Ethical dilemmas of a large national multi-centre study in Australia

Aims and objectives: To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study.

Background: Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects.

Methods: The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC.

Results: Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study.

Conclusions: Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services.

Relevance to clinical practice: The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits. However, in our clinical practice it is vital that clinical audits are undertaken for evaluation purposes. The findings of this study raise awareness of inconsistent ethical processes and highlight the need for expedient ethical review for clinical audits.

Development of a professional practice audit questionnaire for mental health nursing in Aotearoa/New Zealand

This paper reports the three-stage development of a professional practice audit questionnaire for mental health nursing in Aotearoa/New Zealand. In Study 1, clinical indicator statements (n = 99) generated from focus group data, which were considered to be unobservable in the nursing documentation in consumer case notes, were included in a three-round Delphi process. Consensus of ratings occurred for the mental health nurse and academic participants (n = 7) on 83 clinical indicator statements. In Study 2, the clinical indicator statements (n = 67) that met importance and consensus criteria were incorporated into a questionnaire, which was piloted at a New Zealand mental health service. The questionnaire was then modified for use in a national field study. In Study 3, the national field study, registered mental health nurses (n = 422) from 11 New Zealand District Health Board mental health services completed the questionnaire. Five categories of nursing practice were identified: professional and evidence-based practice; consumer focus and reflective practice; professional development and integration; ethically and legally safe practice; and culturally safe practice. Analyses revealed little difference in the perceptions of nurses from different backgrounds regarding the regularity of the nursing practices. Further research is needed to calibrate the scores on each clinical indicator statement with behaviour in clinical practice.

Internal audit - an Asia-Pacific profile and the level of compliance with internal auditing standards

Purpose – The purpose of this paper is to provide an overview of the profile of internal audit in five Asia-Pacific countries and investigate the usage and compliance with the Institute of Internal Auditors (IIA) International Standards for the Professional Practices of Internal Auditing (Standards) by organizations' internal audit activities (IAAs). This paper shows the differences between Australia, China, Japan, New Zealand and Taiwan. It also discusses part of the results of the Common Body of Knowledge 2006 global study conducted by the IIA.

Design/methodology/approach – The paper reports the results of a questionnaire survey sent to the global membership of the IIA in September 2006 on various aspects of internal audit practices.

Findings – The profile of internal audit differs amongst the countries with much older organizations exist in Australia, Japan and New Zealand. Respondents in New Zealand, Japan, Chinese Taiwan, China and Australia all report to have a reasonably high level of usage of Standards. However, Australia has the highest number of respondents who report that they are in full compliance of the Standards.

Originality/value – This is the first global study of internal auditors' compliance with the IIA Standards.

Oxygen delivery to patients after cardiac surgery : a medical record audit

OBJECTIVE: To describe how intensive care nurses manage the administration of supplemental oxygen to patients during the first 24 hours after cardiac surgery.
METHODS: A retrospective audit was conducted of the medical records of 245 adult patients who underwent cardiac surgery between 1 January 2005 and 31 May 2008 in an Australian metropolitan hospital. Physiological data (oxygen saturation measured by pulse oximetry and respiratory rate) and intensive care unit management data (oxygen delivery device, oxygen flow rate and duration of mechanical ventilation) were collected at hourly intervals over the first 24 hours of ICU care.
RESULTS: Of the 245 patients whose records were audited, 185 were male; mean age was 70 years (SD, 10), and mean APACHE II score was 17.5 (SD, 5.14). Almost half the patients (122, 49.8%) were extubated within 8 hours of ICU admission. The most common oxygen delivery device used immediately after extubation was the simple face mask (214 patients, 87%). Following extubation, patients received supplemental oxygen via, on average, two different delivery devices (range, 1-3), and had the delivery device changed an average of 1.38 times (range, 0-6) during the 24 hours studied. Twenty-two patients (9%) received non-invasive ventilation or high-flow oxygen therapy, and 16 (7%) experienced one or more episode of hypoxaemia during mechanical ventilation. A total of 148 patients (60%) experienced one or more episodes of low oxygenation or abnormal respiratory rate during the first 24 hours of ICU care despite receiving supplemental oxygen.
CONCLUSION: These findings suggest that the ICU environment does not protect cardiac surgical patients from suboptimal oxygen delivery, and highlights the need for strategies to prompt the early initiation of interventions aimed at optimising blood oxygen levels in cardiac surgical patients in the ICU.

Audit quality : earnings management in the context of the Asian crisis

This study assumes that evidence regarding audit quality can be derived from the level of earnings management reflected in reported abnormal or discretionary accruals. Given this assumption, audit quality is examined in the context of the 1997 Asian financial crisis using data from Malaysia. Examining audit quality in its association with earnings management across differential macroeconomic periods provides insights that may be otherwise masked. The period of the crisis is partitioned between pre-crisis (1994-1996), crisis (1997-1998) and post-crisis (1999). Using a robust approach to the measurement of abnormal accruals, the association of Big 5/non-Big 5 and Industry Specialist/Industry non-specialist auditors with both the levels of, and change in levels of, abnormal accruals is investigated across and within the crisis sub-periods from 1994-1999. Audit quality is found to be associated with abnormal accruals, and differentially so across macroeconomic period with greater constraint evident post-crisis.

Audit quality : earnings management in the context of the 1997 Asian crisis

This study assumes that evidence regarding audit quality can be derived from the level of earnings management reflected in reported abnormal or discretionary accruals. Given this assumption, audit quality is examined in the context of the 1997 Asian financial crisis using data from Malaysia. Examining audit quality in its association with earnings management across differential macroeconomic periods provides insights that may be otherwise masked. The period of the crisis is partitioned between pre-crisis (1994-1996), crisis (1997-1998) and post-crisis (1999). Using a robust approach to the measurement of abnormal accruals, the association of Big 5/non-Big 5 and Industry Specialist/Industry non-specialist auditors with both the levels of, and change in levels of, abnormal accruals is investigated across and within the crisis sub-periods from 1994-1999. Audit quality is found to be associated with abnormal accruals, and differentially so across macroeconomic period with greater constraint evident post-crisis.