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Lucy Chapman

Freeing up Time to Care

Prof Rebecca Lawton, Prof Robbie Foy, Prof David Alldred and Daisy Halligan

Freeing up time to Care

Thank you to everyone who took the time to complete our short survey. We received more than 39 suggestions in response to the question:

Please tell us what you have had to get rid of, do less of or workaround to free up ‘time to care’.

We received responses from managers, doctors, nurses, dentists, pharmacists and volunteers from England and Scotland. They told us about many different things they had had to stop, or do less of, to free up time to care and to get through the day. Some of the things they had stopped doing were seen as vital for patient safety and they felt worried about not doing them. These comments are referred to as those things that staff ‘need to do but can’t’. There were other practices that staff felt were important and that not doing them could compromise patient care. These are referred to as ‘had to stop/reduce’. Finally, there were some were things that staff felt had little value and should be stopped permanently. These are referred to as ‘things that should stop’. Here are the frequency of responses in each of these categories. Below, we give some examples of the types of things that people told us under each of these headings.

Need to do, but can’t. People referred to NOT:

  • having training, even vital life support courses or having to do them in own time
  • having lunch and team breaks
  • attending or organising multi-disciplinary or multi-service meetings
  • finishing work on time
  • documenting patient history, examining patients or doing investigations thoroughly
  • collecting and providing data for local or national audits

This is summarised in the words of one respondent who said:

‘It is an extreme pressure to feel that it is not possible to do our work as we know it should be done’

Have had to stop/reduce. People referred to NOT:

  • reporting in Datix
  • doing audits
  • doing or supporting quality improvement
  • offering student placements
  • providing the same frequency of appointments for patients
  • writing up notes thoroughly
  • covering appointments
  • producing statutory reports
  • looking at patient records
  • having detailed discussions about end of life choices
  • providing retainers (dental) for patients

One person expresses their opinion about the long-term impact as follows:

‘Many of the initiatives (I have had to stop) would save time, money and/or avoid patient distress longer term so its heartbreaking not to be able to move forward, but at some point I have to see my family too

Things that should stop included

  • Paperwork, particularly duplicating or having to complete multiple forms
  • Meetings, Monitoring, reporting, auditing, producing plans and updates
  • Datixing and making changes based on things that sometimes go wrong

As one responded puts it it is ‘Time to reinvest the time from meetings, reporting and planning into safety actions and improvement’

We also received a range of other comments, not directly related to the question about the challenges of providing care (not just care of high quality) in some settings e.g. how distressing it was to work in the Emergency Department and other ideas about how services could be improved to make them more patient friendly e.g. piggy backing one visit (e.g. eye appointment) onto another (e.g. diabetes appointment).

We would like to express our thanks to everyone who shared their ideas when finding time to do this was difficult. We @yh_pstrc will be using these ideas in planning our research on ‘reducing safety clutter’ within our new research centre – The NIHR Yorkshire and Humber Patient Safety Research Collaboration. We will continue to share our findings.

 

 

Working with older patients and their family members to make sense of qualitative data on safe medicines management: insights from the RESI-Med study

By Giorgia Previdoli, Research Fellow

We need to make medicines management safer

Medicines help people to live longer, even when they are living with multiple long-term conditions. If not well-managed and monitored, however, medicines can potentially cause harm.

According to the National Health Service (NHS) in England a third of the population takes eight or more medicines by the age of 80. It is not just the number of medicines that makes life complicated and increases the risk of harm for patients. Some older people, for example, are expected to remember to take different medicines several times a day, manage visits and tests with different specialists, take regular measures and readings (e.g. blood sugar) and dynamically adapt their medicines doses to the results. Researchers and clinicians use the words “regimen complexity” to describe examples like this. And research shows that as things get complicated, mistakes become more likely. In addition, if medicines are not periodically reviewed, patients may experience inappropriate polypharmacy, which means that they are taking medicines that are no longer needed because they may not be providing benefits, or that may, in combination with other medicines, put them at risk of an adverse drug reaction. Research has shown that older people are particularly at risk, especially if they take many different medicines and have a complex regimen. For example, older patients are more likely to spend time in hospital and experience more serious complications if something goes wrong with their medicines.

According to the World Health Organization (WHO), unsafe practices and errors with medicines cost £38billon each year and is a leading cause of injury and avoidable harm. In the UK only, the estimated cost for medicines errors was £237.4. In 2017, WHO launched a global campaign to raise awareness of the scale of medicines-related harm and make medicines management safer. This year, “Medication without harm” was the theme chosen to mark World Patient Safety Day on the 17 September.

The RESI-Med study and the involvement of patients and family members in data analysis

Researchers at the National Institute of Health Research (NIHR) Yorkshire and Humber Patient Safety Translational Research Centre are addressing these challenges in the RESI-Med project. RESI-Med is a two-year study funded by NIHR and aims to develop an intervention to make medicines self-management safer for older patients who manage many medicines at home.

The RESI-Med study has 3 main steps:

  • Step 1
  • Patient interview study (32 people aged 65 or older)
  • Staff interview study (16 healthcare professionals)
  • Review of interventions to improve medicines management for older adult

 

  • Step 2
  • Co-design of solutions using the Experienced Based Co-Design (EBCD) toolkit by Point of Care.
  • EBCD brings patients and staff together to explore new ways to improve healthcare.

 

  • Step 3
  • 2 focus groups with patients
  • 2 focus groups with staff
  • Prototyping to make our intervention ready to be tested in the real world

In addition to a multidisciplinary team of pharmacists and social researchers, the study team includes a patient with lived experience of managing many medicines in older age as well as a group of older patients and family members of patients who advise the team. In the RESI-Med study patient involvement has played a key role in every stage.

The study team also worked with older patient representatives and family members to make sense of the data collected during interviews with patients. Interviewed patients were very open about their struggles taking and manging medicines and the creative solutions they adopt to cope. To fully understand their reflections, we involved our Patient Advisory Group in the early stages to support our interpretation.

We chose to analyse the interviews using thematic analysis, an approach widely used across social sciences.

Patient involvement in healthcare research is becoming more and more common, but patient involvement in data analysis is still relatively unusual. Dr Catherine Powell, who is part of the RESI-Med team, recently involved a group of heart patients as co-analysists in a process evaluation.

While I was still familiarising myself with the data (the transcripts from the 32 interviews with patients), I studied notes made by and codes suggestions received from our Patient Advisory Group. I found this experience extremely insightful because they revealed aspects that had not captured my attention until that point, especially around the burden and the emotional impact of having to fit many medicines into everyday life. The writing up of the findings is still in progress but the influence of the Patient Advisory Group on the way the themes are taking shape is already clear. I am very grateful for that.

Reflections on the data analysis experience

Six people took part in the data analysis workshop and in the subsequent activities. Their feedback on how they found working on interview transcripts was very positive. I have interviewed one of the Patient Advisory Group members about her experience and this is what she told me. You can read the answers below or, if you prefer, you can watch our more informal chat in this short video.

Link to chat: https://youtu.be/xeiRaHEnzEo

Giorgia: Jan, why did you decide to get involved in this study?

Jan: I have cared for both my parents in their later years when they were taking multiple medications. This brings many challenges and complications and I wanted to be involved in trying to create and develop an intervention to help patients and carers to manage this safely.

Giorgia: Tell me more about your previous experience in other studies?

Jan: I have supported several research studies as a public contributor. My experience has been both good and bad, rewarding and at times challenging and disappointing.

Giorgia: How was your involvement in RESI-Med compared to other studies?

In what respect RESI-Med is different from what you have done before?

Jan: Resi-Med has been different because of the deeply personal connection to the subject and the emotional memories that have come back to the surface in discussions. The PPI group have been very involved from the start and views respected and taken into the development of the study. There was more detailed PPI involvement than other studies I have been involved with.

Giorgia: How was the Thematic Analysis workshop for you? Was it challenging? Did you enjoy it?

Jan: Taking part in the workshop and doing some thematic analysis was a challenge but a rewarding one. It felt that it gave the PPI group an empathy with the patients and the researchers in reading the questions and answers given. It was similar to what I expected in respect of trying to find themes in the text. It was different in that I found the responses from patients were raw and real and some showed real resilience in coping with the challenges/shortcomings in their healthcare. I found this quite emotional.

The support from the researcher and the rest of the PPI group was a great help and the experience of doing this task made me much more aware of real front line research.

 Giorgia: Would you do it again?

Jan: Yes I would most definitely do it again as I feel I now have more experience to share in looking for patterns in the transcripts and it is a very rewarding and challenging experience.  For any public contributors it may be helpful to read a section of a transcript prior to a workshop. They are actual conversations with exact representation of any general chat and pauses and this makes it a challenge to find the important points to include in your notes and initial codes.

Giorgia: What differences do you think it would make to qualitative data analysis in health research if there was more PPI involvement?

Jan: PPI involvement gives another perspective to the researchers in their analysis. The public will use their personal experiences as patients, carers and users of healthcare services to make sense of the data and are not bound by a structure of research strategies and constraints. I feel researchers and PPI groups together will give a fuller more real and rounded picture of patients’ experiences.

Giorgia: What was the best thing you learned from looking at the transcripts?

Jan: The best thing was seeing the real resilience of elderly patients coping with their health and their strength and sense of humour in adversities.

Giorgia: What are the key aspects that make PPI involvement in thematic analysis easier and more productive for the researchers and the PPI group?

Jan: I think the key aspects are the support of researchers and the respect of all views expressed both in the transcripts and in the way people code. This allows all views to be captured.

Implementing safe and routine deprescribing in primary care

It is well documented that the use of medicines has been increasing and continues to rise as we improve how we understand, diagnose and treat different medical conditions. The UK alone has seen a 39% increase in number of medicines dispensed from 2007 to 2017 (NHS Digital, 2018). As the number of medicines available to treat patients grows, it is now commonplace for patients to take five or more medicines concurrently – also known as polypharmacy. This is especially the case for patients age 65 years and over (Gao et al., 2017).

Polypharmacy is not inherently negative and is a natural effect of our healthcare system. A patient with multiple diagnoses requires multiple medicines to treat their various conditions effectively to better quality of life. In addition, if patients experience side effects from their initial treatment plan, additional medicine may be prescribed to counteract this. This is known as the prescribing cascade. This is further intensified because clinical practice guidelines that aid prescribers in prescribing appropriate medicines are based on the idea that a patient has a single disease only (as opposed to the reality of many patients having multiple ailments). From this perspective, it’s quite easy to see how a patient may quickly end up on 5 or more long-term medicines. So, it is important to ensure the necessity of each medicine or polypharmacy risks becoming problematic.

The definition of problematic polypharmacy is instances where many medicines are prescribed inappropriately or the intended benefit of a medicine is not realised (Duerden et al., 2013). Such examples involve instances where the number of tablets a patient takes negatively affects their quality of life or when multiple medicines prescribed are hazardous because of a clinical interaction between the medicines or the cumulative effect they have on the body. This can subsequently lead to adverse drug reactions (ADRs), the use of potentially inappropriate medicines (PIMs), non-adherence to medicines and higher care costs (Pirmohamed et al., 2004). Patient safety is compromised when problematic polypharmacy is present.

An avenue for combating problematic polypharmacy is deprescribing. Deprescribing is identifying and discontinuing medicines where harms outweigh benefits in relation to each individual patient and their treatment goals (Scott et al., 2015). This is a shared decision between patients and healthcare professionals. Research has shown deprescribing to be effective in stopping PIMs whilst showing a lack of significant harm, especially when deprescribing long-term medicines (Iyer et al., 2008). However, the process of deprescribing is not completely without risk, with the risk of relapse of symptoms of the original condition or a risk of symptoms associated with stopping a medicine being present. In summary, deprescribing is important in addressing problematic polypharmacy through stopping unnecessary medicine use, but it’s not completely free of risk. It’s important that deprescribing is routinely considered but conducted safely.

Although deprescribing can help in preventing problematic polypharmacy, much of the deprescribing currently in practice is reactive, meaning a medicine is stopped once a patient has already developed side effects. To maintain patient safety, there is a need for proactive deprescribing so that problematic medicines are stopped before side effects can occur. There is a lack of evidence on how routine proactive deprescribing can occur within our current healthcare safely. Multiple obstacles to routine deprescribing have already been highlighted, including a lack of clinician’s time, competing workloads, and the fear that deprescribing may be seen as a cost-cutting exercise or abandonment of care (Reeve et al., 2013, Doherty et al., 2020). There is little guidance on how to overcome these obstacles and implement routine, safe and proactive deprescribing.

In order to combat problematic deprescribing and better patient safety, this has provided us with a drive to research how routine and safe deprescribing can be implemented into our primary healthcare. We aim to understand what patients and healthcare professionals need for routine and safe deprescribing to occur. This is very important to us as we want deprescribing to work for patients, without negatively affecting healthcare professionals. As pharmacists are known as medicine specialists, we’re also interested in the potential roles of pharmacists in supporting routine deprescribing. Research has highlighted the beneficial role of pharmacists in deprescribing, but little is known about their exact roles (Ailabouni et al., 2019).

Ultimately, we then want to co-design resources with patients and healthcare professionals that make it easier for safe and routine deprescribing to be implemented into practice. It is hoped that this will make it easier to tackle problematic polypharmacy without compromising patient safety.

Daniel Okeowo supervised by Professor David Alldred, Dr Beth Fylan and Dr Syed R. Tabish.

References:

AILABOUNI, N., MANGIN, D. & NISHTALA, P. S. 2019. DEFEAT-polypharmacy: deprescribing anticholinergic and sedative medicines feasibility trial in residential aged care facilities. International Journal of Clinical Pharmacy, 41, 167-178.

DOHERTY, A. J., BOLAND, P., REED, J., CLEGG, A. J., STEPHANI, A. M., WILLIAMS, N. H., SHAW, B., HEDGECOE, L., HILL, R. & WALKER, L. 2020. Barriers and facilitators to deprescribing in primary care: a systematic review. BJGP Open, 4.

DUERDEN, M., AVERY, T. & PAYNE, R. 2013. Polypharmacy and medicines optimisation: Making it safe and sound [Online]. The King’s Fund, 11–13 Cavendish Square, London W1G 0AN: The King’s Fund.  [Accessed].

GAO, L., MAIDMENT, I., MATTHEWS, F. E., ROBINSON, L., BRAYNE, C., FUNCTION, O. B. O. T. M. R. C. C. & STUDY, A. 2017. Medication usage change in older people (65+) in England over 20 years: findings from CFAS I and CFAS II. Age and Ageing, 47, 220-225.

IYER, S., NAGANATHAN, V., MCLACHLAN, A. J. & LE COUTEUR, D. G. 2008. Medication withdrawal trials in people aged 65 years and older: a systematic review. Drugs Aging, 25, 1021-31.

NHS DIGITAL. 2018. Prescriptions Dispensed in the Community – Statistics for England, 2007-2017 [Online]. Available: https://digital.nhs.uk/data-and-information/publications/statistical/prescriptions-dispensed-in-the-community/prescriptions-dispensed-in-the-community-england—2007—2017 [Accessed].

PIRMOHAMED, M., JAMES, S., MEAKIN, S., GREEN, C., SCOTT, A. K., WALLEY, T. J., FARRAR, K., PARK, B. K. & BRECKENRIDGE, A. M. 2004. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ, 329, 15-19.

REEVE, E., TO, J., HENDRIX, I., SHAKIB, S., ROBERTS, M. S. & WIESE, M. D. 2013. Patient Barriers to and Enablers of Deprescribing: a Systematic Review. Drugs & Aging, 30, 793-807.

SCOTT, I. A., HILMER, S. N., REEVE, E., POTTER, K., LE COUTEUR, D., RIGBY, D., GNJIDIC, D., DEL MAR, C. B., ROUGHEAD, E. E., PAGE, A., JANSEN, J. & MARTIN, J. H. 2015. Reducing Inappropriate Polypharmacy: The Process of Deprescribing. JAMA Internal Medicine, 175, 827-834.

 

NIHR PSTRCs Symposium on the future of Patient Safety: Insights from PhD student attendees.

The three NIHR Patient Safety Translational Research Centres (PSTRC) hosted a joint symposium on the 16th June at the Queens Hotel in Leeds to discuss the future of patient safety research. The symposium was an extremely welcomed opportunity to see colleagues face-to-face and despite highlighting many shortcomings in the current landscape of patient safety, the atmosphere was vibrant with encouraging presentations that focused on three key themes: insight, involvement and improvement.

In the ‘Involvement’ session, we heard from Prof Bryony Dean Franklin, Prof Jane O’Hara and Prof Caroline Saunders. As a PhD student, it was great to hear about simple yet effective ways of collaborating with a diverse range of people, particularly groups we traditionally considered ‘hard-to-reach’ but are now understanding that with effective networking with organisations and meaningful engagement, are enthusiastic to be involved. At the end of this session, I felt encouraged that the future of patient safety research will incorporate understanding that to meet the needs of everyone, we need to involve them effectively. I felt empowered to use the techniques suggested by presenters in my own work.

The ‘Insight’ session was led by Dr. Lindsay Dewa from Imperial PSTRC, Dr. Richard Williams from Greater Manchester PSTRC and Prof. Rebecca Lawton from Yorkshire and Humber PTSRC. The session highlighted insight from patients, staff and health data taken from research carried out over the last five years across the PSTRCs. Insight from the following three areas of research was discussed:

– How to pragmatically and meaningfully involve patients and the public throughout the entire process of co-production.

– How electronic patient records stored in the Greater Manchester Care Record can be used to inform interventions to improve patient safety and enhance health research.

– The value of using staff intelligence to better understand problems such as ‘safety clutter’ to improve safety. Learning from staff experiences of previous harm to provide safety intelligence for improvement was also highlighted.

A highlight of this session was learning about the variety of inclusive and person-centred methods that we can use to gather insight from patients and staff to improve patient safety.

The ‘Improvement’ session was led by Dr Jonathan Benn from YH PSTRC, Dr Ana Luisa Neves from Imperial PSTRC and Professor Tony Avery from GM PSTRC. The overall theme was digitally enabled improvement and specifically socio-technical interventions in hospitals and general practice. Examples were the evaluation of a digital hospital command centre, the use of virtual primary care during the COVID19 pandemic and reducing patient harm from medication errors by identifying patients at risk using a pharmacist-led IT-based intervention. For me as a PhD student, the key highlight from this session was the range of research methods that was being used to explore, develop, implement and evaluate digital patient-safety interventions; ranging from systematic reviews and routine data, to ethnographic observations and qualitative interviews, as well as clinical trials and national training packages.

Key learning from the Symposium

Daisy Halligan (PhD Student)

  1. The need to respect unique individuality so that the healthcare system can work for all (Dr. Frances Healy).
  2. It was inspiring to hear the panel discuss what the future of patient safety research should focus on. Some ideas mentioned during the discussion included: tackling inequalities, including more patients and carers as lay researchers, making better use of routinely collected data and improving patient safety in ways other than implementing policies, guidelines and interventions.
  3. The Symposium poster competition was a fantastic opportunity to learn about the different research projects taking place across the three centres. I was really pleased to have won the poster prize for the Yorkshire and Humber PSTRC on a study that explored the barriers and facilitators to de-implementing low-value safety practices.

Caitlin Wilson (PhD Student)

 

 

 

 

 

  1. “Much has been accomplished in patient safety research, but much more needs to be done” (Dr Frances Healey)
  2. If we want to address inequality and inequity in patient safety research then we need to not only consider healthcare providers’ perspectives (freedom from harm) but also patients’ perspectives (“I feel safe”) (Professor Bryony Dean Franklin)
  3. Great opportunity to learn from and network with leaders in the field of patient safety research, as well as NHS organisations, including Dr Fiona Bell, Head of Research at Yorkshire Ambulance Service NHS Trust.

Emily Parker (PhD Student)

A particular highlight for me was seeing presenters from various disciplines make suggestions which rationalised some of my PhD work. For example, it was great to see staff wellbeing being emphasised and patient-centred approaches to clinical risk investigation being prioritised for future research. My three key takeaways from the day were:

  1. Continuing with a career in patient safety research means I will be able to foster strong relationships with communities, organisations and a wide range of people.
  2. Addressing inequalities for patients is impossible without addressing them for staff. This is a key area I am interested in, particularly the experience of non-clinical staff who have not received as much research attention but contribute greatly to patient safety.
  3. I have new ideas for how I can navigate recruitment of a diverse range of patients and staff, with Professor Caroline Saunders boosting my confidence in approaching and involving community organisations.

Overall, we thoroughly enjoyed the joint symposium. It was great to meet researchers from the other PSTRCs and catch-up with colleagues from Yorkshire & Humber. Seeing the artist’s impressions of the day was a particular highlight and a great example of how the key messages of a presentation can be clearly communicated in a really engaging way! The panel of patient safety experts who hosted the Q&A session left us all feeling enthusiastic and intrigued about where our career’s can take us in Patient Safety research. We can’t wait for the next opportunity to collectively meet again.

Symposium, Queens Hotel

Visual artist impression of the symposium


          
        

Can we adapt the way we do research when involving healthcare staff as research participants?

Dr Raabia Sattar, Dr Jane Heyhoe & Professor Rebecca Lawton

 

NHS staff live the health system every day and have much to offer research about healthcare (Marjanovic et al., 2019). Their first-hand experience and insight means that staff have a unique role in applied health research that seeks to improve the delivery of care and support staff wellbeing.  Applied health research is beneficial for patients, healthcare staff, and organisations. A review by Harding et al (2107) found that staff participation in research was associated with increased organisation level patient satisfaction, improved efficiency of care, and lower staff turnover. Increased levels of research engagement by healthcare staff may improve the processes of care (Boaz et al., 2015).

While NHS healthcare staff can make important contributions to research, there are a number of barriers to staff taking part.  These include a lack of time to participate in research (Marjanaovic et al., 2019), a lack of funding to support engagement (Bryant., 2014; Brereton, L., et al., 2017), and a lack of support by leadership (Evanst et al., 2013; French et al., 2016; Mitchell et al., 2015). While research has been at the centre of an effective response to Covid-19, pressures on staff have only increased during the last two years, meaning that staff ability to be involved in research as participants is also under pressure. At the same time, the Covid-19 crisis and the associated changes in practice, work pressures and emotional toll mean that now more than ever the voices of NHS staff need to be heard. This is vital if we are to learn from and respond to their first-hand experiences of delivering care during these unprecedented times and to ensure the development of the most appropriate interventions, policies and frameworks to continue to improve healthcare.

The traditional ways of including staff in research have involved methods such as face-face interviews, focus groups and questionnaires, as well as observations of the work as done via ethnographic studies. Undoubtedly, these types of research techniques are needed to address certain research questions. However, as researchers, it is important that we take into account that when we ask healthcare staff take part in such research activities, they are away from their clinical duties and responsibilities. We must also consider, what are we offering staff in return for their time? Can we adapt the way we involve participants in our research so that there is greater participant gain? Below, we provide an example of an alternative participation approach we have used for one of our research projects.

An example of an innovative approach: CASE (Conversations About Safety and Emotions)
How we express emotion and interpret emotion in others is integral to important aspects of healthcare such as decision making, team functioning and effective leadership.  Healthcare professionals are required to make clinical decisions in contexts that are emotionally charged and require healthcare staff to actively manage their own and others emotions (Kozlowski et al, 2017). Although there is now increasing recognition that emotions play an important role in staff wellbeing, patient experience and the delivery of safe care, research within this area is limited. Therefore, the aim of this study was to explore the role of emotion in maternity practice within hospital settings.

 We were planning this study during the initial months of Covid-19, and we quickly realised that healthcare staff within the NHS were now being faced by immense service pressures. After discussions with a member of our team, a consultant obstetrician, we started to think more about reciprocity as part of the research contract. Most research groups provide feedback to participants about the findings of their research and make recommendations that can be used to improve practice, but benefits associated with the ‘process’ of being a participant in research are less frequently deliberated. This notion of benefits of participation was central to our research design. We worked with our clinical partners to develop a workshop series focusing on delivering evidence and supporting staff to think about the evidence on emotion and safety. The series – Conversations About Safety and Emotion was delivered during scheduled training time (Friday afternoons). Whilst delivering the workshop we planned to collect data by recording the break out room discussions which we ran as short focus groups. Using this innovative approach allowed us as researchers to capture the data we required for our study, whilst also offering healthcare staff training.

This study is now underway and takes the form of a programme of four online interactive training workshops, with a mixture of teaching and group discussions. These workshops are multi-disciplinary in nature, and include maternity clinicians including midwives and obstetricians as well as senior leaders. The workshops are delivered by psychologists and a consultant obstetrician. We have delivered the first workshop which focused on feeling psychologically safe in teams, to a mixture of 37 midwives and obstetricians. All participants signed up and consented to the recording and analysis of discussions during the workshops, at least 24 hours in advance of the training workshop.  Feedback on the experience from staff was that they were supported and encouraged to engage in discussions about challenging issues in a safe space and that both the formal presentation and the discussions contributed to their learning. We believe this is a mutually beneficial method of delivering research, as we are able to collect research data, whilst also providing healthcare staff with evidence-based training and knowledge which they are able to apply to real life settings within their NHS workplace.

Conclusion
Involving NHS healthcare staff within research is fundamental to improving patient care, staff wellbeing and patient safety. However, due to the immense work pressures healthcare staff are facing, as researchers, we must adapt the way we involve staff in our research to ensure that they benefit from taking part. We are keen to hear from others about how they have adapted research so that healthcare staff benefit from the process of being engaged in that research. We also welcome the views of healthcare staff on how they would like to be involved in research and what we, as researchers, can do to reduce the burden and increase the benefits.

Please comment below.

 

Can we adapt the way we do research when involving healthcare staff as research participants?

Can we adapt the way we do research when involving healthcare staff as research participants?

Dr Raabia Sattar, Dr Jane Heyhoe & Professor Rebecca Lawton

NHS staff live the health system every day and have much to offer research about healthcare (Marjanovic et al., 2019). Their first-hand experience and insight means that staff have a unique role in applied health research that seeks to improve the delivery of care and support staff wellbeing.  Applied health research is beneficial for patients, healthcare staff, and organisations. A review by Harding et al (2107) found that staff participation in research was associated with increased organisation level patient satisfaction, improved efficiency of care, and lower staff turnover. Increased levels of research engagement by healthcare staff may improve the processes of care (Boaz et al., 2015).

While NHS healthcare staff can make important contributions to research, there are a number of barriers to staff taking part.  These include a lack of time to participate in research (Marjanaovic et al., 2019), a lack of funding to support engagement (Bryant., 2014; Brereton, L., et al., 2017), and a lack of support by leadership (Evanst et al., 2013; French et al., 2016; Mitchell et al., 2015). While research has been at the centre of an effective response to Covid-19, pressures on staff have only increased during the last two years, meaning that staff ability to be involved in research as participants is also under pressure. At the same time, the Covid-19 crisis and the associated changes in practice, work pressures and emotional toll mean that now more than ever the voices of NHS staff need to be heard. This is vital if we are to learn from and respond to their first-hand experiences of delivering care during these unprecedented times and to ensure the development of the most appropriate interventions, policies and frameworks to continue to improve healthcare.

The traditional ways of including staff in research have involved methods such as face-face interviews, focus groups and questionnaires, as well as observations of the work as done via ethnographic studies. Undoubtedly, these types of research techniques are needed to address certain research questions. However, as researchers, it is important that we take into account that when we ask healthcare staff take part in such research activities, they are away from their clinical duties and responsibilities. We must also consider, what are we offering staff in return for their time? Can we adapt the way we involve participants in our research so that there is greater participant gain? Below, we provide an example of an alternative participation approach we have used for one of our research projects.

An example of an innovative approach: CASE (Conversations About Safety and Emotions)
How we express emotion and interpret emotion in others is integral to important aspects of healthcare such as decision making, team functioning and effective leadership.  Healthcare professionals are required to make clinical decisions in contexts that are emotionally charged and require healthcare staff to actively manage their own and others emotions (Kozlowski et al, 2017). Although there is now increasing recognition that emotions play an important role in staff wellbeing, patient experience and the delivery of safe care, research within this area is limited. Therefore, the aim of this study was to explore the role of emotion in maternity practice within hospital settings.

 

We were planning this study during the initial months of Covid-19, and we quickly realised that healthcare staff within the NHS were now being faced by immense service pressures. After discussions with a member of our team, a consultant obstetrician, we started to think more about reciprocity as part of the research contract. Most research groups provide feedback to participants about the findings of their research and make recommendations that can be used to improve practice, but benefits associated with the ‘process’ of being a participant in research are less frequently deliberated. This notion of benefits of participation was central to our research design. We worked with our clinical partners to develop a workshop series focusing on delivering evidence and supporting staff to think about the evidence on emotion and safety. The series – Conversations About Safety and Emotion was delivered during scheduled training time (Friday afternoons). Whilst delivering the workshop we planned to collect data by recording the break out room discussions which we ran as short focus groups. Using this innovative approach allowed us as researchers to capture the data we required for our study, whilst also offering healthcare staff training.

This study is now underway and takes the form of a programme of four online interactive training workshops, with a mixture of teaching and group discussions. These workshops are multi-disciplinary in nature, and include maternity clinicians including midwives and obstetricians as well as senior leaders. The workshops are delivered by psychologists and a consultant obstetrician. We have delivered the first workshop which focused on feeling psychologically safe in teams, to a mixture of 37 midwives and obstetricians. All participants signed up and consented to the recording and analysis of discussions during the workshops, at least 24 hours in advance of the training workshop.  Feedback on the experience from staff was that they were supported and encouraged to engage in discussions about challenging issues in a safe space and that both the formal presentation and the discussions contributed to their learning. We believe this is a mutually beneficial method of delivering research, as we are able to collect research data, whilst also providing healthcare staff with evidence-based training and knowledge which they are able to apply to real life settings within their NHS workplace.

Conclusion
Involving NHS healthcare staff within research is fundamental to improving patient care, staff wellbeing and patient safety. However, due to the immense work pressures healthcare staff are facing, as researchers, we must adapt the way we involve staff in our research to ensure that they benefit from taking part. We are keen to hear from others about how they have adapted research so that healthcare staff benefit from the process of being engaged in that research. We also welcome the views of healthcare staff on how they would like to be involved in research and what we, as researchers, can do to reduce the burden and increase the benefits.

Please comment below.

From Kingston to Yorkshire: An Internship in Patient Safety

By Kayley Perfetto, Ph.D. Student, Queen’s University, Kingston, Ontario, Canada

 

In March 2020, I was faced with a choice. I was nearing the end of the second semester of my first year in my Ph.D. program in Health Quality (HQ) and the following semester I was expected to begin an internship. In order to apply the knowledge and skills gained during two semesters of course work, first-year Ph.D. HQ students are required to complete a 200-hour internship at a location that aligns with their areas of interest. Based upon a suggestion from my Ph.D. supervisor, planning had been underway since November 2019 and I was excitedly preparing for a trip to Yorkshire, England. I had been looking forward to spending two weeks on-site with the Yorkshire Quality and Safety Research (YQSR) Group which hosts the NIHR Yorkshire and Humber Patient Safety Translational Research Centre (YH PSTRC), assisting with two pre-determined research projects. Unfortunately, at that time the COVID-19 pandemic had started to take hold of the world and my carefully laid out plans had to be abandoned and I needed to decide what to do next. The faculty at Queen’s provided my classmates and I the option of completing, what was supposed to be an in-person internship, virtually, or delaying our internships for a year, and hope for the best that international travel could occur in a year’s time.

To provide a bit of context, I will share a little bit about Queen’s University and the HQ program that I am fortunate to be a part of. Queen’s University is located in beautiful Kingston, Ontario, Canada, a city with a population of 136 000, along Lake Ontario. Queen’s University is Canada’s oldest University as it predates the founding of Canada by 28 years. The university was modeled after universities in Edinburgh and Glasgow.

My PhD colleagues and I onsite during our intensive week in beautiful snowy Kingston, January 2020

I live in London, Ontario, a city that is roughly four hours from Kingston and therefore my Ph.D. is being completed virtually. The HQ Graduate programs are designed for individuals like myself, health care professionals who are working in the field, who want to further their education in quality and patient safety. I am a physiotherapist by training, and I am currently working as a Patient Safety Specialist in a hospital organization in London, Ontario.

 

 

Lovely Queen’s University

Lovely Queen’s University

After careful consideration and meetings with my supervisor and the YQSR team to discuss whether my internship could be made virtual, I decided to give it a go and hope for the best. Utilizing a variety of virtual technologies and many emails, I have been able to contribute to three research projects, (one of which I am currently contributing to) one of which used qualitative data to understand the experiences of patients with learning disabilities and how these experiences impacted patient safety. The other project was a scoping review, completed as the first phase of a large five-phase study, which explored the current involvement of patient and family members in serious incident investigations. Both projects are ongoing at this time and both will be submitted for publication within the next few months. I was invited to present the key learnings from my internship at a virtual YQSR staff meeting in March 2021 and I shared my experiences at the academic series held at Queen’s University.

 

Screen shot of an interview with Professor. Jane O’Hara and Dr. Abigail Albutt (and me)

Through the guidance and support from the YQSR team, this internship allowed me to gain a deeper understanding of my substantive area of interest, patient and family involvement in patient safety, the knowledge that has been invaluable as I develop my thesis. During my internship, I was able to (and continue to!) work alongside and network with some renowned researchers in the field, learn more about their current projects and hear their perspectives on the direction research in this area is heading. Being part of these three projects, allowed me to consolidate what I learned in my first year Ph.D. courses, gaining an increased understanding of the practical aspects of conducting research.

This internship provided me with so many opportunities, but what I feel most fortunate about is having the opportunity to meet such wonderful people. The team at YQSR was warm and welcoming and was genuine in the desire to make this experience a success. They provided resources and experiences that they felt would be helpful for me and shared information about themselves and their experiences going through the pandemic. This internship was possible due to the commitment and collaboration between the team at YQSR and Ph.D. HQ team. When my original plans were unexpectedly altered by COVID-19, both groups worked together to ensure that I was able to continue with and benefit from my internship. For their dedication to ensuring that I had the best experience possible, I offer a heartfelt thank you and hope someday soon I have the opportunity to thank you in person.

 

World Patient Safety Day 2021: Yorkshire Quality and Safety Group

World Patient Safety Day 2021: Yorkshire Quality and Safety Group

The third annual World Patient Safety Day takes place on 17th September 2021. Established by the World Health Assembly[1], the day is all about increasing public awareness and understanding and working towards global solidarity and action on patient safety. Each year, the World Health Organization (WHO) selects a theme to highlight a priority area for action. This year’s theme is ‘Safe maternal and newborn care’, with the WHO encouraging us to ‘Act now for safe and respectful childbirth!’.

Every day 810 women and 6700 newborns lose their lives. While the greatest burden of these deaths is in low- and middle-income countries, confidential enquiry reports in the UK highlight that maternal mortality is higher in older women, those living in the most deprived areas and amongst women from ethnic minority groups[2]. Most of these deaths are preventable through the provision of safe, effective and high quality care. Although coverage of evidence-based interventions such as antenatal care and skilled birth attendance have increased rapidly, the quality and safety of care provided to mothers and babies is often lacking. Reducing the safety risks during pregnancy and around the time of birth is critical for maternal and newborn survival.

In this blog we outline some of the work being carried out by researchers in the Yorkshire Quality and Safety Research group (YQSR), based at Bradford Royal Infirmary, which contributes to our understanding, and implementation, of safe maternal and newborn health care and services. We work closely with colleagues in the Patient Safety Collaborative, and the Improvement Academy, to facilitate translation of research findings into a range of initiatives to improve safety for mothers and newborns. Read their World Patient Safety Day blog here.

Strong teams lead to safer births

Rising birth rates and increasing complexity of births in UK maternity services has led to increasingly multi-disciplinary teams of healthcare staff, particularly during childbirth. Failures in teamwork and communication continue to be identified as substantial contributors to compromised patient safety in both research and in high profile inquiries into maternity services3 4.

Dr Siobhan McHugh (Research Fellow, YQSR Group) explored the use of video reflexive ethnography (VRE) as a tool for the improvement of communication at the multi-disciplinary clinical handover on labour ward. Using video footage of the handover captured in situ to prompt discussion, multi-disciplinary staff groups were prompted to collaboratively identify areas for change or improvement, and ideas to address these areas. Siobhan has worked closely with two local maternity units (St. James’ Hospital, Leeds Teaching Hospitals NHS Trust and Bradford Royal Infirmary, Bradford Teaching Hospitals Foundation Trust) supporting them to use VRE to improve the multi-disciplinary handover on labour ward. Both projects resulted in staff-led changes to the structure of the handover. For the team at St. James’ Hospital this meant re-designing the handover to meet the different needs of obstetric and theatre teams better, ensuring theatre staff felt better prepared for any emergent safety concerns. For the team at Bradford Royal Infirmary, the work led to re-designing the handover to ensure multi-disciplinary input was welcomed, rather than a single one-way flow of information, allowing for more extensive discussion and awareness of emergent safety concerns or risk. Staff at both sites also reported improvements in clinical confidence, timely escalation of high risk cases, staff well-being and multi-disciplinary team culture. You can find out more about Siobhan’s research on Twitter (@YH_PSTRC, @yqsrdotorg, @skmc84). She has also presented a short snapshot video on her use of VRE in healthcare improvement which is available here.

Establish a safety culture in which healthcare workers are not afraid to speak up

Maternity is a high-risk environment and adverse events can have an impact on the affected women, partners and/or families and the midwives, doctors and others involved. An important element in managing the aftermath of these events is disclosure. Dr Raabia Sattar (Research Fellow, YQSR) focused on this topic for her PhD, specifically focusing on the support needed by healthcare professionals to do disclosure well.

The systematic review, conducted as part of Raabia’s PhD, highlights key elements of disclosure that are valued by patients. These include relevant information about the adverse event, accountability and an apology, and commitment to preventing future recurrences of the event. The review also found that health workers face a number of barriers when trying to disclose events to patients. To address this, Raabia and colleagues have developed a disclosure training workshop and top tips on how to do disclosure, hosted on our second victim website.

Led by Professor Jane O’Hara, the Patient and Family Involvement in Serious Incident Investigations (Learn Together) project aims to co-design guidance to support more meaningful involvement of patients and their families in serious incident investigations following adverse events in healthcare. The PFI SII team have worked with patients, families, healthcare staff, investigators and policy makers to co-design guidance to sit alongside Trust investigation policies. Starting in October 2021, the team will work with four participating NHS Trusts and the Healthcare Safety Investigation Branch (HSIB), to test this guidance during serious incident investigations. With the HSIB, the PFI SII team will focus specifically on investigations following serious adverse events during active childbirth. The aim of the guidance is to support investigators to more meaningfully involve patients, families and healthcare staff in investigations to enable better learning following healthcare harm.

Build trust, and engage and empower all women

Dr Gemma Louch (Senior Research Fellow, YQSR) and colleagues have been reviewing the evidence on patient safety for people with learning disabilities in acute hospital settings. A key finding in their recent scoping review, was that women with learning disabilities are more likely to experience complications of pregnancy and birth, including pre-eclampsia, pre-term birth, caesarean birth and small for gestational age babies. The NIHR, along with other national policy and funding bodies, recognises the lack of evidence about how maternity services are experienced by parents with learning disabilities. Gemma and colleagues aim to address this research gap with future research on how maternity services support parents with learning disabilities to identify what improvements are needed.

Setting and implementing global standards for safe and respectful maternal and newborn care

Dr Helen Smith (Senior Research Fellow, YQSR) has been committed to improving quality and safety of maternity care throughout her career and has valued the opportunity to work with WHO on guidelines that set standards for maternal and new-born care. WHO’s guidelines aim to promote health, prevent harm, and encourage evidence-based clinical practice and policy. Helen has worked with WHO’s Department for Maternal, Child and Adolescent Health and Ageing on guidelines for health promotion interventions for maternal and newborn health, interventions to manage health complications of FGM, home-based records for maternal, newborn and child health, implementing Maternal Death Surveillance and Response (MDSR) and postnatal care (forthcoming).

Supporting policy makers and health workers to implement safe and effective interventions requires just as much if not more effort than producing the recommendations. Helen has a special interest in implementation of safe, effective and respectful childbirth care. She helped set up the Better Births Initiative which had strong regional reach in Africa, and more recently has worked on factors that affect implementation of interventions for maternal and newborn health. Helen has recently been working with the WHO team to prepare a new implementation toolkit alongside the forthcoming postnatal care guidelines. The toolkit will help countries to adapt the recommendations to their context, update their policies, and identify factors that are likely to influence implementation of safe and effective postnatal care interventions.

We hope this blog has given you an indication of the research conducted within YQSR. As a multidisciplinary group we are committed to conducting high quality research on NHS and patient priorities, across a range of specialities including maternal and newborn health. We develop and evaluate innovative solutions to patient safety problems and deliver research that makes healthcare safer. We work closely with the Improvement Academy to facilitate translating research findings into practice. You can read more about their work to support high quality, safe maternity care here.

Written by: Dr Helen Smith (Senior Research Fellow) and Dr Siobhan McHugh (Research Fellow), Yorkshire Quality and Safety group

[1] The WHA is the decision-making body of WHO; held annually in Geneva and attended by all WHO Member States.

[2] https://www.npeu.ox.ac.uk/mbrrace-uk/reports

3https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/408480/47487_MBI_Accessible_v0.1.pdf

4 https://www.donnaockenden.com/downloads/news/2020/12/ockenden-report.pdf

 

 

 

Networking & building connections as an early career researcher

By Caitlin Wilson (Twitter: @999_Caitlin), Dr Fiona Bell (@fionablairbell) & Professor Julia Williams (@DrJuliaWilliams)

Undertaking a PhD is about developing a researcher identity. Traditionally, this occurred through one-to-one mentor relationships, which often continued throughout a researcher’s career. However, nowadays early career researchers need to gain experience and develop connections with multiple people through networking (Ansmann et al., 2014). In fact, a study by Wolff and Moser (2009) suggests that networking is related to career progression and career satisfaction across a multitude of sectors.

PhDs can often be an isolating experience (Cantor, 2020), something which has undoubtedly been emphasized through the COVID19 pandemic and subsequent working from home, but intentional networking has been key to my PhD journey so far. Within this blog post, I share my experience of networking as an early career researcher, with valuable input from Dr Fiona Bell, Head of Research at Yorkshire Ambulance Service NHS Trust, and Professor Julia Williams, Head of Research at the College of Paramedics.

  1. Social media

Without social media I would not be a PhD student at the NIHR Yorkshire and Humber Patient Safety Translational Research Centre. It was through a re-tweet from @fionablairbell in March 2019 that I became aware of this amazing opportunity. The trick to Twitter and other social media platforms such as ResearchGate, LinkedIn etc., is to follow key people in your area of interest.

  1. Networking with peers

As an experienced clinician, I am fortunate to be surrounded by supportive colleagues, many of whom I would call friends. However, my peer network extends beyond those geographically close to me or those who I work with clinically. Seminars, workshops, conferences, webinars and courses both virtually and face-to-face have allowed me to connect with many people who I would consider peers. I perceive the value of these networking relationships to often be higher than the course content.

  1. Near-to-peer mentoring

In addition to peer-to-peer networking, there is a great benefit to connecting with people who are slightly ahead of you in your journey as an early career researcher. These are the people to contact when you have a question you feel is too trivial for your supervisors or just need a word of encouragement that it is indeed possible to survive your PhD.

  1. Networking with NHS organisations

Expertise, knowledge and enthusiasm for any topic are generally not centrally held in any NHS organisation. NHS ambulance services cover large geographies and have staff spread across their region delivering care in the community. Therefore, networking in this setting is really key to getting to the ‘right’ people to support you research area. It pays to attend internal meetings at the planning stage to get buy-in and engagement with key stakeholders who have existing connections and can advocate for you through established formal or informal connections. Keeping the whole network updated ensures that association is not lost when people or services change, and allows your network to evolve as the project develops.

  1. Networking with networks

Within your area of practice, there will already be formal networks and organisations, which researchers at any level can access to forge links and make new contacts. For me, this was the Research Centre at the College of Paramedics, but also included collaboration across other disciplines and professions, such as within the YH PSTRC. Research is stronger when developed in teams, so get involved in different research-focused organisations wherever and whenever you can. Often opportunities emerge through these contacts, which could help strengthen your networking activities as well as develop your research knowledge and expertise.

To further explore the topic of early career researcher identity and networking, I have been granted an NIHR Short Placement Award for Research Collaboration (SPARC) supervised by Professor Julia Williams, in her capacity as paramedic-lead for the NIHR Incubator for Emergency Care. Although it is a ‘short’ placement award, the virtual nature of the placement is allowing for a more flexible approach throughout 2021/22, during which I plan to establish an online forum for paramedic researchers, where networking, mentoring and collaborating will be encouraged and supported.

 References

Ansmann, L., Flickinger, T.E., Barello, S., Kunneman, M., Mantwill, S., Quilligan, S., Zanini, C. and Aelbrecht, K. 2014. Career development for early career academics: Benefits of networking and the role of professional societies. Patient Education and Counseling. 97(1), pp.132-134.

Cantor, G. 2020. The loneliness of the long-distance (PhD) researcher. Psychodynamic Practice. 26(1), pp.56-67.

Wolff, H.-G. and Moser, K. 2009. Effects of networking on career success: A longitudinal study. Journal of Applied Psychology. 94(1), pp.196-206.

Are medical device regulations safe?

Photo by Svilen Milev from FreeImages

 

Existing provision of regulations for medical devices may be insufficient for the digital age.  In our recent paper, we argue that the complexity of healthcare information systems is not being acknowledged and incorporated in the design of many regulations and standards.

National Institute for Care Excellence (NICE) guidance from 2015 promoted the use of QRISK2. This computerised tool calculated someone’s risk of having a heart attack or stroke in the next 10 years. It was designed, developed and approved in accordance with the safety guidelines at the time. But by 2016, the regulatory agency in the UK raised an alert about the use of the computerised tool in some practices.

Thankfully, the errors in the risk calculated by QRISK2 were minimal. The UK’s commitment to electronic health systems were leveraged to track down the source of the problem and follow up with patients. Although the connectivity of the UK’s increasingly-digitised healthcare system helped to remedy some safety concerns, its connectedness can also be a cause for concern.

What’s the problem?

Perhaps the biggest problem faced by regulators of medical devices is that there isn’t just a single problem to solve. Healthcare is an ever-changing and complex system, where not only the parts need to be considered, but their interactions, too. With so many dynamic interacting parts, it can be practically impossible and hubristic to think we can observe and control everything.

Designed by vector_corp, available at Freepik

 

Many standards are available but are not compulsory. For example, decisions made by the European Union in the 1980s separated law and technical standards, which makes it difficult to enforce standards (1). Even if standards were enforceable, they often don’t acknowledge the contemporary systemic and connected ecology of medical devices in the age of digital health and Healthcare 4.0 (2).

Are regulations safe for patients?

It has become increasingly apparent that existing regulation of medical devices is insufficient for the digital age, despite progress in the European Union’s Medical Device Regulation (3). In our paper, we argue that the complexity of healthcare information systems is not being acknowledged and incorporated in the design of many regulations and standards (4).

Medical device regulations were initially created for hardware devices rather than software and offer one-shot approvals rather than supporting iterative innovation and learning. Such iterative development has been the keystone to agile methods in product and service innovation that enable timely responsiveness to emerging contexts. A further issue with many medical device regulations is the bias toward loss-transfer approaches that attempt to manage the fallout of harm instead of mitigating hazards becoming harmful. This often manifests as bias toward known hazards, despite unknown hazards being an expected consequence of health care as a complex adaptive system.

What’s being done about it?

Despite the aforementioned concerns, many theoretical and practical strategies have been proposed to improve the provision of effective medical devices in a safe and timely manner. In our paper, we summarise nine recommendations that focus on embedding less-reductionist and stronger systemic perspectives into regulations and standards (4). These recommendations include a Safety II perspective of risk (5), systemic models of accident and safety (6–8), realignment of standards and regulations, and gradual approval of devices. Frameworks like Idea-Development-Exploration-Assessment-Long-term-study (IDEAL) are examples of gradual approval processes that have shown some effectiveness (9).

Advocates for digital health care about its speed, coverage, and capacity but perhaps without considering its own suite of challenges (10) and safety concerns, e.g. underuse, misuse or abuse due to lack of training and improper integration. Future development of regulations should make it easier for clinical and academic institutions like the NIHR PSTRCs to produce healthcare information technology in a way that contributes state-of-the-art patient care and safety science insight.

How can I get involved?

What other recommendations would you like to see? What other ways are there to foster the production of healthcare products that are simultaneously effective and safe? Let us know your thoughts by commenting below or joining in on the conversation on Twitter.

References

  1. Altenstetter C. EU and member state medical devices regulation. Int J Technol Assess Health Care. 2003;1(2003):228–48.
  2. Aceto G, Persico V, Pescapé A. Industry 4.0 and Health: Internet of Things, Big Data, and Cloud Computing. J Ind Inf Integr [Internet]. 2020;18(February 2019):100129. Available from: https://doi.org/10.1016/j.jii.2020.100129
  3. Medicines and Healthcare products Regulatory Agency. An introductory guide to the medical device regulation (MDR) and the in vitro diagnostic medical device regulation (IVDR) [Internet]. 2020. Available from: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/640404/MDR_IVDR_guidance_Print_13.pdf
  4. McInerney CD, Scott B, Johnson OA. Are regulations safe? Reflections from developing a digital cancer decision support tool. JCO Clin Cancer Informatics. 2021;353–63.
  5. Hollnagel E. Safety-I and safety-II: the past and future of safety management. Ashgate; 2018.
  6. Ravitz AD, Sapirstein A, Pham JC, Doyle PA. Systems approach and systems engineering applied to health care: Improving patient safety and health care delivery. Johns Hopkins APL Tech Dig (Applied Phys Lab. 2013;31(4):354–65.
  7. Underwood P, Waterson P. Systemic accident analysis: Examining the gap between research and practice. Accid Anal Prev [Internet]. 2013;55:154–64. Available from: http://dx.doi.org/10.1016/j.aap.2013.02.041
  8. Leveson NG. A new accident model for engineering safer systems. Saf Sci. 2004;42(4):237–70.
  9. Hirst A, Philippou Y, Blazeby J, Campbell B, Campbell M, Feinberg J, et al. No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations. Ann Surg. 2019;269(2):211–20.
  10. Sittig DF, Wright A, Coiera E, Magrabi F, Ratwani R, Bates DW, et al. Current challenges in health information technology–related patient safety. Health Informatics J. 2020;26(1):181–9.