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Content Article
Patients with vision or hearing loss frequently encounter difficulties accessing vital health information, medication instructions, and effectively using medical devices. This report for the Patient Safety Commissioner for England, commissioned from Professor Margaret Watson, highlights serious gaps and deficiencies in the way that people with visual and/or hearing impairment or loss (referred to as sensory impairment) are able to access and use medicines and medical devices safely. This report presents the results of a short-term study to explore the challenges experienced by patients with sensory impairment in relation to their safe and effective access to and use of medicines and medical devices. This study was conducted from September to December 2024. The primary data that were generated were derived from three sources: Focus groups involving individuals with visual impairment or loss, including people with diabetes. Key Informant responses to an electronic survey. Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card reports. Patients reported distressing experiences due to inaccessible packaging, unreadable patient information, inadequate communication about medication changes and a lack of suitable reporting mechanisms for issues. The report makes the following recommendations: The MHRA needs to review – working alongside patients – whether their current guidance and regulations for the licencing and packaging of medicines goes as far as is possible to enable their safe use by those with sensory impairment. The Association of the British Pharmaceutical Industry (ABPI), MHRA and Department of Health and Social Care (DHSC) should work together to restart work – alongside published milestones – to digitise paper-based patient information leaflets via the existing UK Electronic Patient Information Task Force (ePIL). As part of this restart, ePIL – working with patients – should examine how to maximise the benefits of this work for patients with sensory impairment. NHS England’s Diabetes Programme Team should launch a patient reference group to assess, understand and mitigate the barriers and enablers to the safe and effective roll-out of medical devices and other education programmes for the management of diabetes (such as DAFNE) for those with sensory impairments. DHSC and NHS England need to ensure the work announced to improve and expand the NHS App in ‘Reforming elective care for patients’ includes an assessment – conducted with the input of patients – to determine whether further accessibility improvements are required, especially for people with visual impairment. In a number of other areas, the report states that the Patient Safety Commissioner wants to make observations to a number of bodies – highlighting the outcome without specifying the solutions, in keeping with the ethos of the recent Health Services Safety Investigations Body (HSSIB) report ‘Recommendations but no action: improving the effectiveness of quality and safety recommendations in healthcare.’ The report makes the following observations: A patient’s medical record needs to include a prominent flag of accessibility needs and detailed information about these needs to ensure that the healthcare professional can provide any required reasonable adjustments. All relevant healthcare professionals – including community pharmacists – must have sufficient access to these patient records and flags. Healthcare professionals, particularly community pharmacy personnel and others involved in the direct supply of medicines and medical devices, must have sufficient funding to support the additional time and resources required by to undertake assessments of patient needs and provide the required ‘reasonable adjustments’ for medicines and medical devices. With the anticipated increase in prevalence of sensory impairment amongst the general population, further guidance is required to promote evidence-based practice by health and social care professionals in terms of the medicine journey of people with sensory impairment. It is also crucial that there is provision of training to healthcare professionals (ideally within the undergraduate curricula) regarding the needs of people with sensory impairment. People with experience of sensory impairment should be included in the design of medical devices, as well as user information and instructions to accompany their supply and use. Manufacturers need to provide more resources to facilitate the demonstration of the effective use of medical devices, especially for people with visual impairment.- Posted
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News Article
Parents are putting more trust into ChatGPT than actual doctors, study finds
Patient Safety Learning posted a news article in News
Parents are trusting ChatGPT for medical advice over actual doctors and nurses, a new study found. Researchers at the University of Kansas also found that parents also say AI-generated text is credible, trustworthy and moral. “When we began this research, it was right after ChatGPT first launched — we had concerns about how parents would use this new, easy method to gather health information for their children,” lead author and doctoral student Calissa Leslie-Miller said in a release. “Parents often turn to the internet for advice, so we wanted to understand what using ChatGPT would look like and what we should be worried about.” Participants in the study were given health-related text, reviewing content generated by healthcare professionals and the OpenAI chatbot ChatGPT. They were not told who, or what, authored the texts. They were asked to rate the texts based on five criteria - perceived morality, trustworthiness, expertise, accuracy and how likely they would be to rely on the information. In many cases, parents couldn’t tell which content was generated by ChatGPT or by the experts. When there were significant differences in ratings, ChatGPT was rated to be more trustworthy, accurate and reliable than the expert-generated content. Read full story Source: The Independent, 30 October 2024- Posted
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Content Article
ChatGPT and other large language models have the potential to transform the health information landscape online. However, lack of domain-specific expertise and known errors in large language models raise concerns about the widespread adoption of content generated by these tools for parents making healthcare decisions for their children. The aim of this study is to determine if health-related text generated by ChatGPT under the supervision of an expert is comparable to that generated by an expert regarding persuasiveness and credibility from the perspective of a parent. Results indicate that prompt engineered ChatGPT is capable of impacting behavioural intentions for medication, sleep, and diet decision-making. Additionally, there was little distinction between prompt engineered ChatGPT and content experts on perceived morality, trustworthiness, expertise, accuracy, and reliance. Notably, when differences were present, prompt engineered ChatGPT was rated as higher in trustworthiness and accuracy, and participants indicated they would be more likely to rely on the information presented by prompt engineered ChatGPT compared to the expert. -
Event
This masterclass will focus on developing your role as a SIRO (Senior Information Risk Owner) in health and social care. Key learning objectives: Understanding the role of the Senior Information Risk Owner. Identifying Information Risks across the organisation. Working with others to mitigate the risk to patients, staff and organisation. Confidence that all reasonable technical and organisation measure are in place. Giving assurance to the Board that risks have been considered, mitigated or owned. Understand the requirements of external confidence that policies, procedures are in place to deal with Data Breaches. hub members receive a 20% discount. Email [email protected] for discount code. Register- Posted
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Community Post
Better use of data for medication safety in hospitals
Kenny Fraser posted a topic in Medicine management
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NHS hospital staff spend countless hours capturing data in electronic prescribing and medicines administration systems. Yet that data remains difficult to access and use to support patient care. This is a tremendous opportunity to improve patient safety, drive efficiencies and save time for frontline staff. I have just published a post about this challenge and Triscribe's solution. I would love to hear any comments or feedback on the topic... How could we use this information better? What are hospitals already doing? Where are the gaps? Thanks- Posted
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- Medication - related
- Patient identification
- Patient safety strategy
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- User-centred design
- Workforce management
- Information sharing
- Staff engagement
- Training
- Time management
- Allergies
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- Urinary tract infections
- Antimicrobial resistance (AMR)
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Content Article
On the 23 January 2023 the Minister for Mental Health and Women’s Health Strategy, Maria Caulfield MP, announced the commencement of a rapid review into patient safety in mental health inpatient settings in England. The review Chair, Dr Geraldine Strathdee, was asked to consider how improvements could be made to the way that data and information is used in relation to patient safety in mental health inpatient care settings and pathways, including for people with a learning disability and autistic people. This report contains the findings of this review and an associated set of recommendations. Below is a brief summary of the main recommendations set out in this report. The findings and recommendations in full can be read here. Recommendation 1 NHS England should establish a programme of work, co-produced with experts by experience and key national, regional and local leaders, including Care Quality Commission (CQC), Integrated Care Systems (ICSs), provider collaboratives, independent safeguarding bodies, professional bodies, provider representatives and third sector organisations, among others, to agree how to make sure that providers, commissioners and national bodies are ‘measuring what matters’ for mental health inpatient services, and can access the information they need to provide safe, therapeutic care. Recommendation 2 Digital platforms that allow the collection of core patient information and associated data infrastructure must allow submissions into relevant national data sets, directly or through other interoperable platforms, and facilitate data flows between systems of different local provider organisations to support joined-up understanding of care pathways. These systems should allow the data collected to be made available to different decision makers, including CQC, at the appropriate level of aggregation and without requiring duplicative submissions, and allow benchmarking across trusts and independent sector providers. NHS England’s Transformation Directorate should scope out options for how this ambition could be delivered, including cost implications and a value for money assessment to help providers meet this aim specifically for mental health, including specific ways in which mental health electronic patient record improvement and data sharing can be prioritised and interdependencies with other systems and programmes of work. Recommendation 3 ICSs and provider collaboratives should bring together trusts and independent sector providers, along with other relevant stakeholders such as independent safeguarding bodies, across all healthcare sectors to facilitate the cross-sector sharing of good practice in data collection, reporting and use. Recommendation 4 The Department of Health and Social Care, in partnership with NHS England and CQC and supported by key experts from across governmental and non-governmental organisations, should convene all the relevant organisations who collect and analyse mortality data to determine what further action is needed to improve the timeliness, quality and availability of that data. Recommendation 5 Provider boards should take the following actions to improve their capacity to identify, prevent and respond to risks to patient safety: Every provider board should urgently review its membership and skillset and ensure that the board has an expert by experience and carer representative. Every provider board should ensure that its membership has the skills to understand and interpret data about mental health inpatient pathways and ensure that a responsive quality improvement methodology is embedded across their organisations. CQC should assess and report on whether the membership of the boards of providers of mental health inpatient services includes experts by experience (including carer) representatives and whether boards are maintaining an appropriately high level of data literacy and quality improvement expertise on mental health inpatient pathways among their membership as part of their assessments. Every provider board should urgently review its approach to board reports and board assessment frameworks to ensure that they highlight the key risks in all of their mental health inpatient wards, as set out in the safety issues framework, and that they support the board to take action to mitigate risks and improve care, including both quantitative data and qualitative ‘soft intelligence’ such as feedback from patients, staff and carers. NHS England should review and update the guidance on board assessment frameworks. Recommendation 6 Trust and provider leaders, including board members, should prioritise spending time on wards regularly, including regular unannounced and ‘out-of-hours’ visits, to be available to and gather informal intelligence from staff and patients. Recommendation 7 All providers of NHS-funded care should review the information they provide about their inpatient services to patients and carers annually and make sure that comprehensive information about staffing, ward environment, therapeutic activity and other relevant information about life on the wards is available. CQC should assess the quality, availability and accessibility of this information as part of their assessment of services. Recommendation 8 ICSs and provider collaboratives should map out the pathway for all their mental health service lines to establish which parties need access to relevant data at all points on the pathway and take steps to ensure that data is available to those who need it. Recommendation 9 ICSs will develop system-wide infrastructure strategies by December 2023 and the mental health estate needs to be fully incorporated and represented in these strategies and in subsequent local action plans. This recommendation is for local ICSs to review the mental health estate to inform these and future strategies, recognising there are evidence-based therapeutic design features that can contribute to reducing risk and improving safety. Recommendation 10 Providers should review their processes for allowing ward visitors access to mental health inpatient wards with a view to increasing the amount of time families, carers, friends and advocates can spend on wards. The Department of Health and Social Care should consider what more can be done to strengthen the expectation for all health and care providers in England to allow visiting. Recommendation 11 All providers of NHS-funded care should meet the relevant core carer standards set by the National Institute for Health and Care Excellence (NICE) and Triangle of Care, England. Regulators, including CQC and professional regulators, should consider how to monitor the implementation of these carer standards, especially where there is greater risk of unsafe closed cultures developing. ICSs should consider how to routinely seek carer feedback. Inpatient staff training programmes should identify how they can benefit from carer trainers. For patients detained under the Mental Health Act, families and carers should be part of all detention reviews. Recommendation 12 Professional bodies, such as the Royal Colleges, should come together across healthcare sectors to form an alliance for compassionate professional care. This multi-professional alliance should: work together and learn from each other to identify ways to drive improvement in the quality of compassionate care and safety across all sectors, including mental health services, and how they can support staff to provide it along with their specialist data units, where they exist, contribute to the work set out in recommendation. Recommendation 13 Except where specified, these recommendations should be implemented by all parties within 12 months of the publication of this report. Government ministers, through the Department of Health and Social Care, should review progress against these recommendations after 12 months.- Posted
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News Article
Former BBC Technology correspondent Rory Cellan-Jones, now a writer and podcaster, has Parkinson's disease. Two weeks ago, after fracturing his elbow in a nasty fall, he found out just how difficult it can be to get answers from the NHS. "Getting information about one's treatment seems like an obstacle race where the system is always one step ahead. But communication between medical staff within and between hospitals also appears hopelessly inadequate, with the gulf between doctors and nurses particularly acute. "I also sense that, in some cases, new computer systems are slowing not speeding information through the system. On Saturday morning, as we waited in the surgical assessment unit, four nurses gathered around a computer screen while a fifth explained to them all the steps needed to check-in a patient and get them into a bed. It took about 20 minutes and appeared to be akin to mastering some complex video game beset with bear traps." Rory's latest experience as a customer of the health service has left him convinced that more money and more staff won't solve its problems without some fundamental changes in the way it communicates. Read full story Source: BBC News, 29 October 2023- Posted
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Content Article
Healthcare systems rely on self-advocacy from service users to maintain the safety and quality of care. Systemic bias, service pressures and workforce issues often deny agency to patients at times when they need to have most control over representation of their story. This drives diagnostic error, treatment delay or failure to treat important conditions. In maternal care, perinatal mental health and thrombosis are significant challenges. With funding from SBRI Health care, Ulster University and Southern Health and Social Care Trust are developing an NLP powered platform that will empower mothers to be more active agents in their perinatal care. Download the poster below.- Posted
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Content Article
Hindsight bias (colloquially known as ‘the retrospectoscope’) is the tendency to perceive past events as more predictable than they actually were. It has been shown to play a significant role in the evaluation of an past event, and has been demonstrated in both medical and judicial settings. This study in Clinical Medicine aimed to determine whether hindsight bias impacts on retrospective case note review, through an internet survey completed by doctors of different grades. The authors found that in some cases, doctors are markedly more critical of identical healthcare when a patient dies compared to when a patient survives. Hindsight bias while reviewing care when a patient survives might prevent identification of learning arising from errors. They also suggest that hindsight bias combined with a legal duty of candour will cause families to be informed that patients died because of healthcare error when this is not a fact.- Posted
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Content Article
To receive and participate in medical care, patients need high quality information about treatments, tests, and services—including information about the benefits of and risks from prescription drugs. Provision of information can support ethical principles of patient autonomy and informed consent, facilitate shared decision making, and help to ensure that treatment is sensitive to, and meets the needs and priorities of, individuals. Patients value high quality, written information to supplement and reinforce the verbal information given by clinicians. This is the case even for those who do not want to participate in shared decision making. The aim of this study was to evaluate the frequency with which relevant and accurate information about the benefits and related uncertainties of anticancer drugs are communicated to patients and clinicians in regulated information sources in Europe. The findings of this study highlight the need to improve the communication of the benefits and related uncertainties of anticancer drugs in regulated information sources in Europe to support evidence informed decision making by patients and their clinicians.- Posted
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Content Article
EasyFOI is an email address compiler designed to help you send identical freedom of information requests to multiple organisations. Journalists, researchers and ordinary members of the public use the FOI act every day to request all kinds of information from statutory public bodies. You may want to request the same information from different organisations. But it can be hard to find a central list of every public body in the country, let alone their FOI inboxes (which don't tend to follow a standard format). EasyFOI is here to make that easier. Instead of searching for each organisation's contact details, or compiling your own database, you can use this simple tool to copy the appropriate email address for every relevant organisation straight into your device's clipboard. You can also use the EasyFOI generator to help you write your request in seconds. The EasyFOI database doesn't yet cover all public bodies. But it's expanding all the time, and currently includes more than 1,000 organisations.- Posted
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News Article
Data regulator issues new guidance for healthcare sector on transparency
Patient Safety Learning posted a news article in News
The UK’s data protection regulator has published new guidance for health and social care organisations it says will help them be more transparent about how personal information is being used. The Information Commissioner’s Office (ICO) said the new guidance would provide regulatory certainty to organisations on how they should keep people properly informed as technology is increasingly used to deliver care and carry out research. The regulator said focus on the issue was needed as the health and social care sector routinely handles sensitive information about the most intimate aspects of peoples’ health, and that under data protection law, people have a right to know what is happening to their personal information. Being transparent is essential to building public trust in health and social care services Anne Russell, head of regulatory policy projects at the ICO, said the ever-increasing use of technology meant personal data was more important than ever, and so therefore was more transparency. “Being transparent is essential to building public trust in health and social care services,” she said. “If people clearly understand how and why their personal information is being used, they are likely to feel empowered to share their health information to both access care and support initiatives such as medical research. “As new technologies are developed and deployed in the health sector, our personal information is becoming more important than ever to boost the efficiency and public benefit of these systems. “With this bespoke guidance, we want to support health and social care organisations by improving their understanding of effective transparency, ensuring that they are clear, open and honest with everyone whose personal information is being used.” Read full story Source: The Independent, 15 April 2024- Posted
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AI chatbots ‘lack safeguards to prevent spread of health disinformation’
Patient Safety Learning posted a news article in News
Many popular AI chatbots, including ChatGPT and Google’s Gemini, lack adequate safeguards to prevent the creation of health disinformation when prompted, according to a new study. Research by a team of experts from around the world, led by researchers from Flinders University in Adelaide, Australia, and published in the BMJ found that the large language models (LLMs) used to power publicly accessible chatbots failed to block attempts to create realistic-looking disinformation on health topics. As part of the study, researchers asked a range of chatbots to create a short blog post with an attention-grabbing title and containing realistic-looking journal references and patient and doctor testimonials on two health disinformation topics: that sunscreen causes skin cancer and that the alkaline diet is a cure for cancer. The researchers said that several high-profile, publicly available AI tools and chatbots, including OpenAI’s ChatGPT, Google’s Gemini and a chatbot powered by Meta’s Llama 2 LLM, consistently generated blog posts containing health disinformation when asked – including three months after the initial test and being reported to developers when researchers wanted to assess if safeguards had improved. In response to the findings, the researchers have called for “enhanced regulation, transparency, and routine auditing” of LLMs to help prevent the “mass generation of health disinformation”. Read full story Source: The Independent, 20 March 2024 -
Event
This masterclass will focus on developing your role as a SIRO (Senior Information Risk Owner) in health and social care. Key learning objectives Understanding the role of the Senior Information Risk Owner Identifying Information Risks across the organisation Working with others to mitigate the risk to patients, staff and organisation. Confidence that all reasonable technical and organisation measure are in place Giving assurance to the Board that risks have been considered, mitigated or owned Understand the requirements of external confidence that policies, procedures are in place to deal with Data Breaches Facilitated by: Andrew Harvey IG Consultant BJM IG Privacy Ltd Register hub members receive a 20% discount code. Email [email protected] for discount code. -
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Community Post
Hi everybody This is Jaione from Spain (we are in the North, Basque Region) and i am a nurse working in collaboration with the Patient Safety Team in our local NHS (Basque Health Service). First of all, I would like to congratulate the team for this hub which i think is a wonderful idea. Secondly, i would like to apologize for the language, since, although i lived in England many years ago, that is not the case anymore and I'm afraid i don't speak as well as I used to. I would like to comment a problem that we encounter very often in our organization which is related to patient's regular medications when they are admitted to hospital. We do have online prescriptions for both acute and community settings but the programs don't really speak to each other so, for example, if I take a blood pressure pill everyday and i get admitted into hospital, chances are that my blood pressure tablet won't get prescribed during my in-hospital stay. The logical thing to do would be to change both online systems so they communicate to each other, but that's not possible at the moment. I wanted to ask whether other systems have the same problem and, if so, if there is any strategy implemented to alleviate this issue. I hope i have expressed myself as clearly as possible. Thanks very much once more for this hub! Kind regards Jaione- Posted
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News Article
In a bid to fight against misinformation about the coronavirus vaccines, a group of scientists from all over the world have created an online guide to building a ‘truth sandwich’. The guide serves to arm people with practical tips, up-to-date information and evidence to talk reliably about the vaccines, and enable them to constructively challenge associated myths. The scientists, led by the University of Bristol, are appealing to everyone to understand the facts set out in the 'COVID-19 Vaccine Communication Handbook', follow the guidance and spread the word. Professor Stephan Lewandowsky, the lead author of the guide, said: “Vaccines are our ticket to freedom and communication about them should be our passport to getting everyone on board." “The way all of us refer to and discuss the COVID-19 vaccines can literally help win the battle against this devastating virus by tackling misinformation and improving uptake, which is crucial." Read full story Source: The Independent, 7 January 2021 -
Content Article
This document from the Patient Safety Authority outlines final recommendations to acute care facilities in the USA regarding patient weights. The Patient Safety Authority is responsible for submitting recommendations to the Department of Health (Department) in the US for changes in health care practices and procedures which may be instituted for the purpose of reducing the number and severity of serious events and incidents. Having accurate patient information (for example, age, allergies, laboratory results) helps practitioners select medications, doses and routes of administration. One vital piece of information, the patient's weight, is especially important, because it is used to calculate the appropriate dose of a medication (for example, mg/kg, mcg/kg, mg/m2). A prescribed or dispensed medication dose can differ significantly from the appropriate dose because of missing or inaccurate patient weights. Patients in oncology treatment, patients with renal insufficiency, or who are elderly, paediatric or neonatal are at greater risk for adverse drug events, because they are more vulnerable to the effects of an error, and their weight may change frequently over short periods of time. Formulas such as the Cockcroft-Gault equation, which is used to calculate creatinine clearance to aid in the dosing of medications, and the Harris-Benedict formula, which is used to calculate basal metabolic rate, rely on knowledge of an accurate patient weight. Also, both height and weight are needed to use nomograms to determine body surface area and body mass index, for example, when calculating doses for chemotherapy. In the United States, most patients are weighed in pounds. But weighing and documenting patients' weights in pounds introduces the need to convert the weight into kilograms—an error-prone process—to conduct weight-based and other dosing. Another risk when measuring the patient's weight in pounds is failing to convert the weight into kilograms but recording that weight in kilograms (that is, documenting a weight of 200 lbs. as 200 kg instead of 90.9 kg), resulting in more than two-fold dosing errors. This document recommends a number of procedures to ensure accurate patient weights. Further reading Weight-based medication errors: How to tip the scale in the right direction- Posted
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The United States is one of only three countries in the world that does not use the metric system. Yet, every single medication prescribed today is based on it. In addition to dosages based on the metric system, some doses are also very dependent on patient weight. These include blood thinners, certain antibiotics, chemotherapy agents, and many pediatric doses. The very young, very old, and people with certain medical conditions are at the highest risk of experiencing harm because their bodies are more sensitive to the effects of an error. Calculations made with incorrect weights can have devastating, if not fatal, consequences. Further reading Patient Safety Authority Department of Health: Final recommendation to ensure accurate patient weights- Posted
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Content Article
The Accessible Information Standard directs and defines a specific, consistent approach to identifying, recording, flagging, sharing and meeting individuals’ information and communication support needs by NHS and adult social care service providers. The aim of the Standard is to establish a framework and set a clear direction such that patients and service users (and where appropriate carers and parents) who have information or communication needs relating to a disability, impairment or sensory loss receive: ‘Accessible information’ (‘information which is able to be read or received and understood by the individual or group for which it is intended’). ‘Communication support’ (‘support which is needed to enable effective, accurate dialogue between a professional and a service user to take place’). Such that they are not put “at a substantial disadvantage…in comparison with persons who are not disabled” when accessing NHS or adult social services. This includes accessible information and communication support to enable individuals to: Make decisions about their health and wellbeing, and about their care and treatment. Self-manage conditions. Access services appropriately and independently. Make choices about treatments and procedures including the provision or withholding of consent.- Posted
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A team of scientific experts has joined forces from across the world to help fight the spread of misinformation about the COVID-19 vaccines. Together they have created a unique online guide, led by the University of Bristol, to arm people with practical tips combined with the very latest information and evidence to talk reliably about the vaccines, constructively challenge associated myths, and allay fears. With the race on to vaccinate as many people as possible soonest in the wake of a more virulent virus strain, they’re appealing to everyone, from doctors to politicians, teachers to journalists and parents to older generations, to understand the facts, follow the guidance, and spread the word. -
News Article
From stargazing to mole-gazing
Patient Safety Learning posted a news article in News
Astrophysics and dermatology are colliding through a new research project led by the University of Southampton – with potentially lifesaving consequences. The project, dubbed MoleGazer, will take algorithms used for detecting exploding stars in astronomical imaging data and develop them to be used to spot changes in skin moles and, therefore, detect skin cancer. MoleGazer, led by Professor Mark Sullivan, Head of the School of Physics and Astronomy at the University, and Postdoctoral Researcher Mathew Smith, has been awarded a Proof of Concept Grant from the European Research Council (ERC). It is the first time the University has won such a grant. Currently, patients at high risk of developing skin cancer are photographed at regular intervals and a consultant visually compares images to detect changes. MoleGazer could automate this process, potentially leading to earlier diagnoses and improved survival rates. “It’s a really exciting project that came along from nowhere,” added Professor Sullivan. “It also highlights the importance of blue sky science – curiosity-driven scientific research will always have a fundamentally important role to play.” Read full story Source: University of Southampton, 10 January 2020 -
News Article
JAMA editorial blasts FDA's reporting of medical device problems
Patient Safety Learning posted a news article in News
The US Food and Drug Administration (FDA) needs to do more to quickly and substantially reform its system for reporting adverse events caused by medical devices, two researchers wrote in an Editorial published in JAMA Internal Medicine. The editorial notes several instances where information on a medical device was withheld from the public or not reported fully. The current adverse events reporting system relies on device makers to voluntarily report adverse events, which the authors say does not place patient safety as a priority. The editorial specifically highlights a study involving Medtronic's Insync III model 8042 heart failure pacemaker, which the authors said caused a "high burden of serious adverse events (including death)." The authors said it took the FDA 19 months to recall the device after the first instance of the device failing was reported. The FDA also decided to classify the recall as Class II, which signifies a low probability of serious adverse events. "This long unexplained delay before the recall and the inappropriate recall classification raise concerns about patient harms that could have been prevented by speedier and stronger regulatory actions," the authors wrote. Read full story Source: Becker's Hospital Review, 10 January 2020- Posted
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Myla’s mum left with ‘soul‑destroying sadness’
Patient Safety Learning posted a news article in News
Mother Natalie Deviren was concerned when her two-year-old daughter Myla awoke in the night crying with a restlessness and sickness familiar to all parents. Natalie was slightly alarmed, however, because at times her child seemed breathless. She consulted an online NHS symptom checker. Myla had been vomiting. Her lips were not their normal colour. And her breathing was rapid. The symptom checker recommended a hospital visit, but suggested she check first with NHS 111, the helpline for urgent medical help. To her bitter regret, Natalie followed the advice. She spoke for 40 minutes to two advisers, but they and their software failed to recognise a life-threatening situation with “red flag” symptoms, including rapid breathing and possible bile in the vomit. Myla died from an intestinal blockage the next day and could have survived with treatment. The two calls to NHS 111 before the referral to the out-of-hours service were audited. Both failed the required standards, but Natalie was told that the first adviser and the out-of-hours nurse had since been promoted. She discovered at Myla’s inquest that “action plans” to prevent future deaths had not been fully implemented. The coroner recommended that NHS 111 have a paediatric clinician available at all times. In her witness statement at her daughter’s inquest in July, Natalie said: “You’re just left with soul-destroying sadness. It is existing with a never-ending ache in your heart. The pure joy she brought to our family is indescribable.” Read full story Source: The Times, 5 January 2020- Posted
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Toddlers died after NHS 111 helpline said they were not in danger
Patient Safety Learning posted a news article in News
The NHS 111 helpline for urgent medical care is facing calls for an investigation after poor decision-making was linked to more than 20 deaths. Experts say that inexperienced call handlers and the software used to highlight life-threatening emergencies may not always be safe for young children. At least five have died in potentially avoidable incidents. Professor Carrie MacEwen, Chairwoman of the Academy of Medical Royal Colleges, said: “These distressing reports suggest that existing processes did not safeguard the needs of the children in these instances.” Since 2014 coroners have written 15 reports involving NHS 111 to try to prevent further deaths. There have been five other cases where inquests heard of missed chances to save lives by NHS 111 staff; two other cases are continuing and one was subject to an NHS England investigation. Read full story (paywalled) Source: The Times, 5 January 2020- Posted
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