Models and methods of work system design need to be developed and implemented to advance research in and design for patient safety. In this paper we describe how the Systems Engineering Initiative for Patient Safety (SEIPS) model of work system and patient safety, which provides a framework for understanding the structures, processes and outcomes in health care and their relationships, can be used toward these ends. An application of the SEIPS model in one particular care setting (outpatient surgery) is presented and other practical and research applications of the model are described. Most errors and inefficiencies in patient care arise not from the solitary actions of individuals but from conflicting, incomplete, or suboptimal systems of which they are a part and with which they interact. To improve the design of these systems, the US Institute of Medicine (IOM) has proposed the application of engineering concepts and methods-in particular, human factors and systems engineering. 1-3Emphasis on system design was promoted in a recent report by the National Academy of Engineering and the IOM: ''… it is time to… establish a vigorous new partnership between engineering and health care and hasten a transition to a patient-centered 21st century health care system''.4 Our research program, the Systems Engineering Initiative for Patient Safety (SEIPS, http:// www2.fpm.wisc.edu/seips/), originally funded by the Agency for Healthcare Research and Quality, meets this challenge through a novel integration of human factors and healthcare quality models and proposes the SEIPS model of work system 5-7 and patient safety. Patient safety researchers clearly recognize the need for human factors engineering and systems approaches to patient safety research, analysis, and improvement. However, noticeably missing from the patient safety literature are models to guide studies to empirically examine system design in relation to patient safety and medical errors. The model described by Reason, 8 often referred to as the ''Swiss cheese'' model, is probably the most well known system model used within the patient safety community. Vincent et al 9 have expanded Reason's model and described seven categories of factors that influence clinical practice, such as organizational and management factors, work environment, team factors, task factors and patient characteristics. The Haddon model, which is used commonly in epidemiology and injury prevention, has been proposed for use in quality and safety. A comparison of the strengths and weaknesses of the SEIPS model, the Reason/Vincent model, and Donabedian's quality model is shown in table 1. The SEIPS model explains how the design of the work system can impact not only the safety of patients but also employee and organizational outcomes. Employee outcomes include safety, health, satisfaction, stress and burnout; organizational outcomes include rates of turnover, injuries and illnesses, and organizational health (profitability).In this paper we describe the SEIPS model and its research and pra...

IMPORTANCEVaccination against COVID-19 provides clear public health benefits, but vaccination also carries potential risks. The risks and outcomes of myocarditis after COVID-19 vaccination are unclear.OBJECTIVE To describe reports of myocarditis and the reporting rates after mRNA-based COVID-19 vaccination in the US. DESIGN, SETTING, AND PARTICIPANTS Descriptive study of reports of myocarditis to the Vaccine Adverse Event Reporting System (VAERS) that occurred after mRNA-based COVID-19 vaccine administration between December 2020 and August 2021 in 192 405 448 individuals older than 12 years of age in the US; data were processed by VAERS as of September 30, 2021. EXPOSURES Vaccination with BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna).MAIN OUTCOMES AND MEASURES Reports of myocarditis to VAERS were adjudicated and summarized for all age groups. Crude reporting rates were calculated across age and sex strata. Expected rates of myocarditis by age and sex were calculated using 2017-2019 claims data. For persons younger than 30 years of age, medical record reviews and clinician interviews were conducted to describe clinical presentation, diagnostic test results, treatment, and early outcomes. RESULTS Among 192 405 448 persons receiving a total of 354 100 845 mRNA-based COVID-19 vaccines during the study period, there were 1991 reports of myocarditis to VAERS and 1626 of these reports met the case definition of myocarditis. Of those with myocarditis, the median age was 21 years (IQR, 16-31 years) and the median time to symptom onset was 2 days (IQR, 1-3 days). Males comprised 82% of the myocarditis cases for whom sex was reported. The crude reporting rates for cases of myocarditis within 7 days after COVID-19 vaccination exceeded the expected rates of myocarditis across multiple age and sex strata. The rates of myocarditis were highest after the second vaccination dose in adolescent males aged 12 to 15 years (70.7 per million doses of the BNT162b2 vaccine), in adolescent males aged 16 to 17 years (105.9 per million doses of the BNT162b2 vaccine), and in young men aged 18 to 24 years (52.4 and 56.3 per million doses of the BNT162b2 vaccine and the mRNA-1273 vaccine, respectively). There were 826 cases of myocarditis among those younger than 30 years of age who had detailed clinical information available; of these cases, 792 of 809 (98%) had elevated troponin levels, 569 of 794 (72%) had abnormal electrocardiogram results, and 223 of 312 (72%) had abnormal cardiac magnetic resonance imaging results. Approximately 96% of persons (784/813) were hospitalized and 87% (577/661) of these had resolution of presenting symptoms by hospital discharge. The most common treatment was nonsteroidal anti-inflammatory drugs (589/676; 87%). CONCLUSIONS AND RELEVANCEBased on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men. This risk should be ...

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This is a prepublication version of an article that has undergone peer review and been accepted for publication but is not the final version of record. This paper may be cited using the DOI and date of access. This paper may contain information that has errors in facts, figures, and statements, and will be corrected in the final published version. The journal is providing an early version of this article to expedite access to this information. The American Academy of Pediatrics, the editors, and authors are not responsible for inaccurate information and data described in this version.

Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes examples of some of the regulatory challenges faced and some resources for those who wish to learn more about them.

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Recent studies indicate potential links among work organization, job stress, and work-related musculoskeletal disorders (WRMDs). In this paper we propose several pathways for a theoretical relationship between job stress and WRMDs. These pathways highlight the physiological, psychological, and behavioral reactions to stress that can affect WRMDs directly and indirectly. One model stipulates that psychosocial work factors (e.g., work pressure, lack of control), which can cause stress, might also influence or be related to ergonomic factors such as force, repetition, and posture that have been identified as risk factors for WRMDs. In order to fully understand the etiology of WRMDs, it is important to examine both physical ergonomic and psychosocial work factors simultaneously. Smith and Carayon-Sainfort (1989) have proposed a model of the work system for stress management that provides a useful framework for conceptualizing the work-related factors that contribute to WRMDs. Practical applications of this research include practitioners taking into account psychosocial work factors and job stress in their efforts to reduce and control WRMDs.

Background‘Adverse childhood experiences’ (ACEs) are associated with increased risk of negative outcomes in later life: ACEs have consequently become a policy priority in many countries. Despite ACEs being highly socially patterned, there has been very little discussion in the political discourse regarding the role of childhood socioeconomic position (SEP) in understanding and addressing them. The aim here was to undertake a systematic review of the literature on the relationship between childhood SEP and ACEs.MethodsMEDLINE, PsycINFO, ProQuest and Cochrane Library databases were searched. Inclusion criteria were: (1) measurement of SEP in childhood; (2) measurement of multiple ACEs; (3) ACEs were the outcome; and (4) statistical quantification of the relationship between childhood SEP and ACEs. Search terms included ACEs, SEP and synonyms; a second search additionally included ‘maltreatment’. Overall study quality/risk of bias was calculated using a modified version of the Hamilton Tool.ResultsIn the ACEs-based search, only 6 out of 2825 screened papers were eligible for qualitative synthesis. The second search (including maltreatment) increased numbers to: 4562 papers screened and 35 included for synthesis. Eighteen papers were deemed ‘high’ quality, five ‘medium’ and the rest ‘low’. Meaningful statistical associations were observed between childhood SEP and ACEs/maltreatment in the vast majority of studies, including all except one of those deemed to be high quality.ConclusionLower childhood SEP is associated with a greater risk of ACEs/maltreatment. With UK child poverty levels predicted to increase markedly, any policy approach that ignores the socioeconomic context to ACEs is therefore flawed.PROSPERO registration numberCRD42017064781.