Abstract: Purpose – In this article we lay out the change management practices adopted by financial firms in small states within the Eurozone. We determine whether these organisations have the ability to identify triggers for change (Red Flags) and subject them to eight thematic elements to understand whether management practices can continue to exist and support operational environments, even when unexpected circumstances affect their day to day operations and processes. In doing this we examine the extent to which the eight thematic elements from the model designed by Dalli Gonzi, (2019) (The Dali Model) can assist organisations in risk identification and business continuity planning. Design/methodology/approach – A self-administered questionnaire purposely designed for this study was administered to personnel working in internal controls within financial institutions of small Eurozone states. The participants were asked to grade statements using a 5-point Likert scale, ‘1’ being ‘totally disagree’ and ‘5’ being totally agree’ to the statement posed under the thematic elements forming the basis of the Dali Model. Findings – Factor analysis provided support for the eight hypothesised dimensions of the decision-making model: connection, capacity, governance, network, policy, training, process improvement, standards. Originality/value – The study provides a better understanding and support of “best practice” in change management through an understanding and assessment of the eight factors that are the basis of this model. It addresses practical recommendations to ensure application to a wider frame of use.

The Clinical Trials Transformation Initiative (CTTI) Investigator Qualification Project addresses the need for a more efficient and effective means of identifying qualified clinical investigators and delegates. Selection of investigators and delegates who are qualified by training and experience to conduct clinical trials is essential to safeguarding protections for study participants and ensuring data quality and integrity. Sponsors generally document investigator qualification through training on the principles of good clinical practice (GCP), as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), adopted by regulatory authorities in the US, Japan and the European Union. Although these GCP principles provide an important foundation for promoting the conduct of quality clinical trials, the industry standard “one-size-fits-all” GCP training may not fully prepare investigators and delegates for conducting quality clinical trials. Routine GCP training alone may not be sufficient to prepare an inexperienced member of a site team, while repeating such training is unlikely to enhance the qualifications of an experienced researcher. The CTTI project team used findings from qualitative research activities, as well as input from an expert meeting with multiple stakeholders, to identify gaps and redundancies in the current training of investigators and their delegates and recommend practical, action-based solutions. CTTI provides recommendations on how to implement a more efficient and effective means of qualification for investigators and delegates, determine whether a site team is a good fit for a particular protocol, and improve the quality of clinical trial conduct.

Background: Good clinical practice (GCP) training is the industry standard for ensuring the quality conduct of registrational clinical trials. However, concerns have been raised about whether the current structure and delivery of GCP training sufficiently prepares clinical investigators and their delegates to conduct clinical trials. Methods: We conducted qualitative semi-structured interviews with 13 clinical investigators and 10 research sponsors to 1) examine characteristics of the quality conduct of sponsored clinical trials, including critical tasks and concerns perceived as essential for trial quality, 2) identify key knowledge and skills required to perform critical tasks, and 3) identify gaps and redundancies in GCP training and areas of improvement to ensure the quality conduct of clinical trials. We used applied thematic analysis to analyze the data. Results: The top three tasks identified as critical for the quality conduct of clinical trials were obtaining informed consent, ensuring protocol compliance, and protecting participants’ health and safety. Respondents acknowledged that GCP principles address each of these critical tasks; however, they described many challenges and burdens of GCP training, including high training frequency and repetitive content. Respondents suggested moving beyond GCP training as a mere check-box activity by making it more effective, engaging, and interactive. They also emphasized that applying GCP principles in a real-world, skills-based environment would increase the relevance of GCP training to investigators and their delegates. Conclusion: Our findings indicate that although investigators and sponsors recognize that GCP training addresses critical tasks necessary to the quality conduct of clinical trials, they articulated the need for significant improvement in the design, content, and presentation of GCP training.

Ayurveda as a healthcare system has survived for thousands of years but continues to be dogged by reported lack of efficacy of the treatments in clinical trials. The reported lack of efficacy could be due to a real lack of efficacy (which then contradicts the survival of Ayurveda as a functional medical system enjoying considerable public patronage) or could be attributed to inadequacies in the efforts towards evidence generation or in a larger context the overall scientific conduct of research in Ayurveda. In an effort towards better evidence generation, there is an immediate need for standardizing the design, conduct and reporting of clinical trials of Ayurveda but it is a daunting task. For this effort to benefit the scientific endeavors of Ayurveda researchers, it should allow the researchers to be able to apply Ayurveda’s multi-component, individualized and inherently holistic approach. Statistical principles can benefit this effort. Statistical hypothesis testing (SHT) is central to these statistical principles and also aligns well with conventional scientific principles of evidence generation. Although there are challenges with SHT, good practitioners engaged in it do much more than just apply the mathematical theory behind it. As a particular example, lot of time in clinical trial designing is spent in addressing biases and designing trials prudently by minimizing the effect of such biases. SHT can benefit such an effort objectively. There is a need for Ayurveda researchers to engage deeply and mindfully about biases in study design in order to gain scientific validity and acceptability. The article highlights issues that arise in Ayurveda research, and discusses few ways of dealing with these issues using statistical principles.

Violence is a complex and multifaceted problem requiring a holistic and individualized response. The Good Lives Model (GLM) suggests violence occurs when an individual experiences internal and external obstacles in the pursuit of universal human needs (termed primary goods). With a twin focus, GLM-consistent interventions aim to promote attainment of primary goods, whilst simultaneously reducing risk of reoffending. This is achieved by improving an individuals’ internal (i.e., skills and abilities) and external capacities (i.e., opportunities, environments, and resources). This paper proposes that collaborations between different agencies (e.g., psychological services, criminal justice systems, social services, education, community organizations and healthcare) can support the attainment of primary goods through the provision of specialized skills and resources. Recommendations for ensuring interagency collaborations are effective are outlined, including embedding a project lead, regular interagency meetings and training, establishing information sharing procedures, and defining the role each agency plays in client care.

For their clinical use Mesenchymal Stromal Cells (MSCs), isolated from bone marrow (BM-MSCs) are considered Advanced Therapy Medicinal Products (ATMP) and need to be produced according to Good Manufacturing Practice (GMP). Human platelet lysate (HPL) represents a good GMP-compliant alternative to animal serum and after pathogen inactivation with Psoralen was more efficient and safer to produce MSCs in GMP. In this study MSCs cultivated in FBS (FBS-MSC) or inactivated HPL (iHPL-MSC), were compared for their immunomodulant properties. In particular, the effects of MSCs on: 1)proliferation of total Lymphocytes (Ly) and on naïve T Ly subsets induced to differentiate versus Th1 and Th2 Ly; 2) the immunophenotype of different T cell subsets; 3)the cytokine release to verify Th1, Th2 and Th17 polarization were analyzed by using in vitro co-culture system. We observed that iHPL-MSCs showed the same immunomodulant properties observed in the FBS-MSCs co-cultures. Although, a more efficient effect on the increase of naïve T cells and, in the Th1 cytokine release related to iHPL was observed. This study confirms that iHPL, used as medium supplement, may be considered a good alternative to FBS for a GMP-compliant MSC expansion to preserve their immunomodulant proprieties.

Aflatoxin contaminated maize is of public health concern in Kenya. Training farmers on good agricultural practice (GAP) has been touted as a mitigative measure. Little is known of the effect of such training on aflatoxin levels in maize grown in Kenya. This study evaluated what effect training farmers on GAP has on aflatoxin levels in maize grown in in maize grown in Kaptumo, Kilibwoni, and Kipkaren divisions in Nandi County. Ninety farmers were recruited for the study and interviewed on GAP. Maize samples were additionally collected from the participating farmers and analyzed for aflatoxins using competitive enzyme-linked immunosorbent assay (c-ELISA). All farmers prepared the land before planting, did correct spacing between the planted crops, carried out weeding, cleaned their stores before use, checked the condition of the maize after harvesting, sorted maize after shelling, and knew aflatoxins. A majority of the farmers (90%) used fertilizers, dried maize after harvesting, knew that aflatoxins were harmful to humans, and used clean transport in transporting the harvested maize. About 98% of farmers did stooking after harvesting and 97% used wooden pallets in the maize stores. The percentage of farmers who practiced early planting, top dressing, crop rotation, raising stores above the ground, applying insecticide after shelling and feeding damaged/rotten seeds to their animals was 84–96%, 62–80%, 67–85%, 86–98%, 63–81%, and 7–21% respectively. About 18/90 (20%) of all farmers reported that they had a relative who had died from liver cancer and the mean aflatoxin levels in season 1 were significantly different from season 2 (1.92 ± 1.07 ppb; 1.30 ± 1.50 ppb). Our findings suggest that although training farmers to adopt good agricultural practices was observed to be efficient in mitigating the problem of aflatoxins, the receptiveness of farmers to different aspects of the training may have differed. Therefore, in designing an optimized regional aflatoxin contamination strategy, local applicability should be considered.

Food waste is one of the greatest challenge to sustainability in developed and developing countries. In the former, food waste is concentrated in the final part of the chain. Too Good To Go is a digital platform aimed to prevent food waste, where consumers can buy magic boxes from different outlets containing food products that are approaching their end-of-life. However, the mechanism of the platform enable the outlets to publish their offering much in advance of the pick-up time, raising the question whether the food sold on the platform is effectively a leftover or a planned production. Our empirical study gathers data from over 1200 outlets in Rome on the Too Good To Go platform.

The state of epidemic emergency in force in our country since March and the related requirement to implement various sanitary procedures constitute problems for the operation of all companies. However, the unique operation of underground mining companies increases their scale considerably. However, despite initial turbulent moments related to the occurrence of an unknown threat, it was possible to stabilise the situation in all such companies as a result of implementing various anti-threat actions. Following the initial introduction to basic properties of the SARS-CoV-2 coronavirus, the paper presents the results of the study (a case study) on actions taken in individual mining companies. There was an attempt to formulate the so-called good work practices recommended to be applied.

Performance appraisal is a fundamental indicator in public accountability to achieve the good governance principles. Hence, this study aims to analyze the performance measurement that can improve performance on government agencies in South Sulawesi, Indonesia. The study was conducted in qualitative approach. The research found that non-integrated models of performance measurement in South Sulawesi are inefficient and ineffective. Inefficiency happens because it uses time and cost resources separately, while being ineffective is because both models focuses on each goal instead on performance goals and the process is not supported by the actual management.

This research aims to determine the influence of the independent commissioners, audit committee, institutional ownership, firm size and leverage against the integrity of the financial reporting information. This research is quantitative research with the causal approach. This study uses secondary data and panel data regression analysis method. The research results prove that audit committee, institutional ownership and leverage effect on the integrity of the financial reporting information. But it does not prove that the independent commissioner and firm size effect on the integrity of the financial reporting information.

A wide range of research has been developed in the empirical literature regarding income and price elasticities of health care expenditure (HCE). The results are mixed, as researchers employ different methodologies and data sources. The benefits of the panel data method, such as greater data variation, less collinearity, and more degrees of freedom, made it attractive among economists. However, the pooled mean group (PMG) method provides robust estimates compared to conventional methods, such as the mean group estimator and dynamic fixed-effects estimator. As such, this paper applies the PMG method to scrutinize the effect of income and price on U.S. health care consumption using a panel of 46 states. The income and price elasticities were found to be 0.85 and -0.48, respectively, which partially describes the recessionary decline in health care consumption following the Great Recession. In addition, the model reveals that the short-run income elasticity is smaller than the long-run. This confirms that U.S. health care consumption follows the permanent income hypothesis. Consequently, the short-run efficacy of public policies targeting HCE remains limited. The results of this paper suggest reconsidering and adjusting health care policies during a recession so as to avoid probable long-run adverse effects on HCE.

This research contributes to the development of theories regarding the relationship between Corporate Social Responsibility (CSR) and investment decisions. Acquisition of stock returns that exceed normal predictions depends on the successful implementation of Good Corporate Governance (GCG). This study aims to examine investors' reactions to information on CSR disclosure in several countries that are members of the Association of Southeast Asian Nations (ASEAN). Furthermore, this study also examines the role of implementing GCG in strengthening the impact of CSR disclosure on investor relations as measured by abnormal stock returns. The sampling technique used was purposive Sampling. The research was conducted on Manufacturing Companies in countries that are members of ASEAN during 2017-2019. The estimation model used to analyze data is a multiple regression model. The results showed that CSR information was able to increase investors' positive reactions. Meanwhile, GCG practice is proven to strengthen the impact of CSR information on investment decisions. Other variables involved in this study, namely audit quality, company size, debt level, and sales growth, are not proven to influence abnormal stock returns.

The 2019 Coronavirus pandemic which was initially referred to as 2019-nCoV, was first identified in Wuhan, China. Early response from the Chinese government included quarantine of infected persons, isolation and total lockdown of Wuhan province to prevent further spread. With the spread of the disease across national borders and declaration of the disease as a global pandemic, there has been a robust response by the international community to contain this deadly virus and prevent its further spread worldwide. Africa is not left out of this rampaging pandemic with documented cases in over 40 countries and still rising. Although extensive studies have been carried out on the novel SARS-CoV-2 on its pathogenesis, mode of infection and virulence but much is still unknown. However, potentially infectious samples are received routinely in the medical laboratory for analysis. This technical note reviews good laboratory practice (GLP) and processes across the different specialities of Medical Laboratory practice that should minimize the risk of infection to laboratory staff especially in resource-limited settings.

In relation to organizational performance measurement, there is a growing concern about the creation of value for people, society and the environment. The traditional corporate reporting does not adequately satisfy the information needs of stakeholders for assessing an organization’s past and future potential performance. Practitioners and scholars have developed new non-financial reporting frameworks from a social and environmental perspective, giving birth to the field of Integrated Reporting (IR). The Economy for the Common Good (ECG) model and its tools to facilitate sustainability management and reporting can provide a framework to do it. The present study is the first one that empirically validates such metrics on a sample of 206 European firms. Consequently, it allows knowledge to advance as it checks their statistical validity and reliability.

The COVID-19 pandemic has exposed the inadequacies of the current healthcare system and needs a paradigm change, which is holistic, and community based illustrated by the healing wheel. The present paper proposes that existential positive psychology (PP 2.0) represents a promising approach to meet the rising needs in palliative care. This framework has a twofold emphasis on (a) How to transcend and transform suffering as the foundation for wellbeing, and (b) how to cultivate our spiritual and existential capabilities to achieve personal growth and flourishing. We propose that these objectives can be achieved simultaneously through dialectical palliative counselling, as illustrated by Wong’s integrative meaning therapy (Wong, 2020) and Lo’s Conceptual Model of CALM Therapy in palliative care (Lo et al., 2014). We then discuss existential suffering in general and at the last stage of life in particular; we also review recent research and interventions on existential suffering in palliative patients. Finally, we outline the objectives and the strategies of IMT in providing palliative counselling for palliative care and hospice patients.

Commons and food are experiencing a revival in recent years and yet the links between both are almost absent in academic and political discourses. Commons are often portrayed as historical and yet innovative governing mechanisms that can challenge the State-Market hegemony. On the other side, food is both a relevant agent of change and a major driver of planetary destruction, being thus cause and solution to multiple crises that affect humankind. Departing from the commodification of food as one root cause of the broken global food system, this text firstly situates and discusses the different schools of thought (or epistemologies) that have addressed the private/public, commodity/commons nature of goods in general, and then explores how those schools have considered food in particular. To do so, the author has defined five epistemologies, four academic (economic, legal, historical and political) and one non-academic (grassroots activists). The analysis highlights how those epistemologies have yielded incommensurable understandings and conflicting vocabularies, hence creating confusion in the socio-political realm and even rejection around the idea of food being considered as a commons. The economic epistemic regard has reigned over the others by applying an approach to commons, public and private goods that is theoretical, reductionist and ontological instead of phenomenological, therefore preventing or obscuring other scholarly or practical understanding of commons. When applied to food, the iron law of economics dictated that food, a private good based on rivalry and excludability, shall be better allocated through market mechanisms with absolute proprietary rights and valued as a pure commodity. This reductionist view collides with the plurality of meanings of food in different societies, civilisations and historical periods, as other schools of thought indicate. The author uses diverse epistemic tools to re-construct food as a commons, based on its essentiality to human beings and societies and the customary and contemporary praxis to produce, consume and govern food collectively through non-market mechanisms for more than 2000 centuries. As commoning has instituting power to create different political and legal frameworks, if food is valued differently the entire architecture of the global food system would change, as the grassroots activist school claims. Re-commoning food defies the legal and political scaffoldings that sustain the hegemony of market and state decision-makers over eaters and food producers and informs sustainable forms of food production (agro-ecology), new collective practices of governance (food democracies) and alternative policies to regain control over the food system (food sovereignty). Food as a commons is an agent of change with transformative power, no matter what economists say.

The cyclic regeneration of human endometrium is guaranteed by the proliferative capacity of Endometrial Mesenchymal Stromal Cells (E-MSCs). Due to this, the autologous infusion of E-MSCs has been proposed to support endometrial growth in a wide range of gynecological diseases. We aimed to compare two different endometrial sampling methods, the surgical curettage and the Vacuum Aspiration Biopsy Random Assay, and to validate a novel xeno-free method to culture human E-MSCs. Six E-MSCs cell lines were isolated after a mechanical tissue homogenization and cultured using human platelet lysate. E-MSCs were characterized for the colony formation capacity, proliferative potential and multilineage differentiation. The expression of mesenchymal and stemness markers was tested by FACS analysis and Real-Time PCR, respectively. Chromosomal alterations were evaluated by karyotype analysis, whereas tumorigenic capacity and invasiveness were tested by soft agar assay. Both endometrial sampling techniques allowed to efficiently isolate and expand E-MSCs using a xeno-free method preserving their mesenchymal and stemness phenotype, proliferative potential and multi-lineage differentiation ability during the culture. No chromosomal alterations and invasive/tumorigenic capacity were observed. Herein we report the first evidence of efficient E-MSCs isolation and culture in Good Manufacturing Practice compliance conditions, suggesting Vabra endometrial sampling as alternative to surgical curettage.

Despite extensive investigations of the Depression Anxiety Stress Scales-21 (DASS-21) since its development in 1995, its factor structure and other psychometric properties still need to be firmly established, with several calls for revising its item structure. Employing confirmatory factor analysis (CFA), this study examined the factor structure of the DASS-21 and five shortened versions of the DASS-21 among psychiatric patients (N = 168) and the general public (N = 992) during the COVID-19 confinement period in Saudi Arabia. Multigroup CFA, Mann Whitney W test, Spearman’s correlation, and coefficient alpha were used to examine the shortened versions of the DASS-21 (DASS-13, DASS-12, DASS-9 (two versions), and DASS-8) for invariance across age and gender groups, discriminant validity, predictive validity, item coverage, and internal consistency, respectively. Compared with the DASS-21, all three-factor structures of the shortened versions expressed good fit, with the DASS-8 demonstrating the best fit and highest item loadings on the corresponding factors in both samples (χ2(16, 15) = 16.5, 67.0; p = 0.420, 0.000; CFI= 1.000, 0.998; TLI = 0.999, 0.997; RMSEA = 0.013, 0.059, SRMR = 0.0186, 0.0203). It expressed configural, metric, and scalar invariance across age and gender groups. Its internal consistency was comparable to other versions (α = 0.94). Strong positive correlations of the DASS-8 and its subscales with the DASS-21 and its subscales (r = 0.97 to 0.81) suggest adequate item coverage and good predictive validity of this version. The DASS-8 and its subscales distinguished the clinical sample from the general public at the same level of significance expressed by the DASS-21 and other shortened versions, supporting its discriminant validity. Neither the DASS-21 nor the shortened versions distinguished patients diagnosed with depression and anxiety from other conditions. The DASS-8 represents a valid short version of the DASS-21, which may be useful in research and clinical practice for quick identification of individuals with potential psychopathologies. Diagnosing depression/anxiety disorders may be further confirmed in a next step by clinician-facilitated examinations. Brevity of the DASS-21 would save time and effort used for filling the questionnaire and support comprehensive assessments by allowing the inclusion of more measures on test batteries.