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Implementation of COVID-19 related safety measures such as social distancing, use of PPE and cleaning were strongly supported by most respondents. There was ambivalence around less certain measures such as regular staff antigen and antibody testing. Respondents were most likely to participate in research related to their own condition, COVID-19 research and vaccine research, but less likely to participate in healthy volunteer research, especially if suffering from a pre-existing comorbidity identified with increased risk or were female. There was general agreement that participants are comfortable with new ways of working, such as remote consultation, though women and BAME respondents were less comfortable. Findings raise concerns for health inequalities already impacting some groups in the pandemic. The role of clinical necessity and personal benefit support the reopening of services in line with clinical necessity. Moderate caution in respect of vaccine research relative to patient-participant research presents a challenge for pending recruitment demands, and would benefit from qualitative research to explore themes and concerns in more depth and support development and targeting of key messaging.

“After he died, the little plastic ID band that was around his tiny wrist should have been slipped onto mine. There was nothing more that could have been done for him, but there was plenty that needed to be done for me. I needed an infusion of truth and compassion. And the nurses and doctors who took care of him, they needed it too." Leilani Schweitzer[1] When someone is hurt, it is reasonable to expect the healthcare system to provide care to alleviate symptoms or to cure. It is also reasonable to expect those providing the care to be adequately trained and supported to do so. Yet, when harm is caused by healthcare, the spectrum of harm suffered is not well understood, care needs are not fully recognised and, therefore, the care needed to facilitate optimum recovery is not being provided.[2] In fact, with outrageous frequency, at a time when exceptional care is so desperately needed, those hurting describe how they are further harmed from ‘uncaring’ careless and injurious responses. Healthcare harm is a ‘double whammy’ for patients Healthcare harm is a ‘double whammy’. There’s the primary harm itself – to the patient and/or to those left bereaved – but there is also the separate emotional harm caused specifically by being let down by the healthcare professionals/system in which trust had to be placed.[3] This additional emotional harm has been described as being the damage caused to the trust, confidence and hope of the patient and/or their family.[4] Trust – you rely on professionals to take responsibility for what you cannot do yourself. Confidence - you believe that the system will protect you from harm. Hope – you have the conviction that things will turn out well. Anderson-Wallace and Shale[4] For the patient and family to be able to heal from healthcare harm, appropriate care must be provided not only for the primary injury and any fall out from this, but also this additional emotional injury (being let down by healthcare) and any fall out from that. For example, a parent who loses a child as a result of failures in care will need help to cope with the loss of their child and all of the processes that occur as a result. But they will also need support to cope with having had to hand over responsibility for their child’s safety to healthcare professionals, only to be let down, and all the feelings and processes associated with that. Much needs to happen to restore that parent’s trust, confidence and hope in our healthcare system and the staff within it. This is different to the parent of a child who has passed away from an incurable illness despite exemplary healthcare. A parent let down by healthcare has specific additional care and support needs that need to be met to help them cope and work towards recovery. Healthcare harm also causes emotional harm to the staff involved In 2000, Albert Wu introduced the phrase ‘second victim’ in an attempt to highlight the emotional effects for staff involved in a medical error and the need for emotional support to help their recovery.[5] The term has recently been criticised, since families should be considered the second victim,[6] and the word victim is believed “incompatible with the safety of patients and the accountability that patients and families expect from healthcare providers.”[7] While the term itself may be antagonistic, or misrepresentative, the sentiment – that staff involved in incidents need support to cope with what has happened, and to give them the confidence to do what is needed to help the patient/family heal – certainly stands. When staff are involved in an incident of patient harm, they may lose trust in their own ability and the systems they work in to keep patients safe, and they may worry about their future.[5],[8] They need care and support in order to recover themselves and, crucially, so that they feel psychologically safe and are fully supported to be open and honest about what has happened. They need to feel able to do this without fearing personal detrimental consequences for being honest, such as unfair blame or a risk to their career. This is essential to the injured patient/family receiving the full and truthful explanations and apologies they need in order to regain trust, confidence and hope, and, ultimately, to heal as best they can. So, in addition to patients and families there should be a ‘care pathway’ for staff involved in incidents of harm. A google search on ‘second victim’ reveals a wealth of research on the emotional effects of medical error for staff involved and the best ways to provide support for this, and this is resulting in the emergence of staff support provision to aid recovery.[9] In contrast, very little research has been done into the emotional effects and support needs of families and patients. How is ‘care’ for emotional harm given? The ‘treatment’ of the emotional harm has been described as ‘making amends’ – by restoring trust, confidence and hope.[4] Once a patient has been harmed by healthcare, every interaction (physical, verbal or written) they have with healthcare after that will either serve to help them heal or to compound the emotional harm already suffered. Trew et al.[10] describe harm from healthcare as a “significant loss” and conclude that “coping after harm in healthcare is a form of grieving and coping with loss”. In their model, harmed patients and families proceed through a ‘trajectory of grief’ before reaching a state of normalisation. Some can move further into a deeper stage of grief and seemingly become stuck in what is referred to as complicated grief. They can display signs of psychiatric conditions "if there are substantial unresolved issues, or where there is unsupportive action on the part of individuals associated with the healthcare system and the harm experience”. At the point of the harmful event, the patient/family experiences losses, including a drop in psychological wellbeing. From this point on, healthcare staff and organisations have opportunities to respond. If the response is supportive it may be helpful for the patient/family in coping with the losses. If the response is not supportive, this may cause ‘second harm’ complicating the healing process, leaving the patient/family with unresolved questions, emotions, anger and trust issues. The patient’s psychological wellbeing and ability to return to normal functioning are severely affected. “Most healthcare organizations have proved, in the past at least, extraordinarily bad at dealing with injured patients, resorting at times, particularly during litigation, to deeply unpleasant tactics of delay and manipulation which seriously compounded the initial problems. My phrase ‘second trauma’ is not just a linguistic device, but an accurate description of what some patients experience.” Charles Vincent[11] There is no shortage of individuals who have suffered extensive ‘second harm’ sharing their experiences in the hope this will lead to better experiences for others and some help for themselves to recover. Many are, wrongly, being ‘written off’ as historical cases that can no longer be looked at. This cannot be right – when these people are suffering and need appropriate responses to heal their wounds. The extent of suffering that exists now, in people who have been affected by both primary trauma and then second harm from uncaring defensive responses, or responses that have not taken into account the information patients and families themselves have, or relevant questions they ask, is no doubt nothing short of scandalous. There is a pressing urgency for the NHS to stop causing secondary trauma to affected patients and families. ‘Patient safety’ has to start applying to the harmed patient and their family members’ safety after an adverse event, and not just focus on preventing a repeat of the event in the future. Yes, future occurrences must be prevented, learning is crucial, but so is holistically ‘looking after’ all those affected by this incident. If they are not looked after, their safety is at risk as their ability to heal is severely compromised; in fact they are in danger of further psychological trauma. These same principles apply to affected staff. Avoiding second harm: what happens now and what is needed? This series of blogs will highlight that every interaction a harmed patient or family member has with staff in healthcare organisations (not just clinical staff) after a safety incident should be considered as ‘delivery of care’. With this view, the ‘care interaction’ should be carried out by someone trained and skilled and supported to do so, with the genuine intention of meeting the patient/families’ needs and aiding the patient/family to recover and heal (restore trust, hope and confidence). The interaction / response must not cause further harm. Stress or suffering, and the content of the interaction, for example a letter, should not have been compromised, as often occurs, by competing priorities of the organisation to the detriment of the patient/family. Thus, these blogs will look at: The processes that occur after an incident of harm (Duty of Candour, incident investigation, complaint, inquest) with the aforementioned focus. The care the patient and family need and the obligation (that ought to exist) to meet that need. Processes that are core to the package of ‘care’ to be provided to the harmed or bereaved and to be delivered by skilled and supported ‘care providers’. The blog series will seek to show that meaningful patient engagement in all of these processes is crucial for restoring trust, confidence and hope; therefore, aiding healing of all groups in the aftermath of harm. “It is important to respect and support the active involvement of patients and their families in seeking explanations and deciding how best they can be helped. Indeed at a time which is often characterised by a breakdown of trust between clinician and patient, the principle of actively involving patients and families becomes even more important.” Vincent and Coulter, 2002[3] It will also consider the additional care and support needs that might need to be met alongside these processes in a holistic package of care, such as peer support, specialist medical harm psychological support and good quality specialist advice and advocacy. It will describe what is currently available and what more is needed if healthcare is to provide adequate care for those affected by medical error in order to give them the best chance of recovery. Alongside this, the needs of the staff involved will also be considered. We welcome opinion and comments from patients, relatives, staff, researchers and patient safety experts on what should be considered when designing three harmed patient care pathways: for patients, families and staff. What is the right approach? What actions should be taken? How can these actions be implemented? What more needs to be done? Join in the discussion and give us your feedback so we can inform the work to design a harmed patient care pathway that, when implemented, will reduce the extra suffering currently (and avoidably) experienced by so many. Comment on this blog below, email us your feedback or start a conversation in the Community. References 1. Leilani Schweitzer. Transparency, compassion, and truth in medical errors. TEDxUniversityofNevada. 12 Feb 2013. 2. Bell SK, Etchegaray JM, Gaufberg E, et al. A multi-stakeholder consensus-driven research agenda for better understanding and supporting the emotional impact of harmful events on patients and families. J Comm J Qual Patient Saf 2018;44(7):424-435. 3. Vincent CA, Coulter A. Patient safety: what about the patient? BMJ Qual Saf 2002;11(1):76-80. 4. Anderson-Wallace M, Shale S. Restoring trust: What is ‘quality’ in the aftermath of healthcare harm? Clin Risk 2014;20(1-2):16-18. 5. Wu AW. Medical error: the second victim: The doctor who makes the mistake needs help too. BMJ 2000;320(7237):726-727. 6. Shorrock S. The real second victims. Humanistic Systems website. 7. Clarkson M, Haskell H, Hemmelgarn C, Skolnik PJ. Editorial: Abandon the term “second victim”. BMJ 2019; 364:l1233. 8. Scott SD, Hirschinger LE, Cox KR, McCoig M, Brandt J, Hall LW. The natural history of recovery for the healthcare provider “second victim” after adverse patient events. Qual Saf Health Care 2009;18(5):325-330. 9. Second victim support for managers website. Yorkshire Quality and Safety Research Group and the Improvement Academy. 10. Trew M, Nettleton S, Flemons W. Harm to Healing – Partnering with Patients Who Have Been Harmed. Canadian Patient Safety Institute 2012. 11. Vincent C. Patient Safety. Second Edition. BMJ Books 2010.

Let's start with a summary of where we are in the blogs. I’m told our reader likes the summary (a Mrs Trellis of North Wales). In part one we decided why we investigate an incident and what an incident was. In part two we decided that two investigators (or more) collect facts together in a more accurate way than one would. In part three we gazed into each other’s eyes and concluded that facts are our friends and where they might come from. We decided interviews and photos give us good facts. In part four we were introduced to what human factors is, and what it is all about and how western psychology is about exploiting the worker! In part five we thought that facts are time dependent and men of my age should not wear shorts outside a restaurant/come damaged aircraft. We discussed how dependent witness memories are on the elapsed time for the effective retrieval of information. These blogs, therefore, are asking simple investigation questions of Who, What, When and Why, and basic questions about what can humans do (human factors). So here we are back to the powerful question ‘Why’ but this time, rather than "why investigate an event?", we are asking "why did this event happen?". Most investigations stop at the point of understanding how the person was injured or died. The how they died does not give you enough data to prevent it occurring again. Knowing, for example, that an elderly, lone rail passenger unfamiliar with the station died from head injuries after falling on a platform with the investigation team concluding that ‘they lost their balance and fell backwards’ does not help understand why this happened or how to prevent its reoccurrence. Why did it occur that day, to that person, on that platform? Might an intervention based on the question ‘How’ be that no one over 60, who is unfamiliar with the station and travelling alone, be prohibited from travel. The important question is why and not how. Likewise, a pedestrian is found dead by the side of the road after a collision with a van. How did they die? Well head trauma after collision with a van. How did that occur? The driver said that at night it was too dark to see the running pedestrian. Indeed, at the reconstruction it was very dark. But after 25 questions of ‘why’ came the critical ones. Why was a person out running in near total darkness without a light? Why could the van driver not see them? Why was there no light (torch etc) found with the pedestrian so they could run without falling into the numerous pot holes? Why that van and why that pedestrian. The why (in this case) comes from human factors research into perceptual thresholds of how much light needs to hit the retina for the cognitive process to start. Long story, but the answer to why was a murder disguised as a traffic accident. Which takes us back to my first blog – what’s an accident – this was not a rare random event with multiple causes. It had one cause – top tip sleeping with a colleague’s partner is not a good idea. Unless you answer why, then there is no intervention and that ‘why’ is ‘why’ we do this. Becoming a 5-year-old The skill of an investigator in human factors is to keep asking the question Why (and perhaps not to insist an infographic is needed). Like my 5-year-old self. Why can’t I ride my bike to the next town… But why, but why. The police car brought me back last time – I was not lost. This may explain why a disproportionate number of my friends are clinical psychologists! Case studies Two case studies. Let’s stick to rail. I can do why are anaesthetics rooms so small, but I’ll get all emotional! If I’m found dead in an alley it’s a hospital facilities manager wot did it. Case One A train station where there are 17 serious incidents on a single set of steps down to platform 1. It’s a traditional Victorian design urban station with access at street level and platforms below the booking hall. All platforms are connected by a glass overpass. No other platform (there are six) has an issue. One case is a fatality. How did they occur? The answer is – the person fell down the stairs. Head injuries and broken legs (not the same person!) are common. The ‘how ‘is answered. The why is not. Why did they fall down the stairs we asked. “There are stairs and people will fall down them” came the reply. Why? “Well there are stairs and people will fall down them”. But why these stairs, why this platform, and why 17 people? Well, came the reply, we will have to put a poster up telling people ‘these are stairs.’ Why did they fall we asked? We have a poster telling people how not to fall down them and how to use stairs (hold the handrail) they replied. We asked as a five-year-old would – why do you think these people have problems with these stairs? So, let’s think of the why questions after some facts. Might be worth also predicting that posters are the sign of defeat and result from only asking ‘how’. Also, putting posters above stairs, so that people look at them and not the stairs, is another classic failure of understanding human performance. Some facts Timetable information shows platform 1 is the city bound platform. Observations indicate that people descend the stairs very rapidly when there is a train present at the platform. Secondary observations come to understand that running starts at the ticket office overlooking the glass passageway over to the platform. Incident data reveals peak at rush hour above that of exposure (rise in passenger numbers). Only platform 1 can been seen from the walkway and the ticket office. The ‘why’ hypotheses was that as people became aware of the train arriving at the city bound platform, they made a run for it. We interviewed several of those injured. Most common statement from the predominantly local people was “I knew I would miss the train as I could see it at the platform, so I ran”. The remedy was to put plastic obscuring film over the glass walkway so you could not see if a train was at the platform. No cognisance of a train’s presence = no rapid stair descents. Only journeys into the city appear to be highly time dependent. Outcome After 11 years, no incidents on the stairs, no aggression to the ticket office staff (give me my ticket now!) and posters removed. Why – we asked ‘why’ not ‘how’. Removing ‘safety’ posters is always a good idea. I’m still trying to find out what an internal brand consultant is – they were against the removal of posters. Answers if you know what these are and how they make the world better please. Case 2 At a train station, there were 27 falls ‘down the steps’ of which four were citizens from the USA. These citizens of America are after the compensation for ‘foreseeable’ injury in the US courts. Think expensive when compared to compensation claims in the UK. As above, ‘the how’ was they were injured by a fall. Why at this station? Why these people? Some facts Incident data revealed all those falling down the stairs were visitors to the area (based on address supplied). Plans of the Victorian station reveals it’s a small (four platform station) with over 80 different exit route combinations, via three underpasses. Exit here is time-critical – it’s near an airport with a connecting bus. There are over 130 signs containing over 900 words of advice. Observations and interviews showed that perhaps passengers lost spatial and situational awareness (more in later blogs) and became disoriented. CCTV images showed one passenger was walking up and down the platform twice, then walking through one of the underpasses six times, before they injured their arm when the bag got caught in the handrail and they ‘went down, way down, the steps’ ( from Incident report). Our initial hypothesis was that a lost and disoriented passenger with bags will find stairs more of a challenge than one who is not. Remedy We removed most of the signs on the platforms and underpasses and replaced with one type of exit sign. Whether its exit to the airport or exit to the pub it’s still an exit. Locals – not represented at all in the data – know which of the combination of exits will get them to the pub. Outcome No incidents in 12 years, and the platform staff last year took rail executives around ‘their’ station telling them how easy it was to prevent slips, trips and falls because “someone asked why”. Why, and multiple causes Early on in our blog life together we said that accidents have multiple causes. In healthcare we are not sure how many variables there are and even the extent of the problem. We also described that the cause is about the ‘environment’, the ‘human’, the ‘system of working’ or the ‘equipment’. We decided together this determines ‘who should investigate’. Engineering failings are done by engineers, for systems failures investigations by nursing staff are recommended. Well here the ‘Why' word repeated on the first day is the solution to find out who should investigate. When do you know you have possibly stopped asking why too early? The common reasons for stopping asking the question ‘why’ is when you get to one of the following conclusions: 1. Its human error. 2. It’s the person who had the incidents fault – but remember organisations fail not people. If you get these conclusions, keep going and ask your friendly human factors person for help. Remember, one of the limits of investigations is that you can’t ask questions about things you don’t know about – obvious really, but that’s why there should be two of you and perhaps one of those is a human factors person. A major failing in root cause analysis is this fact is always overlooked. 3. I cannot ask ‘why’ anymore without getting asked to leave the building/the NHS/the human race… The solution is to ask questions using the Socratic method. More later when we think about logic – but the Greek philosophy types nailed it many centuries ago (just like they invented human factors in medicine; ergonomics they called it). Citing Professor Wiki once more and to appeal to the midwifes among you, the Socratic method is: “a form of cooperative argumentative dialogue between individuals, based on asking and answering questions to stimulate critical thinking and to draw out ideas and underlying presuppositions. It is named after the Classical Greek philosopher Socrates and is introduced by him in Plato's Theaetetus as midwifery (maieutic) because it is employed to bring out definitions implicit in the interlocutors' beliefs, or to help them further their understanding”. Again, this is part of the human factors persons training and why we ask the questions in the way we do to members of the investigation team (sorry). There is a management consultancy (boo hiss) methodology called the ‘5 why method’, and its creeps into the root cause analysis nonsense (more boos). But just asking why without the Socratic teachings tends to just annoy people. Exploring ‘Why’ as an equal to the person you are talking to is more respectful and gets better data, and you should not get thumped. Who asks why and to whom? In later blogs we shall chat about interviewing witnesses. This blog is about the internal dialogue in the investigation team or, if there is just one of you, the internal monologue. Asking why to a witness is generally not the thing to do. Its common in healthcare but the witness cannot report Why, they only know the How. Witnesses provide facts, the team finds answers from those facts ('Where do facts come from?'). Summary The ‘Why’ word is very powerful when added to a blank sheet of paper and a pen in the hand of the investigator and means that you focus on the outcome and not on a process. As replies to my earlier blogs – about how healthcare is all about process and not outcomes – well one word and some paper mean you can just focus on prevention. And dear reader why we investigate is to prevent it occurring – in the words of Metallica – 'Nothing else matters'. And finally... The station (discussed above) where elderly people represent the dataset. All falling backwards on platform 1 and our initial (yours and mine dear reader) remedy was to exclude over 60s from it unless they were trained. Suggestions of why and what questions would you ask. Comments below. Top tip – no one was running and all very cognisant of the train times, and all but one sober. Happy if you want to test out the Socratic method now. Posters, as a solution, are not permitted. Read Martin's other blogs Why investigate? Part 1 Why investigate? Part 2: Where do facts come from (mummy)? Who should investigate? Part 3 Human factors – the scientific study of man in her built environment. Part 4 When to investigate? Part 5

Key benefits of tool Raises the profile of Health & Safety – engages the workforce to talk about health and safety issues. Captures sensitive information – participants respond anonymously. Enables active management of health and safety - allows companies to highlight both areas of concern and good practice. Provides a baseline measure - can help you evaluate whether health and safety initiatives have had the desired effects on performance. Key features Generates paper and HTML versions of the questionnaire. Quick wizard guides the user through easy set up to produce the survey. The survey can be tailored towards the organisation, for example by incorporating the company logo and supporting Management statement and by tailoring terminology within the SCT statements. Allows for up to 9 demographic questions and an additional 6 open questions. The software automatically analyses the data to produce a series of charts and also allows detailed filtering to further interrogate your findings

The web page includes information on: Which deaths are reported to the coroner What happens next after a death is reported About identifying the body Coroner liaison officers Post mortem examinations Post mortem results Returning the body Funeral arrangements Inquests

The second edition takes a more practical approach with coverage of methods, interventions and applications and a greater range of domains such as medication safety, surgery, anaesthesia, and infection prevention. New topics include: work schedules error recovery telemedicine workflow analysis simulation health information technology development and design patient safety management. Reflecting developments and advances in the five years since the first edition, the book explores medical technology and telemedicine and puts a special emphasis on the contributions of human factors and ergonomics to the improvement of patient safety and quality of care. In order to take patient safety to the next level, collaboration between human factors professionals and health care providers must occur. This book brings both groups closer to achieving that goal.

This web page addresses some of the myths around eating disorders and includes videos of patients with eating disorders talking about their experiences.

Talking openly about cancer and our experiences makes a huge difference in increasing understanding, overcoming stigma and reducing fear. This page give you access to numerous stories from around the world from people living with and have experience of living with cancer.

The report by INQUEST sets out the following recommendations to improve safety and prevent future deaths: 1. Halt prison building, commit to an immediate reduction in the prison population and divert people away from the criminal justice system. 2. Prison staff, including healthcare staff, require improved training to meet minimum human rights standards to ensure the health, well-being and safety of prisoners. 3. Ensure access to justice for bereaved families through the provision of automatic non-means tested legal aid funding for specialist legal representation to cover preparation and representation at the inquest and other legal processes. Funding should be equivalent to that of the state bodies/public authorities and corporate bodies represented. 4. Establish a ‘National Oversight Mechanism’ – a new and independent body tasked with the duty to collate, analyse and monitor learning and implementation arising out of post death investigations, inquiries and inquests. This body must be accountable to parliament to ensure the advantage of parliamentary oversight and debate. It should provide a role for bereaved families and community groups to voice concerns and provide a mandate for its work. 5. Ensure accountability for institutional failings that lead to deaths in prison. For example, full consideration should be given to prosecutions under the Corporate Manslaughter and Corporate Homicide Act, where ongoing failures are identified and the prison service and health providers have been forewarned. The reintroduction of The Public Authority (Accountability) Bill would also establish a statutory duty of candour on state authorities and officers and private entities.

This report from the New South Wales Agency for Clinical Innovation draws on scientific literature, empirical data and experiential evidence from patients, carers and clinicians regarding over-diagnosis and over-treatment in frail elderly patients. Underlying reasons for over-diagnosis and over-treatment include professional, cultural, organisational, health system, patient and carer and technology issues. A shift towards balanced care that supports realistic expectations and delivery models informed by research, empirical and experiential knowledge is required to address issues related to over-treatment and over-diagnosis.

This short, moving, animation has been produced to support the Justice for LB campaign.

Key take home messages Placing our faith in data management to improve patient experience at the frontline is dangerous. The fixation on right solutions, the desire to roll-out changes quickly and an assumption that impact measurement as depicted on a graph, do not help and potentially even distract emphasis away from the human interactions that patients and their relatives need. The positive ways that staff responded to an approach that allows them to put concepts of data to one side, and that gives them permission to relate on more human levels, suggests that they too need these interactions. Large datasets have their place in large organisations but perhaps are best kept away from frontline care.