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Objectives To audit the transparent and open science standards ofhealth and medical sciences journal policies and explore the impact of the COVID-19 pandemic. Design Repeat cross-sectional study. Setting 19 journals listed in Google Scholar’s Top Publications for health and medical sciences. Participants Blood, Cell, Circulation, European Heart Journal, Gastroenterology, Journal of Clinical Oncology, Journal of the American College of Cardiology, Nature Genetics, Nature Medicine, Nature Neuroscience, Neuron, PLoS ONE, Proceedings of the National Academy of Sciences, Science Translational Medicine, The British Medical Journal, The Journal of the American Medical Association, The Lancet, The Lancet Oncology, and The New England Journal of Medicine Main outcome measures We used the Transparency and Openness Promotion (TOP) guideline and the International Committee of Medical Journal Editors (ICMJE) requirements for disclosing conflicts of interest (COIs) to evaluate journals standards. Results TOP scores slightly improved during the COVID-19 pandemic, from a median of 5 (IQR: 2–12.5) out of a possible 24 points in February 2020 to 7 (IQR: 4–12) in May 2021, but overall, scores were very low at both time points. Journal policies scored highest for their adherence to data transparency and scored lowest for preregistration of study protocols and analysis plans and the submission of replication studies. Most journals fulfilled all ICMJE provisions for reporting COIs before (84%; n = 16) and during (95%; n = 18) the COVID-19 pandemic. Conclusions The COVID-19 pandemic has highlighted the importance of practising open science. However, requirements for open science practices in audited policies were overall low, which may impede progress in health and medical research. As key stakeholders in disseminating research, journals should promote a research culture of greater transparency and more robust open science practices.

Background Given the crucial role the circulatory system plays in maintaining normal physiological function and homeostasis, acute disruption of this system, whether through thromboembolism or haemorrhage, carries with it the possibility of severe morbidity and high risk of mortality. The prevention of thromboembolism is a key pillar of patient safety, both inside hospitals and in the community. In 2021, the Office for National Statistics (ONS) reported 7365 deaths related to blood clots [1]. The National Thrombosis Survey, published by Thrombosis UK in collaboration with the Getting it Right First Time (GIRFT) programme, in 2021, identified 13% of hospital-acquired thromboses as being preventable, and most were related to inadequate thromboprophylaxis [2]. The report also identified 12 cases (3%) of these preventable venous thromboembolism events led to fatal pulmonary embolism (PE). However, blood clots also occur in other settings, including care homes and the community, where data on preventable clots is less clear. The National Institute for Health and Care Excellence (NICE) outlines key guidance in reducing the risk of thromboembolism, including risk assessment, prophylaxis, and follow-up [3]. Understanding the factors increasing the risk of acute or chronic haemorrhages, or directly causing them, are key to preventing morbidity and mortality from these events. A number of potentially modifiable risk factors increase the risk of bleeds, including unsafe environments contributing to falls and trauma, and issues surrounding anticoagulant medications – indeed, one study found that the in-hospital mortality from major bleeding in patients on oral anticoagulants was 21% [4]. The reason to study both thromboembolism and haemorrhage in tandem is there is occasional overlap between the two events, such as intracranial bleeds leading to space-occupying clots, and disseminated intravascular coagulation (DIC) increasing the risk of subsequent bleeding. Management (or mismanagement) of anticoagulant medications can increase the risk of either condition. Not all clots and bleeds are preventable, however it is important to understand what factors surrounding these events are modifiable to prevent serious harm. Since 1984, coroners have had a duty to report and communicate a death where the coroner believes that action should be taken to prevent future deaths [5]. These reports, named Prevent Future Deaths, are mandated under Paragraph 7 of Schedule 5, Coroners and Justice Act 2009, and regulations 28 and 29 of The Coroners (Investigations) Regulations 2013 [6,7]. A detailed analysis of PFDs implicating clots or bleeds could highlight preventable factors leading specifically to death, the most severe outcome following both events. This is important to inform clinical staff managing patients at risk of or who have experienced both conditions, public health policy, and guideline creation.

1.0 Background Globally, 313 million surgical procedures are performed each year (1). However, of those 4.2 million people die within 30 days of the operation (2). In England and Wales over 3.1 million surgical procedures were undertaken in 2020 (3). It is estimated that in the United Kingdom (UK) death occurs within 30 days after 1.1% of operations and within 90 days after 2.3% (4). A systematic review and meta-analysis in medical settings suggests that preventable patient harm is more prevalent in surgical settings (10%) than in the overall patient population (6%) (5). Similarly, a retrospective case record review of acute hospitals in England showed that patients admitted under surgical specialists were more likely to have a preventable death than those under medical ones (6). Although evidence hints at an important association between surgery and preventable deaths, the operations involved, the types of harms that lead to death, and the reasons for such harms remain underexplored. Unlike pharmacological interventions, which have robust regulatory processes and national agencies (e.g. the Medicines and Healthcare products Regulatory Agency - MHRA), the regulation of surgical interventions is more complex (7). Surgeons are regulated by the General Medical Council (GMC) and hospitals are reviewed by various bodies, including the Care Quality Commission (CQC) (8). The Royal College of Surgeons and specialty associations provide guidance on surgical practice (9). However, there is no single overarching vigilance system for collecting harms from all surgical procedures to improve learning. For medical products, the MHRA’s Yellow Card Scheme collects information on suspected harms from healthcare products in the UK, including medications, vaccines, and medical devices (10). Both the public and healthcare professionals can report safety concerns, such as a suspected adverse reaction to a medication. Surgical registries in the UK are used to collect information about outcomes of specific surgical procedures; these include the National Joint Registry (NJR), the National Hip Fracture Database (NHFD), and the National Bariatric Surgery Registry (NBSR) (11). Since 1984, coroners in England and Wales have had a duty to report and communicate details of deaths when the coroner believes that action should be taken to prevent future deaths (12). Prevention of Future Deaths reports, henceforth referred to as PFDs, were introduced to provide coroners with an official system for reporting such deaths. PFDs are mandated under Paragraph 7 of Schedule 5 of the Coroners and Justice Act 2009, and under Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013 (13,14). If a coroner deems that a death could have been prevented, it is their duty to write a PFD and to send it to individuals and/or organisations that are capable of action. When a person or organisation receives a PFD report from a coroner, they have 56 days in which they must respond by statute. The PFD system has three processes: 1) coroners generate PFDs and send them to relevant parties; 2) recipients respond to concerns raised in PFDs and propose actions; 3) recipients undertake proposed actions to prevent similar deaths. A narrative review of studies investigating PFDs identified 17 publications that examined PFDs (15). Most included studies explored preventable deaths involving medicines (n=8; 47%). The review explored the strengths and limitations of PFDs and showed that PFDs offer important information that could support hospitals to improve patient safety. However, the review also identified inconsistent reporting, low response rates to PFDs, and difficulty in accessing, analysing, and monitoring PFDs, which currently limits their use. Deaths involving surgery had not yet been researched. Investigation of PFDs involving surgery could provide insights for improving patient safety as well as an approach for vigilance to improve learning and reduce risks for individuals undergoing surgery.

The objective of this review is to map the literature regarding prehospital pain management to assess the types of treatments used and their effectiveness and to identify knowledge gaps.

Background Sepsis is defined by the World Health Organisation (WHO) as the “life-threatening organ dysfunction caused by a dysregulated host response to infection”, in line with international consensus definitions [1,2]. Data from the Global Burden of Disease survey estimated that in 2017 there were 48.9 million cases and 11 million sepsis-related deaths worldwide [3]. Estimates of the numbers of deaths related to sepsis are difficult as they rely on the accurate recognition and coding of sepsis among patients. The UK Sepsis Trust estimates that in 2017-2018 there were around 200,000 cases of sepsis in the UK, with around 52,000 associated deaths [4]. Despite recognition of the importance of preventing sepsis, little is known about the number of preventable deaths related to sepsis, and what factors / processes fail in practice leading to such deaths. One analysis of 568 patients admitted to hospital with sepsis in the USA found that 3.7% of sepsis-associated deaths were definitely or moderately preventable when reviewed by clinicians [5]. The burden of preventable morbidity and mortality from sepsis worldwide is thought to be significant [4]. Since 1984, coroners have had a duty to report and communicate a death where the coroner believes that action should be taken to prevent future deaths10. These reports, named Prevent Future Deaths, are mandated under Paragraph 7 of Schedule 5, Coroners and Justice Act 2009, and regulations 28 and 29 of The Coroners (Investigations) Regulations 201311,12. A detailed analysis of PFDs implicating sepsis could highlight factors surrounding sepsis leading specifically to death, the most severe outcome following this event. This is important to inform clinical staff managing patients at risk of, or with suspected or confirmed sepsis. public health policy, and sepsis-related research. Aims and Objectives The aim of our study is to systematically characterise sepsis-related PFDs, and analyse the concerns raised by coroners in these reports. Our objectives are to discover: 1. The number of PFDs involving sepsis 2. The years of life lost from such deaths 3. Geographical variations in reporting such deaths 4. The number and types of concerns voiced by coroners 5. How these concerns related temporally to sepsis (increasing the risk of sepsis, in the immediate recognition or management of sepsis, or medium and long-term management of sepsis) 6. The numbers and types of individuals or organisations to whom the PFDs were addressed 7. The number of responses received within the 56-day requirement 8. The types of actions taken by organisations in response to coroner concerns

A systematic case series of coroners' reports in England and Wales 2013-22 1.0 Background Globally, deaths involving females are less likely than males to be registered and have a valid cause of death (1). The most recent statistics of prevalence across a lifetime (year ending March 2020), from the UK Government, show over 27% of women had experienced a form of domestic abuse since the age of 16 (2). In the year ending March 2022, 7% of women aged 16 and over were victims of domestic abuse and 3% of women aged 16 and over were victims of sexual assault, in England and Wales (3). In the year ending March 2020, 81 women were killed in a domestic homicide - equivalent to 46% of adult female homicide victims (4). There are tragic high-profile cases of female victims of homicides reported, such as Sarah Everard, Julia James, Bibaa Henry and Nicole Smallman, but the occurrences of violence are likely to be under reported (5). Violence against women and girls can encompass a range of abuse types, which affect women and girls more than men and boys, including domestic homicide, domestic abuse, sexual assault, abuse experienced as a child, female genital mutilation (FGM), forced marriage, and harassment (6). Qualitative studies into public awareness and attitudes towards domestic violence support the need for the introduction of sustained interventions, such as the suggestion for National Institute for Clinical Excellence (NICE) to consider ‘recommending the routine use of a rapid screening tool for domestic violence’ (7). In February 2014, NICE published guidelines for multi-agency services, aiming to help identify, prevent and reduce domestic violence and abuse (8). The Government’s Domestic Abuse Act is regularly updated, including consultation in 2018 from NHS England, to tackle domestic abuse ‘at every stage from prevention through to rehabilitation’ (9). Currently, in England and Wales, domestic homicide reviews (DHRs) are also conducted to identify lessons to be learned in domestic abuse-related deaths. However, their emergency as a ‘policy initiative has been little considered’, with criticism DHRs contain differences in participant status and concerns with system functioning, access, and quality to these reviews, which cannot replace coroners’ reports (10). Since 1984, in England and Wales, coroners have had a duty to report and communicate details of deaths when the coroner believes that action should be taken to prevent future deaths (11). These reports, named Prevention of Future Deaths reports (PFDs), are mandated under Paragraph 7 of Schedule 5 of the Coroners and Justice Act 2009, and under Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013 (12). When a person or organization receives a PFD from a coroner, they have 56 days in which they must respond by statute. However, there is no mechanism in place to enforce, audit or analyse PFDs, their responses, or the inactions and potential actions taken. Several case series have been conducted on coroners’ PFDs, involving medicines, cardiovascular diseases, and deaths during the covid-19 pandemic (https://preventabledeathstracker.net/research/) (13). However, no study has investigated PFDs specifically in women and girls, nor has an investigation into preventable deaths involving violence been conducted. Furthermore, PFDs are often biased towards a predominance of both male cases reported to coroners and the proportion of cases proceeding to inquest (14), and when female deaths do process to inquest they are less likely to result in a verdict of unnatural death than male deaths (15). 2.0 Aims and objectives We aim to systematically analyse coroners’ concerns in PFDs in which instances of violence against women and girls were attributed to the death. Our objectives are to discover: 1. the number of PFDs involving violence against women and girls that caused or contributed to the death, and the nature of the death. 2. the number and the types of concerns raised in PFDs involving violence against women and girls. 3. the number and type of recipients who received these PFDs and their rates of responses. 4. assess the actions taken or proposed in responses, or any inactions to prevent future deaths in cases of violence against women and girls.

Background Injury-related emergency department admissions (ED) are common: The EU reported an average of 30 million injury-related ED admissions annually between 2009 and 2018.1 Similarly, in 2019, the US reported nearly 27 million non-fatal injury-related ED admissions.2 Furthermore, retrospective studies suggest that pain is common in those prior to hospitalization, with reported prevalences of 35% to 70%.3–5 Such studies report that prehospital pain is as undertreated as it is common.5–7 Undertreated prehospital pain can be defined as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage that was not managed to a tolerable level, as measured on a validated pain scale, with a known, effective pharmacologic or nonpharmacologic treatment(s) during the prehospital period” (Appendix 1). The undertreatment of prehospital pain contributes to physiologic instability by increasing circulating catecholamine levels exacerbating acute injury or illness, which result in disability, delayed healing, and prolonged hospital admissions.8,9 Inadequately treated pain may result in the development of chronic pain syndromes, post-traumatic stress disorder, or addiction to prescribed and illicitly obtained opioid drugs.6,9 A review of trauma pain in emergency settings from 2006 to 2017 in Europe found that prehospital pain was treated using opioids, N-methyl-D-aspartate (NMDA) receptor antagonists like ketamine, non-steroidal anti-inflammatory drugs (NSAID), intravenous (IV) paracetamol, inhaled methoxyflurane, and inhaled nitrous oxide.5 A systematic review (SR) of the prehospital use of synthetic opioids compared to morphine to treat acute pain, published in 2022, aggregated data from 12 studies reporting similar effectiveness and safety of synthetic opioids compared to morphine.10 The authors of the SR also reported the evidence was scant and its overall quality low.10 Although these studies have increased our knowledge of prehospital analgesia, it is still unclear what treatment is most effective in decreasing pain severity in adults requiring treatment for pain in prehospital settings. Therefore, an up-to-date systematic scoping review is needed to synthesize the literature on pain management of adults in the prehospital setting to determine what treatments are being used, their effectiveness, and remaining knowledge gaps. Research question What is known in the literature about the types of pain management treatments and their effectiveness used in adults in the prehospital setting of OECD countries and what knowledge gaps exist? Objective The objective of this review is to map the literature regarding prehospital pain management to assess the types of treatments used, their effectiveness, and to identify knowledge gaps.

Background Falls are the second leading cause of unintentional injury deaths worldwide1. In 2020, there were 6,410 deaths reported from accidental falls in England and Wales, with 5,850 of these representing persons ≥65 years old2. Falls can lead to traumatic injury, such as hip fracture3 or head injury, which may lead directly to mortality. Additionally, falls can act as the initiating factor in a chain of events that lead to death, such as immobility after a fall precipitating a fatal pneumonia4. Preventing significant morbidity and mortality related to falls remains a challenge both in the community and inpatient settings. Risk factors for falls in younger populations include hazardous working environments and alcohol and substance misuse1. Falls in the elderly population are associated with lower-energy impact (i.e. falls from standing)5 due to risk factors such as cognitive decline4, fall-risk increasing drugs6, systemic infections7, and decline in physical function8. A previous fall in an elderly person is associated with fear of falling, leading to activity restriction and further decline in physical function9. Not all falls are avoidable, however it is important to understand what factors preceding and following a fall are modifiable to prevent serious harm. Since 1984, coroners have had a duty to report and communicate a death where the coroner believes that action should be taken to prevent future deaths10. These reports, named Prevent Future Deaths, are mandated under Paragraph 7 of Schedule 5, Coroners and Justice Act 2009, and regulations 28 and 29 of The Coroners (Investigations) Regulations 201311,12. A detailed analysis of PFDs implicating falls could highlight factors surrounding a fall leading specifically to death, the most severe outcome following a fall. This is important to inform clinical staff managing patients with a risk of falls and patients who have fallen, public health policy, and falls-related research. Aims and Objectives The aim of our study is to systematically characterise falls-related PFDs, and analyse the concerns raised by coroners in these reports. Our objectives are to discover: 1. The number of PFDs involving falls 2. The years of life lost from such deaths 3. Geographical variations in reporting such deaths 4. The number and types of concerns voiced by coroners 5. How these concerns related temporally to the fall (leading up to the fall, in the immediate management of the fall, or medium and long-term consequences of the fall) 6. The numbers and types of individuals or organisations to whom the PFDs were addressed 7. The number of responses received within the 56-day requirement 8. The types of actions taken by organisations in response to coroner concerns

Chronic pain is pain that persists or recurs for more than 3-months (1). It is estimated that 35% to 51% of adults in the UK experience chronic pain (2). In 2016, pain and pain-related diseases were graded as the main cause of disability and disease burden globally, with neck and lower back pain being the leading cause of disability (3). Not only is chronic pain a major burden on health systems, but it also impacts those from lower socioeconomic backgrounds more greatly, with those from less affluent areas experiencing more pain and more severe pain (4). Moreover, a systematic review showed that those with chronic pain suffer negative effects on their quality of life, and social, family, and occupational life (5). People with chronic pain may be offered various interventions which have varying levels of benefits and harms, including death. The National Institute for Health and Care Excellence (NICE) guidelines suggest assessing the person with chronic pain holistically and offering a range of management options including physical activity, psychological therapy, and acupuncture (6). Despite these recommendations, the use of analgesics, such as opioids, are often used, which provide minimal benefits for people with chronic non-cancer pain (7). Moreover, the use of opioids has also increased the risk of all-cause mortality in people with chronic pain (8). Surgery can also be offered for people with chronic pain. However, procedures are risky, and pain usually returns within six to 12 months (7,9). Therefore, understanding the causes of death in people with chronic pain since the changes in NICE guidelines will improve the evidence on the safety of treatment and management strategies for those living with chronic pain. Despite these data, systematic reviews on mortality and chronic pain are uncommon. In 2014, a systematic review of global studies was published (10). In this review, ten were included with four studies conducted in the UK. The review concluded that in people with chronic pain, there was a slight increase in mortality, and included mortalities associated with cancer (10). Moreover, the review included varying definitions of pain and did not explicitly focus on chronic pain. Since the 2014 review, cohort studies in people with chronic pain and mortality have been published (11,12), with Macfarlane et al. (2017) conducting a meta-analysis of the literature on mortality and chronic widespread pain including cancer-related mortalities (12). Therefore, an update-to-date systematic review on mortality and chronic noncancer pain is required to understand if the risk of mortality in a person with chronic noncancer pain. Currently, there are registered systematic reviews investigating mortality and spinal pain (13), and mortality and back pain (14). There are no reviews broadening the search to include all types of chronic noncancer pain, associated mortality, and risk factors worldwide. Therefore, this review aims to determine the prevalence and causes associated with death in people with chronic noncancer pain worldwide.

This project aims to conduct a systematic review of mortality in people with chronic noncancer pain worldwide.

Emily McFadden,1 Sarah Lay-Flurrie,1,2 Constantinos Koshiaris,1 Georgia C Richards,1,3 Carl Heneghan1,3 1Centre for Evidence Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; 2EMEA Real World Methods and Evidence Generation, IQVIA, London, UK; 3Global Centre on Healthcare and Urbanisation, Kellogg College, University of Oxford, Oxford, UKCorrespondence: Emily McFaddenCentre for Evidence Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UKTel +44 1865 617940Email emily.mcfadden@phc.ox.ac.ukPurpose: Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) may be treated with surgical mesh devices; evidence of their long-term complications is lacking.Patients and Methods: Rates of diagnoses of depression, anxiety or self-harm (composite measure) and sexual dysfunction, and rates of prescriptions for antibiotics and opioids were estimated in women with and without mesh surgery, with a diagnostic SUI/POP code, registered in the Clinical Practice Research Datalink (CPRD) gold database.Results: There were 220,544 women eligible for inclusion; 74% (n = 162,687) had SUI, 37% (n = 82,123) had POP, and 11% (n = 24,266) had both. Women undergoing mesh surgery for SUI or POP had about 1.1 times higher rates of antibiotic use. Women with no previous history of the outcome, who underwent mesh surgery had 2.43 (95% CI 2.19– 2.70) and 1.47 (95% CI 1.19– 1.81) times higher rates of depression, anxiety, or self-harm, 1.88 (95% CI 1.50– 2.36) and 1.64 (95% CI 1.02– 2.63) times higher rates of sexual dysfunction and 1.40 (95% CI 1.26– 1.56) and 1.23 (95% CI 1.01– 1.49) times higher opioid use for SUI and POP, respectively. Women with a history of depression, anxiety and self-harm had 0.3 times lower rates of these outcomes with SUI or POP mesh surgery (HR for SUI 0.70 (95% CI 0.67-0.73), HR for POP 0.72 (95% CI 0.65-0.79)). Women with a history of opioid use who had POP mesh surgery had about 0.09 times lower rates (HR 0.91 (95% CI 0.86– 0.96)) of prescriptions. Negative control outcome analyses showed no evidence of an association between asthma consultations and mesh surgery in women with POP, but the rate was 0.09 times lower (HR 0.91 (95% CI 0.87– 0.94)) in women with SUI mesh surgery, suggesting that study results are subject to some residual confounding.Conclusion: Mesh surgery was associated with poor mental and sexual health outcomes, alongside increased opioid and antibiotic use, in women with no history of these outcomes and improved mental health, and lower opioid use, in women with a previous history of these outcomes. Although our results suggest an influence of residual confounding, careful consideration of the benefits and risk of mesh surgery for women with SUI or POP on an individual basis is required.Keywords: urinary incontinence, epidemiology, mental health, sexual dysfunction, pain management

Supplemental material, sj-docx-1-shr-10.1177_20542704221132139 for Open science and conflict of interest policies of medical and health sciences journals before and during the COVID-19 pandemic: A repeat cross-sectional study by Antoni D. Gardener, Ellen J. Hick, Chloe Jacklin, Gifford Tan, Aidan G. Cashin, Hopin Lee, David Nunan, Elaine C. Toomey and Georgia C. Richards in JRSM Open

This is a retrospective analysis of controlled opioid drugs that have been dispensed by private prescribers in England.