Random Audits Research Articles

Experience of implementing a novel random sampling BICR audit for investigator (INV)-assessed progression-free survival (PFS) in the PALOMA-3 trial.

1058 Background: PFS has frequently been used as a primary endpoint for evaluating efficacy of anticancer therapies in randomized clinical trials. Given high correlation between INV and independent (BICR) assessments with respect to the relative treatment effect, a pre-planned BICR audit of INV progression assessment in a random subgroup of patients (pts) instead of a BICR review of all progression assessments can be an acceptable approach to verify the INV assessments and to evaluate the potential bias in INV PFS results. Methods: PALOMA-3 was a randomized, double blind, placebo (PCB) controlled, Ph 3 study with the primary objective of demonstrating the superiority of palbociclib (PAL) + fulvestrant (F) over PCB + F in women with HR+, HER2- metastatic breast cancer (MBC). The primary endpoint was INV assessed PFS. BICR assessment of PFS was performed with the use of a novel audit approach involving a random sample–based BICR to verify if the INV assessed PFS was accurate. A third-party core imaging laboratory performed the blinded review for a randomly selected subgroup of pts (~40%). NIH and PhRMA methods were used to evaluate the potential for bias in the INV PFS results. Results: PAL + F improved PFS in patients with HR+, HER2- MBC. The observed INV HR was 0.46 (95% CI: 0.36, 0.59; stratified 1-sided p < 0.0001) in favor of PAL + F. The median PFS was 9.5 mo (95% CI: 9.2, 11.0) in the PAL + F arm and 4.6 mo (95% CI: 3.5, 5.6) in the PCB + F arm (Lancet Oncol. 2016; 17: 425–39). The estimated HR of the complete BICR data incorporating the information from the complete INV assessed PFS and the random sample audited BICR subgroup was 0.33 with the upper bound of the 1-sided 95% CI of 0.47. The results confirmed the INV assessed treatment effect and detected no INV bias in favor of PAL + F. Conclusions: PALOMA-3 is the first registrational trial to use a BICR audit and has received positive reviews from regulatory agencies. The experience of implementing the random sampling BICR audit in PALOMA-3 demonstrates that this approach can be used for randomized, double blind oncology trials with solid tumors where INV assessed PFS is the primary endpoint and a large treatment effect is targeted. Sponsor: Pfizer. Clinical trial information: NCT01942135.

On optimal audit mechanisms for environmental taxes

We consider the auditing problem of an environmental enforcement agency with fixed audit resources: How to decide which firms to audit after having observed the firms' taxable emissions reports. The goal of the agency is to implement the socially efficient emissions level. The audit mechanism is the agency's sole choice variable, while other variables such as the tax rate on emissions and the fine for non-compliance are determined by other governmental actors. The fines and budget of the agency are constrained in such a way that the common random audit mechanism fails to implement socially efficient emissions. Assuming perfect information among the firms, we derive an optimal audit mechanism capable of implementing the socially efficient emissions level. The optimal audit mechanism creates a contest exploiting the strategic interdependencies between the firms, where the probability of winning (not being audited) for each firm depends on costly efforts (their taxable emissions reports).

A direct observation method for auditing large urban centers using stratified sampling, mobile GIS technology and virtual environments

BackgroundWith the expansion and growth of research on neighbourhood characteristics, there is an increased need for direct observational field audits. Herein, we introduce a novel direct observational audit method and systematic social observation instrument (SSOI) for efficiently assessing neighbourhood aesthetics over large urban areas.MethodsOur audit method uses spatial random sampling stratified by residential zoning and incorporates both mobile geographic information systems technology and virtual environments. The reliability of our method was tested in two ways: first, in 15 Ottawa neighbourhoods, we compared results at audited locations over two subsequent years, and second; we audited every residential block (167 blocks) in one neighbourhood and compared the distribution of SSOI aesthetics index scores with results from the randomly audited locations. Finally, we present interrater reliability and consistency results on all observed items.ResultsThe observed neighbourhood average aesthetics index score estimated from four or five stratified random audit locations is sufficient to characterize the average neighbourhood aesthetics. The SSOI was internally consistent and demonstrated good to excellent interrater reliability. At the neighbourhood level, aesthetics is positively related to SES and physical activity and negatively correlated with BMI.ConclusionThe proposed approach to direct neighbourhood auditing performs sufficiently and has the advantage of financial and temporal efficiency when auditing a large city.

Tax Evasion and Inequality

This paper attempts to estimate the size and distribution of tax evasion in rich countries. We combine random audits - the key source used to study tax evasion so far - with new micro-data leaked from large offshore financial institutions - HSBC Switzerland (Swiss leaks) and Mossack Fonseca (Panama Papers) matched to population-wide wealth records in Norway, Sweden, and Denmark. We find that tax evasion rises sharply with wealth, a phenomenon random audits fail to capture. On average about 3% of personal taxes are evaded in Scandinavia, but this figure rises to close to 30% in the top 0.01% of the wealth distribution, a group that includes households with more than $45 million in net wealth. A simple model of the supply of tax evasion services can explain why evasion rises steeply with wealth. Taking tax evasion into account increases the rise in inequality seen in tax data since the 1970s markedly, highlighting the need to move beyond tax data to capture income and wealth at the top, even in countries where tax compliance is generally high. We also find that after reducing tax evasion - by using tax amnesties - tax evaders do not legally avoid taxes more. This result suggests that fighting tax evasion can be an effective way to collect more tax revenue from the very wealthy.

An Evidence-Based Infant Safe Sleep Program to Reduce Sudden Unexplained Infant Deaths.

A six-member interdisciplinary team comprising nurses, a physician, an occupational therapist, and a respiratory therapist developed a safe sleep program in an effort to identify and implement evidence-based safe sleep practices for infants in the NICU. The team examined the literature on sleep-related death and safe sleep practices, consulted with colleagues in NICUs at nearby hospitals and clinics, and conducted an audit of practices related to putting infants to sleep in the NICU. The initiative included the use of infant sleep sacks, the development of a clinical practice guideline to promote safe sleep, and the delivery of standardized discharge education for caregivers in the NICU and safe sleep classes for expectant mothers and caregivers in the community. The team educated NICU staff on the new practice guideline in November and December 2014, and implemented the clinical intervention in January 2015. Random unit audits showed that prior to implementation of the safe sleep program, NICU nurses had followed safe sleep practices only 20% of the time; after implementation, however, safe sleep practices were followed an average of about 90% of the time. In-hospital and community-oriented evidence-based teaching on safe sleep practices and environments was associated with no sleep-related infant deaths after discharge from our NICU in calendar year 2015. A multifaceted safe sleep program offers many benefits to both the NICU and its patients. The implementation of a standardized safe sleep program provides an enormous opportunity to improve the health and well-being of the community. All hospitals that care for mothers and infants should adopt a safe sleep program.

Análisis aleatorios de seguridad en tiempo real, una herramienta transformadora adaptada a los nuevos tiempos

Real-time random safety audits constitute a tool designed to transfer knowledge from the sources of scientific evidence to the patient bedside. It has proven useful in critically ill patients, improving safety in the process of critical patient care, turning unsafe situations into safe ones in daily practice, and ensuring adherence to scientific evidence. In parallel, the design and methodology involved affords process indicators that will make it possible to know how we provide care for our patients, evolution over time (with regular feedback for professionals), the impact of our interventions, and benchmarking.

Auditorías de seguridad en tiempo real en una unidad neonatal

BackgroundRandom audits are a safety tool to help in the prevention of adverse events, but they have not been widely used in hospitals. The aim of the study was to determine, through random safety audits, whether the information and material required for resuscitation were available for each patient in a neonatal intensive care unit and determine if factors related to the patient, time or location affect the implementation of the recommendations. Material and methods:Prospective observational study conducted in a level III-C neonatal intensive care unit during the year 2012. The evaluation of written information on the endotracheal tube, mask and ambu bag prepared of each patient and laryngoscopes of the emergency trolley were included within a broader audit of technological resources and study procedures. The technological resources and procedures were randomly selected twice a week for audit. Appropriate overall use was defined when all evaluated variables were correctly programmed in the same procedure. ResultsA total of 296 audits were performed. The kappa coefficient of inter-observer agreement was 0.93. The rate of appropriate overall use of written information and material required for resuscitation was 62.50% (185/296). Mask and ambu bag prepared for each patient was the variable with better compliance (97.3%, P=.001). Significant differences were found with improved usage during weekends versus working-day (73.97 vs. 58.74%, P=.01), and the rest of the year versus 3rd quarter (66.06 vs. 52%, P=.02). ConclusionsOnly in 62.5% of cases was the information and the material necessary to attend to a critical situation urgently easily available. Opportunities for improvement were identified through the audits.

I Know What You Did Last Cycle: Improving the Detection of State Campaign Finance Violations

This article investigates what state campaign finance regulatory agencies can do to increase perceptions among regulatees, specifically state legislators, that violations will be successfully detected. We test hypotheses that random audits and transparency-enhancing policies will promote perceptions that campaign finance violations are identified. With the use of an original survey of state legislators, we found that both strategies are effective. Agencies increase perceptions that they detect violations when their regulatees are subject to random audit. Additionally, agencies can bolster perceptions of third-party monitoring by increasing the information available to third-party monitors through transparent disclosure practices.

Tax Compliance Decision Analysis: Audit Strategy, Audit Rate, Perceived Probability of Audit, and Taxpayer Ethics

This study aims to provide empirical evidence that audit strategy, audit rate, perceived probability of audit and taxpayer ethics have impact on tax compliance. This Research employs the experimental laboratory method with multiple treatment design to refer behavioral change in tax compliance decision. 156 voluntary student participants were recruited from three major; accounting, management, and economics major. The participants grouped into random and fixed group adaptable with audit strategy treatment. Random selection is used to establish participant to each group. Audit rate treatment was classified in four audit level; uninformed audit rate, 10%, 20%, and finally 30%. Perceived probability of audit treatment; subjects determine the percentage of perceived audit. Furthermore taxpayer ethics treatment uses tax ethics film. The results provide empirical evidence that in the random group, strategy random audit, audit rate, perceived probability of audit and taxpayer ethics have significant relationship with tax compliance decision. Conversely, fixed group disprove that audit fixed strategy insignificantly with tax compliance decisions. Audit fixed strategy and audit rate have indirect relationship to tax compliance decision by perceived probability of audit. These results from both of group may suggest that taxpayers will increase the tax compliance decision when his possibility to be audited is high. Taxpayer ethics has significant impact on tax compliance decision at all audit level. Taxpayer ethics plays an important role of increased tax compliance decision. This study has implication for judgment theory to consider taxpayer ethics.

More Time for Science and Less Time for Administration?

That is the question posed, among other cognate issues, by the Alexander–Murray Bill introduced by the leadership of the Senate Health Committee. In the midst of a raucous political season that can only be characterized as highly unusual, to say the least, this bipartisan duo has remarkably and insightfully targeted an increasing problem for the scientific community, namely the never ending and expanding administrative burden of conducting scientific research in the United States. Between the demands from each NIH Institute, and the Divisions within individual institutes, and a researcher’s institution—often compounded by reports to both individual schools (eg, medicine or public health, and the university as a whole), individual entities within the university (eg, IRB, IACUC), not to mention, individual hospital systems (eg, Veterans Administration, university hospitals, community and county hospitals)—the labyrinthine nature of the requisite reporting is substantial. Add to these the frequent scheduled and random audits that require many hours of attention, and are often announced by frightening language that proclaim the power to shut down research programs for non-compliance, and one can begin to realize that this is far from an ideal situation in which the spirit of discovery can thrive. Both the bill’s sponsor and the authors of this commentary recognize, of course, the need for rigorous oversight of scientific research—the paramount importance of strictly abiding to the protection of human and laboratory animal subjects in research, the need to be transparent about potential conflicts of interest, and to be vigilant about scientific misconduct. This administrative burden not only weighs heavily on current funded investigators but serves as a negative influence on junior investigators who, witnessing the dwindling research time of their senior colleagues, coupled with the difficult funding climate, are too easily dissuaded from moving forward in an academic career. In addition, the cost burden falls upon taxpayers, who want their NIH to facilitate rapid-paced development of cures, but instead are seeing subtractions from what is available for research activities in the name of creating and maintaining new layers of oversight upon scientists.

Leading Organizational Change by Addressing the Need to Improve Accurate Blood Pressure Assessment of the Perinatal Patient Who is Obese

Obstetric Poster Presentation Purpose for the Program Obesity and hypertension create significant obstacles in caring for the perinatal patient. The convergence of these two health issues and initiatives surrounding them provided an opportunity to improve care for this population. In 2014, more than 1.9 billion adults who were 18 years and older were overweight worldwide. Of these, more than 600 million were obese. In Illinois there was a continued increase in obesity rates from 12.1% in 1990 to 29.4% in 2013. This trend was reflected in the Loyola Perinatal Center’s Obesity in the Perinatal Population Quality Improvement Project, where an audit indicated that 55% of the randomly selected charts identified women as obese. It was observed that in our unit, the wrong size cuff often was used in obtaining blood pressure reading. A second initiative, which was being developed by the Illinois Perinatal Quality Collaborative, focused on hypertension.

Continuing professional development of registered social workers in New Zealand

Continuing professional development (CPD) is a significant feature of contemporary practice in most professions. In New Zealand, the Social Workers Registration Board (SWRB) is empowered under legislation to set expectations for CPD. Initially NZ-registered social workers were expected to undertake 150 hours of CPD activities across a three-year period. A random audit undertaken in 2010 found that social workers were not planning their CPD activities in a purposeful way (Duke, 2012), and were struggling to meet the target and as a consequence the requirements were reduced. A content analysis of CPD logs was undertaken in order to provide a snapshot of CPD activities of 84 randomly selected registered social workers. Findings demonstrate that, while a broad range of activities were undertaken by social workers, there was only weak evidence for the enhancement of reflective practice. Engagement in scholarly activity and research was low among the randomly selected group.

Pathways to Citizen Accountability: Brazil’s Bolsa Família

This article examines the pathways – citizen-driven, bottom-up oversight or state-centred administrative controls – that have played the largest role in promoting the accountability of the Bolsa Família programme. The exploratory analysis draws on interviews with local and federal officials as well as beneficiaries of the Bolsa Família in order to identify the ways monitoring and accountability have evolved in practise and on the ground. Field research highlights that citizen- and community-driven participatory mechanisms for ongoing monitoring and accountability are relatively weak. Top-down administrative regulations, such as programmatic transparency and random audits, have largely worked to protect the integrity of the programme. The article concludes by discussing the opportunities for greater community-driven participatory oversight in the future.

What happens when a woman wins an election? Evidence from close races in Brazil

We analyze close elections between male and female mayoral candidates in Brazilian municipalities to provide novel evidence on the role of women as policymakers. Using an objective measure of corruption based on random government audits, we find that female mayors are less likely to engage in corruption compared to male mayors. We also find that female mayors hire fewer temporary public employees than male mayors during the electoral year and tend to attract less campaign contributions when running for reelection. Moreover, our results show that female mayors have a lower reelection probability than male mayors. We interpret our findings as suggesting that male incumbents are more likely to engage in strategic behavior and this improves their electoral performance. Other explanations receive less support from the data.

Regulatory performance of audit tournaments and compliance observability

This paper examines the effectiveness of traditional regulatory schemes and newly emerging social information schemes for achieving compliance. Our experiment focuses on two stochastic audit schemes for enforcing regulatory compliance. In the Random Audit mechanism firms are randomly chosen for inspection. In the Tournament Audit mechanism the probability of inspection increases with the degree of estimated underreporting. To study the effects of social information, the experiment varies the observability of identity, output, and compliance decisions. Optimal output is theoretically independent of the auditing scheme, but equilibrium reporting is higher under the Tournament mechanism than Random auditing. Experimental findings are broadly consistent with the theoretical predictions for reporting, but deviate modestly for output. In particular, we find that average output is lower and reporting is higher in the Tournament treatment compared to the Random Audit treatment. At the individual level, a majority of participants misreported in most periods. Social observability does not affect output or reporting significantly in either of the audit treatments.

Fraud Detection on Bulk Tax Data Using Business Intelligence Data Mining Tool: A Case of Zambia Revenue Authority

2 Abstract: Zambia Revenue Authority (ZRA) generates large volumes of data that need complex mechanisms in order to extract useful tax information. The purpose of the study was to develop a data mining model for detection of fraud on tax and taxpayer data for ZRA. This study focused on two areas. These were (1) the baseline study that helped to establish the extent of the challenges in fraud detection for the tax payers and (2) the automation and development of the fraud detection tool using the results from the baseline study. Our baseline study showed that the current methodologies, processes, architectures, and technologies that were being used to transform raw data into meaningful and useful information were tedious and time consuming. In order to detect fraud they depended on random audits, informants and under-cover operations. A model which implements outlier algorithms for fraud detection, Continuous Monitoring of Distance Based and Distance Based Outlier Queries was then developed. We used both algorithms to analyse the domestic tax payments to detect underpayments and overpayments according to business rules. Underpayments and overpayments are marked as outliers. Results generated by our tool showed improved accuracy and takes less time in order to detect under and over payments as outliers when compared to the older methods.

The Dynamic Effects of Audits: An Experimental Assessment

Governments and tax administrators around the world rely on the premise that both random and non-random audits will deter tax evasion. This paper is the first in the tax compliance literature to present experimental evidence collected from U.S. residents that this premise may be, at least in part, wrong. Counter-intuitively, I find that random audits encourage taxpayers to cheat more. Where audits were framed as being “random”, participants increased their levels of evasion in the tax periods immediately following the audit. This effect, however, did not plague audits that were framed for participants as being non-random. When a separate group of participants faced audits in which detected evasion could “flag” a participant for one or more future audits, participants cheated less in the periods immediately following the audit. Overall, average compliance in response to non-random audits systematically and significantly dominated average compliance in response to random audits. This result remained robust to the addition of a series of demographic controls as well as the inclusion of participant and time fixed effects. By revealing strong behavioral responses to the way tax audits are presented, this paper (1) opens important new avenues for experimental and controlled field trial research on audit dynamics, and (2) underscores the potential benefits to tax administrators of being more transparent with taxpayers about the nature of audit selection.

Predictive analytics and the targeting of audits

The literature on audit strategies has focused on random audits or on audits conditioned only on income declaration. In contrast, tax authorities employ the tools of predictive analytics to identify taxpayers for audit, with a range of variables used for conditioning. The paper explores the compliance and revenue consequences of the use of predictive analytics in an agent-based model that draws upon a behavioral approach to tax compliance. The taxpayers in the model form subjective beliefs about the probability of audit from social interaction, and are guided by a social custom that is developed from meeting other taxpayers. The belief and social custom feed into the occupational choice between employment and two forms of self-employment. It is shown that the use of predictive analytics yields a significant increase in revenue over a random audit strategy.

Smart pumps and random safety audits in a Neonatal Intensive Care Unit: a new challenge for patient safety.

BackgroundRandom safety audits (RSA) are a safety tool enabling prevention of adverse events, but they have not been widely used in hospitals. The aim of this study was to use RSAs to assess and compare the frequency of appropriate use of infusion pump safety systems in a Neonatal Intensive Care Unit (NICU) before and after quality improvement interventions and to analyse the intravenous medication programming data.MethodsProspective, observational study comparing the frequency of appropriate use of Alaris® CC smart pumps through RSAs over two periods, from 1 January to 31 December 2012 and from 1 November 2014 to 31 January 2015. Appropriate use was defined as all evaluated variables being correctly programmed into the same device. Between the two periods they were established interventions to improve the use of pumps. The information recorded at the pumps with the new security system, also extracted for one year.ResultsFifty-two measurements were collected during the first period and 160 measurements during the second period. The frequency of appropriate use was 73.13 % (117/160) in the second period versus 0 % (0/52) in the first period (p < 0.0001). Information was recorded on 44,924 infusions; in 46.03 % (20,680/44,924) of cases the drug name was recorded. In 2.5 % (532/20,680) of cases there was an attempt to exceed the absolute limit.ConclusionsRandom Safety Audits were a very useful tool for detecting inappropriate use of pumps in the NICU. The improvement strategies were effective for improving appropriate use and programming of the intravenous medication infusion pumps in our NICU.

The PLCO Cancer Screening Trial: Background, Goals, Organization, Operations, Results.

The randomized PLCO trial was designed to answer four primary questions: does screening for these cancers using often promoted tests reduce cancer-specific mortality? Nearly 155,000 men and women were allocated to screening or usual care arms in a 1:1 ratio under a centralized, secure randomization algorithm at ten competitively selected screening centers nationwide. Screened men received PSA blood tests and digital rectal examinations. Screened women received CA125 blood tests and trans-vaginal ultrasound. Both men and women in the screened arm received anterolateral view chest x-ray and 60 cm flexible sigmoidoscopy. Blood specimens were collected at each screening visit and buccal cell DNA was collected once from the usual care participants. Histology slides were collected for cancer cases. Participants completed a baseline questionnaire covering health and risk factors and a dietary questionnaire. Data collected on standardized machine-readable forms were scanned remotely at screening and laboratory sites utilizing PLCO dedicated, NCI provided and configured computer systems for quality checks, archiving, and analysis. Comprehensive quality assurance was implemented over recruitment, consenting, randomization, screening, data management, records keeping, patient-specific screening results reporting, follow-up, and data analysis. Performance and data quality were monitored on-site and remotely by data edits, site visits, and random record audits. Specially trained and certified professionals performed screening procedures and medical record abstracting. An independent committee of medical specialists reviewed and certified case-specific cause of death. Scientific leadership was provided by NCI Project Officers, PLCO principal investigators, external consultants, and an independent data and safety monitoring board.