The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions

ObjectivesLittle is known about the management of female genital mutilation (FGM) in primary care. There have been significant recent statutory changes relevant to general practitioners (GPs) in England, including a mandatory reporting duty. We undertook a realist synthesis to explore what influences how and when GPs discuss FGM with their patients.SettingPrimary care in England.Data sourcesRealist literature synthesis searching 10 databases with terms: GPs, primary care, obstetrics, gynaecology, midwifery and FGM (UK and worldwide). Citation chasing was used, and relevant grey literature was included, including searching FGM advocacy organisation websites for relevant data. Other potentially relevant literature fields were searched for evidence to inform programme theory development. We included all study designs and papers that presented evidence about factors potentially relevant to considering how, why and in what circumstances GPs feel able to discuss FGM with their patients.Primary outcome measureThis realist review developed programme theory, tested against existing evidence, on what influences GPs actions and reactions to FGM in primary care consultations and where, when and why these influences are activated.Results124 documents were included in the synthesis. Our analysis found that GPs need knowledge and training to help them support their patients with FGM, including who may be affected, what needs they may have and how to talk sensitively about FGM. Access to specialist services and guidance may help them with this role. Reporting requirements may complicate these conversations.ConclusionsThere is a pressing need to develop (and evaluate) training to help GPs meet FGM-affected communities’ health needs and to promote the accessibility of primary care. Education and resources should be developed in partnership with community members. The impact of the mandatory reporting requirement and the Enhanced Dataset on healthcare interactions in primary care warrants evaluation.PROSPERO registration numberCRD42018091996.

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Mandatory Reporting and Adolescent Sexual Assault

Trauma Violence & Abuse ◽

10.1177/15248380211030239 ◽

2021 ◽

pp. 152483802110302

Author(s):

Caroline Bailey ◽

Jessica Shaw ◽

Abril Harris

Keyword(s):

Sexual Assault ◽

Sexual Violence ◽

Key Words ◽

Scoping Review ◽

Well Being ◽

Mandatory Reporting ◽

Age Group ◽

Long Term Consequences ◽

The Impact

Adolescents experience alarmingly high rates of sexual violence, higher than any other age-group. This is concerning as sexual violence can have detrimental effects on teens’ personal and relational well-being, causing long-term consequences for the survivor. Still, adolescents are hesitant to report the assault or seek out services and resources. When an adolescent survivor does seek out services, they may interact with a provider who is a mandatory reporter. This scoping review sought to synthesize the current U.S.-based research on the role, challenges, and impact of mandatory reporting (MR) in the context of adolescent sexual assault. Database searches using key words related to MR, sexual assault, and adolescence identified 29 peer-reviewed articles. However, none of these articles reported on empirical investigations of the phenomenon of interest and instead consisted of case studies, commentaries, and position papers. The scoping review was expanded to provide a lay of the land of what we know about the intersection of adolescent sexual assault and MR. Results of the review indicate that though implemented broadly, MR policies vary between individuals, organizations, and states and have historically been challenging to implement due to this variation, conflicts with other laws, tension between these policies and providers’ values, and other factors. Based on the available literature, the impact of MR in the context of adolescent sexual assault is unknown. There is a critical need for research and evaluation on the implementation and impact of MR policies, especially in the context of adolescents and sexual violence.

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INVESTIGASI PENGARUH KONDISI LALU LINTAS DAN ASPEK METEOROLOGI TERHADAP KONSENTRASI PENCEMAR SO2 DI KOTA SEMARANG

Jurnal Presipitasi Media Komunikasi dan Pengembangan Teknik Lingkungan ◽

10.14710/presipitasi.v13i1.21-27 ◽

2016 ◽

Vol 13 (1) ◽

pp. 21

Author(s):

Titik Istirokhatun ◽

Ita Tetriana Agustini ◽

Sudarno Sudarno

Keyword(s):

Air Pollution ◽

Sulfur Dioxide ◽

Human Health ◽

Adverse Reactions ◽

Meteorological Factors ◽

Ambient Air ◽

Health Problems ◽

Traffic Light ◽

Road Users ◽

The Impact

The presence of air pollution in ambient air is closely related to the incidence of adverse reactions affecting human health. One of harmful pollutants and potentially major cause health problems is sulfur dioxide (SO 2 ). The number of vehicles that are passing and queuing on the crossroads because of traffic light can affect the concentration of SO 2 . Besides, in these locations there are a lot of road users which are potentially exposed by contaminants, so information about the concentration of SO 2 is important to know. This study aimed to investigate the impact of meteorological factors and the number of vehicles on SO 2 concentrations. Impinger was used for air sampling, and pararosaniline method was used for determining SO 2 concentration. Sampling and calculation of the number of passing vehicles were performed 3 times ie in the morning, afternoon and evening. Based on the results of the study, the highest concentrations of SO 2 were on the range of 15-21 mg/Nm3.

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Transfusion-associated adverse reactions (TAARs) and cytokine accumulations in the stored blood components: the impact of prestorage versus poststorage leukoreduction

Oncotarget ◽

10.18632/oncotarget.23136 ◽

2017 ◽

Vol 9 (4) ◽

pp. 4385-4394 ◽

Cited By ~ 9

Author(s):

Chih-Chun Chang ◽

Tai-Chen Lee ◽

Ming-Jang Su ◽

Hsiu-Chen Lin ◽

Fang-Yi Cheng ◽

...

Keyword(s):

Adverse Reactions ◽

Blood Components ◽

The Impact ◽

Stored Blood

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Review of Best Practices for CLABSI Prevention and the Impact of Recent Legislation on CLABSI Reporting

SAGE Open ◽

10.1177/2158244016677747 ◽

2016 ◽

Vol 6 (4) ◽

pp. 215824401667774 ◽

Cited By ~ 1

Author(s):

Benjamin Woodward ◽

Reba Umberger

Keyword(s):

Best Practices ◽

Healthcare Providers ◽

Bloodstream Infections ◽

Central Line ◽

Mandatory Reporting ◽

Future Research ◽

Common Source ◽

Healthcare Associated Infection ◽

Extrinsic Factors ◽

The Impact

Central line-associated bloodstream infections (CLABSI) are a very common source of healthcare-associated infection (HAI). Incidence of CLABSI has been significantly reduced through the efforts of nurses, healthcare providers, and infection preventionists. Extrinsic factors such as recently enacted legislation and mandatory reporting have not been closely examined in relation to changes in rates of HAI. The following review will examine evidence-based practices related to CLABSI and how they are reported, as well as how the Affordable Care Act, mandatory reporting, and pay-for-performance programs have affected these best practices related to CLABSI prevention. There is a disconnect in the methods and guidelines for reporting CLABSI between these programs, specifically among local monitoring agencies and the various federal oversight organizations. Future research will focus on addressing the gap in what defines a CLABSI and whether or not these programs to incentivize hospital to reduce CLABSI rates are effective.

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Mandatory corporate social responsibility in India: reporting reality, issues and way forward

Meditari Accountancy Research ◽

10.1108/medar-11-2020-1063 ◽

2021 ◽

Vol ahead-of-print (ahead-of-print) ◽

Author(s):

Pawan Taneja ◽

Ameeta Jain ◽

Mahesh Joshi ◽

Monika Kansal

Keyword(s):

Corporate Social Responsibility ◽

Social Responsibility ◽

Mandatory Reporting ◽

Content Type ◽

Csr Reporting ◽

Reporting Requirements ◽

Expectation Gap ◽

The Government ◽

Corporate Social ◽

The Impact

Purpose Since 2013, the Indian Companies Act Section 135 has mandated corporate social responsibility (CSR) reporting by Indian central public sector enterprises (CPSEs). CSR reporting is regulated by multiple Government of India ministerial agencies, each requiring different formats and often different data. This study aims to understand the impact of these multiple regulatory bodies on CSR reporting by Indian CPSEs; evaluate the expectation gap between regulators and the regulated; and investigate the compliance burden on CPSEs. Design/methodology/approach An interview-based approach was adopted to evaluate the perspectives of both regulators and regulated CPSEs on the impact of the new regulations on CSR reporting quality. The authors use the lens of institutional theory to analyse the findings. Findings Driven by coercive institutional pressures, CPSEs are overburdened with myriad reporting requirements, which significantly negatively impact CPSEs’ financial and human resources and the quality of CSR activity and reports. It is difficult for CPSEs to assess the actual impact of their CSR activities due to overlapping with activities of the government/other institutions. The perceptions of regulators and the regulated are divergent: the regulators expect CPSEs to select more impactful CSR projects to comply with mandatory reporting requirements. Originality/value The findings of this study emphasise the need for meaningful dialogue between regulators and the regulated to reduce the expectation gap and establish a single regulatory authority that will ensure that the letter and spirit of the law are followed in practice and not just according to a tick-box approach.

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Quantitative impacts of mandatory integrated reporting

Journal of Financial Reporting and Accounting ◽

10.1108/jfra-08-2018-0066 ◽

2019 ◽

Vol 17 (4) ◽

pp. 604-634 ◽

Cited By ~ 2

Author(s):

Elaine Conway

Keyword(s):

Financial Performance ◽

Financial Risk ◽

Risk Measures ◽

Ordinary Least Squares ◽

Mandatory Reporting ◽

Stock Exchanges ◽

Integrated Reporting ◽

Content Type ◽

Environmental Goals ◽

The Impact

Purpose This paper aims to examine the impact of the 2011 mandatory introduction of integrated reporting (<IR>) on the financial performance, risk and institutional shareholding of listed companies in South Africa to assess whether there is a benefit to <IR> and which may encourage greater adoption of it globally. It contrasts the results with two other African stock exchanges (Nigeria and Egypt with no mandatory <IR>) and examines whether <IR> quality also has an impact on these and on environmental, social and governance (ESG) disclosure scores. Design/methodology/approach A series of multivariate ordinary least squares regressions was estimated on a range of financial, risk, institutional and ESG data from firms on the three African stock exchanges, between 2006 and 2015. Findings Financial performance and risk in South African firms appear to have decreased since the start of mandatory reporting, but institutional shareholding has increased. The production of higher quality reports is associated with decreased financial performance and risk, higher institutional shareholding and increased ESG scores. Originality/value This study is first to test the quantitative effects of <IR> and <IR> quality on a broad range of financial performance and risk measures and the level of institutional shareholding. It also adds to the literature by assessing how the quality of <IR> can impact the ESG scoring of the business. Hence, this study is of interest to firms looking to adopt <IR> for its benefits and to regulatory bodies considering the mandatory adoption of <IR> in support of achievement of national social and environmental goals.

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A quality evaluation approach to disclosing third mission activities and intellectual capital in Italian universities

Journal of Intellectual Capital ◽

10.1108/jic-02-2017-0042 ◽

2018 ◽

Vol 19 (1) ◽

pp. 178-201 ◽

Cited By ~ 19

Author(s):

Daniela Di Berardino ◽

Christian Corsi

Keyword(s):

Intellectual Capital ◽

Quality Evaluation ◽

Mandatory Reporting ◽

Third Mission ◽

Research Activity ◽

Content Type ◽

Evaluation Approach ◽

The University ◽

The Impact

Purpose Using the quality evaluation approach, the purpose of this paper is to analyze the contribution of intellectual capital (IC) to the development of the third mission in Italian universities, defining the impact of these activities in the regional context. This research aims to verify if the mandatory reporting on quality discloses the contribution of IC to value creation, enhancing the universities’ awareness about IC management and third mission development. Design/methodology/approach The convergence between IC framework and quality evaluation approach is tested through an empirical research on a sample of 71 Italian universities funded by the government. Statistical analyses use data collected for the period 2004-2014 during the national assessment for research activity and third mission performance. The impact of third mission on the university ecosystem is verified using the indexes related to the territorial development rates. Findings This research found significant IC disclosure in the quality evaluation model and it highlights the possible integration between the IC measures and the quality evaluation indicators. The research findings show also a positive impact of third mission activities in the university ecosystem and the relevant role of structural capital and relational capital in the development of third mission. These findings encourage a collegial discussion in the university governance and among academics, stimulating a strategic behavior in the whole system Research limitations/implications The paper focuses the attention on research activity and third mission, considering the final results provided by an external stakeholder of university. Further research must include the role of teaching activity and the opinion of universities’ managers, researchers and administrative staff. Originality/value Following the neo-institutional sociology perspective, this research analyses for the first time the convergence between the solid experience of quality assessment and the immature IC culture in Italian universities. This analysis explores the value created by intangible activities in the university ecosystem, with a longitudinal perspective, contributing to the fourth stage of the IC literature.

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Capital Market Pressure, Disclosure Frequency-Induced Earnings/Cash Flow Conflict, and Managerial Myopia (Retracted)

The Accounting Review ◽

10.2308/accr.2005.80.1.1 ◽

2005 ◽

Vol 80 (1) ◽

pp. 1-20 ◽

Cited By ~ 89

Author(s):

Sanjeev Bhojraj ◽

Robert Libby

Keyword(s):

Stock Market ◽

Cash Flow ◽

Capital Market ◽

Cash Flows ◽

Mandatory Reporting ◽

Managerial Myopia ◽

Near Term ◽

The Impact ◽

Market Pressures ◽

Market Pressure

We examine the effects of increased capital market pressure and disclosure frequency-induced earnings/cash flow conflict on myopic behavior. In our experiments, experienced financial managers choose between projects where a conflict exists between near-term earnings and total cash flow. Managers more often choose projects that they believe will maximize short-term earnings (and price) as opposed to total cash flows in response to increased capital market pressure resulting from a pending stock issuance, holding constant agency frictions and other stock market pressures. When faced with increased capital market pressure, changes in disclosure frequency cause managers to behave more or less myopically depending on the impact of the change on the pattern of earnings and the resulting earnings/cash flow conflict. Our study provides insights into managers' beliefs about stock market pressures, mandatory reporting, and the availability of alternative communications channels, and contributes to literature on managerial myopia and earnings management, as well as current debates over disclosure frequency.

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The COVID-19 Vaccination Hesitancy Among the People With Inflammatory Bowel Disease in China: A Questionnaire Study

Frontiers in Public Health ◽

10.3389/fpubh.2021.731578 ◽

2021 ◽

Vol 9 ◽

Author(s):

Xia Wu ◽

Jue Lin ◽

Heena Buch ◽

Quchen Ding ◽

Faming Zhang ◽

...

Keyword(s):

Inflammatory Bowel Disease ◽

Bowel Disease ◽

Adverse Reactions ◽

Anonymous Questionnaire ◽

The People ◽

History Of ◽

Inflammatory Bowel ◽

The Impact ◽

Vaccination Hesitancy ◽

Interview Questionnaire

Objective: To explore the attitudes and views of patients with inflammatory bowel disease (IBD) on COVID-19 vaccination.Methods: An online interview questionnaire concerning the acceptance or hesitancy toward vaccination for COVID-19 was designed and 543 patients with IBD in China were invited to complete the structured self-administered anonymous questionnaire.Results: Of all the participants, 50.7% were indecisive about the vaccination and only 16.0% opted for it. Vaccination hesitancy was significantly associated with women and those without medical or biomedical backgrounds. The acceptance of COVID-19 vaccination was higher in participants with no history of immune-modifying therapies, especially in those without immunosuppressants. Participants who considered vaccination critically important to self-health or the health of others were more likely to choose immediately or later vaccination. Safety and potential adverse reactions, personal hypoimmunity, efficacy, and reliability of COVID-19 vaccines were the top three concerns of the participants that were independent of their willingness for vaccination.Conclusions: This study discloses the presence of hesitancy for COVID-19 vaccination in patients with IBD. Further studies are warranted to evaluate the efficacy and safety of COVID-19 vaccines in IBD individuals, with a specific focus on the impact of immune-modifying therapies. Health education and recommendation from authoritative sources may facilitate COVID-19 vaccination efforts.

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