An investigation of the shortcomings of the CONSORT 2010 statement for the reporting of group sequential randomised controlled trials: a methodological systematic review

Background It can be argued that adaptive designs are underused in clinical research. We have explored concerns related to inadequate reporting of such trials, which may influence their uptake. Through a careful examination of the literature, we evaluated the standards of reporting of group sequential (GS) randomised controlled trials, one form of a confirmatory adaptive design. Methods We undertook a systematic review, by searching Ovid MEDLINE from the 1st January 2001 to 23rd September 2014, supplemented with trials from an audit study. We included parallel group, confirmatory, GS trials that were prospectively designed using a Frequentist approach. Eligible trials were examined for compliance in their reporting against the CONSORT 2010 checklist. In addition, as part of our evaluation, we developed a supplementary checklist to explicitly capture group sequential specific reporting aspects, and investigated how these are currently being reported. Results Of the 284 screened trials, 68(24%) were eligible. Most trials were published in “high impact” peer-reviewed journals. Examination of trials established that 46(68%) were stopped early, predominantly either for futility or efficacy. Suboptimal reporting compliance was found in general items relating to: access to full trials protocols; methods to generate randomisation list(s); details of randomisation concealment, and its implementation. Benchmarking against the supplementary checklist, GS aspects were largely inadequately reported. Only 3(7%) trials which stopped early reported use of statistical bias correction. Moreover, 52(76%) trials failed to disclose methods used to minimise the risk of operational bias, due to the knowledge or leakage of interim results. Occurrence of changes to trial methods and outcomes could not be determined in most trials, due to inaccessible protocols and amendments. Discussion and Conclusions There are issues with the reporting of GS trials, particularly those specific to the conduct of interim analyses. Suboptimal reporting of bias correction methods could potentially imply most GS trials stopping early are giving biased results of treatment effects. As a result, research consumers may question credibility of findings to change practice when trials are stopped early. These issues could be alleviated through a CONSORT extension. Assurance of scientific rigour through transparent adequate reporting is paramount to the credibility of findings from adaptive trials. Our systematic literature search was restricted to one database due to resource constraints.

Does stakeholder pressure influence corporate GHG emissions reporting? Empirical evidence from Europe

Purpose – The purpose of this paper is to seek to shed light on the practice of incomplete corporate disclosure of quantitative Greenhouse gas (GHG) emissions and investigates whether external stakeholder pressure influences the existence, and separately, the completeness of voluntary GHG emissions disclosures by 431 European companies. Design/methodology/approach – A classification of reporting completeness is developed with respect to the scope, type and reporting boundary of GHG emissions based on the guidelines of the GHG Protocol, Global Reporting Initiative and the Carbon Disclosure Project. Logistic regression analysis is applied to examine whether proxies for exposure to climate change concerns from different stakeholder groups influence the existence and/or completeness of quantitative GHG emissions disclosure. Findings – From 2005 to 2009, on average only 15 percent of companies that disclose GHG emissions report them in a manner that the authors consider complete. Results of regression analyses suggest that external stakeholder pressure is a determinant of the existence but not the completeness of emissions disclosure. Findings are consistent with stakeholder theory arguments that companies respond to external stakeholder pressure to report GHG emissions, but also with legitimacy theory claims that firms can use carbon disclosure, in this case the incomplete reporting of emissions, as a symbolic act to address legitimacy exposures. Practical implications – Bringing corporate GHG emissions disclosure in line with recommended guidelines will require either more direct stakeholder pressure or, perhaps, a mandated disclosure regime. In the meantime, users of the data will need to carefully consider the relevance of the reported data and develop the necessary competencies to detect and control for its incompleteness. A more troubling concern is that stakeholders may instead grow to accept less than complete disclosure. Originality/value – The paper represents the first large-scale empirical study into the completeness of companies’ disclosure of quantitative GHG emissions and is the first to analyze these disclosures in the context of stakeholder pressure and its relation to legitimation.

Exploring the issues in sustainable development journal reporting

There is concern about the environmental claims organisations make in corporate social reports and advertising. Similar concerns may also occur with reporting of environmental initiatives in journals. This paper explores what information is being conveyed in academic and industry journals. In particular, we examine the types of projects that are discussed and the level of detail provided in the reporting of sustainable development initiatives to identify what is being communicated and whether there is substance to the reporting. The results show that there are issues with the lack of detail reported and its anecdotal nature.

Indian student concerns about violence : exploring student perceptions

While considerable attention has been given to the spate of attacks on Indian students in Australia in 2009 and 2010, less attention has been paid to how the students who were at the centre of the furore perceived the violence. In this paper we explore the perceptions of Indian postgraduate and undergraduate male students studying in Melbourne, Australia, based on data gathered in focus groups. Analysis revealed four broad themes in students' explanations for the attacks: race hate versus opportunism, intercultural issues, systemic ineffectiveness, and media reporting. Students' perceptions of the reasons for the attacks were divided in some areas and aligned in others. There was divergence among students about whether the attacks were race hate crime or opportunistic, and about intercultural issues. Students' perceptions were aligned on issues of systemic ineffectiveness and media reporting. In the current context of decreased international enrolments from Indian students, in which we seek to better understand them, the findings provide implications for international student policy and planning priorities.

Audit fees, non-audit fees and auditor going-concern reporting decisions in the United Kingdom

The accounting profession has come under increased scrutiny over recent years about the growing number of non-audit fees received from audit clients and the possible negative impact of such fees on auditor independence. The argument advanced is that providing substantial amounts of non-audit services to clients may make it more likely that auditors concede to the wishes of the client management when difficult judgments are made. Such concerns are particularly salient in the case of reporting decisions related to going-concern uncertainties for financially stressed clients. This study empirically examines audit reports provided to financially stressed companies in the United Kingdom and the magnitude of audit and non-audit service fees paid to the company’s auditors. We find that the magnitude of both audit fees and non-audit fees are significantly associated with the issuance of a going-concern modified audit opinion. In particular, financially stressed companies with high audit fees are more likely to receive a going-concern modified audit opinion, whereas companies with high non-audit fees are less likely to receive a goingconcern modified audit opinion. Additional analyses indicate that the results are generally robust across alternative model and variable specifications. Overall, evidence supports the contention that high non-audit fees have a detrimental effect on going-concern reporting judgments for financially stressed U.K. companies.

Absence of corporate social reporting (CSR) in Bangladesh: a research note

This paper aims to broaden the present CSR literature by extending its focus to the absence of CSR within a developing country, an area which, to date, is relatively under researched in comparison to the more widely studied presence of CSR within developed Western countries. In particular this paper concentrates upon the lack of disclosure on three particular eco-justice issues: child labour, equal opportunities and poverty alleviation. We critically examine why this is the case and thereby illuminate underlying motives behind corporate unwillingness to address these issues. For this purpose, 23 semi-structured interviews were undertaken with senior corporate managers in Bangladesh. The findings suggest that the main reasons for non-disclosure include lack of legal requirements, lack of knowledge/awareness, poor performance and fear of bad publicity. Given these findings the paper raises some serious concerns as to why corporations would ever be expected to voluntarily report on eco-justice issues where performance is poor and negative publicity would be generated. These significant issues require careful consideration by policy makers at the national, regional and international levels.

An examination of adverse drug reaction reporting to the yellow card scheme

Chief pharmacists in 209 hospitals were surveyed about ADR reporting schemes, the priority given to ADR reporting, and attitudes towards ADR reporting. ADR reporting had a low managerial priority. Local reporting schemes were found to be operating in 37% trusts, but there were few plans to start new schemes. Few problems were discovered by the introduction of pharmacist ADR reporting. Chief pharmacists had concerns about the competence of hospital pharmacists to detect ADRs and were in favour of increased training. Lack of time on wards, and recruitment difficulties were suggested as reasons for hospital pharmacist under-reporting. Teaching hospitals appeared to have an increased interest in ADR reporting. A retrospective analysis of reporting trends within the West Midlands region from 1994, showed increasing or stable reporting rates for most sectors of reporters, except for general practitioners (GPs). The West Midlands region maintained higher ADR reporting rates than the rest of the UK. National reporting figures showed a worrying decline in ADR reports from healthcare professionals. Variation was found in the ADR reporting rates of Acute NHS Hospital Trusts and Primary Care Trusts (PCTs) in the West Midlands region, including correlations with prescribing rates and other PCT characteristics. Qualitative research into attitudes of GPs towards the Yellow Card scheme was undertaken. A series of qualitative interviews with GPs discovered barriers and positive motivators for their involvement in the Yellow Card scheme. A grounded theory of GP involvement in the Yellow Card scheme was developed to explain GP behaviour, and which could be used to inform potential solutions to halt declining rates of reporting. Under-reporting of ADRs continues to be a major concern to those who administer spontaneous reporting schemes.

Stakeholders' perceptions of corporate social reporting in Bangladesh

Recent calls in the corporate social reporting (CSRep) literature have emphasized the importance of giving voice to non-managerial stakeholder groups in the social reporting process. The research, presented in this paper, employs recent work in stakeholder theory and CSRep to examine the perceptions of a diverse set of non-managerial stakeholders in the context of a developing country, Bangladesh. A series of semi-structured interviews were conducted with individuals who identify with various non-managerial stakeholder groups. Interviewees generally believed that the motivation and practice of CSRep in Bangladesh is developing in response to pressures from international markets and is producing largely cosmetic responses. Also, they expressed concerns that, given the economic, political, and social conditions in Bangladesh, premature adoption of strict CSRep standards may lead to increased corruption and other unintended consequences. Whilst some of the interviewees sharply criticized the current process of imposing social accounting codes/standards on developing countries which fail to consider the important local socio-economic context, the findings suggest that there is overwhelming support for mandatory externally verified CSRep based on the principles of peoples' right to know, full disclosure/completeness, and relevance, which are anchored in the broader principles of transparency and stakeholder accountability. © 2010 Springer Science+Business Media B.V.

The absence of corporate social responsibility reporting in Bangladesh

This paper aims to broaden the present corporate social responsibility (CSR) reporting literature by extending its focus to the absence of CSR reporting within a developing country, an area which, to date, is relatively under researched in comparison to the more widely studied presence of CSR reporting within developed Western countries. In particular this paper concentrates upon the lack of disclosure on three particular eco-justice issues: child labour, equal opportunities and poverty alleviation. We examine why this is the case and thereby illuminate underlying motives behind corporate unwillingness to address these issues. For this purpose, 23 semi-structured interviews were undertaken with senior corporate managers in Bangladesh. The findings suggest that the main reasons for non-disclosure include lack of resources, the profit imperative, lack of legal requirements, lack of knowledge/awareness, poor performance and the fear of bad publicity. Given these findings the paper raises some serious concerns as to why corporations would ever be expected to voluntarily report on eco-justice issues where performance is poor and negative publicity would be generated and profit impaired. Further research is still required to uncover current injustices and to imagine what changes can be made.

An exploration of the absence of corporate social reporting (CSR) in Bangladesh

This paper aims to broaden the present CSR literature by examining the absence of CSR within the context of a developing country. This is an area which to date is relatively under researched in comparison to the more widely studied presence of CSR within developed Western countries. For this purpose, 23 semi-structured interviews were undertaken with senior corporate managers in Bangladesh. The findings suggest that the main reasons for non-disclosure include lack of legal requirements and lack of knowledge/awareness. The other reasons mentioned are lack of resources, poor performance and fear of bad publicity and inherent dangers in additional disclosures. The paper has raised some serious public policy concerns by exploring the underlying motives for absence of CSR in general and some eco-justice issues in particular (e.g. child labour, equal opportunities and poverty alleviation). These significant issues require careful consideration by the policy makers at the national, regional and international levels.

Audit pricing, reporting quality, and auditor switches in the post -SOX period

The Sarbanes-Oxley Act represents an important watershed event in the history and regulation of the accounting profession. In this dissertation, I develop arguments as to why we can expect differences in auditor behavior before and after SOX and empirically test if indeed there were differences in auditor behavior before and after SOX. My dissertation consists of three essays. For the three essays, I investigate issues related to auditor independence, audit pricing, the impact of auditor changes in the post-SOX period. The motivation for the first part of my research comes from the SEC's assertions that there are differences between types of non-audit services in terms of their potential to adversely impact auditor independence. The first part of my dissertation empirically validates the SEC's assertions that auditors would be more conservative in those instances where the tax and other non-audit services fee ratios are high but not when the audit-related fee ratio is high. The second part of my study examines if auditors are less likely to "low ball" their audit fees in the period after SOX than in the period preceding SOX. Legislators, regulators, and the media have expressed concerns that auditors "low ball" the fees for initial year audits and that such low-balling can lead to reduced audit quality. I find that there is significant initial year audit fee discount in pre-SOX period and but the fee discount does not hold in post-SOX periods. The third part of my dissertation examines the association between auditor switches and auditor conservatism. I find that a large portion of Big 4 clients switch to non-Big 4 auditors and there is no significant evidence indicating that successor auditors are more conservative in the post-SOX period.

EuroClonality/BIOMED-2 guidelines for interpretation and reporting of Ig/TCR clonality testing in suspected lymphoproliferations.

PCR-based immunoglobulin (Ig)/T-cell receptor (TCR) clonality testing in suspected lymphoproliferations has largely been standardized and has consequently become technically feasible in a routine diagnostic setting. Standardization of the pre-analytical and post-analytical phases is now essential to prevent misinterpretation and incorrect conclusions derived from clonality data. As clonality testing is not a quantitative assay, but rather concerns recognition of molecular patterns, guidelines for reliable interpretation and reporting are mandatory. Here, the EuroClonality (BIOMED-2) consortium summarizes important pre- and post-analytical aspects of clonality testing, provides guidelines for interpretation of clonality testing results, and presents a uniform way to report the results of the Ig/TCR assays. Starting from an immunobiological concept, two levels to report Ig/TCR profiles are discerned: the technical description of individual (multiplex) PCR reactions and the overall molecular conclusion for B and T cells. Collectively, the EuroClonality (BIOMED-2) guidelines and consensus reporting system should help to improve the general performance level of clonality assessment and interpretation, which will directly impact on routine clinical management (standardized best-practice) in patients with suspected lymphoproliferations.

Management accounting and supply chains: actions, concerns, and networks

What does this thesis do? This thesis uses Actor-Network Theory (ANT) to examine how a UK retailer’s organization and strategy, and, in turn, its form of management accounting was shaped by its supply chain. The thesis does this by reporting on four related themes in the form of four inter-connected essays. The first essay undertakes a state-of-the-art review of the literature. It examines how accounting issues within supply chains permeate ‘matters of concern’. In accordance with this idea of ANT, the essay illustrates how issues emerged, controversies developed, and matters evolved through an actor-network of accounting researchers within the supply chain domain. This leads on to the second essay, which exemplifies the nature of the UK’s retailing industry within which the supply chain case organization emerged and developed. The purposes of the essay are twofold: to introduce the contextual ramifications of the case organization; and to illustrate the emergence of a new market logic, which led to the creation of a global supply chain and a new form of management accounting therein. The third essay reports on a qualitative case study. It analyses the dualistic relation between ostensive and performative aspects of supply chain strategy, reveals how accounting numbers act as an obligatory passage point within this dualism, and makes a contribution to the ANT debate around the issue of whether and how a dualism between ostensive and performative aspects exists. The final essay reports on another case analysis of institutionalizing a heterarchical form of management accounting: a distributed form of intelligence that penetrates through lateral accountable relations. The analysis reveals a new form of management accounting characterised by ambiguity; it emphasizes the possibilities of compromises and negotiations, and it thus contributes to knowledge by combining an aspect of ANT with heterarchical tendencies in the world of contemporary organizations. Finally, the thesis concludes that it is the supply chain that organises today’s neoliberal capitalism; and it is management accounting that unites both human and non-human actors within such supply chains, despite that form of management accounting being ambiguous. The thesis comprises the introduction, these four essays, and the conclusion.