title: The decision to notify patients following a dental infection control breach: a scoping review study of historical incident outcomes and guidance with development of a novel decision-making algorithm to support public health incident management
Creators: name: Gordon, Lorna Elizabeth
Publisher: name: University of Glasgow
Year: 2020
Subjects: subject: Infection control, dentistry, incident management, patient notification exercise, scoping review, public health, blood borne viruses.

description: Background: Following a healthcare incident which has created a risk of blood borne virus transmission, a patient notification exercise can be implemented to inform patients that they have been exposed to an unanticipated and unacceptable risk of harm as a result of medical error. Those managing the incident must consider all the facts of the case as well as the negative and positive implications, before reaching a decision on whether a patient notification exercise is required. One of the goals of notification is to detect the presence of blood borne virus infection within the exposed patient population thus providing the opportunity for treatment. The risk of transmission, within this setting, however, is thought to be extremely low. Patient notification exercises are thought to create stress for patients, carry significant financial costs and reflect poorly on the health service. Most notification exercises identify very few new blood borne virus diagnoses and almost never identify incident-related transmissions (Close et al 2013; Mason et al 2008; Conrad et al 2011; Blatchford et al 2000; Roy et al 2005; Henderson et al 2017). Detection of transmissions and the concept of transparency must be balanced against any negative effects created by the exercise. Currently, incident management teams must make their risk assessment and decision regarding notification without the support of formal guidance and with no up-to-date synthesis of evidence from previous dental incidents. One of the aims of this doctoral study was to design and present an evidence-based decision-making algorithm to aid the incident management team’s decision-making process regarding patient notification, following a dental infection control breach. Methods: This doctoral work comprises a scoping review study with three components: a stakeholder consultation, a review of the published and grey incident literature and a policy mapping exercise (Davis et al 2009). In the stakeholder consultation, purposive sampling was utilised to seek out and record the responses of those with experience of managing United Kingdom dental incidents. Participants were interviewed using a specifically developed questioning route and semi-structured interview style. The literature review was used to identify articles which either reported or focused on the management of (a) specific dental incident(s) or were considered to be an opinion piece on large-scale medical patient notification exercises. In regards to the grey literature, the chief investigator was directed to unpublished United Kingdom incident reports by key contacts and organisations. One of the chief investigators’ educational supervisors, Dr Roy had access to a number of Scottish reports through her role as senior epidemiologist within Health Protection Scotland and had historically been involved in the management of such incidents occurring in Scotland. The chief dental officers of each devolved United Kingdom nation were contacted and every health protection team across England, Wales and Northern Ireland were emailed. The UK Advisory Panel for Healthcare Workers Infected with Blood Borne Viruses (UKAP 2019) was also contacted and a list of the dental incidents for which they had provided advice, was supplied. Four different data extraction forms were used to collect information from reports and articles based on incident type, with the intention of presenting qualitative data as a narrative synthesis and quantitative data in the form of graphs and tables. In the guidance mapping exercise, an initial list of websites to search was formulated based on recommendations from stakeholder consultation participants, the medical college librarian and university public health lecturers. Further sites were included based on the chief investigator’s personal knowledge and utilisation of the resource ‘Grey Matters’ (Canadian Agency for Drugs and Technologies in Health 2015). Guidance documents were included if their use was cited by those managing incidents or they provided guidance on a) how to grade/assess the risk associated with an infected healthcare worker/infection control incident and/or b) when to notify patients following an infected healthcare worker/infection control incident and/or c) when duty of candour/disclosure standards are triggered. Results: One hundred and forty nine dental incidents from six developed countries occurring between 1990 and 2017 were identified. Around half of infection control incidents (48% of 40) went to notification compared to 14% of those involving infected healthcare workers (n=107). Infection control incidents account for an increasing proportion of those managed (3.6% from 1990-1999 but 35.8% from 2010-2017). The stakeholder consultation, literature and guidance revealed that transmission risk was considered to be the most influential decision factor regarding patient notification, however, level of risk was rarely applied to incident management in a structured or consistent way. There was a consensus that, although very important, risk could not be calculated accurately and that at best, only qualitative descriptions such as ‘low’, ‘very low’ or ‘negligible’ could be applied (Mason et al 2008; Millership et al 2007; Unpublished reports 2001-2017). Minimal information could be drawn from historical ‘proven transmission’ events as they are rare, occurred long ago and/or lacked contextual detail. The limited conclusions that could be drawn suggested that incidents involving syringe reuse, multi-dose vials, extractions and oral surgery settings present a greater risk of patient-to-patient BBV transmission. Multiple sources suggested that if transmissions (patient-to-patient or healthcare worker to patient) have already been identified, or are strongly suspected, then notification and testing is necessary. However, of the four proven, reported dental blood borne virus transmissions since 1990, not one identified any further transmissions via their associated notification exercises. This suggests that any incident-related transmissions which require detection may all reliably be identified prior to the use of a patient notification exercise. This review suggested that there was significant pressure to be candid with patients following an incident, a mantra which has arisen due to historical paternalism and an awareness of the new Duty of Candour legislation which may override any consideration of risk level (CQC 2014; GMC 2015; Scottish Government 2018). Decision makers often contemplated; what the public would want and their reactions to finding out an organisation had not been open with them. Unsurprisingly, notification was deemed essential when the public were already aware of an incident. The professional and statutory Duty of Candour was often weighed against the perceived opportunity costs of conducting notification, the significant expenditure of time, staff and workload as well as the predicted psychological impact on patients and reputational consequences for the dental profession which could result in patients not seeking dental care. Notification appeared to be conducted based on the need to err on the side of caution. Patient safety was the priority and with a challenging risk assessment, no guidance or information from other incident management teams and unclear Duty of Candour guidance, notification and testing was utilised to respect the importance of transparency and mitigate the risks of both not adhering to legislation and leaving patients undiagnosed. Research gaps: Decision makers were not only hampered by an absence of guidance but also by an inability or struggle to ascertain what others have done in the past. This doctoral work discovered that within the United Kingdom there is no central repository for incident data, incident details are rarely published (15%) and there is a lack of sharing of lessons learned amongst public health teams. When reports are made available or their data are presented in a published journal article, no standardised way of reporting exists and there are inconsistencies in both the amount and detail of information presented. There was great variability in the types of journal that featured articles on patient notification. Creation of a central repository of ‘blood borne virus transmission risk’ incident information and an increase in publication activity with agreement on the most suitable type of journal is needed. Standardised data collection will facilitate comparison of homogenous incident outcomes. Duty of Candour and its application to large-scale incidents and dental practices must be clarified. It is recommended that further guidance is formulated, by those who drafted both the Scottish and English ‘Duty of Candour’ legislation, to aid incident management team members in understanding its applicability to large-scale patient disclosure (Care Quality Commission 2014; Scottish Government 2018). Findings from this doctoral study strongly support utilisation of a limited notification response. Limited notification can be seen as a compromise between the two options of conducting or not conducting a patient notification exercise. It involves adapting notification to reduce expenditure of resources or involvement of all practice patients. By notifying only those patients who are deemed to be at the highest risk, resources and time are saved with less patients having to undergo the distress of notification and testing. Conclusion: Undoubtedly, there is a desire from those tasked with investigating and managing these incidents, for guidance that will support their deliberations on the need for patient notification. The work of this thesis showed that such guidance would be challenging to develop, not just because of a lack of evidence to support the impact of a patient notification exercise (both positive and negative) but also because these incidents are all unique, and the investigations nuanced. Consequently, the best that can be provided is an algorithm which will standardise the approach to the discussion by identifying the key factors that should be considered. This does not of course mean that similar incidents will result in a similar management strategy, but it would ensure that any course of action is based on a robust appraisal of relevant factors and can be justified on a scientific, ethical and/or pragmatic basis. Findings from this doctoral scoping review study were incorporated into a novel process (the Patient Notification Exercise (PNE) post-Dental Decontamination Breach (DDB) Decision-Making (DM) algorithm). This research product is designed to guide the flow and structure of decision-making, reassure IMTs that all necessary factors have been considered and provide consistent justifications for decisions made which, with reference to the algorithm, can easily be explained to third parties.