforms are often difficult to enact and the changes that policy-makers envisage and aspire to may not translate into practice, or change may take longer because working practices are institutionalised. This is apparent in a policy of open disclosure and is complicated by the levels at which the policy needs to be delivered. The US VA classifies the strength of patient safety interventions based on the probability that they will reduce risks; checklists are classed as weak interventions. Being Open is, in fact, a clear set of guidance rather than a checklist per se, but short pieces of advice run the risk of being used in such a way. It is intended to act as a simple reminder of what to do, but unless it is coupled with attitude change and efforts to remove barriers to actually disclosing, it will continue to have limited impact. This has been demonstrated by both the reviews of the literature and the interviews with stakeholders.

Both the literature reviews and participants’ accounts identified a range of benefits of a more open culture as well as reasons for the reluctance within health-care institutions to fully implement policies of open disclosure in an international context and, more specifically, in the context of the Being Open guidance. Virtually all stakeholders discussed the need for cultural change when considering ways to make Being Open become more ingrained in health-care practice. Respondents explicitly referred to how a change was needed from persistent negative associations in relation to reporting incidents towards a focus on the positive outcomes of learning from mistakes, and improving practice and care. Although there was a lack of familiarity with the guidance itself beyond general principles, there was a widely held belief that poor implementation may be due to a lack of appreciation of hypothesised benefits. Despite the enthusiasm for a move to a culture of openness, issues around defining the events that should be disclosed persist, and there is a pressing need to establish a robust evidence base in relation to open disclosure practice. Health-care institutions and the individuals who work within them need to be receptive and responsive to patient concerns about unanticipated outcomes in relation to their care, whether these are mistakes, errors or simply a case of unmet expectations. This approach may allow patients to participate in the broader agenda of contributing to improving quality and safety of care. The nature of the patient–professional relationship would seem to be crucial in achieving a disclosure which supports information-giving to patients and families and mitigates risk for the organisation, but this is currently unsupported by established training or professional support.

A number of gaps in the evidence base persist and current practice is based mostly on expert consensus rather than an existing evidence base. This needs to be addressed if culture change is to occur and disclosure is to be performed consistently and with skill. At a fundamental level, there is a tension between the pragmatic guidance issued by a number of professional bodies and organisations and the more in-depth critiques of what being consistent and transparent in health care really means. The tension between a more reflexive sociological approach and a systems failure paradigm has not been fully resolved. There appears to be a protective agenda from the systems approach which focuses on learning and the non-attribution of blame. However, the literature and respondent accounts highlight that emotions are a very real part of disclosure for both patients and their families and the members of the health-care teams involved. Further work needs to focus on how these two paradigms can be used to inform disclosure of events to patients and support for patients and professionals, and to provide learning for health-care systems effectively.

It has been suggested that there are several common contextual factors which contribute to successful implementation of safety practices: commitment from the top, dedicated staff and financial resource, an open process to encourage buy-in and enthusiasm from end users, and sheer persistence. 246 In the small number of reports of institutions where authors report progress in open disclosure, these factors are all apparent, and it would seem that efforts to improve open disclosure practice in the UK will require the same. The impetus for change is currently strong, with influential reports and public opinion very much behind increased openness in health care and more transparency in relation to learning from error, and we would suggest that efforts towards change should ensure that this normative cultural change in the policy and public spheres is captured and facilitated in practice. This will require visible support from influential parties such as professional and indemnifying organisations and senior members of trust boards to facilitate clinicians in having the confidence to negotiate complex decision-making in relation to disclosure practice, and to promote skill-building throughout careers through formal support and insightful mentoring.

Chapter 6 Future research

This work has highlighted that there are a number of areas which require further investigation.

At the level of individual health-care trusts we have little information about how the Being Open guidance is being interpreted and implemented in local policy. Mapping this would allow the identification of any potentially well-developed implementation which could be tested in other settings. More work is required to better understand the facilitating and impeding factors that have the greatest influence on disclosure and how these might vary by context (at the level of profession, trust, patient and clinician characteristics). Exploration of the links between outcomes of interest for risk managers (and those concerned with clinical governance) and open disclosure is needed to determine whether or not outcomes relating to safety can be used as proxy measures for a successful disclosure process.

Very little is currently known about the influence of specific factors such as how the level of training undertaken, speciality or professional environment might affect attitudes towards disclosure, or the effect of particular training models in supporting or discouraging disclosure. Future research will need to determine whether or not educational and institutional interventions actually reduce the influence of impeding factors or enhance the influence of facilitating factors. This requires good-quality effectiveness studies with robust controlled studies and appropriate outcomes that reflect both patient-centred outcomes and clinician and organisational outcomes. Future studies should explore the mechanisms through which open disclosure might address and reduce some of the psychological and health-related consequences of error for patients, their families and the health-care providers involved.

Observational work in any context is challenging but in the context of disclosure conversations this may be even more so. Practitioners often find the observation of practice challenging, and using observational methods in relation to disclosure conversations would pose many difficulties for consent and methods. This said, there seems to be a need for a number of interesting but methodologically challenging studies. Being able to understand in more detail the impact of organisational culture and leadership styles on disclosure practice at the hospital and departmental level, and the ways in which individuals interact during specific disclosure conversations, seems essential for understanding and improving the status quo. These studies are likely to employ complex mixed-methods approaches to capture observational, experiential and quantitative outcomes in relation to disclosure practice. What is also clear is that any evidence base is unlikely to be able to make hard and fast statements about what works. More likely are broad statements about what tends to work, for whom and in what circumstances. Best and Holmes240 also suggest realist evaluation as a tool to generate such statements to understand and explain different outcomes. The realist review is still an emergent field but may be a useful way to take forward a more detailed examination of contexts where openness is perceived to be established. Future research might examine which disclosure styles patients perceive as competent, and assess their causal impacts on objective and relational disclosure outcomes. The involvement of patients and the insights this perspective may bring to the prevention of adverse events and promotion of service improvement should also be considered. The need to observe and explore real-time disclosure as well as in anticipation of and after disclosure interactions is apparent.

Most of the work looking at disclosure takes place in secondary care and the majority of respondents we engaged with were based in secondary care. There is almost no literature addressing other contexts more specifically, either internationally or in the UK. We know little about some health-care contexts, such as private health care, social care providers, general practice, learning disability or mental health settings as five examples, but this is not an exhaustive list. These areas require focused exploration to determine the transferability of findings from other, more general contexts.

Chapter 7 Summary of evidence-based guidance for managers to facilitate the implementation of open disclosure in individual trusts

As part of the commissioning brief for this project we were asked to produce some short evidence-based pragmatic guidance which NHS managers may wish to consider in relation to developing and implementing local policy for open disclosure. The lack of a robust evidence base in relation to the majority of individual Being Open principles, and the arguments presented in this work for the problems associated with the use of such guidance to improve or guide practice, means that the following suggestions are based largely on expert opinion and consensus. In using them organisations should be mindful of their extensive and inherent limitations. As such, they are tentative observations. These would need to be revisited and revised as the evidence base in relation to specific principles develops.

Organisations may wish to consider assembling a multidisciplinary team to establish the working definitions to which the policy will apply. As part of this they may wish to consider the following factors in team composition. All levels of the organisation, from the board down, should be represented, including senior and junior doctors and nurses, and service managers including clinical governance and risk management. Consideration should be given to the inclusion of lay members to keep policy and practice focused on the needs of patients and families who have experienced harm. This is supported by the findings from both reviews and our interviews with stakeholders.

In considering the specific principles of the Being Open guidance, we suggest the following points for consideration by trusts.

Acknowledgement Try to ensure that everyone in the organisation is working to the same definition of an event that requires disclosure and that patients and families are also clear about the events that will be disclosed. Explore and acknowledge the difficulties associated with definitions. Consider a small group who can discuss any contentious events, perhaps with lay representation to enhance transparency.

Truthfulness, timeliness and clarity of communication Try to ensure that patients and families are given information relating to events as soon as possible. Although investigations may be ongoing, convey this uncertainty to families and keep them updated with facts as they emerge.

Apology Apologies are important to families. These should be sincere and issued as soon as any error or mistake is established. Trusts may wish to provide regular updates and support to ensure that clinicians and risk management are clear about both professional and legal obligations in relation to open disclosure.

Recognising patient and carer expectations If the expectations of the patients and carers are established before, during and after treatment, this may help in discussing perceptions of harm and error when outcomes are unexpected. This can be facilitated by ensuring that accurate information is given, that patients and families understand possible outcomes and risks and that information is updated if and when necessary to manage expectations.

Professional support Trusts may wish to consider the availability of professional support for those involved in disclosure. This may take the form of individuals who model good practice within the institution or specific training available in open disclosure. There is little evidence for any particular model of training over another, but given the observed complexity of decision-making in relation to disclosure and disclosure work, opportunities to practise conversations and apply reflexive thinking alongside reflection on real disclosure are likely to provide the most useful approaches. Consider multidisciplinary training and support. Working alongside patient groups and advocates to ensure that such training is also focused on the needs of patients is also likely to be important.

Risk management and systems improvement Patients may have useful insights into systems informed by a unique perspective and as experts in their own care. Viewing the disclosure process as a conversation will allow patients and families to add their views on factors which may have contributed to errors or harms.

Multidisciplinary responsibility Errors are usually systemic in nature, involving a number of team members. There is no evidence to support any particular discipline as being more effective in disclosure. Trusts may consider exploring the use of team disclosure and consulting with patients about the information they require to tailor the best approach and the best team to be involved in the disclosure process.

Clinical governance Try to ensure that the focus of disclosures remains in the realm of quality. Counting and recording disclosures is important but not at the expense of monitoring quality. A more reflective approach to capturing performance of the organisation in relation to disclosure processes is likely to yield more sophisticated insights into quality and help to inform future efforts to improve. Asking individuals how the process met their needs and what could be improved, in the case of both individuals enacting disclosures and families, may be useful.

Confidentiality Try to ensure that issues of confidentiality are not invoked to prevent patients from accessing information or discussions which they need to understand error or harm. Being unable to discuss an error with those directly involved can be a particular frustration for families, for whom this may be part of the process of coming to terms with what has happened to them. Try to support clinicians to be able to talk directly with patients and families.

Continuity of care The focus of open disclosure should be on the care of patients rather than on mitigating organisational risk. Preserving continuity of care by respecting patient choice and consulting with them about what their care preferences are moving forward after an adverse event are likely to contribute to maintaining the patient–provider relationship in the best interests of the patient.

Acknowledgements

The Being Open research team would like to thank all the patients, their family members and representatives, clinicians, policy stakeholders and managers who gave their time and views so generously to inform this project. We would also like to thank all our clinical collaborators, some of whom facilitated our contact with others who took part in the project. Without the support and co-operation of all those involved this project would not have been possible.

We would like to thank the reviewers of this report for their insightful and thoughtful input which has helped us in further shaping our thoughts and presentation of the work undertaken within this project.

We would also like to thank Sally Baker for her valuable contribution in the administrative support for this study and Karen Scott, Head of Information at Capsticks, who supported the searches of the legal literature.

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Appendix 1 Sampling strategy for qualitative interviews

Appendix 2 Search strategy

Appendix 3 Databases searched

The following databases were searched.

Appendix 4 Ethical permission

Appendix 5 Example topic guide

Appendix 6 Coding framework

Appendix 7 Key characteristics and numbers of study participants by stakeholder group

Appendix 8 Detailed statement for reflexivity

Appendix 9 Reference list of included literature for reviews

References are arranged chronologically by date for unauthored citations followed by alphabetically for first author.

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Anon. Federal bill promotes apologies and negotiations. Contemp OB/GYN 2006;51:26–7.

Anon. How you can encourage doctors to disclose errors. Healthc Risk Manag 2006;28:115.

Anon. Physicians still resist full disclosure of errors. Healthc Risk Manag 2006;28:112–15.

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Anon. Professional update. The art of presenting bad news vs the risk of getting sued. Contemp OB/GYN 2006;51:25.

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Anon. Surgeons less likely to disclose errors: study says surgeons provide fewer details. Same-Day Surg 2006;30:124–5.

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Anon. What patients want to know about adverse events. Bandolier 2006;13:4.

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