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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]

Background: Schizophrenia is mostly a chronic disorder whose symptoms include psychosis, negative symptoms and cognitive dysfunction. Poor adherence is common and related relapse can impair outcomes. Long-acting injectable antipsychotics (LAIs) may promote treatment adherence and decrease the likelihood of relapse and rehospitalization. Using LAIs in first-episode psychosis (FEP) and early-phase (EP) schizophrenia patients could benefit them, yet LAIs have traditionally been reserved for chronic patients. Methods: A three-step modified Delphi panel process was used to obtain expert consensus on using LAIs with FEP and EP schizophrenia patients. A literature review and input from a steering committee of five experts in psychiatry were used to develop statements about patient population, adverse event management, and functional recovery. Recruited Delphi process psychiatrists rated the extent of their agreement with the statements over three rounds (Round 1: paper survey, 1:1 interview; Rounds 2–3: email survey). Analysis rules determined whether a statement progressed to the next round and the level of agreement deemed consensus. Measures of central tendency (mode, mean) and variability (interquartile range) were reported back to help panelists assess their previous responses in the context of those of the overall group. Results: The Delphi panelists were 17 psychiatrists experienced in treating schizophrenia with LAIs, practicing in seven countries (France, Italy, US, Germany, Spain, Denmark, UK). Panelists were presented with 73 statements spanning three categories: patient population; medication dosage, management, and adverse events; and functional recovery domains and assessment. Fifty-five statements achieved ≥ 80% agreement (considered consensus). Statements with low agreement (40-79%) or very low agreement (< 39%) concerned initiating dosage in FEP and EP patients, and managing loss of efficacy and breakthrough episodes, reflecting current evidence gaps. The panel emphasized benefits of LAIs in FEP and EP patients, with consensus that LAIs can decrease the risk of relapse, rehospitalization, and functional dysfunction. The panel supported links between these benefits and multidimensional longer-term functional recovery beyond symptomatic remission. Conclusions: Findings from this Delphi panel support the use of LAIs in FEP and EP schizophrenia patients regardless of disease severity, number of relapses, or social support status. Gaps in clinician knowledge make generating evidence on using LAIs in FEP and EP patients critical. [ABSTRACT FROM AUTHOR]

Background Several authors have developed and applied methods to routine data sets to identify the nature and rate of complications following interventional procedures. But, to date, there has been no systematic search for such methods. The objective of this article was to find, classify and appraise published methods, based on analysis of clinical codes, which used routine healthcare databases in a United Kingdom setting to identify complications resulting from interventional procedures. Methods A literature search strategy was developed to identify published studies that referred, in the title or abstract, to the name or acronym of a known routine healthcare database and to complications from procedures or devices. The following data sources were searched in February and March 2013: Cochrane Methods Register, Conference Proceedings Citation Index - Science, Econlit, EMBASE, Health Management Information Consortium, Health Technology Assessment database, MathSciNet, MEDLINE, MEDLINE in-process, OAIster, OpenGrey, Science Citation Index Expanded and ScienceDirect. Of the eligible papers, those which reported methods using clinical coding were classified and summarised in tabular form using the following headings: routine healthcare database; medical speciality; method for identifying complications; length of follow-up; method of recording comorbidity. The benefits and limitations of each approach were assessed. Results From 3688 papers identified from the literature search, 44 reported the use of clinical codes to identify complications, from which four distinct methods were identified: 1) searching the index admission for specified clinical codes, 2) searching a sequence of admissions for specified clinical codes, 3) searching for specified clinical codes for complications from procedures and devices within the International Classification of Diseases 10th revision (ICD- 10) coding scheme which is the methodology recommended by NHS Classification Service, and 4) conducting manual clinical review of diagnostic and procedure codes. Conclusions The four distinct methods identifying complication from codified data offer great potential in generating new evidence on the quality and safety of new procedures using routine data. However the most robust method, using the methodology recommended by the NHS Classification Service, was the least frequently used, highlighting that much valuable observational data is being ignored. [ABSTRACT FROM AUTHOR]

Background: Non-steroidal anti-inflammatory drugs (NSAIDs) are a common cause of adverse drug events (ADEs), but renal risks of NSAIDs are less well quantified than gastrointestinal and cardiac risks. This paper reports a systematic review of published population-based observational studies examining the risk of acute kidney injury (AKI) associated with NSAIDs in community-dwelling adults and those with pre-existing chronic kidney disease (CKD).Methods: MEDLINE and EMBASE databases were searched until June 2016, and 3789 papers screened. Ten studies reporting NSAID risk of AKI in the general population were included in random effects meta-analysis, of which five additionally reported NSAID risk in people with CKD.Results: In the general population, the pooled odds ratio (OR) of AKI for current NSAID exposure was 1.73 (95%CI 1.44 to 2.07), with somewhat higher risk observed in older people (OR 2.51, 95%CI 1.52 to 2.68). In people with CKD, individual study OR of AKI due to current NSAID exposure ranged from 1.12 to 5.25, with pooled estimate OR 1.63 (95% CI 1.22 to 2.19).Conclusions: No study reported baseline risk of AKI in different populations meaning absolute risks could not be estimated, but baseline risk and therefore the absolute risk of NSAID exposure is likely to be higher in people with CKD and older people. Large population based studies measuring AKI using current definitions and estimating the absolute risk of harm are needed in order to better inform clinical decision making. [ABSTRACT FROM AUTHOR]

Background: Sarcopenia is increasingly recognized as a correlate of ageing and is associated with increased likelihood of adverse outcomes including falls, fractures, frailty and mortality. Several tools have been recommended to assess muscle mass, muscle strength and physical performance in clinical trials. Whilst these tools have proven to be accurate and reliable in investigational settings, many are not easily applied to daily practice. Methods: This paper is based on literature reviews performed by members of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) working group on frailty and sarcopenia. Face-to-face meetings were afterwards organized for the whole group to make amendments and discuss further recommendations. Results: This paper proposes some user-friendly and inexpensive methods that can be used to assess sarcopenia in real-life settings. Healthcare providers, particularly in primary care, should consider an assessment of sarcopenia in individuals at increased risk; suggested tools for assessing risk include the Red Flag Method, the SARC-F questionnaire, the SMI method or different prediction equations. Management of sarcopenia should primarily be patient centered and involve the combination of both resistance and endurance based activity programmes with or without dietary interventions. Development of a number of pharmacological interventions is also in progress. Conclusions: Assessment of sarcopenia in individuals with risk factors, symptoms and/or conditions exposing them to the risk of disability will become particularly important in the near future. [ABSTRACT FROM AUTHOR]

Background: Vaccine hesitancy has been a growing challenge for public health in recent decades. Among factors contributing to vaccine hesitancy, concerns regarding vaccine safety and Adverse Events (AEs) play the leading role. Moreover, cognitive biases are critical in connecting such concerns to vaccine hesitancy behaviors, but their role has not been comprehensively studied. In this study, our first objective is to address concerns regarding vaccine AEs to increase vaccine acceptance. Our second objective is to identify the potential cognitive biases connecting vaccine hesitancy concerns to vaccine-hesitant behaviors and identify the mechanism they get triggered in the vaccine decision-making process.Methods: First, to mitigate concerns regarding AEs, we quantitatively analyzed the U.S. Vaccine Adverse Event Reporting System (VAERS) from 2011 to 2018 and provided evidence regarding the non-severity of the AEs that can be used as a communicable summary to increase vaccine acceptance. Second, we focused on the vaccination decision-making process. We reviewed cognitive biases and vaccine hesitancy literature to identify the most potential cognitive biases that affect vaccine hesitancy and categorized them adopting the Precaution Adoption Process Model (PAPM).Results: Our results show that the top frequent AEs are expected mild reactions like injection site erythema (4.29%), pyrexia (3.66%), and injection site swelling (3.21%). 94.5% of the reports are not serious and the average population-based serious reporting rate over the 8 years was 25.3 reports per 1 million population. We also identified 15 potential cognitive biases that might affect people's vaccination decision-making and nudge them toward vaccine hesitancy. We categorized these biases based on the factors that trigger them and discussed how they contribute to vaccine hesitancy.Conclusions: This paper provided an evidence-based communicable summary of VAERS. As the most trusted sources of vaccine information, health practitioners can use this summary to provide evidence-based vaccine information to vaccine decision-makers (patients/parents) and mitigate concerns over vaccine safety and AEs. In addition, we identified 15 potential cognitive biases that might affect the vaccination decision-making process and nudge people toward vaccine hesitancy. Any plan, intervention, and message to increase vaccination uptake should be modified to decrease the effect of these potential cognitive biases. [ABSTRACT FROM AUTHOR]

Background: The aims of this systematic review and meta-analysis are to examine the prevalence of adverse mental health outcomes, both short-term and long-term, among SARS patients, healthcare workers and the general public of SARS-affected regions, and to examine the protective and risk factors associated with these mental health outcomes.Methods: We conducted a systematic search of the literature using databases such as Medline, Pubmed, Embase, PsycInfo, Web of Science Core Collection, CNKI, the National Central Library Online Catalog and dissertation databases to identify studies in the English or Chinese language published between January 2003 to May 2020 which reported psychological distress and mental health morbidities among SARS patients, healthcare workers, and the general public in regions with major SARS outbreaks.Results: The literature search yielded 6984 titles. Screening resulted in 80 papers for the review, 35 of which were included in the meta-analysis. The prevalence of post-recovery probable or clinician-diagnosed anxiety disorder, depressive disorder, and post-traumatic stress disorder (PTSD) among SARS survivors were 19, 20 and 28%, respectively. The prevalence of these outcomes among studies conducted within and beyond 6 months post-discharge was not significantly different. Certain aspects of mental health-related quality of life measures among SARS survivors remained impaired beyond 6 months post-discharge. The prevalence of probable depressive disorder and PTSD among healthcare workers post-SARS were 12 and 11%, respectively. The general public had increased anxiety levels during SARS, but whether there was a clinically significant population-wide mental health impact remained inconclusive. Narrative synthesis revealed occupational exposure to SARS patients and perceived stigmatisation to be risk factors for adverse mental health outcomes among healthcare workers, although causality could not be determined due to the limitations of the studies.Conclusions: The chronicity of psychiatric morbidities among SARS survivors should alert us to the potential long-term mental health complications of covid-19 patients. Healthcare workers working in high-risk venues should be given adequate mental health support. Stigmatisation against patients and healthcare workers should be explored and addressed. The significant risk of bias and high degree of heterogeneity among included studies limited the certainty of the body of evidence of the review. [ABSTRACT FROM AUTHOR]

Background: Older adults (> 65 years) with multiple chronic conditions (MCC) and depressive symptoms experience frequent transitions between hospital and home. Care transitions for this population are often poorly coordinated and fragmented, resulting in increased readmission rates, adverse medical events, decreased patient satisfaction and safety, and increased caregiver burden. There is a dearth of evidence on best practices in the provision of transitional care for older adults with MCC and depressive symptoms transitioning from hospital-to-home. This paper presents a protocol for a two-armed, multi-site pragmatic effectiveness-implementation trial of Community Assets Supporting Transitions (CAST), an evidence-informed nurse-led six-month intervention that supports older adults with MCC and depressive symptoms transitioning from hospital-to-home. The Collaborative Intervention Planning Framework is being used to engage patients and other key stakeholders in the implementation and evaluation of the intervention and planning for intervention scale-up to other communities.Methods: Participants will be considered eligible if they are > 65 years, planned for discharged from hospital to the community in three Ontario locations, self-report at least two chronic conditions, and screen positive for depressive symptoms. A total of 216 eligible and consenting participants will be randomly assigned to the control (usual care) or intervention (CAST) arm. The intervention consists of tailored care delivery comprising in-home visits, telephone follow-up and system navigation support. The primary measure of effectiveness is mental health functioning of the older adult participant. Secondary outcomes include changes in physical functioning, depressive symptoms, anxiety, perceived social support, patient experience, and health and social service use and cost, from baseline to 6- and 12-months. Caregivers will be assessed for caregiver strain, depressive symptoms, anxiety, health-related quality of life, and health and social service use and costs. Descriptive and qualitative data from older adult and caregiver participants, and the nurse interventionists will be used to examine implementation of the intervention, how the intervention is adapted within each study region, and its potential for sustainability and scalability to other jurisdictions.Discussion: A nurse-led transitional care strategy may provide a feasible and effective means for improving health outcomes and patient/caregiver experience and reduce service use and costs in this vulnerable population.Trial Registration: # NCT03157999 . Registration Date: April 4, 2017. [ABSTRACT FROM AUTHOR]

Background: Youth facing barriers created by social marginalization are at a greater risk of adverse health outcomes, lower educational and occupational attainment, and decreased overall quality of life as adults. The negative psychosocial and physiological consequences of significant barriers to positive development during youth may be mitigated by interventions promoting physical activity, psychosocial development, and healthy behaviours. Sport for Development programming is a possible opportunity for youth facing barriers to engage in activities that foster positive youth development, which may improve socioeconomic outcomes, quality of life and long-term health status in this population. This paper outlines the study protocol measuring impact of an urban Sport for Development facility on positive youth development in youth facing barriers.Methods/design: Participants aged 6-29 will be recruited from programs at an urban Sport for Development facility to a 2-year prospective longitudinal mixed-methods study. Participants will be stratified by age into three cohorts with age-specific outcomes. Age-specific positive youth development outcomes will be assessed quantitatively by self-report and pedometer at baseline and after 6 months, 1-year, and 2-years of program participation. Focus groups will provide data regarding youth experience and the impact of facility and program components on youth outcomes.Discussion: Our findings will inform best-practice and feasibility of a Sport for Development facility delivering programs in a socially and economically challenged urban setting in a high-income country.Trial Registration: ISRCTN67016999. Date of registration: October 22, 2019. [ABSTRACT FROM AUTHOR]

Background: The effectiveness and safety of acupuncture therapy to delay lung function decline in chronic obstructive pulmonary disease (COPD) remain unclear. This study aimed to determine whether acupuncture, as an adjunctive therapy to COPD-guided medication, could prevent lung function decline. Methods: This randomised, two-centre study was conducted between February 2022 and July 2023. Men and women aged 40–80 years with COPD were recruited. Participants received active or sham acupuncture three times a week (36 sessions total). The primary outcome was the change in the percentage of forced expiratory volume for 1 s to the predicted value (FEV1%) between the baseline and after the intervention. Results: Overall, 238 participants were screened, and 74 (58 men [78.4%]; mean [standard deviation] age, 69.6 [7.2] years) were randomised into the acupuncture and sham acupuncture groups (37 per group). After the intervention, the change in FEV1% was 1.35 (95% confidence interval [CI]: -0.47 to 3.17) and -2.44 (95% CI: -4.56 to -0.33) in the acupuncture and sham acupuncture groups, respectively. The difference was -3.97 (95% CI: -6.2 to -1.74), and the adjusted difference was -3.46 (95% CI: -5.69 to -1.24, P = 0.003) between the groups. A significantly less decline was found in forced expiratory volume for 1 s in the acupuncture group. All treatment-related adverse events (acupuncture = 11, sham = 2) were mild. Conclusions: Compared with sham acupuncture, acupuncture plus medication may delay lung function decline. However, further studies with a larger sample size and longer-term follow-up are needed to clarify the effects. [ABSTRACT FROM AUTHOR]

In this paper, we show how we have applied the Clinical Narrative Temporal Relation Ontology (CNTRO) and its associated temporal reasoning system (the CNTRO Timeline Library) to trend temporal information within medical device adverse event report narratives. 238 narratives documenting occurrences of late stent thrombosis adverse events from the Food and Drug Administration's (FDA) Manufacturing and User Facility Device Experience (MAUDE) database were annotated and evaluated using the CNTRO Timeline Library to identify, order, and calculate the duration of temporal events. The CNTRO Timeline Library had a 95% accuracy in correctly ordering events within the 238 narratives. 41 narratives included an event in which the duration was documented, and the CNTRO Timeline Library had an 80% accuracy in correctly determining these durations. 77 narratives included documentation of a duration between events, and the CNTRO Timeline Library had a 76% accuracy in determining these durations. This paper also includes an example of how this temporal output from the CNTRO ontology can be used to verify recommendations for length of drug administration, and proposes that these same tools could be applied to other medical device adverse event narratives in order to identify currently unknown temporal trends. [ABSTRACT FROM AUTHOR]

Background: Advanced head and neck squamous cell carcinoma (HNSCC) has a poor prognosis, and new treatment options are needed. Combining immunotherapies with differing mechanisms of action may enhance clinical benefits compared with single-agent immunotherapy. Epacadostat, an indoleamine 2,3 dioxygenase 1 inhibitor, plus pembrolizumab, a PD-1 inhibitor, showed promising activity in advanced HNSCC in the phase 1/2 KEYNOTE-037/ECHO-202 trial. Methods: KEYNOTE-669/ECHO-304 is a randomized, open-label, phase 3 study evaluating the efficacy and safety of pembrolizumab plus epacadostat, pembrolizumab monotherapy, and the EXTREME regimen (cetuximab with a platinum [carboplatin or cisplatin] and 5-fluorouracil) in recurrent/metastatic (R/M) HNSCC. Participants had no prior systemic therapy for R/M HNSCC and were randomly assigned (2:1:2) to pembrolizumab 200 mg intravenously every 3 weeks plus epacadostat 100 mg orally twice daily, pembrolizumab monotherapy, or EXTREME. The primary endpoint was objective response rate (ORR; investigator assessment). Secondary endpoints were safety and tolerability. Change in serum kynurenine was an exploratory endpoint. Study enrollment was discontinued early as a strategic decision on May 2, 2018, and response assessment was discontinued after first on-study imaging assessment at week 9. Data cut-off was January 17, 2019. Results: Between December 1, 2017, and May 2, 2018, 89 patients were randomly allocated to pembrolizumab plus epacadostat (n = 35), pembrolizumab monotherapy (n = 19), or EXTREME (n = 35). ORR (95% CI) was 31% (17%–49%) for pembrolizumab plus epacadostat, 21% (6%–46%) for pembrolizumab monotherapy, and 34% (19%–52%) for EXTREME. Treatment-related adverse events (TRAEs) occurred in 82% (n = 28) of patients receiving pembrolizumab plus epacadostat, 63% (n = 12) receiving pembrolizumab monotherapy, and 100% (n = 34) receiving EXTREME. Grade 3–4 TRAEs occurred in 24% (n = 8) of patients receiving pembrolizumab plus epacadostat, 16% (n = 3) receiving pembrolizumab monotherapy, and 82% (n = 28) receiving EXTREME. No deaths occurred due to AEs. Pembrolizumab plus epacadostat treatment reduced kynurenine levels but not to that of healthy subjects. Conclusions: Pembrolizumab plus epacadostat and pembrolizumab monotherapy provided a similar response rate to EXTREME and demonstrated a manageable safety profile in patients with R/M HNSCC. Trial registration: NCT03358472. Date of trial registration: November 30, 2017. [ABSTRACT FROM AUTHOR]

Background: Knowledge about patient safety in orthodontics is scarce. Lack of standardisation and a common terminology hinders research and limits our understanding of the discipline. This study aims to 1) summarise current knowledge about patient safety incidents (PSI) in orthodontic care by conducting a systematic literature search, 2) propose a new standardisation of PSI terminology and 3) propose a future research agenda on patient safety in the field of orthodontics. Methods: A systematic literature search was performed in the main online sources of PubMed, Web of Science, Scopus and OpenGrey from their inception to 1 July 2023. Inclusion criteria were based on the World Health Organization´s (WHO) research cycle on patient safety. Studies providing information about the cycle's steps related to orthodontics were included. Study selection and data extraction were performed by two of the authors. Results: A total of 3,923 articles were retrieved. After review of titles and abstracts, 41 articles were selected for full-text review and 25 articles were eligible for inclusion. Seven provided information on the WHO's research cycle step 1 ("measuring harm"), twenty-one on "understanding causes" (step 2) and twelve on "identifying solutions" (step 3). No study provided information on Steps 4 and 5 ("evaluating impact" or "translating evidence into safer care"). Conclusion: Current evidence on patient safety in orthodontics is scarce due to a lack of standardised reporting and probably also under-reporting of PSIs. Current literature on orthodontic patient safety deals primarily with "measuring harms" and "understanding causes of patient safety", whereas less attention has been devoted to initiatives "identifying solutions", "evaluating impact" and "translating evidence into safer care". The present project holds a proposal for a new categorisation, terminology and future research agenda that may serve as a framework to support future research and clinical initiatives to improve patient safety in orthodontic care. Registration: PROSPERO (CRD42022371982). [ABSTRACT FROM AUTHOR]

Background: Patient safety is defined as the prevention of harm to patients and aims to prevent errors. This analysis explores factors associated with the reported occurrence of patient safety incidents (PSIs) in general practices in Ireland at the start of the COVID-19 pandemic. Methods: The PRICOV-19 was a cross-sectional study to record the (re)organisation of care provided in general practice and changes implemented during the COVID-19 pandemic in 38 countries. Primary outcomes include three potential scenarios of PSIs: delayed care due to practice factors, delayed care due to patient factors, and delayed care due to triage. Exploratory variables included demographic and organisational characteristics, triage, collaboration, and strategies to safeguard staff members' well-being. Results: Of the 172 participating Irish general practices, 71% (n = 122) recorded at least one potential PSI. The most frequent incident was delayed care due to patient factors (65%), followed by practice (33%) and triage (30%). Multivariate analysis showed that delayed care due to patient factors was associated with changes in the process of repeat prescriptions (OR 6.7 [CI 95% 2.5 to 19.6]). Delayed care due to practice factors was associated with suburbs/small towns (OR 4.2 [1.1 to 19.8]) and structural changes to the reception (OR 3.5 [1.2 to 11.4]). While delayed care due to patient factors was associated with having a practice population of 6000–7999 patients (OR 4.7 [1.1 to 27.6]) and delayed care due to practice factors was associated with having a practice population of 2000–3999 patients (OR 4.2 [1.2 to 17.1]). No linear associations were observed with higher or lower patient numbers for any factor. Delayed care due to triage was not associated with any exploratory variables. Conclusion: The COVID-19 pandemic resulted in dramatic changes in the delivery of care through general practices in Ireland. Few factors were associated with the reported occurrence of PSIs, and these did not show consistent patterns. Sustained improvements were made in relation to repeat prescriptions. The lack of consistent patterns, potentially confirms that the autonomous decisions made in general practice in response to the challenges of the COVID-19 pandemic could have benefitted patient safety (See Graphical abstract). [ABSTRACT FROM AUTHOR]

Background: To illustrate the 10-year risks of urinary adverse events (UAEs) among men diagnosed with prostate cancer and treated with different types of therapy, accounting for the competing risk of death.Methods: Prostate cancer is the second most common malignancy among adult males in the United States. Few studies have reported the long-term post-treatment risk of UAEs and those that have, have not appropriately accounted for competing deaths. This paper conducts an inverse probability of treatment (IPT) weighted competing risks analysis to estimate the effects of different prostate cancer treatments on the risk of UAE, using a matched-cohort of prostate cancer/non-cancer control patients from the Surveillance, Epidemiology and End Results (SEER) Medicare database.Results: Study dataset included men age 66 years or older that are 83% white and had a median follow-up time of 4.14 years. Patients that underwent combination radical prostatectomy and external beam radiotherapy experienced the highest risk of UAE (IPT-weighted competing risks: HR 3.65 with 95% CI (3.28, 4.07); 10-yr. cumulative incidence = 36.5%).Conclusions: Findings suggest that IPT-weighted competing risks analysis provides an accurate estimator of the cumulative incidence of UAE taking into account the competing deaths as well as measured confounding bias. [ABSTRACT FROM AUTHOR]

Background: Maternity intrapartum care research and clinical care more often focus on outcomes that minimise or prevent adverse health rather than on what constitutes positive health and wellbeing (salutogenesis). This was highlighted recently in a systematic review of reviews of intrapartum reported outcomes where only 8% of 1648 individual outcomes, from 102 systematic reviews, were agreed as being salutogenically-focused. Added to this is variation in the outcomes measured in individual studies rendering it very difficult for researchers to synthesise, fully, the evidence from studies on a particular topic. One of the suggested ways to address this is to develop and apply an agreed standardised set of outcomes, known as a 'core outcome set' (COS). In this paper we present a protocol for the development of a salutogenic intrapartum COS (SIPCOS) for use in maternity care research and a SIPCOS for measuring in daily intrapartum clinical care.Methods: The study proposes three phases in developing the final SIPCOSs. Phase one, which is complete, involved the conduct of a systematic review of reviews to identify a preliminary list of salutogenically-focused outcomes that had previously been reported in systematic reviews of intrapartum interventions. Sixteen unique salutogenically-focused outcome categories were identified. Phase two will involve prioritising these outcomes, from the perspective of key stakeholders (users of maternity services, clinicians and researchers) by asking them to rate the importance of each outcome for inclusion in the SIPCOSs. A final consensus meeting (phase three) will be held, bringing international stakeholders together to review the preliminary SIPCOSs resulting from the survey and to agree and finalise the final SIPCOSs for use in future maternity care research and daily clinical care.Discussion: The expectation in developing the SIPCOSs is that they will be collected and reported in all future studies evaluating intrapartum interventions and measured/recorded in future intrapartum clinical care, as routine, alongside other outcomes also deemed important in the context of the study or clinical scenario. Using the SIPCOSs in this way, will promote and encourage standardised measurements of positive health outcomes in maternity care, into the future. [ABSTRACT FROM AUTHOR]

Background: Optimizing transitional care by practicing family-centered care might reduce unplanned events for patients who undergo major abdominal cancer surgery. However, it remains unknown whether involving family caregivers in patients' healthcare also has negative consequences for patient safety. This study assessed the safety of family involvement in patients' healthcare by examining the cause of unplanned events in patients who participated in a family involvement program (FIP) after major abdominal cancer surgery. Methods: This is a secondary analysis focusing on the intervention group of a prospective cohort study conducted in the Netherlands. Data were collected from April 2019 to May 2022. Participants in the intervention group were patients who engaged in a FIP. Unplanned events were analyzed, and root causes were identified using the medical version of a prevention- and recovery-information system for monitoring and analysis (PRISMA) that analyses unintended events in healthcare. Unplanned events were compared between patients who received care from family caregivers and patients who received professional at-home care after discharge. A Mann-Whitney U test was used to analyze data. Results: Of the 152 FIP participants, 68 experienced an unplanned event and were included. 112 unplanned events occurred with 145 root causes since some unplanned events had several root causes. Most root causes of unplanned events were patient-related factors (n = 109, 75%), such as patient characteristics and disease-related factors. No root causes due to inadequate healthcare from the family caregiver were identified. Unplanned events did not differ statistically (interquartile range 1–2) (p = 0.35) between patients who received care from trained family caregivers and those who received professional at-home care after discharge. Conclusion: Based on the insights from the root-cause analysis in this prospective multicenter study, it appears that unplanned emergency room visits and hospital readmissions are not related to the active involvement of family caregivers in surgical follow-up care. Moreover, surgical follow-up care by trained family caregivers during hospitalization was not associated with increased rates of unplanned adverse events. Hence, the concept of active family involvement by proficiently trained family caregivers in postoperative care appears safe and feasible for patients undergoing major abdominal surgery. [ABSTRACT FROM AUTHOR]

Background: Lack of agreed terminology and definitions in healthcare compromises communication, patient safety, optimal management of adverse events, and research progress. The purpose of this scoping review was to understand the terminologies used to describe central venous access devices (CVADs), associated complications and reasons for premature removal in people undergoing cancer treatment. It also sought to identify the definitional sources for complications and premature removal reasons. The objective was to map language and descriptions used and to explore opportunities for standardisation. Methods: A systematic search of MedLine, PubMed, Cochrane, CINAHL Complete and Embase databases was performed. Eligibility criteria included, but were not limited to, adult patients with cancer, and studies published between 2017 and 2022. Articles were screened and data extracted in Covidence. Data charting included study characteristics and detailed information on CVADs including terminologies and definitional sources for complications and premature removal reasons. Descriptive statistics, tables and bar graphs were used to summarise charted data. Results: From a total of 2363 potentially eligible studies, 292 were included in the review. Most were observational studies (n = 174/60%). A total of 213 unique descriptors were used to refer to CVADs, with all reasons for premature CVAD removal defined in 84 (44%) of the 193 studies only, and complications defined in 56 (57%) of the 292 studies. Where available, definitions were author-derived and/or from national resources and/or other published studies. Conclusion: Substantial variation in CVAD terminology and a lack of standard definitions for associated complications and premature removal reasons was identified. This scoping review demonstrates the need to standardise CVAD nomenclature to enhance communication between healthcare professionals as patients undergoing cancer treatment transition between acute and long-term care, to enhance patient safety and rigor of research protocols, and improve the capacity for data sharing. [ABSTRACT FROM AUTHOR]

Background: Manual therapies are commonly used by healthcare professionals when caring for children. However, few prospective studies have evaluated their adverse events (AEs). This study aims to assess the feasibility of a pragmatic prospective study aiming to report the immediate and delayed (48-hours post-treatment) AEs associated with manual therapies in children aged 5 or younger. Preliminary data on AEs frequency are also reported. Methods: Between July 2021 and March 2022, chiropractors were recruited through purposive sampling and via a dedicated Facebook group for Quebec chiropractors interested in pediatrics. Legal guardians of patients aged 5 or younger were invited to fill out an online information and consent form. AEs were collected using the SafetyNET reporting system, which had been previously translated by the research team. Immediate AEs were collected through a questionnaire filled out by the legal guardian immediately after the treatment, while delayed AEs were collected through a questionnaire sent by email to the legal guardian 48 h after the treatment. Feasibility was assessed qualitatively through feedback from chiropractors and quantitatively through recruitment data. Results: Overall, a total of 28 chiropractors expressed interest following the Facebook publication, and 5 participated. An additional two chiropractors were enrolled through purposive sampling. In total, 80 legal guardians consented to their child's participation, and data from 73 children were included for the analysis of AEs. At least one AE was reported in 30% of children (22/73), and AEs were mainly observed immediately following the treatment (16/22). The most common AEs were irritability/crying (11 children) or fatigue/tiredness (11 children). Feasibility analysis demonstrated that regular communication between the research team and clinicians, as well as targeting clinicians who showed great interest in pediatrics, were key factors for successful research. Conclusion: Results suggest that it is feasible to conduct a prospective pragmatic study evaluating AEs associated with manual therapies in private practices. Direct communication with the clinicians, a strategic clinicians' recruitment plan, and the resulting administrative burden should be considered in future studies. A larger study is required to confirm the frequency of AEs reported in the current study. Trial registration: ClinicalTrials.gov., NCT05409859, Registered on June 3 2022. https://clinicaltrials.gov/study/NCT05409859. [ABSTRACT FROM AUTHOR]

Background: Acupuncture is known for a harmless treatment when administered by well-trained clinicians. However, multiple case reports of traumatic adverse events (AEs) related to acupuncture treatments continue to be published in literature. In this review, we evaluated the reporting quality and conducted causality assessments of case studies that have reported acupuncture-related traumatic AEs in Korea. Methods: Eight databases were searched from their inception to January 2024. Only Korean case studies that reported traumatic AEs following acupuncture procedures were included without any language restrictions. Reporting quality was evaluated based on patient characteristics, AEs, and acupuncture practice. Causality was assessed using the modified WHO-UMC causality criteria. Results: Twenty-eight studies were included from a total of 1,154 identified studies. The quality of reporting in the included studies was low overall. While the descriptions of patient characteristics and AEs were relatively well detailed, most information on acupuncture practice was not reported at all. During the causality assessment, only three (10.7%) studies were judged to be "certain". Twelve (42.9%) studies were "unassessable" because they inadequately described the information necessary for decision-making. It was practically difficult to establish the causality between acupuncture and AEs, as well as the appropriateness of acupuncture practice. Conclusions: Insufficient and inappropriate reporting was observed in most case studies reporting acupuncture-related traumatic AEs in Korea. To overcome these limitations, we have suggested tentative guidelines in the form of a set of items that should be reported by future authors who plan to publish case studies on acupuncture-related traumatic AEs in a clinical setting. [ABSTRACT FROM AUTHOR]

Background: Postoperative adverse events are known to increase length of stay and cost. However, research on how adverse events affect patient flow and operational performance has been relatively limited to date. Moreover, there is paucity of studies on the use of simulation in understanding the effect of complications on care processes and resources. In hospitals with scarcity of resources, postoperative complications can exert a substantial influence on hospital throughputs. Methods: This paper describes an evaluation method for assessing the effect of complications on patient flow within a cardiac surgical department. The method is illustrated by a case study where actual patient-level data are incorporated into a discrete event simulation (DES) model. The DES model uses patient data obtained from a large hospital in Oman to quantify the effect of complications on patient flow, costs and surgical throughputs. We evaluated the incremental increase in resources due to treatment of complications using Poisson regression. Several types of complications were examined such as cardiac complications, pulmonary complications, infection complications and neurological complications. Results: 48 % of the patients in our dataset experienced one or more complications. The most common types of complications were ventricular arrhythmia (16 %) followed by new atrial arrhythmia (15.5 %) and prolonged ventilation longer than 24 h (12.5 %). The total number of additional days associated with infections was the highest, while cardiac complications have resulted in the lowest number of incremental days of hospital stay. Complications had a significant effect on perioperative operational performance such as surgery cancellations and waiting time. The effect was profound when complications occurred in the Cardiac Intensive Care (CICU) where a limited capacity was observed. Conclusions: The study provides evidence supporting the need to incorporate adverse events data in resource planning to improve hospital performance. [ABSTRACT FROM AUTHOR]

Background: Patient safety in primary care is an emerging field of research with a growing evidence base in western countries but little has been explored in the Gulf Cooperation Council Countries (GCC) including the Sultanate of Oman. This study aimed to review the literature on the safety culture and patient safety measures used globally to inform the development of safety culture among health care workers in primary care with a particular focus on the Middle East. Methods: A systematic review of the literature. Searches were undertaken using Medline, EMBASE, CINAHL and Scopus from the year 2000 to 2014. Terms defining safety culture were combined with terms identifying patient safety and primary care. Results: The database searches identified 3072 papers that were screened for inclusion in the review. After the screening and verification, data were extracted from 28 papers that described safety culture in primary care. The global distribution of the articles is as follows: the Netherlands (7), the United States (5), Germany (4), the United Kingdom (1), Australia, Canada and Brazil (two for each country), and with one each from Turkey, Iran, Saudi Arabia and Kuwait. The characteristics of the included studies were grouped under the following themes: safety culture in primary care, incident reporting, safety climate and adverse events. The most common theme from 2011 onwards was the assessment of safety culture in primary care (13 studies, 46%). The most commonly used safety culture assessment tool is the Hospital survey on patient safety culture (HSOPSC) which has been used in developing countries in the Middle East. Conclusions: This systematic review reveals that the most important first step is the assessment of safety culture in primary care which will provide a basic understanding to safety-related perceptions of health care providers. The HSOPSC has been commonly used in Kuwait, Turkey, and Iran. [ABSTRACT FROM AUTHOR]

Background: Concern exists regarding the potential for chiropractic treatment to cause adverse effects in individuals with scoliosis. The aim of this paper is to present the self-reported responses of 189 scoliosis patients over 3198 unique visits, collected over one calendar year from nine chiropractic clinics, regarding how they felt and the side effects they experienced immediately after chiropractic treatment. Methods: Thirty six private chiropractic clinics specializing in the treatment of scoliosis were asked to participate in a prospective study regarding the side-effects of the chiropractic treatment of scoliosis; 9 agreed to participate. A response form was provided to each scoliosis patient at the end of their clinic visit, and consisted of two questions: "How do you feel after your treatment today?" and "Did you experience any side-effects as a result of your treatment today?" Results: One hundred eighty nine informed consent forms were collected and 3198 response forms were collected, suggesting an average of 17 visits per patient. Patients reported feeling worse post-treatment after 5.0 % of the visits. The incidence of side-effects was 29.7 %. Muscle soreness accounted for 35.2 % of all side effects. 99.9 % of all side effects were classified as mild. Six moderate side-effects (sprains/strains) were reported out of 3,198 visits. There were no reported cases of severe side effects. Conclusion: Mild side effects were common, although the frequency was slightly lower than the average for chiropractic interventions. The rate of moderate side effects reported was one per 533 visits involving the care of 189 scoliosis patients surveyed from 9 chiropractic offices over a timeframe of one calendar year. No serious adverse events occurred that required medical attention, hospital stays, or surgical intervention. Based upon this preliminary data, side effects reported by scoliosis patients immediately after chiropractic treatment appear to be relatively common but generally benign. [ABSTRACT FROM AUTHOR]

Background: Ipilimumab is a fully human monoclonal antibody directed against cytotoxic T-lymphocyte antigen-4, a key negative regulator of T-cell activation approved by the Food and Drug Administration as of March 2011 for the treatment of metastatic melanoma. As a result of the up-regulation of the immune system, several immune-mediated adverse effects have been reported including colitis, dermatitis, hepatitis and rarely hypophysitis. The most frequent immune-mediated adverse effects described in literature include gastrointestinal toxicity such as diarrhea, colitis and case of colitis and ileitis. Case presentation: In this paper we report an interesting case of immune-mediate ileitis without colitis in a 54 years old woman with metastatic melanoma treated with ipilimumab. We also discuss about case management and the possible pathological mechanisms considering also previous reports. Conclusions: The aim of this article is to support further investigations concerning epigenetic and genetic analysis in order to personalize biological therapy and to reduce immune related adverse events observed after ipilimumab administration. [ABSTRACT FROM AUTHOR]

Background: Endometriosis-related pain encompassing dysmenorrhea, dyspareunia, and chronic pelvic pain, reduces the quality of life in premenopausal women. Although treatment options for endometriosis alleviate this pain, approximately one-third of women still experience pain even after receiving treatment, indicating the need for novel approaches to pain relief in those women. The Angel Touch device (AT-04) is a portable magnetic fields irradiation device that incorporates a combination of mixed alternative magnetic fields at 2 kHz and 83.3 MHz. A phase III trial confirmed the efficacy and safety of AT-02, a prototype of AT-04, for pain relief in patients with fibromyalgia. Methods: This is a phase III, multicenter, prospective, randomized, sham device-controlled, double-blind, parallel study. The participants will be premenopausal women aged > 18 years who have endometriosis-related pain with at least moderate severity. Considering dropouts, 50 participants have been deemed appropriate. Eligible women will be centrally registered, and the data center will randomly allocate them in a 1:1 ratio to the intervention and control groups. Women in the intervention group will receive electromagnetic wave irradiation generated by AT-04 and those who in the control group will wear a sham device for 16 weeks, and both groups will wear AT-04 for another 4 weeks. The primary outcome measure is the change in the Numeric Rating Scale score at 16 weeks compared with the baseline. Secondary outcome measures are efficacy for pelvic pain including dysmenorrhea and non-menstrual pain, and chronic pelvic pain not related to menstruation, dysmenorrhea, and dyspareunia, and improvement of quality of life during the study period. Safety will be evaluated by device defects and the frequency of adverse events. The study protocol has been approved by the Clinical Study Review Board of Chiba University Hospital, Chiba, Japan, and will be conducted in accordance with the principles of the Declaration of Helsinki and the Japanese Clinical Trials Act and relevant notifications. Discussion: This study aims to develop a novel method of managing endometriosis-related pain. The AT-04 is an ultralow-invasive device that can be used without inhibiting ovulation, suggesting potential benefits to women of reproductive-age. Trial registration number Japan Registry of Clinical Trials (jRCTs032230278). Plain language summary: Endometriosis is a chronic inflammatory disorder that negatively impacts reproductive health via endometriosis-related pain, infertility, and endometriosis-associated ovarian cancer. Although current therapeutic options for endometriosis are effective for the endometriosis-related pain, approximately one-third of women still experience pain even after receiving treatment, indicating the need for novel approaches to pain relief in those women. This is the first randomized controlled trial to investigate the efficacy and safety of a novel portable pain management device, AT-04, that incorporates a combination of mixed alternating magnetic fields, for endometriosis-related pain. This is a multicenter, prospective, sham device-controlled, double-blind, parallel study. Enrolled women will have undergone standard hormonal treatment for endometriosis at baseline, and this allows for assessing whether the device remains effective when used in conjunction with existing treatment methods. The study also will explore the impact of AT-04 on reducing the size of ovarian endometriotic cysts that reflect the activity of endometriosis. The study reflects the strong desire by physicians to liberate women from the unbearable pain associated with endometriosis. The sole efficacy of AT-04 in treating endometriosis-related pain is difficult to evaluate as there is a possibility that menstrual cycles may influence the assessment of pain and quality of life. However, the study findings regarding the effectiveness of AT-04 for the treatment of endometriosis-related pain may benefit women with endometriosis who have pain that is not effectively relieved by other treatments. Consequently, it may contribute to the improvement of reproductive health within society. [ABSTRACT FROM AUTHOR]

Background: Hospital-acquired pressure injuries are a major patient safety concern in intensive care units that are considered largely preventable adverse events by adherence to nursing standards of care. The hypothesis of this research was to investigate the prevalence of hospital-acquired pressure injuries in intensive care units (ICUs) of the Eastern Mediterranean Region. Methods: This study was designed as a systematic review and meta-analysis. All articles published on Pressure ulcer prevalence in the ICUs of hospitals in Eastern Mediterranean Region countries, identified by searching PubMed through MEDLINE, Web of Science, Scopus, and Google Scholar from January 1, 2011, until September 22, 2023. The reference lists of these articles were checked for additional relevant studies. Data were analyzed using the Comprehensive Meta-Analysis Software (v.2.2.064). Results: A total of 15 articles met the inclusion criteria. Based on the random-effects model, the overall Pressure ulcer prevalence rate was 16.6% (95% CI (8.6-29.6)). Both the highest and lowest prevalence was observed in Jordan in 2011 at 83.1% (95% CI (71.2- 90.7)) and in 2012 at 0.9% (95% CI (0.5- 1.5)), respectively. The results showed that publication year, average age, and sample size were the main causes of heterogeneity between the reviewed studies (p < 0.05). Conclusion: This systematic review and meta-analysis of the pertinent peer-reviewed literature revealed a high prevalence of hospital-acquired pressure injuries of 16% in intensive care units of Eastern Mediterranean region. Therefore, it is necessary for health policymakers and managers in Eastern Mediterranean Region to take necessary measures to prevent the incidence of Pressure ulcers in hospitals, especially in ICUs. [ABSTRACT FROM AUTHOR]

Background: Patient safety in primary care is a developing field with an embryonic but evolving evidence base. This narrative review aims to identify tools that can be used by family practitioners as part of a patient safety toolkit to improve the safety of the care and services provided by their practices. Methods: Searches were performed in 6 healthcare databases in 2011 using 3 search stems; location (primary care), patient safety synonyms and outcome measure synonyms. Two reviewers analysed the results using a numerical and thematic analyses. Extensive grey literature exploration was also conducted. Results: Overall, 114 Tools were identified with 26 accrued from grey literature. Most published literature originated from the USA (41%) and the UK (23%) within the last 10 years. Most of the literature addresses the themes of medication error (55%) followed by safety climate (8%) and adverse event reporting (8%). Minor themes included; informatics (4.5%) patient role (3%) and general measures to correct error (5%). The primary/secondary care interface is well described (5%) but few specific tools for primary care exist. Diagnostic error and results handling appear infrequently (<1% of total literature) despite their relative importance. The remainder of literature (11%) related to referrals, Out-Of-Hours (OOH) care, telephone care, organisational issues, mortality and clerical error. Conclusions: This review identified tools and indicators that are available for use in family practice to measure patient safety, which is crucial to improve safety and design a patient safety toolkit. However, many of the tools have yet to be used in quality improvement strategies and cycles such as plan--do--study--act (PDSA) so there is a dearth of evidence of their utility in improving as opposed to measuring and highlighting safety issues. The lack of focus on diagnostics, systems safety and results handling provide direction and priorities for future research. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic endangered the quality of health care and the safety of patients and health care workers (HCWs). This provided challenges for HCWs' resilience and for hospital management and probably increased risks for patient safety incidents (PSI). HCWs may also have experienced psychological consequences as second victims of PSI, but evidence on this is lacking. Therefore, we mapped HCWs' experiences with PSI during the second wave of COVID-19, the associations of these experiences with the hospital management of patient safety culture and HCWs' interests in receiving further training. Methods: We obtained data from 193 HCWs working at the COVID-related departments of one large hospital in eastern Slovakia via a questionnaire developed in direct collaboration with them. We measured PSI experiences as various HCWs' experiences with near miss and adverse events and the hospital management of patient safety culture using indicators such as risk of recurrence, open disclosure and second victim experiences. For analysis, we used logistic regression models adjusted for age and gender of the HCWs. Results: One-third of the hospital HCWs had experienced PSI; these were more likely to expect adverse events to recur (odds ratio, OR = 2.7–3.5). Regarding the hospital management of patient safety culture, the HCWs' experiencing openly disclosed PSI was associated with one negative outcome, i.e. conflicts among colleagues (OR = 2.8), and one positive outcome, i.e. patients' acceptance of their explanation and apologies (OR = 2.3). We found no associations for any other essential domains after disclosure. PSI experiences were strongly associated with psychological indicators of second victimhood, such as sadness, irritability, anxiety and depression (OR = 2.2–4.3), while providing support was not. The majority of the HCWs would like to participate in the suggested trainings (83.4%). Conclusion: HCWs with PSI experiences reported poor hospital management of the patient safety culture, which might reflect they missed the opportunities to strengthen their resilience, especially during the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]

Background: Patient safety is a global challenge influenced by perceived patient safety culture. However, limited knowledge exists regarding the patient safety culture perceived by hospital clinical managers and its associated factors. This study aims to investigate the perceptions of patient safety culture and associated factors among clinical managers of tertiary hospitals in China. Methods: A cross-sectional survey was conducted from June 19 to July 16, 2021, involving 539 clinical managers from four tertiary hospitals in Changsha City of Hunan Province. The Hospital Survey on Patient Safety Culture (HSOPSC) was utilized to assess perceived patient safety culture. Bivariate, multivariable linear regression, and logistic regression analyses were performed. Results: The mean score for the total HSOPSC was 72.5 ± 7.6, with dimensional scores ranging from 62.1 (14.9) to 86.6 (11.7). Three dimensions exhibited positive response rates (PRRs) < 50%, indicating areas that need to be improved: "nonpunitive response to errors" (40.5%), "staffing" (41.9%), and "frequency of events reported" (47.4%). Specialized hospitals (β = 1.744, P = 0.037), female gender (β = 2.496, P = 0.003), higher professional title (β = 1.413, P = 0.049), a higher education level (β = 1.316, P = 0.001), and shorter time delays per shift (β=-1.13, P < 0.001) were correlated with higher perceived patient safety culture. Education level, work department, "teamwork within a unit", "management support for patient safety", "communication openness", and "staffing" dimensions were associated with patient safety grades (all P < 0.05). Years worked in hospitals, occupation, education level, work department, hospital nature, professional title, "communication openness", and "handoffs & transitions" were associated with the number of adverse events reported (all P < 0.05). Conclusions: Our study revealed a generally low level of patient safety culture perceived by clinical managers and identified priority areas requiring urgent improvement. The associated factors of patient safety culture provide important guidance for the development of targeted interventions in the future. Promoting patient safety by optimizing the patient safety culture perceived by clinical managers should be prioritized. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to increase the understanding of emotions and coping strategies used by head and neck cancer patients before cancer treatment, and to explore their emotions and coping strategies in relation to symptoms and side effects after treatment. Furthermore, we aimed to investigate the patients' perceptions of received treatment and support. Methods: Semi-structured in-depth interviews were conducted with 10 patients who had been treated for head and neck cancer, which included radiotherapy, at the Department of Oncology and the Department of Oral and Maxillofacial Surgery at Sahlgrenska University Hospital in Gothenburg. The interviews were analyzed in accordance with the method for Qualitative Content Analysis. Results: The result picture revealed three head themes. The first theme "Management of simultaneously influencing mind-sets before cancer treatment" described the patients experiences of feeling "Scared and worried," "Lonely and disappointed," and "Relieved and confident", and how they tried to handle the diagnosis and preparations for treatment by "Applying a positive mind-set", "Searching for support," and "Trusting the healthcare system". The second theme "Experiences of becoming a pale shadow of oneself", illustrated experiences of affecting post-treatment symptoms and side effects. To which, the last theme "Handling contextual influencing experiences after cancer treatment" displayed post-treatment emotions of being "Shocked and disappointed" and "Concerned and unsupported" but also "Grateful and forward-thinking", where strategies such as "Appreciating Life", "Networking socially," and "Adapting to the new life" were used. Conclusions: The results indicated the need for a more patient-centered care approach, with clearer structures and improved individual support both before and after treatment and in connection to rehabilitation. Patients' cognitive changes after cancer treatment should be considered in the aftercare, which should also include adaptation to situation and strengthening of patients' self-management as a goal. [ABSTRACT FROM AUTHOR]

Background: Nurses play an essential role in patient safety. Inadequate nursing physical assessment and communication in handover practices are associated with increased patient deterioration, falls and pressure injuries. Despite internationally implemented rapid response systems, falls and pressure injury reduction strategies, and recommendations to conduct clinical handovers at patients' bedside, adverse events persist. This trial aims to evaluate the effectiveness, implementation, and cost–benefit of an externally facilitated, nurse-led intervention delivered at the ward level for core physical assessment, structured patient-centred bedside handover and improved multidisciplinary communication. We hypothesise the trial will reduce medical emergency team calls, unplanned intensive care unit admissions, falls and pressure injuries. Methods: A stepped-wedge cluster randomised trial will be conducted over 52 weeks. The intervention consists of a nursing core physical assessment, structured patient-centred bedside handover and improved multidisciplinary communication and will be implemented in 24 wards across eight hospitals. The intervention will use theoretically informed implementation strategies for changing clinician behaviour, consisting of: nursing executive site engagement; a train-the-trainer model for cascading facilitation; embedded site leads; nursing unit manager leadership training; nursing and medical ward-level clinical champions; ward nurses' education workshops; intervention tailoring; and reminders. The primary outcome will be a composite measure of medical emergency team calls (rapid response calls and 'Code Blue' calls), unplanned intensive care unit admissions, in-hospital falls and hospital-acquired pressure injuries; these measures individually will also form secondary outcomes. Other secondary outcomes are: i) patient-reported experience measures of receiving safe and patient-centred care, ii) nurses' perceptions of barriers to physical assessment, readiness to change, and staff engagement, and iii) nurses' and medical officers' perceptions of safety culture and interprofessional collaboration. Primary outcome data will be collected for the trial duration, and secondary outcome surveys will be collected prior to each step and at trial conclusion. A cost–benefit analysis and post-trial process evaluation will also be undertaken. Discussion: If effective, this intervention has the potential to improve nursing care, reduce patient harm and improve patient outcomes. The evidence-based implementation strategy has been designed to be embedded within existing hospital workforces; if cost-effective, it will be readily translatable to other hospitals nationally. Trial registration: Australian New Zealand Clinical Trials Registry ID: ACTRN12622000155796. Date registered: 31/01/2022. [ABSTRACT FROM AUTHOR]

Purpose: Socially disadvantaged patients may lack self-efficacy to navigate a complex health system making them vulnerable to healthcare inequity. We aimed to develop an Index of social vulnerability that predicts increased risk of negative healthcare events (e.g. emergency hospitalization), independent of chronic disease burden. The analysis illustrates the conceptual and practical steps leading to the development of a pragmatic Index of social vulnerability to limited healthcare self-efficacy. Methods: Using data from a 3-year cohort of 2507 adult primary care patients in Québec (Canada), we applied two complementary structural equation modelling approaches—Partial Least Squares Path Modelling (PLS-PM) and Multiple indicators and Multiple Causes (MIMIC) modelling—to identify a minimal set of social characteristics that could be summed into an Index related to limited healthcare self-efficacy. We then used logistic regression to determine if the Index predicted: hospital emergency department use; hospital admissions; unmet need for care, and others. We privileged parsimony over explanatory capacity in our analytic decisions to make the Index pragmatic for epidemiologic and clinical use. Results: The Individual Social Vulnerability Index is the weighted sum of five indicators: two indicators of social support; educational achievement; financial status; limited language proficiency. The Index predicts increased likelihood of all negative healthcare outcomes except unmet need, with a clear threshold at Index ≥ 2. The effect is independent of chronic disease burden. Conclusion: When social deficits outweigh social assets by two or more (Index ≥ 2), there is an increased risk of negative healthcare events beyond the risk attributable to poor health. The Index is a pragmatic tool to identify a minority of patients who will require additional support to receive equitable healthcare. [ABSTRACT FROM AUTHOR]

Background: Hospitalized older adults spend as much as 95% of their time in bed, which can result in adverse events and delay recovery while increasing costs. Observational studies have shown that general mobility interventions (e.g., ambulation) can mitigate adverse events and improve patients' functional status. Mobility technicians (MTs) may address the need for patients to engage in mobility interventions without overburdening nurses. There is no data, however, on the effect of MT-assisted ambulation on adverse events or functional status, or on the cost tradeoffs if a MT were employed. The AMBULATE study aims to determine whether MT-assisted ambulation improves mobility status and decreases adverse events for older medical inpatients. It will also include analyses to identify the patients that benefit most from MT-assisted mobility and assess the cost-effectiveness of employing a MT. Methods: The AMBULATE study is a multicenter, single-blind, parallel control design, individual-level randomized trial. It will include patients admitted to a medical service in five hospitals in two regions of the USA. Patients over age 65 with mild functional deficits will be randomized using a block randomization scheme. Those in the intervention group will ambulate with the MT up to three times daily, guided by the Johns Hopkins Mobility Goal Calculator. The intervention will conclude at hospital discharge, or after 10 days if the hospitalization is prolonged. The primary outcome is the Short Physical Performance Battery score at discharge. Secondary outcomes are discharge disposition, length of stay, hospital-acquired complications (falls, venous thromboembolism, pressure ulcers, and hospital-acquired pneumonia), and post-hospital functional status. Discussion: While functional decline in the hospital is multifactorial, ambulation is a modifiable factor for many patients. The AMBULATE study will be the largest randomized controlled trial to test the clinical effects of dedicating a single care team member to facilitating mobility for older hospitalized patients. It will also provide a useful estimation of cost implications to help hospital administrators assess the feasibility and utility of employing MTs. Trial registration: Registered in the United States National Library of Medicine clinicaltrials.gov (# NCT05725928). February 13, 2023. [ABSTRACT FROM AUTHOR]

Introduction: The "second victim" phenomenon refers to the distress and other negative consequences that physicians experience when they commit medical error. There has been increasing awareness about this phenomenon and efforts are being made to address it. However, there is dearth of information about it in developing countries. This study explored the experiences of surgical resident doctors of the University College Hospital in Ibadan, Nigeria about the "second victim" phenomenon and the support they had following medical errors. Methods: This is a phenomenology study in which qualitative data were obtained from interviews with 31 resident doctors across 10 surgical units/departments. Interviews were transcribed verbatim, and data were coded inductively. Data were analyzed using content analysis method. Themes and subthemes were generated using axial coding. The themes were then integrated using selective coding. Results: There were 31 participants and 10(32.3%) were females. All had witnessed other physicians encountering medical errors while 28(90.3%) had been directly involved in medical errors. Most of the errors were at the inter-operative stage. Prolonged work hours with inadequate sleep were identified as major causes of most medical errors. The feelings following medical errors were all negative and was described as 'stressful'. Most of the residents got support from their colleagues, mostly contemporaries following medical errors, and many viewed medical errors as a learning point to improve their practice. However, there was a general belief that the systemic support following medical errors was inadequate. Conclusion: The "second victim" phenomenon was common among the study group with consequent negative effects. Normalizing discussions about medical errors, reduction of work hours and meticulous intraoperative guidance may reduce medical errors and its consequences on the surgical residents. Steps should be taken within the system to address this issue effectively. [ABSTRACT FROM AUTHOR]

Background: Asthma is a common chronic inflammatory airway affecting over 260 million people worldwide, and characterized, in the large majority of cases, by the so-called "type 2 inflammation". Fractional exhaled nitric oxide (FENO) testing is noninvasive point-of-care tool to assess type 2 inflammation and therefore improve asthma management. It has been suggested to determine eligibility for a specific biologic therapy and predict likelihood to respond. The aim of this study was to estimate the overall economic impact of an extensive use of FENO testing on the Italian population with asthma, including extra costs of testing and savings generated by more appropriate prescriptions, increased adherence and lower frequency of exacerbations. Methods: A cost of illness analysis was firstly performed to estimate the yearly economic burden from the National Healthcare Service (NHS) perspective in Italy of the management of asthmatic patients with standard of care (SOC) according to the application of GINA (Global Initiative for Asthma) guidelines; then, we evaluated the changes in the economic burden in patient management by introducing FENO testing into clinical practice. The cost items considered were: visits/exams, exacerbations, drugs, management of adverse events caused by short-term oral corticosteroids use. Efficacy of FeNO test and SOC is based on literature evidence. Costs refer to published data or Diagnosis Related Group/outpatient tariffs. Results: Considering one asthma visit every 6 months, the total yearly cost for the management of patients with asthma in Italy is 1,599,217,876€ (409.07€ per patient), while for FENO testing strategy this figure is 1,395,029,747€ (356.84€ per patient). An increased utilization rate of FENO testing from 50 to 100% of patients may lead to savings for the NHS from about 102 to 204 million € compared to SOC. Conclusions: Our study showed that FeNO testing strategy may improve the management of asthmatic patients leading to significant savings for the NHS. [ABSTRACT FROM AUTHOR]

Background: Omega-3 polyunsaturated fatty acids (n-3 PUFAs) confers anti-inflammatory efficacy, which has been suggested to be effective for patients with osteoarthritis (OA). However, previous studies evaluating the influence of n-3 PUFAs supplementation in patients with OA showed inconsistent results. We performed a systematic review and meta-analysis to comprehensively evaluate the influence of n-3 PUFAs on symptom and joint function of patients with OA. Methods: Relevant randomized controlled trials (RCTs) were obtained by searching PubMed, Embase, and Cochrane Library databases. A random-effects model was employed to combine the results. Results: Nine RCTs with 2070 patients with OA contributed to the meta-analysis. Pooled results showed that n-3 PUFAs supplementation could significantly relieve the arthritis pain as compared to placebo (standardized mean difference [SMD]: − 0.29, 95% confidence interval [CI] − 0.47 to − 0.11, p = 0.002, I2 = 60%). Besides, supplementation with n-3 PUFAs was also associated with improved joint function (SMD: − 0.21, 95% CI − 0.34 to − 0.07, p = 0.002, I2 = 27%). Subgroup analysis showed consistent results of studies with arthritis pain and joint function evaluated by the Western Ontario-McMaster University Osteoarthritis Index and other scales (p for subgroup difference = 0.33 and 0.34, respectively). No severe treatment-related adverse events (AEs) were observed in the included patients, and the incidence of overall AEs was similar between groups (odds ratio: 0.97, 95% CI 0.64–1.45, p = 0.86, I2 = 0%). Conclusions: Supplementation of n-3 PUFAs is effective to relieve pain and improve joint function in patients with OA. [ABSTRACT FROM AUTHOR]

Background: The prevalence of cutaneous adverse food reactions (CAFRs) in dogs and cats is not precisely known. This imprecision is likely due to the various populations that had been studied. Our objectives were to systematically review the literature to determine the prevalence of CAFRs among dogs and cats with pruritus and skin diseases. Results: We searched two databases for pertinent references on August 18, 2016. Among 490 and 220 articles respectively found in the Web of Science (Science Citation Index Expanded) and CAB Abstract databases, we selected 22 and nine articles that reported data usable for CAFR prevalence determination in dogs and cats, respectively. The prevalence of CAFR in dogs and cats was found to vary depending upon the type of diagnoses made. Among dogs presented to their veterinarian for any diagnosis, the prevalence was 1 to 2% and among those with skin diseases, it ranged between 0 and 24%. The range of CAFR prevalence was similar in dogs with pruritus (9 to 40%), those with any type of allergic skin disease (8 to 62%) and in dogs diagnosed with atopic dermatitis (9 to 50%). In cats presented to a university hospital, the prevalence of CAFR was less than 1% (0.2%), while it was fairly homogeneous in cats with skin diseases (range: 3 to 6%), but higher in cats with pruritus (12 to 21%) than in cats with allergic skin disease (5 to 13%). Conclusions: Among dogs and cats with pruritus and those suspected of allergic skin disease, the prevalence of CAFR is high enough to justify this syndrome to be ruled-out with a restriction (elimination)-provocation dietary trial. This must especially be considered in companion animals with nonseasonal pruritus or signs of allergic dermatitis. [ABSTRACT FROM AUTHOR]

Background: Children with OSAS are prone to various airway complications during tracheal extubation after tonsillectomy and adenoidectomy due to oropharyngeal secretions and oozing blood. However, few studies have examined the effect of position on airway complications after tracheal extubation in children with OSAS. The aim of this study was to investigate the appropriate position for extubation in children with OASA. Methods: A total of 459 children aged 3–14 years with OSAS who underwent tonsillectomy and adenoidectomy were recruited for this study. All children were treated with the same surgical approach and standard anesthesia methods of induction of anesthesia, tracheal intubation and maintenance of anesthesia. At the end of surgery, the children were delivered to the post anesthesia care unit and randomly divided into three groups: Group A: Head-high 0° in lateral position; Group B: Head-high 15° in lateral position; Group C: Head-high 30° in lateral position. The main outcomes of this study were the pulse oxygen saturation (SpO2) and the Sedation-Agitation Scale (SAS) scores of the children after extubation, the outflow of oral-nasal secretions and the respiratory complications. Secondary outcomes were blood pressure, heart rate, end-respiratory carbon dioxide, respiratory rate, and post-operative awakening time of the children in three groups. Results: Data from a total of 423 children were statistically analyzed, 141 in Group A, 142 in Group B, and 140 in Group C. The main results showed a significant decrease in choking response after extubation in Group B (46.5%) and Group C (40.7%) compared to Group A (60.3%) (P < 0.05). The SAS score for postoperative agitation was higher in Group A (4.6 ± 0.9) than in Group B (4.4 ± 0.7) and Group C (4.3 ± 0.6) (P < 0.05). Also the SpO2 after extubation was higher in Group B (97.2%) and Group C (97.1%) than in Group A (95.8%) (P < 0.05). In contrast, there was no difference in the occurrence of respiratory complication and postoperative agitation in children between Group B and Group C (all P > 0.05). In addition, there was no difference in the amount of oral-nasal secretions among the children in the three groups (all P > 0.05). Conclusion: The head-high 15° lateral position and head-high 30° lateral position can reduce the incidence of airway complications and agitation and provide safe and comfortable extubation conditions for children during the peri-extubation period after tonsillectomy and adenoidectomy, which has certain clinical guidance value. Trial registration: Registration Number: NO.ChiCTR2200055835(20,01,2022) https://www.chictr.org.cn [ABSTRACT FROM AUTHOR]

Background and Objective: Considering that physicians and patients widely use acupuncture, it is necessary to explore its adverse effects during treatment. Herein, an evidence map was generated based on published studies to identify acupuncture-induced adverse effects and assess their severity, with the overarching goal of providing references for safe and effective implementation. Methods: A comprehensive literature search was performed in four public databases (PubMed, Embase, Web of science, and the Cochrane Library) to identify relevant studies published up to 15th June 2022. In addition, relevant studies were explored in the Epistemonikos database and reference lists were retrieved as a supplement. A MeaSurement Tool to Assess systematic Reviews, Version 2 (AMSTAR-2) quality assessment tool was applied to determine the methodological quality of included systematic reviews (SRs) and/or meta-analysis (MAs), whereas Microsoft Excel 2019 tool was used for data extraction and coding. Heatmaps were generated to display disease type, countries of origin for the first authors, and the sample sizes of original studies. Moreover, bubble charts comprehensively presented intervention categories, adverse reaction types, and evidence levels. Results: A total of 535 SRs involving 33 adverse reactions were included. Among them, 22 studies were rated as high quality, 28 as moderate, 106 as low, and the rest were of critically-low quality. Numerous adverse effects were described in the studies, including syncope (86 SRs), organ or tissue injury (233 SRs), systemic reactions (113 SRs), infection (19 SRs), and other adverse events (373 SRs). Importantly, these adverse reactions were mainly associated with 19 acupuncture techniques, including electroacupuncture (n = 67), manual acupuncture (n = 47) and acupoint catgut embedding (n = 41). Furthermore, the 535 SRs described 23 diseases, among which symptoms, signs or clinical findings (83 SRs), mental, behavioral or neurodevelopmental disorders (67 SRs), and diseases of the nervous system (66 SRs) had the highest incidence. Conclusion: This evidence mapping explores the adverse effects of acupuncture, showing that there are multiple types of adverse reactions to acupuncture, with milder symptoms. The methodological assessment revealed that most of the included studies were of low- or critically low-quality. Therefore, there is a need for future randomized controlled trials and SRs to comprehensively analyze acupuncture-related adverse events in order to provide reliable and credible evidence. [ABSTRACT FROM AUTHOR]

Background: Epidural electrical stimulation (EES) of the spinal cord has been FDA approved and used therapeutically for decades. However, there is still not a clear understanding of the local neural substrates and consequently the mechanism of action responsible for the therapeutic effects. Method: Epidural spinal recordings (ESR) are collected from the electrodes placed in the epidural space. ESR contains multi-modality signal components such as the evoked neural response (due to tonic or BurstDR™ waveforms), evoked muscle response, stimulation artifact, and cardiac response. The tonic stimulation evoked compound action potential (ECAP) is one of the components in ESR and has been proposed recently to measure the accumulative local potentials from large populations of neuronal fibers during EES. Result: Here, we first review and investigate the referencing strategies, as they apply to ECAP component in ESR in the domestic swine animal model. We then examine how ECAP component can be used to sense lead migration, an adverse outcome following lead placement that can reduce therapeutic efficacy. Lastly, we show and isolate concurrent activation of local back and leg muscles during EES, demonstrating that the ESR obtained from the recording contacts contain both ECAP and EMG components. Conclusion: These findings may further guide the implementation of recording and reference contacts in an implantable EES system and provide preliminary evidence for the utility of ECAP component in ESR to detect lead migration. We expect these results to facilitate future development of EES methodology and implementation of use of different components in ESR to improve EES therapy. [ABSTRACT FROM AUTHOR]

Background: Safety incident (SI) reporting and learning via incident reporting systems (IRSs) is used to identify areas for patient safety improvement. The chiropractic patient incident reporting and learning system (CPiRLS) is an online IRS that was launched in the UK in 2009 and, from time to time, has been licensed for use by the national members of the European Chiropractors' Union (ECU), members of Chiropractic Australia and a Canada-based research group. The primary aim of this project was to analyse the SIs submitted to CPiRLS over a 10-year period to identify key areas for patient safety improvement. Method: All SIs reported to CPiRLS between April 2009 and March 2019 were extracted and analysed. Descriptive statistics were used to describe: (1) the frequency of SI reporting and learning by the chiropractic profession, and (2) the character of reported SIs. Key areas for patient safety improvement were developed following a mixed methods approach. Results: A total of 268 SIs were recorded on the database over the 10-year period, 85% of which originated from the UK. Evidence of learning was documented in 143 (53.4%) SIs. The largest subcategory of SIs related to post-treatment distress or pain (n = 71, 26.5%). Seven key areas for patient improvement were developed including: (1) patient trip/fall, (2) post treatment distress/pain, (3) negative effects during treatment, (4) significant post-treatment effects, (5) syncope, (6) failure to recognize serious pathology, and (7) continuity of care. Conclusion: The low number of SIs reported over a 10-year period suggests significant under-reporting, however, an upward trend was identified over the 10-year period. Several key areas for patient safety improvement have been identified for dissemination to the chiropractic profession. Improved reporting practice needs to be facilitated to improve the value and validity of reporting data. CPiRLS is important in identifying key areas for patient safety improvement. [ABSTRACT FROM AUTHOR]

Background: Patient safety is associated with patient outcomes. However, there is insufficient evidence of patient safety in the dental field. This study aimed to compare incidents reported by dentists and physicians, compare the type of errors made by them, and identify how dentists prevent dental errors. Methods: A mixed-methods study was conducted using open data from the Japan Council for Quality Health Care database. A total of 6071 incident reports submitted for the period 2016–2020 were analyzed; the number of dentists' incident reports was 144, and the number of physicians' incident reports was 5927. Results: The percentage of dental intern reporters was higher than that of medical intern reporters (dentists: n = 12, 8.3%; physicians: n = 180, 3.0%; p = 0.002). The percentage of reports by dentists was greater than that by physicians: wrong part of body treated (dentists: n = 26, 18.1%; physicians: n = 120, 2.0%; p < 0.001), leaving foreign matter in the body (dentists: n = 15, 10.4%; physicians: n = 182, 3.1%; p < 0.001), and accidental ingestion (dentists: n = 8, 5.6%; physicians: n = 8, 0.1%; p < 0.001), and aspiration of foreign body (dentists: n = 5, 3.4%; physicians: n = 33, 0.6%; p = 0.002). The percentage of each type of prevention method utilized was as follows: software 27.8% (n = 292), hardware (e.g., developing a new system) 2.1% (n = 22), environment (e.g., coordinating the activities of staff) 4.2% (n = 44), liveware (e.g., reviewing procedure, double checking, evaluating judgement calls made) 51.6% (n = 542), and liveware-liveware (e.g., developing adequate treatment plans, conducting appropriate postoperative evaluations, selecting appropriate equipment and adequately trained medical staff) 14.3% (n = 150). Conclusion: Hardware and software and environment components accounted for a small percentage of the errors made, while the components of liveware and liveware-liveware errors were larger. Human error cannot be prevented by individual efforts alone; thus, a systematic and holistic approach needs to be developed by the medical community. [ABSTRACT FROM AUTHOR]

Background: The study is based on a national cluster randomized trial investigating the effect of electronic patient-reported outcomes (ePRO) on treatment outcomes in breast cancer patients receiving adjuvant chemotherapy. All 13 oncology departments (11 clusters) treating breast cancer patients in Denmark were randomized to use electronic patient-reported outcomes with real-time clinician feedback (ePRO arm) to track symptoms or usual care for eliciting symptoms using a short paper tracking list (usual care arm). The impact of ePRO on clinical outcomes were examined, which is reported elsewhere. The purpose of the present study was to examine patient-reported experience measure (PREM) regarding communication and handling of side effects/symptoms. Methods: For this sub-study, patient representatives were involved in the development of a PREM questionnaire. Patients enrolled in the cluster randomized trial completed the PREM questionnaire at their last treatment visit. Semi-structured telephone-interviews were performed with a subgroup of patients. The interviews were based on an interview guide comprised of the questions from the PREM questionnaire and aimed to elaborate on the PREM questionnaire data. Results: A 12 item PREM questionnaire was developed in partnership with patient representatives. In total, 439 out of 682 patients (64.4%) included patients completed the PREM questionnaire. Telephone semi-structured interviews were performed with 22 patients. In total, 52% (ePRO arm) and 65% (usual care arm) reported having talked with the oncologist/nurse about their responses in the tracking systems before each chemotherapy cycle. Fewer patients in the ePRO arm compared to the usual care arm experienced side effects/symptoms not included in the side effect questionnaire. Patients experienced high satisfaction with oncologists' and nurses' handling of side effects/symptoms. Conclusions: Patients experienced high satisfaction with oncologists' and nurses' handling of chemotherapy adverse events. The study indicates a need for a more comprehensive side effect questionnaire as tracking system covering more symptoms than the one used in usual care today. Trial registration: Clinicaltrials.gov identifier NCT02996201. Registered 19 December 2016, retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Stage III non-small cell lung cancer (NSCLC) is a heterogeneous disease with different subtypes, multidisciplinary teams-led management, and a poor prognosis. Currently, the clinical benefits of stage III NSCLC in the neoadjuvant setting are still unclear. We performed a meta-analysis of published data on neoadjuvant chemoimmunotherapy in stage III NSCLC to systematically evaluate its efficacy and safety. Methods: We searched the databases to identify eligible studies of neoadjuvant chemoimmunotherapy for stage III NSCLC. The primary outcomes mainly included pathological and radiological response outcomes, the feasibility of surgery, and the safety of the regimen. The pathological and radiological response included the rate of major pathologic response (MPR), complete pathologic response (pCR), radiological response outcomes, and R0 resection; The feasibility included the rate of surgical resection, conversion to thoracotomy, surgical complications, pathological downstaging of clinical disease stage. The safety included the incidence of treatment-related adverse events (TRAEs) and severe adverse events (SAEs). R 4.1.3 software was conducted for data analysis, and p < 0.05 was considered statistically significant. Results: Nine trials containing a total of 382 populations were eligible for the meta-analysis, with the pooled surgical resection rate of 90%. Owing to the large heterogeneity of the single-rate meta-analysis, the random effect model was adopted. The estimated pooled prevalence of MPR was 56% (95%CI 0.39–0.72) and of pCR was 39% (95%CI 0.28–0.51). The pooled rate of TRAEs was 65% (95%CI 0.17–0.99) and SAEs was 24% (95%CI 0.05–0.49). Conclusion: Compared to neoadjuvant chemotherapy or immunotherapy, neoadjuvant chemoimmunotherapy achieved more pathological and radiological relief, and has a high surgical resection rate and low risk of conversion to thoracotomy and surgical complications, with poor tolerance of toxicity but rarely developing life-threatening adverse events. In conclusion, neoadjuvant chemoimmunotherapy is suggested to be beneficial for stage III NSCLC. [ABSTRACT FROM AUTHOR]

Objective: Tranexamic acid (TXA) plays a significant role in the treatment of traumatic diseases. However, its effectiveness in patients with traumatic brain injury (TBI) seems to be contradictory, according to the recent publication of several meta-analyses. We aimed to determine the efficacy of TXA treatment at different times and doses for TBI treatment. Methods: PubMed, MEDLINE, EMBASE, Cochrane Library, and Google Scholar were searched for randomized controlled trials that compared TXA and a placebo in adults and adolescents (≥ 15 years of age) with TBI up to January 31, 2022. Two authors independently abstracted the data and assessed the quality of evidence. Results: Of the identified 673 studies, 13 involving 18,675 patients met our inclusion criteria. TXA had no effect on mortality (risk ratio (RR) 0.99; 95% confidence interval (CI) 0.92–1.06), adverse events (RR 0.93, 95% Cl 0.76–1.14), severe TBI (Glasgow Coma Scale score from 3 to 8) (RR 0.99, 95% Cl 0.94–1.05), unfavorable Glasgow Outcome Scale (GOS < 4) (RR 0.96, 95% Cl 0.82–1.11), neurosurgical intervention (RR 1.11, 95% Cl 0.89–1.38), or rebleeding (RR 0.97, 95% Cl 0.82–1.16). TXA might reduce the mean hemorrhage volume on subsequent imaging (standardized mean difference, -0.35; 95% CI [-0.62, -0.08]). Conclusion: TXA at different times and doses was associated with reduced mean bleeding but not with mortality, adverse events, neurosurgical intervention, and rebleeding. More research data is needed on different detection indexes and levels of TXA in patients with TBI, as compared to those not receiving TXA; although the prognostic outcome for all harm outcomes was not affected, the potential for harm was not ruled out. Trial registration: The review protocol was registered in the PROSPERO International Prospective Register of Systematic Reviews (CRD42022300484). [ABSTRACT FROM AUTHOR]

Background: Thoracic epidural analgesia (TEA) has always been the first choice for postoperative pain treatment, but associated complications and contraindications may limit its use. Our study put forward a new analgesic strategy that combines TEA with patient controlled intravenous analgesia (PCIA) to optimize TEA. Methods: Patients undergoing laparotomy were enrolled in this prospective randomized study. Patients were randomized to one of two groups: TEA/PCIA group and TEA group. Patients in TEA/PCIA group received TEA in the day of surgery and the first postoperative day and PCIA continued to use until the third postoperative day. Patients in TEA group received TEA for three days postoperatively. Visual analogue scale (VSA) pain scores at rest and on movement at 6, 24,48,72 h after surgery were recorded. In addition, the incidence of inadequate analgesia, adverse events, time to first mobilization, time to pass first flatus, time of oral intake recovery, time of urinary catheter removal, postoperative length of hospital stay, cumulative opioid consumption, and the overall cost were compared between the two groups. We examined VAS pain scores using repeated measures analysis of variance; P < 0.05 was considered as statistically significant. Results: Eighty-six patients were analysed (TEA/PCIA = 44, TEA = 42). The mean VAS pain scores at rest and on movement in TEA/PCIA group were lower than TEA group, with a significant difference on movement and 48 h postoperatively (P < 0.05). The time to first mobilization and pass first flatus were shorter in TEA/PCIA group (P < 0.05). Other measurement showed no statistically significant differences. Conclusions: The combination of TEA with PCIA for patients undergoing laparotomy, can enhance postoperative pain control and facilitate early recovery without increasing the incidence of adverse effects and overall cost of hospitalization. Trial registration: Chinese Clinical Trial Registry(www.chictr.org.cn), ChiCTR 1,800,020,308, 13 December 2018. [ABSTRACT FROM AUTHOR]

Background: Cancer treatments are associated with a multitude of adverse events (AEs). While both nurses and physicians are involved in patient care delivery and AE assessment, very few studies have examined the differences between nurses' and physicians' reporting and perception of AEs. An approach was recently proposed to assess treatment burden based on reported AEs from the physician's perspective. In this paper, we use this approach to evaluate nurses' perception of burden, and compare nurses' and physicians' assessment of the overall and relative burden of AEs.Methods: AE records for 334 cancer patients from a randomized clinical trial conducted by the SWOG Cancer Research Network were evaluated by 14 nurses at Columbia University Medical Center. Two nurses were randomly selected to assign a burden score from 0 to 10 based on their impression of the global burden of the captured AEs. These nurses did not interact directly with the patients. Scores were compared to previously obtained physicians scores using paired T-test and Kappa statistic. Severity scores for individual AEs were obtained using mixed-effects models with nurses assessments, and were qualitatively compared to physicians'.Results: Given the same AEs, nurses' and physicians' perception of the burden of AEs differed. While nurses generally perceived the overall burden of AEs to be only slightly worse compared to physicians (mean average VAS score of 5.44 versus 5.14), there was poor agreement in the perception of AEs that were in mild to severe range. The percent agreement for a moderate or worse AE was 64% with a Kappa of 0.34. Nurses also assigned higher severity scores to symptomatic AEs compared to physicians (p < 0.05), such as gastrointestinal (4.77 versus 4.14), hemorrhage (5.07 versus 4.14), and pain (5.17 versus 4.14).Conclusions: These differences in the perception of burden of AEs can lead to different treatment decisions and symptom management strategies. Thus, having provider consistency, training, or a collaborative approach in follow-up care between nurses and physicians is important to ensure continuity in care delivery. Moreover, estimating overall burden from both physicians' and nurses' perspective, and comparing them may be useful for deciding when collaborations are warranted. [ABSTRACT FROM AUTHOR]

Background: The future of combined immunotherapy (a PD-1/PD-L1 plus a CTLA-4 antagonist) is very bright. However, besides improving efficacy, combined therapy increases treatment-related adverse events (TRAEs). Also, the clinical application is limited in some solid tumors.Methods: This paper purports to investigate the TRAEs for the combined immunotherapy aiming for a more appropriate utilization of immune checkpoint inhibitors (ICIs) in clinical practice through a meta-analysis.Results: A total of 17 eligible studies covering 2626 patients were selected for a meta-analysis based on specified inclusion and exclusion criteria. The incidence rates of any grade and grade 3 or higher TRAEs were 88% (95%CI, 84-92%) and 41% (95%CI, 35-47%), respectively. The overall incidence of any grade TRAEs leading to discontinuation of treatment was 20% (95%CI, 16-24%). The incidence rate of treatment related deaths was 4.3‰ (95%CI, 1.4‰-8.4‰). Analysis showed that NIVO1 + IPI3 cohort had higher incidences of grade 3 or higher TRAEs (RR = 1.77, 95%CI, 1.34-2.34, p < 0.0001) and any grade TRAEs leading to discontinuation of treatment (RR = 1.81, 95%CI, 1.08-3.04, P = 0.02), compared with NIVO3 + IPI1 regimen.Conclusions: The combined therapy had high TRAEs. The TRAEs, especially grade 3 or higher, led to discontinuation of the treatment. Furthermore, the incidence of treatment-related deaths was rare. Moreover, the NIVO3 + IPI1 regimen, regardless of efficacy, is more recommended because of better tolerance and lower adverse events. [ABSTRACT FROM AUTHOR]

Background: There is evidence that the physician response rate is declining. In response to this, methods for increasing the physician response rate are currently being explored. This paper examines the response rate and extent of non-response bias in a mixed-mode study of Minnesota physicians.Methods: This mode experiment was embedded in a survey study on the factors that influence physicians' willingness to disclose medical errors and adverse events to patients and their families. Physicians were randomly selected from a list of licensed physicians obtained from the Minnesota Board of Medical Practice. Afterwards, they were randomly assigned to either a single-mode (mail-only or web-only) or mixed-mode (web-mail or mail-web) design. Differences in response rate and nonresponse bias were assessed using Fischer's Exact Test.Results: The overall response rate was 18.60%. There were no statistically significant differences in the response rate across modes (p - value = 0.410). The non-response analysis indicates that responders and non-responders did not differ with respect to speciality or practice location.Conclusions: The mode of administration did not affect the physician response rate. [ABSTRACT FROM AUTHOR]

Background: Adverse drug events (ADEs) as well as other preventable adverse events in the hospital setting incur a yearly monetary cost of approximately $3.5 billion, in the United States alone. Therefore, it is of paramount importance to reduce the impact and prevalence of ADEs within the healthcare sector, not only since it will result in reducing human suffering, but also as a means to substantially reduce economical strains on the healthcare system. One approach to mitigate this problem is to employ predictive models. While existing methods have been focusing on the exploitation of static features, limited attention has been given to temporal features.Methods: In this paper, we present a novel classification framework for detecting ADEs in complex Electronic health records (EHRs) by exploiting the temporality and sparsity of the underlying features. The proposed framework consists of three phases for transforming sparse and multi-variate time series features into a single-valued feature representation, which can then be used by any classifier. Moreover, we propose and evaluate three different strategies for leveraging feature sparsity by incorporating it into the new representation.Results: A large-scale evaluation on 15 ADE datasets extracted from a real-world EHR system shows that the proposed framework achieves significantly improved predictive performance compared to state-of-the-art. Moreover, our framework can reveal features that are clinically consistent with medical findings on ADE detection.Conclusions: Our study and experimental findings demonstrate that temporal multi-variate features of variable length and with high sparsity can be effectively utilized to predict ADEs from EHRs. Two key advantages of our framework are that it is method agnostic, i.e., versatile, and of low computational cost, i.e., fast; hence providing an important building block for future exploitation within the domain of machine learning from EHRs. [ABSTRACT FROM AUTHOR]