Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05)

Background and purpose: Trans-Tasman Radiation Oncology Group 96.05 is a prospective randomized controlled trial comparing a single 8 Gy with 20 Gy in five fractions of radiotherapy (RT) for neuropathic pain due to bone metastases. This paper summarizes the quality assurance (QA) activities for the first 234 patients (accrual target 270). Materials and methods: Independent audits to assess compliance with eligibility/exclusion criteria and appropriateness of treatment of the index site were conducted after each cohort of approximately 45 consecutive patients. Reported serious adverse events (SAEs) in the form of cord/cauda equina compression or pathological fracture developing at the index site were investigated and presented in batches to the Independent Data Monitoring Committee. Finally, source data verification of the RT prescription page and treatment records was undertaken for each of the first 234 patients to assess compliance with the protocol. Results: Only one patient was found conclusively not to have genuine neuropathic pain, and there were no detected 'geographical misses' with RT fields. The overall rate of detected infringements for other eligibility criteria over five audits (225 patients) was 8% with a dramatic improvement after the first audit. There has at no stage been a statistically significant difference in SAEs by randomization arm. There was a 22% rate of RT protocol variations involving ten of the 14 contributing centres, although the rate of major dose violations (more than +/- 10% from protocol dose) was only 6% with no statistically significant difference by randomization arm (P = 0.44). Conclusions: QA auditing is an essential but time-consuming component of RT trials, including those assessing palliative endpoints. Our experience confirms that all aspects should commence soon after study activation. Crown Copyright (C) 2003 Published by Elsevier Science Ltd. All rights reserved.

Subordinate-manager gender combination and perceived leadership style influence on emotions, self-esteem and organizational commitment

A theoretical model was developed to investigate the relationships among subordinate-manager gender combinations, perceived leadership style, experienced frustration and optimism, organization-based self-esteem and organizational commitment. The model was tested within the context of a probabilistic structural model, a discrete Bayesian network, using cross-sectional data from a global pharmaceutical company. The Bayesian network allowed forward inference to assess the relative influence of gender combination and leadership style on the emotions, self-esteem and commitment consequence variables. Further, diagnostics from backward inference were used to assess the relative influence of variables antecedent to organizational commitment. The results showed that gender combination was independent of leadership style and had a direct impact on subordinates' levels of frustration and optimism. Female manager-female subordinate had the largest probability of optimism, while male manager teamed with a male subordinate had the largest probability of frustration. Furthermore, having a female manager teamed up with a male subordinate resulted in the lowest possibility of frustration. However, the findings show that the gender issue is not simply female managers versus male managers, but is concerned with the interaction of the subordinate-manager gender combination and leadership style in a nonlinear manner. (C) 2003 Elsevier Inc. All rights reserved.

Use of derivatives in public sector organisations

The present paper develops and tests a model explaining public sector derivative use in terms of budget discrepancy minimization. The model is different from private sector models. Private sector models do not readily translate into the public sector, which typically faces different objectives. Hypotheses are developed and tested using logistic regression over a sample of Australian Commonwealth public sector organizations. It is found that public sector organization derivative use is positively correlated with liabilities and size consistent with the hypotheses concerning budget discrepancy management.

Improving environmental performance in the tourism accommodation sector

While environmental legislation in Australia regulates tourism development, it is less effective in operational areas because of the dependency of tourism on environmental resources that are not managed by operators, and the small but incremental nature of operational impacts. The absence of functional environmental standards for tourism means that little guidance exists: a problem compounded by variability in the diversity of operation types and receiving environments, as well as the accessibility of information by a non-technical audience. While legislation and economic considerations may provide impetus to adopt environmental practices, it is proposed that an environmental philosophy is necessary for tourism businesses to seek out and maintain alternative sustainable modes of operation. Review of the environmental audit process used by a Queensland resort suggests commitment to continual improvement in environmental performance is attributable to individual and corporate ethics. While the case is an ecotourism operation, the literature indicates that these factors have relevance to tourism generally. Although client satisfaction and return on investment objectives are constraints, environmental auditing can provide impetus for practical expression of environmental objectives. Facilitation of ethically-motivated voluntary action may be more effective in achieving tourism's environmental objectives than codifying standards in static legislation.

Classification of perinatal deaths: Development of the Australian and New Zealand classifications

Classifications of perinatal deaths have been undertaken for surveillance of causes of death, but also for auditing individual deaths to identify suboptimal care at any level, so that preventive strategies may be implemented. This paper describes the history and development of the paired obstetric and neonatal Perinatal Society of Australia and New Zealand (PSANZ) classifications in the context of other classifications. The PSANZ Perinatal Death Classification is based on obstetric antecedent factors that initiated the sequence of events leading to the death, and was developed largely from the Aberdeen and Whitfield classifications. The PSANZ Neonatal Death Classification is based on fetal and neonatal factors associated with the death. The classifications, accessible on the PSANZ website (http://www.psanz.org), have definitions and guidelines for use, a high level of agreement between classifiers, and are now being used in nearly all Australian states and New Zealand.

A full cost environmental accounting experiment

A lack of appropriate measurement techniques has constrained full cost environmental accounting (FCEA) experimentation. Yet, there has been little research on the applicability of valuation techniques recently developed by environmental economists within FLEA frameworks. This paper examines a reporting experiment using these valuation techniques that was undertaken by an Australian Government Department managing publicly owned forests. The FCEA experiment was ultimately not successful. However, the implementation experiences of the Department including the reactions of its managers and stakeholders provide an opportunity to critically reflect on the experimental outcomes to extend the current empirical knowledge of corporate social responsibility reporting. Such critical reflection has not been common in past FCEA experimentation. © 2005 Elsevier Ltd. All rights reserved.

Who's really hypertensive? - Quality control issues in the assessment of blood pressure for randomized trials

The characterization of blood pressure in treatment trials assessing the benefits of blood pressure lowering regimens is a critical factor for the appropriate interpretation of study results. With numerous operators involved in the measurement of blood pressure in many thousands of patients being screened for entry into clinical trials, it is essential that operators follow pre-defined measurement protocols involving multiple measurements and standardized techniques. Blood pressure measurement protocols have been developed by international societies and emphasize the importance of appropriate choice of cuff size, identification of Korotkoff sounds, and digit preference. Training of operators and auditing of blood pressure measurement may assist in reducing the operator-related errors in measurement. This paper describes the quality control activities adopted for the screening stage of the 2nd Australian National Blood Pressure Study (ANBP2). ANBP2 is cardiovascular outcome trial of the treatment of hypertension in the elderly that was conducted entirely in general practices in Australia. A total of 54 288 subjects were screened; 3688 previously untreated subjects were identified as having blood pressure >140/90 mmHg at the initial screening visit, 898 (24%) were not eligible for study entry after two further visits due to the elevated reading not being sustained. For both systolic and diastolic blood pressure recording, observed digit preference fell within 7 percentage points of the expected frequency. Protocol adherence, in terms of the required minimum blood pressure difference between the last two successive recordings, was 99.8%. These data suggest that adherence to blood pressure recording protocols and elimination of digit preferences can be achieved through appropriate training programs and quality control activities in large multi-centre community-based trials in general practice. Repeated blood pressure measurement prior to initial diagnosis and study entry is essential to appropriately characterize hypertension in these elderly patients.

The use of internal audit by Australian companies

Purpose – The purpose of this study is to explore the voluntary use of internal audit by Australian publicly listed companies and to identify factors that lead listed companies to have an internal audit function. Design/methodology/approach – Drawing on the Institute of Internal Auditors' definition of internal auditing, the paper predicts that internal audit use is associated with factors related to risk management, strong internal controls and strong corporate governance. To test the predictions, the study combines data from a survey of listed companies with information from corporate annual reports. The paper also provides descriptive information on the use of internal audit. Findings – The results indicate that only one-third of the sample companies use internal audit. While size appears to be the dominant driver, there is also a strong association between internal audit and the level of commitment to risk management. However, the study finds only weak support for an association between the use of internal audit and strong corporate governance. Research limitations/implications – A limitation of our study is that some of the variables in the model may not be good proxies for the factors being measured. Refinement of the model and the variables used provides an opportunity for future research. Practical implications – The limited use of internal audit by Australian companies has important implications for sound corporate governance. Originality/value – This is the first study that identifies factors associated with the use of internal audit by Australian listed companies.

The impact of leadership and change management strategy on organizational culture and individual acceptance of change during a merger

This article reports a longitudinal study that examined mergers between three large multi-site public-sector organizations. Both qualitative and quantitative methods of analysis are used to examine the effect of leadership and change management strategies on acceptance of cultural change by individuals. Findings indicate that in many cases the change that occurs as a result of a merger is imposed on the leaders themselves, and it is often the pace of change that inhibits the successful re-engineering of the culture. In this respect, the success or otherwise of any merger hinges on individual perceptions about the manner in which the process is handled and the direction in which the culture is moved. Communication and a transparent change process are important, as this will often determine not only how a leader will be regarded, but who will be regarded as a leader. Leaders need to be competent and trained in the process of transforming organizations to ensure that individuals within the organization accept the changes prompted by a merger.