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The article comments on a study which investigated early active mobilization during mechanical ventilation in adults in the intensive care unit (ICU), including the clinical outcomes and adverse events.

The article comments on a study which investigated early active mobilization during mechanical ventilation in adults in the intensive care unit (ICU), including the clinical outcomes and adverse events.

Food contact materials (FCM) are estimated to be the largest source of food contamination. Apart from plastics, the most commonly used FCM are made of printed paper and board. Unlike their plastic counterparts, these are not covered by a specific European regulation. Several contamination issues have raised concerns towards potential adverse health effects caused by exposure to substances migrating from printed paper and board FCM. In the current study, an inventory combining the substances which may be used in printed paper and board FCM, was created. More than 6000 unique compounds were identified, the majority (77%) considered non-evaluated in terms of potential toxicity. Based on a preliminary study of their physicochemical properties, it is estimated that most of the non-evaluated single substances have the potential to migrate into the food and become bioavailable after oral intake. Almost all are included in the FACET tool, indicating that their use in primary food packaging has been confirmed by industry. Importantly, 19 substances are also present in one of the lists with substances of concern compiled by the European Chemicals Agency (ECHA). To ensure consumer safety, the actual use of these substances in printed paper and board FCM should be investigated urgently. [ABSTRACT FROM AUTHOR]

An introduction is presented in which author discusses articles on topics including focuses on analyzing the factors influencing ERCP outcomes in PAD patients and compare the technical success of ERCP between PAD and non‑PAD patients.

Exposure to metal-containing aerosols has been linked with adverse health outcomes for almost every organ in the human body. Commercially available techniques for quantifying particulate metals are time-intensive, laborious, and expensive; often sample analysis exceeds $100. We report a simple technique, based upon a distance-based detection motif, for quantifying metal concentrations of Ni, Cu, and Fe in airborne particulate matter using microfluidic paper-based analytical devices. Paper substrates are used to create sensors that are self-contained, self-timing, and require only a drop of sample for operation. Unlike other colorimetric approaches in paper microfluidics that rely on optical instrumentation for analysis, with distance-based detection, analyte is quantified visually based on the distance of a colorimetric reaction, similar to reading temperature on a thermometer. To demonstrate the effectiveness of this approach, Ni, Cu, and Fe were measured individually in single-channel devices; detection limits as low as 0.1, 0.1, and 0.05 μg were reported for Ni, Cu, and Fe. Multiplexed analysis of all three metals was achieved with detection limits of 1, 5, and 1 μg for Ni, Cu, and Fe. We also extended the dynamic range for multi-analyte detection by printing concentration gradients of colorimetric reagents using an off-the-shelf inkjet printer. Analyte selectivity was demonstrated for common interferences. To demonstrate utility of the method, Ni, Cu, and Fe were measured from samples of certified welding fume; levels measured with paper sensors matched known values determined gravimetrically. [ABSTRACT FROM AUTHOR]

Aim: this article proposes a radical new approach to the monitoring and governance of services, and the education and training of nurses to meet ‘failure to rescue’ requirements. Background: healthcare policy in the UK that seeks to ensure safe and effective services for the acutely ill has largely failed, resulting in adult patients dying unnecessarily. Despite grand rhetoric, UK governments have distanced themselves from implementation, resulting in patchy localised developments and creating inconsistent service responses. Design and data sources: this article draws on a review of research and UK policy literature and best international practice to propose a new national framework approach that combines competency development, governance and performance monitoring to address ‘failure to rescue’ shortcomings. Implications for nursing: paramount is a nationally agreed and fit-for-purpose competency tool using simulation to assess staff in order to improve recognition of the deteriorating patient. Service improvements should include increased investment in telemedicine; service performance should be communicated through publicly available ratings and overseen by patient panels; and governance will require strengthening through enhanced Care Quality Commission/Monitor input, which should be linked to the maintenance of foundation trust status. Conclusion: health professional bodies, regulators, providers and the Government must work together to strengthen the safety and effectiveness of acute services. This will require investment in staff competency and enhancement of the governance to ensure services consistently meet public expectations and reduce unnecessary deaths. [ABSTRACT FROM AUTHOR]

Copyright of International Journal of Eating Disorders is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Nursing Journal / Sestrinski Glasnik is the property of Croatian Nurses Association and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Little is known about how adverse events are summarised and reported in trials, as detailed information is usually considered confidential. We have acquired clinical study reports (CSRs) from the European Medicines Agency through the Freedom of Information Act. The CSRs describe the results of studies conducted as part of the application for marketing authorisation for the slimming pill orlistat. The purpose of this study was to study how adverse events were summarised and reported in study protocols, CSRs, and published papers of orlistat trials.Methods and Findings: We received the CSRs from seven randomised placebo controlled orlistat trials (4,225 participants) submitted by Roche. The CSRs consisted of 8,716 pages and included protocols. Two researchers independently extracted data on adverse events from protocols and CSRs. Corresponding published papers were identified on PubMed and adverse event data were extracted from this source as well. All three sources were compared. Individual adverse events from one trial were summed and compared to the totals in the summary report. None of the protocols or CSRs contained instructions for investigators on how to question participants about adverse events. In CSRs, gastrointestinal adverse events were only coded if the participant reported that they were "bothersome," a condition that was not specified in the protocol for two of the trials. Serious adverse events were assessed for relationship to the drug by the sponsor, and all adverse events were coded by the sponsor using a glossary that could be updated by the sponsor. The criteria for withdrawal due to adverse events were in one case related to efficacy (high fasting glucose led to withdrawal), which meant that one trial had more withdrawals due to adverse events in the placebo group. Finally, only between 3% and 33% of the total number of investigator-reported adverse events from the trials were reported in the publications because of post hoc filters, though six of seven papers stated that "all adverse events were recorded." For one trial, we identified an additional 1,318 adverse events that were not listed or mentioned in the CSR itself but could be identified through manually counting individual adverse events reported in an appendix. We discovered that the majority of patients had multiple episodes of the same adverse event that were only counted once, though this was not described in the CSRs. We also discovered that participants treated with orlistat experienced twice as many days with adverse events as participants treated with placebo (22.7 d versus 14.9 d, p-value < 0.0001, Student's t test). Furthermore, compared with the placebo group, adverse events in the orlistat group were more severe. None of this was stated in the CSR or in the published paper. Our analysis was restricted to one drug tested in the mid-1990s; our results might therefore not be applicable for newer drugs.Conclusions: In the orlistat trials, we identified important disparities in the reporting of adverse events between protocols, clinical study reports, and published papers. Reports of these trials seemed to have systematically understated adverse events. Based on these findings, systematic reviews of drugs might be improved by including protocols and CSRs in addition to published articles. [ABSTRACT FROM AUTHOR]

Background: The novel proteasome inhibitor carfilzomib alone or in combination with other agents is already one of the standard therapies for relapsed and/or refractory multiple myeloma (MM) patients and produces impressive response rates in newly diagnosed MM as well. However, carfilzomib-related cardiovascular adverse events (CVAEs) - including hypertension (all grades: 12.2%; grade ≥3: 4.3%), heart failure (all grades: 4.1%; grade ≥3: 2.5%) and ischemic heart disease (all grades: 1.8%; grade ≥3: 0.8%) - may lead to treatment suspensions. At present, there are neither prospective studies nor expert consensus on the prevention, monitoring and treatment of CVAEs in myeloma patients treated with carfilzomib.Methods: An expert panel of the European Myeloma Network in collaboration with the Italian Society of Arterial Hypertension and with the endorsement of the European Hematology Association aimed to provide recommendations to support health professionals in selecting the best management strategies for patients, considering the impact on outcome and the risk-benefit ratio of diagnostic and therapeutic tools, thereby achieving myeloma response with novel combination approaches whilst preventing CVAEs.Results: Patients scheduled to receive carfilzomib need a careful cardiovascular evaluation before treatment and an accurate follow-up during treatment.Conclusions: A detailed clinical assessment before starting carfilzomib treatment is essential to identify patients at risk for CVAEs, and accurate monitoring of blood pressure and of early signs and symptoms suggestive of cardiac dysfunction remains pivotal to safely administer carfilzomib without treatment interruptions or dose reductions. [ABSTRACT FROM AUTHOR]

Introduction: We conducted a systematic review of qualitative evidence to improve understanding of the processes and outcomes of redress and reconciliation following a life‐changing event from the perspectives of individuals experiencing the event and their families. Methods: We searched six bibliographic databases for primary qualitative evidence exploring the views of individuals who have experienced a life‐changing event, and/or their family or carers, of redress or reconciliation processes. This was supplemented with targeted database searches, forward and backward citation chasing and searches of Google Scholar and relevant websites. Title and abstract and full‐text screening were undertaken independently by two reviewers. Data extraction and quality appraisal were conducted by one reviewer and checked by a second. We used a best‐fit framework synthesis approach, drawing upon procedural and restorative justice concepts. Findings: Fifty‐three studies (61 papers) were eligible for inclusion. Forty‐one studies (47 papers) were included in the synthesis, from which we identified four themes. Three themes 'Transparency', 'Person‐centered' and 'Trustworthy' represent the procedural elements required to support a fair and objective process. The fourth, 'Restorative justice' encapsulates how a fair process feels to those who have experienced a life‐changing event. This theme highlights the importance of an empathic relationship between the different parties involved in the redress‐reconciliation process and the significance of being able to engage in meaningful action. Conclusion: Our findings highlight the procedural aspects and context of redress‐reconciliation processes required to ensure that the process and outcomes are experienced as fair. These criteria may be applied to the processes used to investigate both recent and historical patient safety events. Public Contribution: One member of the public affiliated with the Exeter Policy Research Programme Evidence Review Facility helped develop the review protocol. Two people with experience of medically life‐changing events provided insight which corroborated our findings and identified important limitations of the evidence included in this review. [ABSTRACT FROM AUTHOR]

The cybersecurity of medical devices is paramount in a world where everything is increasingly digitised. Attention to how this important defence against malicious actors is regulated must, therefore, also increase. This paper uncovers how the cybersecurity of medical devices is currently regulated and how it can be improved going forward. First, the paper compares the regulation of medical device cybersecurity in the European Union, the United States and the United Kingdom (UK)—differentiating between Great Britain and Northern Ireland as per the current state of the law in the UK. Second, the paper develops a model of how cybersecurity shapes three key areas in the ecosystem of medical devices. These areas are the medical device itself; the structure between the surrounding institutional systems (such as manufacturers and healthcare providers); and the security of the data, the surrounding institutional system and the medical device. Third, based on a comparative analysis and a view of the system from above, the paper puts forward four recommendations on what future regulation should contain to properly regulate the cybersecurity of medical devices: technology specificity, circumvention protection, genuine privacy and security by design. The paper recommends that these four principles be followed. Technology specificity because it guarantees legislation that understands the necessary technical aspects to promote security and safety. Circumvention protection because preventing manufacturers and others from circumventing these requirements decreases risks to the health and wellbeing of patients. Finally, genuine privacy and security by design should be followed to align cybersecurity and privacy with current and future technical capacities. [ABSTRACT FROM AUTHOR]

Healthcare management faces significant challenges related to upward communication. Sharing information in healthcare is crucial to the improvement of person-centered, safe, and effective patient care. An adverse event (AE) is an unintended or unexpected incident that causes harm to a patient and may lead to temporary or permanent disability. Learning from adverse events in healthcare is crucial to the improvement of patient safety and quality of care. Informal communication channels represent an untapped resource with regard to gathering data about the development of AEs. In this viewpoint paper, we start by identifying how informal communication played a key factor in some high-profile adverse events. Then, we present three Critical Challenge points that examine the role of informal communication in adverse events by (1) understanding how the prevailing trends in healthcare will make informal communication more important, (2) explaining how informal communication is part of the group-level sensemaking process, and (3) highlighting the potential role of informal communication in "breaking the silence" around critical and adverse events. Gossip, as one of the most important sources of informal communication, was examined in depth. Delineating the role of informal communication and adverse events within the healthcare context is pivotal to understanding and improving team and upward communication in healthcare organizations. For clinical leaders, the challenge is to cultivate a climate of communication safety, whereby informal communication channels can be used to collect soft intelligence that are paths to improving the quality of care and patient safety. [ABSTRACT FROM AUTHOR]

Accessible Summary: What is known on the subject?: Mental health services report adverse incidents in different ways and the relationship between adverse incidents and the workforce is uncertain. In England, there are national datasets recording all incidents and workforce statistics though there is no peer‐reviewed evidence examining recent trends. What this paper adds to existing knowledge?: Although there has been an overall increase in the number of mental health nurses, more are working in the community and the number of nurses relative to adverse incidents has decreased. There have been service‐provision changes but the role of mental health nurses has not significantly changed in this period, and we can therefore assume that their current practice is saturated with risk or increased reporting. To help understand the relationship between nurses and incidents, we need to transform how incidents are recorded in England. What are the implications for practice?: English mental health services report greater levels of patient‐related factors such as self‐harm or aggression rather than missed or erroneous care. This makes it difficult to understand if a rise in incident frequency is linked to reporting behaviour, patient risk, unsafe/ineffective care or other reasons and therefore planning workforce deployment to improve care quality is problematic. Introduction: There is a paucity of empirical data examining incidents and mental health nurses and the relationship between the two remains uncertain. Aim: Comparison of English national data for incidents and nursing workforce to examine recent trends. Method: Descriptive analysis of two national datasets of incidents and workforce data for England between 2015 and 2022. Results: A 46% increase in incidents was found; the leading causes are self‐harm and aggressive behaviour. Despite the rise in adverse incident reporting, a 6% increase in mental health nurses was found, with more nurses in community settings than hospitals. Discussion: Current services are incident reporting at greater concentrations than in previous years. Patient‐related behaviour continues to be most prominently reported, rather than possible antecedent health services issues that may contribute to reporting. Whilst staffing has increased, this does not seem to have kept pace with the implied workload evident in the increase in incident reports. Implications for Practice: Greater emphasis should be placed on health service behaviour in reporting mechanisms. Self‐harm and aggression should continue to be considered adverse outcomes, but causal health service factors, such as missed care, should be present in pooled reporting to help reduce the occurrence of adverse outcomes. [ABSTRACT FROM AUTHOR]

BACKGROUND CONTEXT Spinal fusion is becoming a candidate for bundled payment; understanding the risk factors for nonhome discharge, postdischarge adverse events (AE), and unplanned readmissions is key in making this system viable. This analysis focuses on the risk factors for these outcomes for patients undergoing posterior cervical decompression and fusion (PCDF), a surgical population especially at risk for AEs and readmission relative to other fusion procedures. PURPOSE To understand the risk factors for nonhome discharge, severe postdischarge AE, and unplanned readmission for patients undergoing PCDF. STUDY DESIGN/SETTING All patients undergoing PCDF between 2012 and 2015 were queried from the National Surgical Quality Improvement Project (NSQIP) database. Patients were identified using the current procedural terminology (CPT) codes 63,045, 63,001, 63,015, 22,210, 22,110 and 22,600. Patients undergoing anterior cervical fusion in the same hospital stay were excluded. PATIENT SAMPLE Over a 4-year period, a total of 8,743 patients underwent PCDF in the NSQIP database. OUTCOME MEASURES Outcomes included nonhome discharge, unplanned 30-day readmission, and severe postdischarge AE (deep wound infection, organ or space infection, wound dehiscence, reintubation, DVT, PE, weaning failure, renal insufficiency, renal failure, CVA, cardiac arrest, MI, sepsis, septic shock, reoperation and death). METHODS Demographic variables and comorbidity status were analyzed using bivariate analysis. Step-wise multiple logistic regression using backward elimination (p=.2) was utilized to analyze the outcomes stated above. Models included the following variables: nonhome discharge, severe predischarge AE, age, operative time, sex, functional status, BMI>40, diabetic status, length of stay, ASA status >2, and history of pulmonary disease, heart disease, hypertension requiring medication, stroke, renal failure or bleeding disorder. RESULTS Patients with nonhome discharges were significantly older (67.4 vs. 58.6 years, p<.0001), sicker (82% vs. 54% ASA 3 and 4, p<.0001), and more functionally dependent (16% vs. 3.4%, p<.0001), with a greater proportion having histories of diabetes, pulmonary disease, cardiac disease, hypertension, renal failure, stroke, and bleeding disorders (all p<.0001). PCDF patients had an increased likelihood of nonhome discharge if they had a severe AE predischarge (OR=1.34, 95% CI: 1.02–1.76, p=.04), a dependent functional status (OR=2.98, 95% CI: 2.43–3.64, p<.0001), or a history of diabetes (OR=1.25, 95% CI: 1.09–1.43; p=.001), heart disease (OR=1.68, 95% CI: 1.03–2.73; p=.04), or bleeding disorder (OR=1.53, 95% CI: 1.11–2.1; p=.009). PCDF patients with nonhome discharges had an increased likelihood of having a severe postdischarge adverse event (OR=1.38, 95% CI: 1.09–1.75; p=.008) and an unplanned readmission (OR=1.39, 95% CI: 1.15–1.68; p=.0008). CONCLUSIONS PCDF patients who are discharged home have a higher likelihood of having a severe adverse event postdischarge and having an unplanned readmission. As LOS remains a common target for cost reduction, it is important to note that it may not be worth sacrificing home discharge for decreased LOS, as these patients will be predisposed to adverse events and return to the hospital. [ABSTRACT FROM AUTHOR]

Background: More new randomized controlled trials (RCTs) on acupuncture have been published in Japan since our last updated systematic review (2010). This systematic review aimed to evaluate the quality of RCTs on acupuncture conducted in Japan and understand the decade-wise changes in the methodological characteristics of the relevant RCTs. Methods: The literature search was performed using Ichushi Web, the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed and our team's compilation of relevant papers. We included full-length papers reporting RCTs that examined the clinical effects of acupuncture on patients in Japan published in or before 2019. We assessed the risk of bias (RoB), sample size, control setting, negative trial reporting, informed consent, ethics approval, trial registration, and adverse event reporting. Results: A total of 99 articles reporting 108 eligible RCTs were identified. The number of RCTs published in each decade was 1, 6, 9, 5, 40, and 47 in the 1960s, 1970s, 1980s, 1990s, 2000s, and 2010s, respectively. Quality assessment using the Cochrane RoB tool revealed that "sequence generation" improved in and after 1990 (73%–80% of RCTs were rated as "low") and "blinding of outcome assessors" slightly improved in and after the 2000s (40%–50% judged as "low"). However, "high" or "unclear" remained the dominant grades in other domains. Clinical trial registration and adverse events were reported only in 9% and 28% of the included RCTs even in the 2010s, respectively. A different acupuncture method or different point selection (e.g., deep vs. shallow insertion) was the most dominant control setting before 1990, while sham (or "placebo") needling and/or sham acupoints became the most dominant in the 2000s. The proportion of RCTs with positive results was 80% in the 2000s and 69% in the 2010s. Conclusions: The quality of RCTs on acupuncture conducted in Japan did not appear to have improved over the decades except for "sequence generation." While the culture of submitting negative trial reports was prevalent in the Japanese acupuncture research milieu as late as the 1990s, the overall quality of the relevant trials needs to be further improved. [ABSTRACT FROM AUTHOR]

The article presents abstracts on neurological topics which involve electroencephalogram (EEC), adverse events and axial interbody arthrodesis.

Objective: The recording of harm and adverse events in psychological trials is essential, yet the types of harm being captured in trials for talking treatments involving children and young people have not been systematically investigated. The aim of this review was to determine how often harm and adverse events are recorded in talking treatments for children and young people, as well as the metrics that are being collected. Method: The ISRCTN was searched for trials involving talking therapies and young people. Of 355 entries, 69 met inclusion criteria. The authors of these records were contacted for further information, and additional searches were conducted of protocols and papers. Results: Findings show that around half of all records mentioned harm or adverse events in at least one piece of study documentation. Overall, metrics commonly collected are as follows: suicide, suicidal ideation and intent, self‐harm, changes to clinical symptomology, and the need for further or additional care. Conclusions: Similar to the wider field of psychological interventions for mental health, the recording of harm and adverse events in children and young people tends to rely on a few key metrics, many of which are borrowed from drug trials. Examples of best practice have been highlighted, as well as recommendations for the progression of this research area. [ABSTRACT FROM AUTHOR]

Aims. To synthesize the evidence on nurses' experiences of their caring role during the COVID‐19 pandemic and identify emerging concepts that have affected nurses within the caring role in relation to (a) their professional lives and (b) their personal lives. Background. The concept of caring is central to the science and art of nursing practice, and fulfilment of the caring role is fundamental to the profession. The COVID‐19 pandemic imposed unprecedented change globally transforming the caring role of the nurse. The WHO highlights that a well‐supported workforce is paramount to emergency preparedness; therefore, understanding the experiences of the nurse's caring role during the COVID‐19 crisis is paramount to practice in future healthcare crises. Methods. A scoping review. Data Sources. Studies published between January 2020 and November 2023 were identified from the following databases: Cumulative Index to Nursing and Allied Health Literature (CINAHL), Coronavirus Database, PUBMED, PsycINFO, PsycArticles, Scopus, Web of Science, and SocINDEX. Reporting Method. The scoping review adhered to the Joanna Briggs Institute (JBI) Preferred Reporting Items for Systematic Reviews and Meta‐Analysis Extension for Scoping Review (PRISMA‐ScR) checklist. Results. The search identified 1,347 studies, subsequent review of title and abstract, resulted in 117 full‐text papers for further eligibility screening, with a total of 52 studies being included in the scoping review. Findings were grouped thematically using the Braun and Clarke (2006) approach. The five distinctive themes that emerged were (a) emotional turmoil, (b) erosion of care, (c) relationships and solidarity, (d) expansion of role, and (e) professional growth. Conclusion. During the COVID‐19 pandemic, there was an evolutionary shift in the caring role of the nurse, on a trajectory from emotional turmoil to professional growth. The process followed a theoretical framework of transformative learning that could support nurses' capability and preparedness in their caring role for future inevitable extreme events and crisis in healthcare. Implications for Nursing Management. Mapping current knowledge of the unprecedented COVID‐19 crisis from a nurse's professional and personal perspective purposefully aims to highlight gaps for future research, education, and policy and is paramount to emergency preparedness and a well‐supported workforce in future healthcare crisis. [ABSTRACT FROM AUTHOR]

In recent years, rapidly changing disease profile patterns, shortage & uneven utilization of healthcare professionals contributed massive burden on the Indian healthcare system, which resulted in varying, fragmented, inconsistent healthcare delivery to the patients and poor patient management. Patients often face and experience many challenges like lack of accessibility, poor patient-healthcare provider relationships, and inadequate quality of care, resulting in unnecessary economic burden in managing their health conditions. Thus Indian healthcare reform is essential in enhancing its capacity to fulfill patients' health needs that can be addressed by focusing on key sustainable strategies and initiatives meant for enhancing coordination of care, expanding services accessibility, redeveloping healthcare infrastructure, implementing workforce innovation and strong governance with the incorporation of core principles such as patient-centeredness, integrated care and collaborative care approaches. The clinical and ambulatory pharmacy practice are fragment of the healthcare delivery which delivers pharmaceutical care and fulfils the needs of patients across healthcare settings. This paper focuses on the present & future perspectives of ambulatory pharmacy practice in India and the factors to be considered for implementing it in patient care. [ABSTRACT FROM AUTHOR]

In patients with cardiogenic shock, this review compares the efficacy of percutaneous microaxial left ventricular assist devices (pLVADs) to intra-aortic balloon pumps (IABPs) or no mechanical circulatory support (MCS). Endorgan hypoperfusion brought on by insufficient cardiac output characterizes the potentially fatal disease known as cardiogenic shock. Relevant papers were found by a thorough search of internet resources and were incorporated into the study. The main outcomes evaluated were: (1) Short-term mortality, (2) hemodynamic indices, (3) organ function, and (4) Length of hospital stay. Considered secondary outcomes were: (1) Adverse events, (2) quality of life, and (3) long-term survival. As shown by increased cardiac output and mean arterial pressure, the findings of this research imply that pLVADs may provide superior hemodynamic support versus IABPs or no MCS. In addition, pLVADs may have better organ function and lower short-term mortality rates than IABPs or no MCS. However, using pLVADs was also linked to a higher risk of unfavorable outcomes, such as bleeding and vascular issues. Data on long-term survival and quality-of-life outcomes were sparse and ambiguous. In conclusion, as compared to IABPs or no MCS, pLVADs may offer more effective hemodynamic support and better short-term outcomes in patients with cardiogenic shock. More investigation is required to fully comprehend the long-term advantages, hazards, and effects of pLVADs on the quality of life in this patient population. [ABSTRACT FROM AUTHOR]

Introduction: The treatment preferences of Chinese physicians who treat nonmetastatic castration-resistant prostate cancer (nmCRPC) and how they weigh the benefits and risks of nmCRPC treatment are still unknown. This study aimed to evaluate Chinese physicians' benefit-risk treatment preferences for nmCRPC and assist in setting nmCRPC treatment goals. Methods: A paper-based discrete choice experiment (DCE) survey was administered to 80 nmCRPC-treating physicians. DCE responses were analyzed to produce the preference weight and the relative importance score for each attribute level. The marginal rate of substitution (MRS) was used to quantify the amount of overall survival (OS) physicians were willing to trade for a reduction in treatment-related adverse events (AEs). We further conducted the exploratory analysis, stratifying physicians from 5 perspectives into different subgroups and examining the treatment preferences and OS trade-off in each subgroup. Results: In terms of efficacy attributes, physicians placed greater emphasis on OS than time to pain progression. With regard to safety attributes, serious fracture was perceived as the most important AE by physicians, followed by serious fall, cognitive problems, skin rash, and fatigue. In the exploratory analysis, we found generally that physicians with less clinical practice experience and those from more economically developed regions placed more emphasis on AEs and were willing to give up more of their patients' OS to reduce the risk of AEs. Conclusion: Physicians from mainland China value the importance of minimizing treatment-related AEs when considering different treatment options for patients with nmCRPC, and they are willing to trade a substantial amount of OS to avoid AEs. [ABSTRACT FROM AUTHOR]

This paper presents a scoping review of the peer-reviewed literature regarding reported risks, adverse effects and mitigation factors related to providing mental health services using telehealth. The paper aims to describe risks and risk management strategies. Publications were included if they reported upon risks, adverse events or mitigation factors experienced, hypothesised or discussed for: any population (any country, any age), service (any mental health services), intervention (telehealth), English language, 2010 to 10 July 2021, any publication type (commentary, research, policy), excluding protocol papers, and self-help tools. The following databases were searched: PsycINFO (from 2010 to 10 July 2021), MEDLINE (2010 to 10 July 2021) and the Cochrane Database from 2010 to 10 July 2021. The search strategy resulted in 1,497 papers and after exclusions a final 55 articles were selected. Results of this scoping review are presented in terms of types of risk, risk by client population, risk by modality (eg group therapy using telehealth) and risk management. Recommendations for future research include gathering and publishing more detailed information regarding near-miss and actual adverse events when delivering mental health assessment and care using telehealth. In clinical practice, training is required for potential adverse events, and to prevent them and reporting mechanisms in place to collate and learn from these. [ABSTRACT FROM AUTHOR]

Accessible Summary: What is known on the subject: Most health professionals working in psychiatric care will experience adverse events (AE) such as service user suicide or violence, during their careerNorway lacks measures to capture potential iatrogenic injuries, such as risk assessment measures, to evaluate patient records for AEs in both inpatient and outpatient psychiatric clinics in hospitals What the paper adds to existing knowledge: We have described an approach to the validation of a research tool between different national contexts; a process that went beyond language translationWe have incorporated the understanding of health professionals and service users; to bring together the lifeworld of the patient with the professional definition of AEs, triggers and risk areas of AEs in a psychiatric context. The service users' experiences resulted in modifications to the tool. What are the implications for nurses: Applying the 'Global Trigger Tool—Psychiatry' in Norway and Sweden can help mental health nurses to prevent iatrogenic harm and reduce the occurrence of AEs through the identification of potential triggers.Implementing 'Global Trigger Tool—Psychiatry' might help mental health nurses to improve patient safety in Norway and Sweden. Introduction: There is little consensus on cross‐cultural and cross‐national adaptation of research instruments. Aim/Question: To translate and validate a Swedish research tool (GTT‐P) to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals in the process. Method: The GTT‐P, designed to identify events in patient records that were triggers for adverse events, was translated to Norwegian using a cross‐cultural adaptation approach. This involved two focus groups with clinical staff, one of which involved service users, and a joint discussion at a Dialogue Conference to generate consensus on the definition of the triggers of potential adverse events identifiable in patient records. Results: We highlight both the differences and commonalities in defining the nature of risks, the adverse events and the triggers of such events. The Dialogue Conference resulted in three modifications of the tool, based on service users' experiences. Service user involvement and co‐production was essential for both the translation and adaptation of the research instrument. Discussion: We have described an approach to the validation of a research tool between different national contexts; a process that went beyond language translation. This approach enables a more nuanced understanding of potential risks within a psychiatric context as it engages differences in the care delivery. Applying the GTT‐P in hospital‐based psychiatric care might help to identify processes that need to be changed in order to promote patient safety and a safer work environment for mental health nurses. Implications for practice: When translating and validating the GTT‐P from Swedish to Norwegian, we have considered the knowledge and experiences of both service users and health professionals. The application of the GTT‐P can promote greater patient safety in hospital settings. [ABSTRACT FROM AUTHOR]

Aims: To describe nurse managers' perceptions of interventions to support nurses as second victims of patient safety incidents and to describe the management of interventions and ways to improve them. Design: A qualitative study using interviews. Methods: A purposive sample of nurse managers (n = 16) recruited from three hospital districts in Finland was interviewed in 2021. The data were analysed using elements of inductive and deductive content analysis. Results: The study identified three main categories: (1) Management of second victim support, which contained three sub‐categories related to the nurse manager's role, support received by the nurse manager and challenges of support management; (2) interventions to support second victims included existing interventions and operating models; and (3) improving second victim support, based on the sub‐categories developing practices and developing an open and non‐blaming patient safety culture. Conclusion: Nurse managers play a crucial role in supporting nurses as second victims of patient safety incidents and coordinating additional support. Operating models for managing interventions could facilitate nurse managers' work and ensure adequate support for second victims. The support could be improved by increasing the awareness of the second victim phenomenon. Implications for the Profession and Patient Care: Mitigating the harmful effects of patient safety incidents can improve nurses' well‐being, reduce burden and attrition risks and positively impact patient safety. Impact: Increasing awareness of the second victim phenomenon and coherent operation models would provide equal support for the nurses and facilitate nurse managers' work. Reporting Method: COREQ checklist was used. What does this paper contribute to the wider global clinical community? Nurse managers' role is significant in supporting the second victims and coordinating additional support.Awareness of the second victim phenomenon and coherent operating models can secure adequate support for the nurses and facilitate nurse managers' work. [ABSTRACT FROM AUTHOR]

Most influenza vaccines are generally safe, but influenza vaccines can cause rare serious adverse events. Some adverse events, such as fever and febrile seizures, are more common in children than adults. There can be differences in the safety of vaccines in different populations due to underlying differences in genetic predisposition to the adverse event. Live attenuated vaccines have not been studied adequately in children under 2 years of age to determine the risks of adverse events; more studies are needed to address this and several other priority safety issues with all influenza vaccines in children. All vaccines intended for use in children require safety testing in the target age group, especially in young children. Safety of one influenza vaccine in children should not be extrapolated to assumed safety of all influenza vaccines in children. The low rates of adverse events from influenza vaccines should not be a deterrent to the use of influenza vaccines because of the overwhelming evidence of the burden of disease due to influenza in children. [ABSTRACT FROM AUTHOR]

Waterpipe (WP) smoking has rapidly grown in popularity in the United States and other Western countries with the fastest uptake among younger individuals. This growth has been encouraged by the misperception that WP smoke is harmless or less harmful than cigarette smoke. To better understand how WP affects the health of young people, we conducted a narrative review of the literature focusing on the adverse health effects of WP smoking in adolescents and younger adults. We searched scientific literature databases including PubMed, MEDLINE, EMBASE, and ISI Web and selected papers that met the inclusion criteria. Sixty-three papers met the inclusion criteria and were selected for review. Data were abstracted from the selected papers into a standardized table. The evidence demonstrates that WP smoking can cause acute lung infection and injury, and carbon monoxide (CO) poisoning, in adolescents and young adults. It is also associated with adverse subclinical effects in this sub-population, including oral and systemic genotoxicity, lung function decline, and the alteration of vascular and hemodynamic functions. Limited evidence that is available indicates associations with psychological and neurological effects and asthma. No identified publications examined the association between WP use and type 2 diabetes, a condition that is associated with cigarette smoking among young people. WP smoking by younger individuals can result in their hospitalization due to systemic CO poisoning and acute lung disease, and induce subclinical adverse effects in the oral cavity, pulmonary system, and in circulation, that are involved in the pathogenesis of local and systemic chronic diseases. [ABSTRACT FROM AUTHOR]

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Simple Summary: Proton Beam Therapy (PBT) is an interesting therapeutic option for children and adolescents with non-rhabdomyosarcoma soft tissue sarcomas (NRSTS). In fact, if it is true that radiotherapy is a key part of the multi-modal treatment of NRSTS patients, it is also true that the risk of radiation-induced side effects represent an important limitation in its use. The unique characteristics of protons can be leveraged to minimize doses to healthy tissue, potentially allowing for increased tumor doses and enhanced preservation of surrounding tissues. International cooperative efforts are required to better define the indications for PBT (based on the patient's age, estimated outcome, and tumor location), taking into account the currently limited number of available proton therapy facilities. This paper provides insights into the use of Proton Beam Therapy (PBT) in pediatric patients with non-rhabdomyosarcoma soft tissue sarcomas (NRSTS). NRSTS are a heterogeneous group of rare and aggressive mesenchymal extraskeletal tumors, presenting complex and challenging clinical management scenarios. The overall survival rate for patients with NRSTS is around 70%, but the outcome is strictly related to the presence of various variables, such as the histological subtype, grade of malignancy and tumor stage at diagnosis. Multimodal therapy is typically considered the preferred treatment for high-grade NRSTS. Radiotherapy plays a key role in the treatment of children and adolescents with NRSTS. However, the potential for radiation-induced side effects partially limits its use. Therefore, PBT represents a very suitable therapeutic option for these patients. The unique depth-dose characteristics of protons can be leveraged to minimize doses to healthy tissue significantly, potentially allowing for increased tumor doses and enhanced preservation of surrounding tissues. These benefits suggest that PBT may improve local control while reducing toxicity and improving quality of life. While clear evidence of therapeutic superiority of PBT over other modern photon techniques in NRSTS is still lacking—partly due to the limited data available—PBT can be an excellent treatment option for young patients with these tumors. A dedicated international comprehensive collaborative approach is essential to better define its role within the multidisciplinary management of NRSTS. Shared guidelines for PBT indications—based on the patient's age, estimated outcome, and tumor location—and centralization in high-level referral centers are needed to optimize the use of resources, since access to PBT remains a challenge due to the limited number of available proton therapy facilities. [ABSTRACT FROM AUTHOR]

There has been a paradigm shift in the treatment of chronic lymphocytic leukemia (CLL) over the past decade. With the advent of self-administered targeted oral anticancer agents (OAAs), the treatment of CLL has begun to shift from the infusion clinic to the patient's home. This introduced new challenges including patient non-adherence, class-specific adverse effects, and financial toxicity to treatment. In this paper, we discuss a structured approach to identifying and addressing barriers to optimal patient outcomes. We will ground our discussion using the five dimensions of adherence as defined by the World Health Organization (WHO): therapy factors, health-system factors, condition-related factors, social/economic factors, and patient factors. We discuss how each of these domains present in patients with CLL. We will also discuss how we can prevent and address these barriers in through the various phases of treatment. A multidisciplinary program to support patients on OAAs is critical for patients with CLL. This team should involve pharmacists and social workers in addition to nursing, advanced practitioner and physician colleagues. The program should aim to identify, prevent, and address patient-specific barriers by offering individualized solutions. We describe how such a program can be designed and implemented. [ABSTRACT FROM AUTHOR]

Primary percutaneous coronary intervention (PCI) is the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI). However, when primary PCI is not available in a timely fashion, fibrinolysis and early transfer for routine PCI is recommended. Prince Edward Island (PEI) is the only province in Canada without a PCI facility, and distances to the nearest PCI-capable facilities are between 290 and 374 kilometers. This results in prolonged out-of-hospital time for critically ill patients. We sought to characterize and quantify paramedic interventions and adverse patient events during prolonged ground transport to PCI facilities post-fibrinolysis. We performed a retrospective chart review of patients presenting to any of four emergency departments (ED) on PEI during the calendar years 2016 and 2017. We identified patients through administrative discharge data and cross referenced with emergent out-of-province ambulance transfers. All included patients were managed as STEMIs in the EDs and subsequently transferred (primary PCI, pharmacoinvasive) directly from the EDs to PCI facilities. We excluded patients having STEMIs on inpatient wards and those transported by other means. We reviewed electronic and paper ED charts plus paper EMS records. We performed summary statistics. We identified 149 patients meeting inclusion criteria. Most patients were males (77.9%), mean age 62.1 (SD 13.8) years. The mean transport interval was 202 (SD 29.0) minutes. Thirty-two adverse events occurred during 24 transports (16.1%). There was one death, and four patients required diversion to non-PCI facilities. Hypotension was the most common adverse event (n = 13, 8.7%), and fluid bolus (n = 11, 7.4%) was the most common intervention. Three (2.0%) patients required electrical therapy. Nitrates (n = 65, 43.6%) and opioid analgesics (n = 51, 34.2%) were the most common drugs administered during transport. In a setting where primary PCI is not feasible due to distance, a pharmacoinvasive model of STEMI care is associated with a 16.1% proportion of adverse events. Crew configuration including ALS clinicians is the key in managing these events. [ABSTRACT FROM AUTHOR]

The presence of chemical contaminants in food is often unavoidable and associated with many adverse health effects. Exposure assessment is the essential element of an overall risk assessment process. While the specific purpose of the exposure assessment process can vary, the main goal is to provide a foundation for health-protective decisions. In recent years, there have been significant advances in exposure assessment methodologies and procedures, subsequently contributing to an increased complexity of the process. This paper aims to provide a generalized, simplified, and practical road map for exposure assessment, pointing to the pros and cons of different methods and challenges that occur while performing this type of study. [ABSTRACT FROM AUTHOR]

We set out to map the (1) living/occupational hazards, (2) health outcomes, and (3) barriers to care that exist for pregnant labor-trafficked people. Eight databases were systematically searched based on inclusion criteria. Five papers were eligible for inclusion. Data on study characteristics, social determinants, hazardous exposures, health outcomes, and barriers to care were extracted and synthesized. Common risk factors and occupational/living hazards were identified. Both were thematically connected with barriers to care and a host of adverse health outcomes. More importantly, a significant gap was discovered with no disaggregated quantitative data on the experience of pregnancy among labor-trafficked people. The interaction of risk factors, occupational/living hazards, and barriers to care experienced by pregnant labor-trafficked people may influence their susceptibility to adverse health outcomes. We need population-based studies, informed by those with lived experience of labor trafficking to examine the experience of pregnancy for labor-trafficked people to improve intervention and support efforts for this population. [ABSTRACT FROM AUTHOR]

Although medical events in lung cancer screening (LCS) such as receiving scan results or interactions with clinicians are recognised as teachable moments (TMs), the views of patients about why this is the case for smoking behaviour change remain uncertain. This systematic review and metasynthesis study is aimed at identifying the reasons why patients believed that medical events during LCS act as TMs for smoking behaviour change. A search strategy was developed for use with MEDLINE, PsycINFO, EMBASE, CINAHL-P, Web of Science databases, and Google Scholar. This helped identify qualitative and mixed-method research which mentioned patients' views of how these TMs result in smoking behaviour change. After screening, final articles were critically appraised; general characteristics and data relevant to the aims were extracted to conduct a line-of-argument metasynthesis. After screening 695 papers, 11 were included. Undergoing LCS scans was seen to act on their intrinsic motivation to reduce smoking as it served as a "wake-up call" and increased awareness of the health consequences of smoking. Receiving positive or negative LCS results resulted in cessation as it was a "health scare" and challenged smoking habits. Interactions with clinicians addressed misconceptions and signposted them to specialist cessation services. Attendees believed that the following encouraged them to change their smoking behaviour: having an intrinsic motivation to quit, their beliefs on smoking and health reframed, their negative emotions appraised, and using LCS to access specialist support. In line with the TM heuristic, these experiences provided the necessary skills, confidence, and motivation to quit. Future research should explore whether the views of the clinicians match those of the attendees to address misconceptions and further develop clinical guidelines. [ABSTRACT FROM AUTHOR]

Medical devices are items used directly or indirectly in the human body and are a prerequisite for hospital treatment of patients, and their quality can have a direct impact on the health of patients, so strengthening the quality control of medical device use is a hot spot of concern in the clinic. Current medical device testing can reduce the occurrence of adverse events, but it cannot be completely avoided, and its work still needs to be further strengthened. In this paper, we design a two-way feature selection algorithm based on PSO_RF. We use random forest to calculate the importance of the feature attributes of the sample data and sort the results in descending order, where a particle swarm algorithm is introduced to optimize the parameters of the random forest algorithm. The 245 medical device adverse event reports received by the testing center were selected, the occurrence and types of adverse events were analyzed retrospectively, and quality control countermeasures for medical device use were formulated. [ABSTRACT FROM AUTHOR]

Aim: To identify outcomes of missed nursing care for adult patients. Design: A five‐stage rapid review process was conducted as follows: refining the question, retrieving relevant studies, determining the studies to be included, organizing the data and synthesizing the results. Methods: Papers published between 2010–2020 that focused on the UK, Europe, the USA and Oceania were searched for keywords in the title and abstract in major databases. The articles that identified the impact of missed nursing care on adults in health care were selected. Results: Seventeen articles met the criteria. Major impacts of missed care in adult settings were increases in mortality, adverse events and failure to maintain. These same studies also identified a range of causative factors linked to ward environment, inadequate staffing levels and skills mix although are inconclusive. Solutions include continuing education, ward and work re‐design, and appropriate skill level. [ABSTRACT FROM AUTHOR]

Avoidable harm—that is, harm to service users caused by unsafe or improper interventions, practices or services and which could have been mitigated or prevented—is embedded in social care legislation and inspections. However, the concept of avoidable harm has largely been defined by policymakers, academics, practitioners, regulators and services, with little known about service users' experiences of avoidable harm in practice. This survivor-controlled review maps and synthesises peer-reviewed literature on service users experience of social and psychological avoidable harm in mental health social care (MHSC) in England. The review was guided by an Advisory Group of practitioners and service users. Six databases were systematically searched between January 2008 and June 2020 to identify relevant literature. Following de-duplication, 3,529 records were screened using inclusion and exclusion criteria. This led to full-text screening of eighty-four records and a final corpus of twenty-two papers. Following data extraction, thematic analysis was used to synthesise data. Six key themes were identified relating to relationships and communication, information, involvement and decision-making, poor support, fragmented systems and power-over and discriminatory cultures. Impacts on MHSC service users included stress, distress, disempowerment and deterioration in mental health. We discuss our findings and indicate future research priorities. [ABSTRACT FROM AUTHOR]

Clinical prediction models are commonly utilized in clinical practice to screen high-risk patients. This enables healthcare professionals to initiate interventions aimed at delaying or preventing adverse medical events. Nevertheless, the majority of these models focus on calculating probabilities or risk scores for medical events. This information can pose challenges for patients to comprehend, potentially causing delays in their treatment decision-making process. Our paper presents a statistical methodology and protocol for the utilization of a Weibull accelerated failure time (AFT) model in predicting the time until a health-related event occurs. While this prediction technique is widely employed in engineering reliability studies, it is rarely applied to medical predictions, particularly in the context of predicting survival time. Furthermore, we offer a practical demonstration of the implementation of this prediction method using a publicly available dataset. [ABSTRACT FROM AUTHOR]

Background: Major depressive disorder (MDD) can have severe impacts on function and quality of life. Up to one third of patients will have an inadequate response to their first line of treatment, with subsequent lines of therapy associated with lower remission rates and higher relapse rates. Recently esketamine has become available for Australian patients, and this agent provides an additional treatment option for those with MDD who have had an inadequate response to two or more antidepressant therapies during the current moderate to severe depressive episode. This paper provides an expert panel's practical recommendations and clinical guidance for establishing esketamine clinics in Australia. Methods: An expert panel (n = 11) comprising psychiatrists, mental health care nurses, pharmacists, and individuals with experience establishing esketamine clinics was convened in Sydney. The panel developed practical recommendations and clinical guidance, which were then further refined. Results: Five key areas were identified: practical considerations for esketamine clinic set‐up, including multidisciplinary care considerations; patient selection; administering esketamine; adverse event management and long‐term follow‐up. Conclusions: Guidance presented in this paper should assist Australian clinicians to set up an esketamine clinic, and provide practical advice on the infrastructure and clinical requirements for treatment of patients with this agent. [ABSTRACT FROM AUTHOR]

The present study aims to illustrate the process of developing, implementing, and clinically validating a new assessment measure, the Trauma and Adverse Life Events (TALE) screening tool, to assess Adverse Childhood Experiences (ACEs) among looked-after children. The TALE was developed by adapting existing ACEs measures to reflect the experiences of looked-after children. The TALE was completed by the local authority social worker for 218 children placed with Five Rivers Child Care (a UK fostering agency, residential, and educational care provider). Reliability was examined and exploratory factor analysis was conducted. Correlations between TALE scores, background variables, and psychosocial wellbeing using the carer-report Strengths and Difficulties Questionnaire (SDQ) and Child Dissociative Checklist (CDC) were also explored. The TALE was found to have acceptable reliability (α =.71). A three-factor solution was found which explained 46.24% of the variance, with factors labelled 'Direct Experience of Abuse', 'Witnessing Harm', and 'Household Dysfunction'. Exposure score was significantly associated with total difficulties score on the SDQ (rs =.24, p <.001) and Impact score was associated with the SDQ's impact score (rs =.33, p <.001). Exposure and Impact scores were both positively correlated with CDC scores (rs =.16, p =.021 and rs =.22, p =.002). This paper presents evidence of the importance of screening looked-after children for ACEs and demonstrates that the TALE is a valid and reliable tool for this purpose. Adverse and traumatic experiences were highly prevalent in this population and appeared to be closely related with children's psychosocial wellbeing. Results emphasise the importance of routine assessment of past experiences within trauma-informed psychological care and intervention planning for looked-after children. [ABSTRACT FROM AUTHOR]

Much of the knowledge and information needed for enabling high-quality clinical research is stored in free-text format. Natural language processing (NLP) has been used to extract information from these sources at scale for several decades. This paper aims to present a comprehensive review of clinical NLP for the past 15 years in the UK to identify the community, depict its evolution, analyse methodologies and applications, and identify the main barriers. We collect a dataset of clinical NLP projects (n = 94; £ = 41.97 m) funded by UK funders or the European Union's funding programmes. Additionally, we extract details on 9 funders, 137 organisations, 139 persons and 431 research papers. Networks are created from timestamped data interlinking all entities, and network analysis is subsequently applied to generate insights. 431 publications are identified as part of a literature review, of which 107 are eligible for final analysis. Results show, not surprisingly, clinical NLP in the UK has increased substantially in the last 15 years: the total budget in the period of 2019–2022 was 80 times that of 2007–2010. However, the effort is required to deepen areas such as disease (sub-)phenotyping and broaden application domains. There is also a need to improve links between academia and industry and enable deployments in real-world settings for the realisation of clinical NLP's great potential in care delivery. The major barriers include research and development access to hospital data, lack of capable computational resources in the right places, the scarcity of labelled data and barriers to sharing of pretrained models. [ABSTRACT FROM AUTHOR]

Background: Although colposcopy is the leading follow-up option for women with abnormal cervical cytology, little is known about its psychological consequences.Objectives: We performed a systematic review to examine: (1) what, if any, are the adverse psychological outcomes following colposcopy and related procedures; (2) what are the predictors of adverse psychological outcomes post-colposcopy; and (3) what happens to these outcomes over time.Search Strategy: Five electronic databases (PubMed, PsychINFO, CINAHL, Web of Science, Scopus) were searched for studies published in English between January 1986 and February 2014.Selection Criteria: Eligible studies assessed psychological wellbeing at one or more time-points post-colposcopy.Data Collection and Analysis: Two reviewers independently screened titles and abstracts. Full texts of potentially eligible papers were reviewed. Data were abstracted from, and a quality appraisal performed of, eligible papers.Main Results: Twenty-three papers reporting 16 studies were eligible. Colposcopy and related procedures can lead to adverse psychological outcomes, particularly anxiety. Ten studies investigated predictors of adverse psychological outcomes; management type and treatment had no impact on this. Seven studies investigated temporal trends in psychological outcomes post-colposcopy; findings were mixed, especially in relation to anxiety and distress. Studies were methodologically heterogeneous.Conclusions: Follow-up investigations and procedures for abnormal cervical cytology can cause adverse psychological outcomes among women. However, little is known about the predictors of these outcomes or how long they persist. There is a need for a more standardised approach to the examination of the psychological impact of colposcopy, especially longer-term outcomes.Tweetable Abstract: Follow-up investigations for abnormal cervical cytology can cause adverse psychological outcome among women. [ABSTRACT FROM AUTHOR]

Rationale: Cervical radiculopathy is initially typically managed conservatively. Surgery is indicated when conservative management fails or with severe/progressive neurological signs. Personalised multimodal physiotherapy could be a promising conservative strategy. However, aggregated evidence on the (cost‐)effectiveness of personalised multimodal physiotherapy compared to surgery with/without post‐operative physiotherapy is lacking. Aim/Objectives: To systematically summarise the literature on the (cost‐)effectiveness of personalised multimodal physiotherapy compared to surgery with or without post‐operative physiotherapy in patients with cervical radiculopathy. Methods: PubMed, Embase, CINAHL, PsycINFO and Web of Science were searched from inception to 1st of March 2023. Primary outcomes were effectiveness regarding costs, arm pain intensity and disability. Neck pain intensity, perceived recovery, quality of life, neurological symptoms, range‐of‐motion, return‐to‐work, medication use, (re)surgeries and adverse events were considered secondary outcomes. Randomised clinical trials comparing personalised multimodal physiotherapy versus surgical approaches with/without post‐operative physiotherapy were included. Two independent reviewers performed study selection, data‐extraction, and risk of bias assessment using the Cochrane RoB 2 and Consolidated Health Economic Evaluation Reporting Standards statement. Certainty of the evidence was determined using Grading of Recommendations, Assessment, Development and Evaluations. Results: From 2109 records, eight papers from two original trials, with 117 participants in total were included. Low certainty evidence showed there were no significant differences on arm pain intensity and disability, except for the subscale 'heavy work' related disability (12 months) and disability at 5–8 years. Cost‐effectiveness was not assessed. There was low certainty evidence that physiotherapy improved significantly less on neck pain intensity, sensory loss and perceived recovery compared to surgery with/without physiotherapy. Low certainty evidence showed there were no significant differences on numbness, range of motion, medication use, and quality of life. No adverse events were reported. Conclusion: Considering the clinical importance of accurate management recommendations and the current low level of certainty, high‐quality cost‐effectiveness studies are needed. [ABSTRACT FROM AUTHOR]

The importance of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) remains crucial in managing chronic HCV infection among patients who have experienced treatment failure and relapse after prior use of direct-acting antivirals (DAAs), as evidenced by high SVR12. However, limited real-world data exists on safety and efficacy. Therefore, the study's goal was to conduct a qualitative systematic review to assess SOF/VEL/VOX's effectiveness and safety. Thorough searches spanned PubMed, Embase, and Scopus, from 2015 to August 1st, 2023. The outcomes assessed were SVR12 and treatment-related adverse events (AEs). We identified and analyzed 12 studies in which SVR12 of the per-protocol (PP) population was 96.7% and of the intention-to-treat (ITT) population was 92.6% showing excellent efficacy of SOF/VEL/VOX. SVR12 rates notably differed among patients: those without GT3 infection (94.20%) and without cirrhosis (97.60%) experienced higher rates compared to patients having GT3 infection (87.40%) and cirrhotic patients (94.20%). Treatment-related AEs were also recorded. To summarize, our study presents evidence that SOF/VEL/VOX serves as an extremely safe and efficacious therapy for HCV-infected patients, previously treated with DAAs. [ABSTRACT FROM AUTHOR]

This paper provides an overview of the HEAT (Healthy Environments for AthleTes) project, which aims to understand the impact of environmental conditions on athlete health and performance during major sporting events such as long-distance running, cycling, and triathlons. In collaboration with the SAFER (Strategies to reduce Adverse medical events For the ExerciseR) initiative, the HEAT project carried out a field campaign at the 2022 Comrades Marathon in the KwaZulu-Natal province of South Africa. The measurement campaign deployed seven weather stations, seven PM2.5 monitors and one spore trap along the 90 km route to capture spatially representative measurements of complex micro-climates, allergenic aerospora, and particulate matter exposure. The results indicate that runners were exposed to moderate risk heat stress conditions. Novel findings from this initial campaign shows elevated and potentially harmful PM2.5 levels at spectator areas, possibly coinciding with small fire events around the race day festivities. Our findings show values PM2.5 levels over the WHO 24-h guidelines at all stations, while 2000 µg/m3 at two stations. However, the lack of an acute exposure standard means direct health impacts cannot be quantified in the context of a sport event. The HEAT project highlights important aspects of race day monitoring; regional scale climatology has an impact on the race day conditions, the microclimatic conditions (pollution and meteorology) are not necessarily captured by proximity instruments and direct environmental measurements are required to accurately capture conditions along the route. [ABSTRACT FROM AUTHOR]

BACKGROUND: Medical devices (MDs) represent the backbone of the modern healthcare system. Considering their importance in daily medical practice, the process of manufacturing, marketing and usage has to be regulated at all levels. Harmonized evidence-based conformity assessment of MDs during PMS relying on traceability of medical device measurements can contribute to higher reliability of MD performance and consequently to higher reliability of diagnosis and treatments. OBJECTIVE: This paper discusses issues within MD post-market surveillance (PMS) mechanisms in order to set a path to harmonization of MD PMS. METHODS: Medline (1980-2021), EBSCO (1991-2021), and PubMed (1980-2021) as well as national and international legislation and standard databases along with reference lists of eligible articles and guidelines of relevant regulatory authorities such as the European Commission and the Food and Drug Administration were searched for relevant information. Journal articles that contain information regarding PMS methodologies concerning stand-alone medical devices and relevant national and international legislation, standards and guidelines concerning the topic were included in the review. RESULTS: The search strategy resulted in 2282 papers. Out of those only 24 articles satisfied the eligibility criteria and were finally included in the review. Papers were grouped per categories: medical device registry, medical device adverse event reporting, and medical device performance evaluation. In addition to journal articles, national and international legislation, standards, and guidelines were reviewed to assess the state of PMS in different regions of the world. CONCLUSION: Although the regulatory framework prescribes PMS of medical devices, the process itself is not harmonized with international standards. Particularly, conformity assessment of MDs, as an important part of PMS, is not measured and managed in a traceable, evidence-based manner. The lack of harmonization within PMS results in an environment of increased adverse events involving MDs and overall mistrust in medical device diagnosis and treatment results. [ABSTRACT FROM AUTHOR]