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Content Article
TrialResults website
Patient-Safety-Learning posted an article in Suggest a useful website
TrialResults.com present the results of completed clinical trials in an easy to understand format. The site allows you to search for clinical trials related to different areas and conditions, and filter results by country and sponsor. You can they view and download a Plain English summary of each trial. It was set up by TrialAssure, a global company committed to clinical trial and human health data transparency for the entire pharmaceutical industry. -
News Article
USA: Despite decades of promises, health research still overlooks women
Patient Safety Learning posted a news article in News
Women are underrepresented in clinical trials, and even lab mice are predominantly male – and the effects show up in almost every aspect of human health Women are twice as likely as men to die from heart attacks; when a nonsmoker dies of lung cancer, it’s twice as likely to be a woman as a man; and women suffer more than men from Alzheimer’s and autoimmune disease. Yet research into these conditions, and many more, generally fails to examine women separately. It’s even less likely to look at disparities affecting women of color – why, for instance, Black women are nearly three times more likely to die in pregnancy than white women are. It’s been 30 years since the US Congress ordered the National Institutes of Health to make sure women were included equally in clinical trials. Despite some progress, research on women still lags, and there’s growing evidence that women and girls are paying the price. “Research on women’s health has been underfunded for decades, and many conditions that mostly or only affect women, or affect women differently, have received little to no attention,” the first lady Jill Biden said in announcing a new White House initiative on women’s health research on 13 November. “Because of these gaps, we know far too little about how to manage and treat conditions like endometriosis, and autoimmune diseases like rheumatoid arthritis. These gaps are even greater for communities that have historically been excluded from research – including women of color and women with disabilities.” Not only do researchers fail to include enough women in clinical trials, they often don’t look for differences between how men and women respond to treatments. Read full story Source: The Guardian, 20 November 2023 Further reading on the hub Dangerous exclusions: The risk to patient safety of sex and gender bias Gender bias: A threat to women’s health Animal testing doesn't work, we need to find new ways of testing the safety of medicines—a blog by Pandora Pound -
Content ArticleUS healthcare organisations continue to grapple with the impacts of the nursing shortage—scaling back of health services, increasing staff burnout and mental-health challenges, and rising labour costs. While several health systems have had some success in rebuilding their nursing workforces in recent months, estimates still suggest a potential shortage of 200,000 to 450,000 nurses in the United States, with acute-care settings likely to be most affected.1 Identifying opportunities to close this gap remains a priority in the healthcare industry. This article highlights research conducted by McKinsey in collaboration with the ANA Enterprise on how nurses are actually spending their time during their shifts and how they would ideally distribute their time if given the chance. The research findings underpin insights that can help organizations identify new approaches to address the nursing shortage and create more sustainable and meaningful careers for nurses.
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News ArticleA new report by US healthcare communications agency GCI Health found that Black women aren't avoiding clinical trials due to mistrust. The reasons for their underrepresentation are “more layered and nuanced.” The report is based on a recent summer survey with 500 responses from Black women across the USA. It reveals that, while the majority (80%) are "open" to participating in a clinical trial, 73% have never been asked to do so. While it's commonly believed that Black women are unwilling to participate in trials due to mistrust of the healthcare and biopharma systems, GCI's survey responses unveiled a more complex perspective. The data suggest “that access to information is the largest barrier to participation, rather than mistrust in the medical establishment, as commonly believed,” GCI Health’s report found. “We often hear that Black women are missing from clinical research because they are ‘hard-to-reach’ or reluctant to participate due to mistrust of the medical establishment,” said Kianta Key, group senior vice president and head of identity experience at GCI Health, in a press release. “In talking with women, we heard something more layered and nuanced that deserved exploration.” “Our industry has a responsibility to reverse years of underrepresentation in clinical trials and do more to support better healthcare outcomes for Black women,” said Kristin Cahill, global CEO of GCI Group, in the release. “Equity is critical to ensure new treatments and health interventions work for everyone. This research helps get us closer to understanding what needs to be done to make positive changes that will save lives and create healthier communities.” Read full story Source: Fierce Pharma, 14 November 2023
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Content ArticlePotentially serious complications occurred in 1 in 18 procedures under the care of an anaesthetist in UK hospitals, according to a national audit by the Royal College of Anaesthetists (RCA). Risks were found to be highest in babies, males, patients with frailty, people with comorbidities, and patients with obesity. Risks were also associated with the urgency and extent of surgery and procedures taking place at night and/or at weekends. The survey, published in Anaesthesia, was the RCA's seventh national audit project (NAP7) and included more than 20,000 procedures at over 350 hospital sites. NAPs study rare but potentially serious complications related to anaesthesia, and are intended to drive improvements in practice. Each focuses on a different topic and NAP7 examined perioperative cardiac arrest. Dr Andrew Kane, consultant in anaesthesia at James Cook University Hospital in Middlesbrough and a fellow at the RCA's Health Services Research Centre in London, said the new data presented "the first estimates for the rates of potentially serious complications and critical incidents observed during modern anaesthetic practice". The data confirmed that individual complications are uncommon during elective practice, but highlight the relatively higher rate of complications in emergency settings.
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Content ArticleThe depleting effect of repeated decision making is often referred to as decision fatigue. Understanding how decision fatigue affects medical decision making is important for achieving both efficiency and fairness in health care. In this study, Persson et al. investigate the potential role of decision fatigue in orthopaedic surgeons' decisions to operate, exploiting a natural experiment whereby patient allocation to time slots is plausibly randomised at the level of the patient. The results show that patients who met a surgeon toward the end of his or her work shift were 33 percentage points less likely to be scheduled for an operation compared with those who were seen first. In a logistic regression with doctor-fixed effects and standard errors clustered at the level of the doctor, the odds of operation were estimated to decrease by 10.5% for each additional patient appointment in the doctors' work shift. This pattern in surgeons' decision making is consistent with decision fatigue. Because long shifts are common in medicine, the effect of decision fatigue could be substantial and may have important implications for patient outcomes.
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Content ArticleThis report investigates just what is happening on the ground in relation to listening to patients, collecting feedback about their experience of services and putting the intelligence that is gathered from different approaches to use. Based on interviews with patient experience managers and others in NHS trusts closely associated with the work of collecting, analysing and using data from patients, it provides answers to questions about: Who is doing this work? What kind of training and preparation do they have for the tasks? Who supports them? Where do they fit in their organisation? To whom do they report? And how do they feel about their roles?
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Content Article
D-coded diabetes
Patient-Safety-Learning posted an article in Diabetes
D-coded diabetes is a tool that aims to simplify complex research studies about diabetes making the science accessible to everyone living with the condition. It uses simple language and images to explain the methodology and results of studies and trials. D-coded diabetes was created by The Diabesties Foundation, a nonprofit organisation aimed at delivering impact by revolutionising advocacy, education and support for people living with Type 1 Diabetes. -
Content Article
In this blog, Pandora Pound, Research Director at Safer Medicines Trust, highlights the patient safety issues that come when we rely on animal testing to determine the safety of new drugs for use in humans. She looks at cases where animal testing has led to the belief that medications were safe to test in human clinical trials—with sometimes tragic results. Highlighting innovative technologies that offer a more accurate picture of the safety of medications in humans, she calls on policy makers to lead a move towards human biology-based approaches. -
Content ArticleHealthcare Organisational Culture (OC) is a major contributing factor in serious failings in healthcare delivery. Despite an increased awareness of the impact that OC is having on patient care, there is no universally accepted way to measure culture in practice. This study from Simpson et al. was undertaken to provide a snapshot as to how the NHS is currently measuring culture. Although the study is based in England, the findings have potential to influence the measurement of healthcare OC internationally.
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Content ArticleThis report documents a meeting held in September 2022 that explored how Consumer Assessment of Healthcare Providers and Systems (CAHPS®) surveys shed light on disparities in patient experience and how improved measurement can advance healthcare equity in the US. Over 600 CAHPS survey users, researchers, healthcare organisation leaders, patient advocates, policymakers, Federal partners and the CAHPS Consortium attended.
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Content ArticleIn England and Wales, law requires that coroners issue a Prevention of Future Death (PFD) report when they believe that action should be taken to prevent future deaths. Prevention of Future Death reports therefore provide an opportunity to learn and prevent harm. This study in the Journal of Patient Safety and Risk Management thematically analyses PFD reports received by the National Institute for Health and Care Excellence (NICE) along with the organisation's response. The study provides insight into the PFD report practices of a national guidance producing and standard setting body in the UK, as well as supporting system-level understanding of current practices in relation to PFD reports. However, the authors note that there are no means to assess if the Chief Coroner's Office and the wider safety system considered NICE's responses adequate or whether the actions taken were effective.
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Content Article
In this interview we talk to Trainee Clinical Psychologist, Sabrina Pilav, about her latest research project exploring negative experiences of coil/ intrauterine device (IUD) procedures. Sabrina explains how their in-depth qualitative methodology could contribute to improvements in the future and shares details of how people can participate.- Posted
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Content ArticleSimulations are routinely used to identify latent safety threats. This article describes the classification of 1,318 latent safety threats identified from 232 simulations. Researchers were then able to issue site-specific and organisation-wide standardised dashboards and summaries, thus allowing for local and systemwide improvements.
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News Article
Sepsis often missed as 50% of screening tools don’t work, study finds
Patient Safety Learning posted a news article in News
Paramedics and A&E doctors often miss signs of sepsis and two of the four ways health professionals screen for the killer condition do not work, a new study claims. Doctors, NHS bosses and health charities have been concerned for years that too many cases of sepsis go undiagnosed, leaving people badly damaged or dead, because sepsis is so hard to detect. Unless a patient is diagnosed quickly, their body’s immune system goes into overdrive in response to an infection and then attacks vital tissues and organs. If left untreated, sepsis can cause shock, organ failure and death. Research from Germany, presented at this week’s European Emergency Medicine Congress in Barcelona, claims to have uncovered significant flaws in two of the four screening tools that health workers use worldwide to identify cases of the life-threatening illness. The four systems are NEWS2 (National Early Warning Score), qSOFA (quick Sequential Organ Failure Assessment), MEWS (Modified Early Warning Score) and SIRS (Systemic Inflammatory Response Syndrome). The researchers analysed records of the care given to 221,429 patients in Germany who were treated by emergency health workers outside hospital settings in 2016. “Only one of four screening tools had a reasonably accurate prediction rate for sepsis – NEWS2. It was able to correctly predict 72.2% of all sepsis cases and correctly identified 81.4% of negative, non-septic cases,” they concluded. NHS England stressed that it already deploys NEWS2, which emerged as the best system. An NHS spokesperson said: “This study shows the NHS actually is using the best screening tool available for detecting sepsis – NEWS2 – and as professional guidance for doctors in England sets out, it is essential that any patient’s wishes to seek a second opinion are respected.” Read full story Source: Guardian, 20 September 2023 -
Content ArticleThis document from the Patient Experience Library aims to map the evidence base for patient experience in digital healthcare. We shine a spotlight on areas of saturation, we expose the gaps and we make suggestions for how research funders and national NHS bodies could steer the research to get better value and better learning.
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Content ArticleThe Medicines and Healthcare products Regulatory Agency (MHRA) are providing an update on a retrospective observational study on the risk to children born to men who took valproate in the 3 months before conception and on the need for the re-analysis of the data from this study before conclusions can be drawn. No action is needed from patients. For female patients, healthcare professionals should continue to follow the existing strict precautions related to preventing the use of valproate in pregnancy (Valproate Pregnancy Prevention Programme).
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Content ArticleThis report by the Nuffield Trust looks at workforce training issues in England, arguing that the domestic training pipeline for clinical careers has been unfit for purpose for many years. It presents research that highlights leaks across the training pathway, from students dropping out of university, to graduates pursuing careers outside the profession they trained in and outside public services. Alongside high numbers of doctors, nurses and other clinicians leaving the NHS early in their careers, this is contributing to publicly funded health and social care services being understaffed and under strain. It is also failing to deliver value for money for the huge taxpayer investment in education and training.
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Event
BHP Lecture Series - Professor Mary Dixon Woods
Sam posted an event in Community Calendar
untilThis lecture will briefly outline challenges in quality and safety in healthcare, will identify the patchy history of attempts to make improvements, will emphasise the need to build and evidence base for improvement, and will outline some of the challenges and opportunities in evidence generation. Mary Dixon-Woods is Director of THIS Institute and The Health Foundation Professor of Healthcare Improvement Studies in the Department of Public Health and Primary Care at the University of Cambridge. Register -
Content ArticleArtificial intelligence, as a nonhuman entity, is increasingly used to inform, direct, or supplant nursing care and clinical decision-making. The boundaries between human- and nonhuman-driven nursing care are blurred with the advent of sensors, wearables, camera devices, and humanoid robots at such an accelerated pace that the critical evaluation of its influence on patient safety has not been fully assessed. Since the pivotal release of To Err is Human, patient safety is being challenged by the dynamic healthcare environment like never before, with nursing at a critical juncture to steer the course of artificial intelligence integration in clinical decision-making. This paper presents an overview of artificial intelligence and its application in healthcare and highlights the implications which affect nursing as a profession, including perspectives on nursing education and training recommendations. The legal and policy challenges which emerge when artificial intelligence influences the risk of clinical errors and safety issues are discussed.
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Content ArticleThe Covid-19 pandemic resulted in major disruption to healthcare delivery worldwide causing medical services to adapt their standard practices. Learning how these adaptations result in unintended patient harm is essential to mitigate against future incidents. Incident reporting and learning system data can be used to identify areas to improve patient safety. A classification system is required to make sense of such data to identify learning and priorities for further in-depth investigation. The Patient Safety (PISA) classification system was created for this purpose, but it is not known if classification systems are sufficient to capture novel safety concepts arising from crises like the pandemic. This study from Purchase et al. aimed to review the application of the PISA classification system during the COVID-19 pandemic to appraise whether modifications were required to maintain its meaningful use for the pandemic context. The study found that PISA taxonomy can be successfully applied to patient safety incident reports to support the first stages in deriving learning and identifying areas for further enquiry. No incidents were identified that warranted new codes to be added to the PISA classification system, which may extend to other substantive public health crises, negating the need for additional, specific coding within such classification systems and related frameworks for similar system-wide constraints.
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Content ArticleClinical trial documents are complex and may have inconsistencies, leading to potential site implementation errors and may compromise participant safety. This study characterises the frequency and type of administrative and potential patient safety interventions (PPSIs) made during the review of oncology trial documents for clinical trial implementation by centralized clinical content specialists. The study demonstrates a gap in patient safety when assessing trial documents for clinical trial implementation. One solution to address this gap is the utilisation of a centralised team of clinical specialists to preemptively review trial documents, thereby enhancing patient safety during clinical trial conduct.
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Content Article
Simulation for non-pedagogical purposes has begun to emerge. Examples include quality improvement initiatives, testing and evaluating of new interventions, the co-designing of new models of care, the exploration of human and organisational behaviour, comparing of different sectors and the identification of latent safety threats. However, the literature related to these types of simulation is scattered across different disciplines and has many different associated terms, thus making it difficult to advance the field in both recognition and understanding. This paper, therefore, aims to enhance and formalise this growing field by generating a clear set of terms and definitions through a concept taxonomy of the literature. -
Content Article
Researchers at the University of Hertfordshire are carrying out a study to better understand women’s negative experiences of IUD procedures. They hope this research will be used to develop new guidance for patients and professionals that reduces the risk of coil procedures being experienced as distressing. If you are aged 16+, have had a coil fitting/removal in the last 2 years in a UK health settings (GPs, sexual health clinics, gynaecologist, and any other medical setting) that you found distressing, and are able to provide a valid UK phone number (mobile or landline), then you are eligible to participate. Full details of the research and how to take part can be found via the link below or by contacting Sabrina at s.pilav@herts.ac.uk. -
Content ArticleThis report presents findings from a rapid evidence review into improvement cultures in health and adult social care settings. The review aims to inform CQC’s approach to assessing and encouraging improvement, improvement cultures and improvement capabilities of services, while maintaining and strengthening CQC’s regulatory role. It also identifies gaps in the current evidence base.
