Article Text

Original research
Helping patients prepare their dependent children for parental death: mixed-methods evaluation of a codeveloped training programme for palliative and allied healthcare professionals in the UK
  1. Jane Cockle-Hearne,
  2. Johanna Elise Groothuizen,
  3. Emma Ream
  1. School of Health Sciences, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK
  1. Correspondence to Dr Jane Cockle-Hearne; j.cockle-hearne{at}surrey.ac.uk

Abstract

Objectives To evaluate how the codesigned training programme, ‘No conversation too tough’, can help cancer, palliative and wider healthcare professionals support patients to communicate with their dependent children when a parent is dying. We examined perceptions of learning provided by the training, its contribution to confidence in communicating with families when a parent is dying, and subjective experience of, and reactions to, the training. We also explored potential changes in practice behaviours.

Design Pre–post, convergent, parallel, mixed-methods study. Motivations for practice change were measured quantitatively, and qualitatively through semi-structured interviews. Non-parametric analysis was conducted for self-efficacy and outcome expectancy measures; descriptive statistics examined perceptions of usefulness; intentions to use learning in practice and reactions to the training. Semi-structured interviews examined motivations and perceptions of learning in depth. A 6-week, practice log recorded immediate practice effects and reflections.

Setting 1-day training delivered 3 times, total delegates 36: online December 2021, February 2022, face-to-face March 2022. Questionnaires delivered correspondingly in online or paper formats, semi-structured interviews online.

Participants Pre–post: palliative care professionals (n=14/12), acute cancer clinical nurse specialists (n=16/11), other healthcare professionals (n=5/5).

Results Positive changes were observed in self-efficacy (17 of 19 dimensions p<0.003) and outcome expectancies (3 of 14 beliefs p<0.036). Perceptions of usefulness and intentions to use learning in practice mean scores were 82–94 (scales 0=low to 100=high). There was high affirmation for sharing learning and influencing change in the workplace and wider practice. Content, style and delivery were positively endorsed. Further elements to be included in the training were identified.

Conclusions The training programme has the potential to effect change in practice behaviours. A large-scale study will evaluate the roll-out of the training delivered to individual professionals and whole teams across the UK. It will provide longer-term feedback to understand practice behaviour and mediators of change across professional roles.

  • Adult oncology
  • EDUCATION & TRAINING (see Medical Education & Training)
  • Adult palliative care

Data availability statement

Data are available on reasonable request.

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STRENGTHS AND LIMITATIONS OF THIS STUDY

  • This was a convergent, mixed-methods, parallel design whereby data were analysed independently, integrated, and interpreted.

  • The Kirkpatrick’s model of evaluation was employed to frame the methods and data analysis in terms of healthcare professionals’ reactions, learning and behaviour.

  • Kirkpatrick level 4, the impact of change on patient outcomes, was not included in the design of this initial evaluation.

  • This was a single-arm study, without a control group.

Introduction

When a parent is dying from a life-limiting condition, open and honest communication between parents and their children is vital for children’s well-being and their future emotional, behavioural and educational development.1 2 Children wish to be informed about their parent’s illness and prognosis and can be resilient if given age-appropriate information and support to grieve.3–5 Nevertheless, parents often feel anxious and ill prepared to hold honest conversations at this time and can be at odds with their partners and wider family over what is best for their children; some avoid telling their children how ill their parent is until death is imminent.6 In this difficult end-of-life period, parents want timely help from healthcare professionals so that they can support and communicate with their dependent children, and prepare them for their parent’s death.7

Palliative care professionals are well placed to provide this support to parents, but services provided to help parents support their children through bereavement vary. Across UK hospice and community palliative care services, the number and types of services available to parents and children are uniformly greater after a parent’s death than before.8 Their focus is more on supporting children’s challenges after bereavement than on preventing them before a parent dies.8 Fundamental to these gaps in provision are healthcare professionals’ stated low confidence in their skills, fear of making a situation worse, uncertainty over parents’ and children’s needs, and fear of the emotional labour required to provide support. Despite evidence that healthcare professionals welcome and benefit from educational training to support parents and families with advanced cancer, ultimately there remains an absence of training specifically related to supporting dying patients who have dependent children.9–11

To address the need for support, a training programme ‘No conversation too tough’, was codeveloped with cancer and palliative care professionals, children’s bereavement specialists (therapists and bereavement charity representatives), those with lived experience of parental bereavement (both bereaved partners and adults bereaved as children), healthcare educators and academic researchers, and representatives from the Ruth Strauss Foundation, a specialist UK cancer charity. The training was designed to provide cancer, palliative care and wider healthcare professionals with knowledge, skills, and confidence to help families prepare for parental death, manage their own emotions around providing support, and to build networks with peers to enhance support for one another both in the workplace and in wider practice. This evaluation aimed to understand delegates’ perception of learning provided by the training, the contribution it made to their confidence in communicating with families when a parent is dying, and their subjective experience of the training. Potential changes in practice behaviours were assessed, and recommendations for future roll-out of the programme were developed.

Methods

Design

We conducted a pre–post, convergent, parallel, mixed-methods study.12 Quantitative and qualitative data were collected in the week before and immediately after training, and a practice log was completed for the following 6 weeks. Data were triangulated: quantitative and qualitative data were analysed independently, integrated and interpreted (online supplemental material 1).

Supplemental material

We used Kirkpatrick’s Model of Evaluation to frame the methods and data analysis.13 This model is widely applied across many sectors, including palliative care and nursing.14–19 It measures effectiveness of training across four levels: (1) an individual’s reaction to the training, (2) learning from the training, (3) changes in behaviour and (4) patient outcomes. This evaluation presents data across levels 1–3.

Reporting followed the Criteria for Describing and Evaluating Training Interventions in Healthcare Professions Checklist.20

The training

The programme comprised 1 day of training which ran twice online and once face to face. 15 places were available for each occasion across which 36 delegates took part in total. Facilitators were registered health and/or social care professionals: the lead was an expert in communications skills training; the second facilitator for the first course was a registered play therapist specialised in working with children; for the second and third course, the second facilitator was a specialist practitioner in preparing families for loss. ‘No conversation too tough’ is described in table 1.21

Table 1

‘No conversation too tough’ training features

Participant recruitment

Healthcare professionals were invited to take part in the course by the supporting UK cancer charity. This took place on a convenience basis via the charity’s existing networks and word of mouth. 15 places were available on each of three courses. Invitations were accepted until all the places were filled. At course registration on the supporting charity’s website, delegates gave their permission for their contact details to be passed to the evaluation team at the University. Informed consent to participate in the evaluation research was then conducted independently via email and telephone by the University. Consent to take part in the questionnaires was a requirement of participation; consent to also take part in the interviews and/or keep a reflective practice log for up to 6 weeks, was optional. Interview participants were selected on participant availability and to ensure a range of job roles and work settings. A pragmatic approach to sample size was adopted given the limited size of the delegate population in this instance.

Quantitative data collection

To assess the potential effect of the training on behaviour change, we included a measure of self-efficacy (the perceived capability to perform a target behaviour).22–24 The measure asked participants to rate their confidence on a scale of 0–100, where 0 represented no confidence and 100 represented full confidence. 19 items across three domains were assessed: confidence in skills learnt, confidence in managing own emotions and confidence in discussing topics learnt about with patients (online supplemental material 2). According to social cognitive theory, self-efficacy is a precursor to a person’s motivation to engage in a specific behaviour. More recent theories have gone further to propose self-efficacy-as-motivation, including it as one of a range of behavioural motives that predict behaviour change.25 Reflecting on this, we included further measures to understand participants' motivations to translate learning from the course into their practice.

Supplemental material

The anticipated consequences of engaging in practice behaviour change were assessed with an outcome expectancies measure; beliefs were rated on a scale of 1–9, where participants were asked across 14 items to rate ‘How likely is it that …’ where 1 represented ‘very likely’ and 9 represented ‘very unlikely’ (online supplemental material 3). Both self-efficacy and outcome expectancy measures were adapted from those used in Sage and Thyme communication skills training in palliative care. Although unvalidated in previous studies, they were developed based on previous research that reported good content and face validity.15 26 27 The measures in our research were tailored to reflect the factors affecting cancer, palliative and wider healthcare professionals’ approaches to having conversations with patients to help them support their dependent children.

Supplemental material

We assessed motivation for behaviour change further through an author-generated questionnaire with closed and open questions. We asked about perceptions of usefulness and intention to use learning, both rated on a scale of 0 (low) to 100 (high); attitudes to change in practice and reactions to the training in respect of contents, teaching and learning styles were each measured on a 5-point Likert scale from strongly agree to strongly disagree. Before the training, we assessed participant characteristics, working practices, reasons and expectations for attending the course (online supplemental materials 4 and 5).

Supplemental material

Supplemental material

For the first two courses, pre and post questionnaires were administered online via the Qualtrics platform (Qualtrics December 2021/February 2022 USA). For the third, held face to face, paper questionnaires were distributed and collected on the day.

Qualitative data collection

Repeated pre–post training, semi-structured interviews were planned with five participants from each training day. JEG, a postdoctoral research fellow with training and experience in qualitative and mixed-methods research, conducted the interviews via video conferencing; interviews lasted 30–40 min each. Pre-training interviews explored motivations, hopes, expectations and past experiences. Post-training interviews covered reactions to the course, perceived changes in skills and confidence, managing one’s own emotions, intentions to use learning in practice, perceptions of making a difference, barriers and facilitators to translating learning into practice and support required in the workplace (online supplemental materials 6 and 7).

Supplemental material

Supplemental material

To understand the immediate effect of the training on practice behaviours, participants were asked to keep a post-training practice log for up to 6 weeks. The log asked participants to choose one example of caring for a patient with dependent children, to think about the situation, how they felt, what they did, what they used from the training, and what they would do again or differently next time.

Data analysis

Questionnaire data were downloaded in SPSS from the Qualtrics platform (IBM SPSS Statistics V.28). Responses to self-efficacy and outcome expectancy measures were analysed to identify changes between pre-assessment and post-assessment using a Wilcoxon signed-rank test. Descriptive statistics were used to assess reactions to the training and intended behaviour change.

Interviews were audio recorded, transcribed, entered into NVivo V.12 and analysed using framework analysis.28 Framework analysis was chosen to enable the data to be compared and contrasted across the range of healthcare professional roles and specialities that characterise this study population. At the same time, its accessible matrix output aided understanding of the breadth and depth of individual participant responses.29 JEG, JC-H and ER read/re-read the transcripts from the first course, identified, discussed and agreed the major themes. JEG applied a coding frame developed from the initial data to the remainder of the transcripts, Free-text responses from the questionnaires were coded separately and subsequently integrated into the coding frame, accounting for duplications (ie, a participant highlighting the same point in both the questionnaire and interview) to avoid ‘double counting’. Themes were compared within and across cases. To examine intended and actual integration of learning into practice, practice log entries were separately analysed with a framework approach.28

The data were triangulated to identify convergent and divergent themes across the datasets.30

Patient and public involvement

Individuals with lived experience of parental bereavement (both bereaved partners and adults bereaved as children) were integral members of the codesign team that developed the training programme; they also contributed to the design of the research and the dissemination plans.

Results

Sample size and characteristics

35 delegates consented to take part in the research and completed the pre-training questionnaires; 28 completed pre-training and post-training questionnaires. 16 participants were interviewed before the training; 14 attended a second interview after the training. 11 participants completed and returned the practice log.

Pre-training and post-training, respectively, n=16/11 were acute oncology clinical nurse specialists, n=14/12 were palliative care professionals, and 5/5 were allied healthcare professionals working in cancer support (n=4) or as a lead research nurse (n=1). Pre and post the majority of participants were female (n=31; 89%: n=25; 89%), over 45 years (n=19; 54%: n=15; 54%) or parents (n=27; 77%: n=20; 72%). A minority had higher education qualifications past undergraduate (n=8; 23%: n=7; 25%), or indicated an ethnic/cultural minority background (n=5; 15%: n=4; 16%). In respect of professional status, pre–post, the majority had been registered over 20 years (n=20; 57%: n=17; 60%) and had been in their current specialism for 5 years or more (n=20; 57%: n=15; 54%) (online supplemental materials 8).

Supplemental material

Quantitative outcomes

Self-efficacy

A Wilcoxon signed-rank test revealed significant positive change after the training on 17 of the 19 items assessed across three domains (z=−2.956 to −4.458 p<0.003, effect size r=−0.40 to −0.61). Participants had more confidence following the training in starting, encouraging and closing conversations, listening, responding, supporting patients empathetically, and discussing relevant issues. Similarly, they felt more confident in managing their own feelings during and after having conversations. The observed change in skills to create a comfortable setting to speak openly did not reach significance; and no change was observed in skills to ask a patient if they have dependent children (table 2).

Table 2

Self-efficacy pre–post training: Wilcoxon signed-rank test

Outcome expectancies

Wilcoxon signed-rank tests revealed significant positive change between pre-training and post-training on three items: participants were less likely to believe (1) they would get too close to a parent if they asked them about their feelings or concerns for their children (Z=−2.524, p=0.012, r=0.34), (2) it would damage the way the patient copes (Z=−2.207, p=0.027, r=−0.30) and (3) that a patient would raise their concerns without being asked (Z=−2.097, p=0.036, r=−0.29) (table 3).

Table 3

Outcome expectations pre–post training: Wilcoxon signed-rank test

Perceptions of usefulness, intentions to use learning

Participants felt the training would leave them more satisfied in their work with parents (scale mean 82/100); it would encourage them to seek out more knowledge and understanding about working with patients with dependent children (scale mean 92/100), and it would be highly useful for supporting patients (scale mean 93/100). There were strong intentions to use learning in practice (scale mean 94/100).

Attitudes to change in practice

The majority of participants agreed/strongly agreed that they would share their learning with colleagues and contacts (26/28, 90%), and that they would be able to influence change in their workplace (25/28 participants, 89%). Nearly three-quarters (20/28, 71%) thought they could change or influence wider practice.

Reactions to the training

Participants were consistently positive about the course. All 28 agreed/strongly agreed that the facilitators worked well together and were knowledgeable, and the topics covered were relevant to them. For the second and third course, we asked about response to the role-play; all 21 participants agreed/strongly agree that the role-play actor performed authentically, and the scenario depicted was realistic. Two provided negative feedback relating to clarity of the training objectives, time available, support materials and role-play (online supplemental material 9).

Supplemental material

Qualitative findings

Two overarching themes were identified and explained motivations: (1) transferring learning into practice and (2) reactions to the training. Verbatims are provided in table 4.

Table 4

Participant verbatim quotes

Transferring learning into practice

Intentions to use learning

The interviews immediately post-training revealed that due to the shortness of time passed, participants had not had an opportunity to apply their learning, but they spoke of intentions to do so. They were aware of the optimal timing to initiate conversations and aimed to enquire more about patients’ children, how ‘children are doing’, explore patient cues to assess readiness for conversation, use listening skills, and ‘be alongside’ patients as they navigate their ‘palliative journey’. They intended in future to look more consciously through clinic notes to establish children’s presence, make efforts to document this, allocate follow-up appointments with patients, ensure they had enough time to ask parents questions about their children, and compile resources for patients on communicating with their children.

Intentions to improve organisational practice

Some participants had shared the training resources with colleagues; several had plans to do so. Some had started to think about changes that could be made to procedures to improve their organisation’s practice; these included reviewing and updating patient documentation systems, building stronger networks with other professionals and developing workshops to be offered to parents.

Barriers to implementing learning

Professional settings and roles influenced participants’ perceptions of the support they could provide families. Those working in acute settings faced challenges including heavy caseloads, limited time and scarce resources that hindered their ability to develop relationships and engage in proactive conversations with parents. Some participants only met patients in their final days of life and felt unable to build meaningful rapport in the way achieved by those who worked with patients longer term. These factors constrained how learning from the training could be implemented. Participants discussed their lack of control over the environment in which to hold conversations; community-based participants were dependent on the home situation they visited, whereas hospital-based participants often found it difficult to find quiet and private spaces for sensitive discussions.

Putting learning into practice

Where post-training, participants had encountered patients with dependent children, practice log entries supported their increased awareness of the importance of engaging parents in conversations around death and dying, and their greater confidence in initiating these conversations. Participants also discussed how the training had reiterated the importance of being open and non-judgemental (eg, in situations where patients were reluctant to discuss their family/children). They recognised the importance of mirroring the patient’s energy, pausing, listening, and providing cues and responses at appropriate times, and had employed these strategies in conversations. After the training, some felt more confident with signposting and liaising with other professionals and organisations.

Reactions to the training

Content and style

Face-to-face training encouraged more networking, enquiry and support. Across both delivery formats, awareness of the importance of having conversations around parental death, and enhanced confidence to initiate such conversations were felt to have increased. Despite levels of experience, all those interviewed found the training suitable for their personal needs; junior participants alluded to knowledge and skills acquisition, more experienced participants referenced validation, updating and expansion of existing knowledge.

Interactive training

The range of delegates’ professional backgrounds was deemed especially beneficial; sharing experiences and learning from others was invaluable. Participants found it useful to learn about practice within other settings and get advice and ideas on innovations to implement in their own practice. Hearing others’ stories validated personal experiences of working with patients with dependent children.

Reality and authenticity

Role-play was one of the most appreciated elements of the training: the professional actor added to the realism and authenticity of scenarios. Whether participating or observing, participants discovered new practice insights and approaches to be used in conversations with parents. Despite positive response to the role-play, the similarity of a scenario to a recent patient experience caused upset for one delegate; another indicated that the role-play strengthened feelings of inadequacy. It was suggested that role-play would work better in a face-to-face context, where appropriate in-person support can be offered.

Resources and additional learning

Participants welcomed being introduced to grief and childhood development theory, and support resources for preparing parents to communicate with their children about parental death, although some would have liked more practical guidance on how to work with these in practice. Many explained how they worked with a diverse range of patient populations that varied in their responses to illness, and the care and support provided by healthcare professionals. It was highlighted that in some cultures, the concepts of death and dying are not accepted and/or openly spoken about. Diversity and inclusivity across cultures and social groups were considered essential to reflect in resources and materials. Similarly, while not a main component of the training, multiple participants would have liked to receive guidance on how to talk to children directly, using age-appropriate language.

Integrating data

Data converged to develop understanding in relation to participants’ intentions to incorporate their learning into their practice and more widely, and to provide guidance for the development and design of the training. These themes are illustrated in table 5 and interpretation is presented in the next section.

Table 5

Convergent themes

Discussion

These evaluation outcomes determined that the ‘No conversation too tough’ training was principally effective in meeting intended aims. After the training delegates felt more empowered to hold conversations with parents about supporting their dependent children. Confidence in skills and the ability to discuss sensitive issues increased, and clear intentions to build empathetic and supportive relationships with patients were displayed. More open-minded beliefs in the consequences of engaging with patients about their dependent children were evident; this is an important element for behaviour change that can increase as experiences of new behaviours progress over time, and new practice is normalised through peer group and external feedback.31 Delegates also revealed determination to use their new learning in practice by being proactive in starting conversations, and making greater use of, and improving, organisational procedures to identify and record the presence of children. These results reflect outcomes of communication skills training developed and researched in palliative care more broadly.15 26

A pertinent finding in this evaluation is that delegates were enthusiastic and exhibited strong intentions to share their learning with colleagues. They welcomed the opportunity during the course to interact with other professionals, and subsequently to build strong networks and influence wider practice. The mix of professionals attending the training offered delegates new perspectives and facilitated learning about, and from, others. Delegates were working across roles and settings and recognised the influence that working contexts had on relationships built with patients; length of time (days/months/years) available to build relationships with patients, the duration of conversations staff time affords, and environments in which these take place, all varied strikingly. To maximise learning, the training needs to take account of, and explore, best practice across professional roles and settings.32 The challenges that exist in today’s healthcare environments, evidenced in this research by concerns over heavy caseloads, limited time and resources, and lack of privacy and space for conversations to build and continue relationships with patients, all impact on scale and scope of possible enhancements in patient support. Provider organisations are crucial in facilitating conducive cultures and environments, not only for ensuring changes in practice behaviours, but also for supporting the emotional well-being of their staff.11

The benefits of face-to-face versus virtual delivery of the training were apparent. The focus of the training is highly sensitive and evoked strong emotions, particularly during role-play. Delegates welcomed the more cohesive face-to-face environment over virtual delivery, as it enabled greater opportunity to share experiences, develop new ideas from others and build supportive relationships with the facilitators and other delegates. There has been an increase in virtual learning since the pandemic and the opportunities this affords for health education are apparent.33 However, in this context, where delegates’ sensitives, experiences and individual responses can require support, a face-to-face format, potentially in conjunction with virtual learning, appeared to offer greater opportunity; it can impart knowledge and skills in a comfortable, supportive, nurturing environment where individuals are less likely to get ‘lost’ without recourse to in-the-moment support.

Further training needs became apparent during the research. Congruent with other research,34 35 several delegates indicated how they were often introduced to children within the care setting, but their own lack of understanding of how to communicate according to children’s ages and levels of development was a significant deterrent to establishing relationships with children, or with their parents when the child was the focus. Delegates also called for a greater focus in the training on the diversity of the families they care for, and delivery of culturally appropriate care. Difference in ethnocultural background, socioeconomic status, and family structure influence patients’ responses to illness, their care needs, and their willingness to talk about death and dying. These have an impact on the nature of the conversation to be had (eg, need for cultural sensitivity, focus on legalities and guardianship in the case of single parenthood). Hitherto, the needs of dependent children and diverse families have been lacking in palliative care policy and guidance, but there are now clear elements set out in the UK Ambitions for Palliative and End of Life Care: A national framework for local action 2021–2026.36

This evaluation of the training programme has limitations. It was a small-scale study, not powered to detect change, nor to assess changes in practice behaviours or their sustainability. Furthermore, it was not designed to assess the impacts of such changes on patient outcomes. In the context of National Health Service (NHS) staff shortages and potential burnout,37 there is a need to ensure training is effective and time efficient, and that evaluation is straightforward and brief enough to capture what is needed. Furthermore, the techniques and advice imparted need to be easily implemented in busy NHS environments. Longer-term, large-scale evaluation is now required.

Conclusions and next steps

‘No conversation too tough’ is the first training programme codeveloped and tested specifically for cancer, palliative care and wider healthcare professionals to help dying parents support their dependent children.11 38 These evaluation findings have shown that training such as ‘No conversation too tough’ has the ability to impart healthcare professionals with the skills, knowledge and confidence to empower them to start conversations about death and dying, progress supportive patient relationships, and in turn, to help their patients to communicate with and support their children.

The findings have supported course refinement, and the training is to be rolled out on a national basis. It will comprise pre-course e-learning, (including an extra module to address cultural and religious diversities in attitudes to death and dying), and a subsequent 1-day face-to-face interactive session. Individual professionals and whole teams will take part across healthcare providers and higher education. Large-scale evaluation will provide feedback to understand behaviour change, what works for whom (which professionals benefit most), and why (mediators of change). In light of demand, a masterclass for communicating directly with children is planned. Future evaluation steps will include sensitive assessment of the impact of the training on family and children’s outcomes.

Data availability statement

Data are available on reasonable request.

Ethics statements

Patient consent for publication

Ethics approval

This study involves human participants and was given a favourable ethical opinion by the University of Surrey Ethics Committee (Ref: FHMS 20-21 165 EGA). Participants gave informed consent to participate in the study before taking part.

Acknowledgments

The authors acknowledge with gratitude the contributions of Deepa Doshi and Angela Cleary at the Ruth Strauss Foundation for their role in the development and implementation of the ‘No conversation too tough’ training programme for cancer and palliative healthcare professionals. One of Ruth Strauss Foundation’s missions is to support parents to prepare their children when a parent has incurable cancer.

References

Supplementary materials

Footnotes

  • Contributors JC-H and ER undertook the planning of this paper. Data collection and management were undertaken by JEG and JC-H. Analysis was conducted by JEG and JC-H and reviewed by ER. The first manuscript was drafted by JC-H and reviewed by ER and JEG. All authors reviewed and gave final approval for the version to be published. JCH is the guarantor.

  • Funding The study was funded by a research grant awarded to the University of Surrey by the Ruth Strauss Foundation. This was supported by MSD funding to the Ruth Strauss Foundation through their 2020 Cancer Community Grants Programme.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.