A pilot study examining the impact of a pragmatic process for improving the cultural responsiveness of non-Aboriginal alcohol and other drug treatment services using routinely collected data in Australia.

Objective: Routine health data has the potential to identify changes in patient-related outcomes, in close to real time. This pilot project used routine data to explore and compare the impact of changes to cultural responsiveness on service use by Aboriginal and Torres Strait Islander (hereafter, Aboriginal) clients in Australia.Methods: The New South Wales Minimum Data Set (MDS) for alcohol and other drug use treatment services was provided for 11 services for a period of 30 months from March 2019 to September 2021 (four months prior to two years after the intervention; data were analysed between March 2022 to February 2023). Change in cultural responsiveness was assessed via practice audits of services at baseline and two years. The average change in audit rating was analysed using a linear mixed regression model. Generalised Linear Mixed Models were used to identify changes in service use by Aboriginal clients. Results: All 11 services showed increased audit scores at two years, with a statistically significant mean increase of 18.6 (out of 63 points; b = 18.32, 95% CI 12.42-24.22). No statistically significant pre-to post-changes were identified in: (1) the proportion of episodes delivered to Aboriginal versus non-Aboriginal clients (OR = 1.15, 95% CI = 0.94-1.40), (2) the number of episodes of care provided to Aboriginal clients per month (IRR = 1.01, 95% CI = 0.84-1.23), or (3) the proportion of episodes completed by Aboriginal clients (OR = 0.96, 95% CI = 0.82-1.13). Conclusions: The lack of statistically significant impact on service use outcomes using MDS contrasts to the improvements in cultural responsiveness, suggesting further work is needed to identify appropriate outcome measures. This may include patient-reported experience measures. This project showed that routine data has potential as an efficient method for measuring changes in patient-related outcomes in response to health services improvements.

The IAEA remote audit of small field dosimetry for testing the implementation of the TRS-483 code of practice.

BACKGROUND: The TRS­483, an IAEA/AAPM International Code of Practice on dosimetry of small static photon fields, underwent testing via an IAEA coordinated research project (CRP). Alongside small field output factors (OFs) measurements using active dosimeters by CRP participants, the IAEA Dosimetry Laboratory received a mandate to formulate a remote small field dosimetry audit method using its passive dosimetry systems. PURPOSE: This work aimed to develop a small field dosimetry audit methodology employing radiophotoluminescent dosimeters (RPLDs) and radiochromic films. The methodology was subsequently evaluated through a multicenter pilot study with CRP participants. METHODS: The developments included designing and manufacturing a dosimeter holder set and the characterization of an RPLD system for measurements in small photon fields using the new holder. The audit included verification of small field OFs and lateral beam profiles for small fields. At first, treatment planning system (TPS) calculated OFs were checked against a reference data set that was available for conventional linacs. Second, calculated OFs were verified through the RPLD measurement of point doses in a machine-specific reference field, 4 cm × 4 cm, 2 cm × 2 cm, and 1 cm × 1 cm, corresponding size circular fields or nearest achievable field sizes. Lastly, profile checks in in-plane and cross-plane directions were done for the two smallest fields by comparing film measurements with TPS calculations at 20%, 50%, and 80% isodose levels. RESULTS: RPLD correction factors for small field measurements were approximately unity. However, they influenced the dose determination's overall uncertainty in small fields, estimated at 2.30% (k = 1 level). Considering the previous experience in auditing reference beam output following the TRS-398 Code of Practice, the acceptance limit of 5% for the ratio of the dose determined by RPLD to the dose calculated by TPS, DRPLD/DTPS, was considered adequate. The multicenter pilot study included 15 participants from 14 countries (39 beams). Consistent with the previous findings, the results of the OF check against the reference data confirmed that TPSs tend to overestimate OFs for the smallest fields included in this exercise. All except three RPLD measurement results were within the acceptance limit, and the spread of results increased for smaller field sizes. The differences between the film measured and TPS calculated dose profiles were within 3 mm for most of the beams checked; deviated results revealed problems with TPS commissioning and calibration of the treatment unit collimation systems. CONCLUSION: The newly developed small field dosimetry audit methodology proved effective and successfully complemented the CRP OF measurements by participants with RPLD audit results.

The characteristics and risk factors of breast cancer patients trend distinctive regional differences: a cross-sectional study.

OBJECTIVE: To determine the characteristics and risk factors of breast cancer patients in a tertiary care setting. METHODS: The retrospective, cross-sectional study was conducted at the Sindh Institute of Urology and Transplantation, Karachi, and comprised data of all patients diagnosed with breast cancer from March 2017 to December 2021. Demographic characteristics, clinical presentation, stage of the disease and histopathological characteristics were noted. Data related to all the variables was not available in all cases. Data was analysed using SPSS 23. RESULTS: Of the 690 patients, 683(99%) were females and 7(1%) were males. The mean age at presentation was 49.3±13.5 years, while the mean duration of symptoms was 10.24±17.64) months. Most of the females were married 642(93%) and multiparous 484(70.9%), while 293(42.5%) had breastfed their children for >1 year, and 412(59.7%) had no history of contraception use. The most common stage at presentation was stage II (48.6%), and most patients had grade II 395(57.2%) invasive ductal carcinoma, with Luminal A molecular subtype noted in 287(41.6%) cases. CONCLUSIONS: The characteristics of breast cancer in the sample had certain distinctions compared to other populations. It is important to integrate all datasets and develop guidelines appropriate to Pakistani population.

Technical note: Radiological clinical equivalence for phantom materials in carbon ion therapy.

PURPOSE: As carbon ion radiotherapy increases in use, there are limited phantom materials for heterogeneous or anthropomorphic phantom measurements. This work characterized the radiological clinical equivalence of several phantom materials in a therapeutic carbon ion beam. METHODS: Eight materials were tested for radiological material-equivalence in a carbon ion beam. The materials were computed tomography (CT)-scanned to obtain Hounsfield unit (HU) values, then irradiated in a monoenergetic carbon ion beam to determine relative linear stopping power (RLSP). The corresponding HU and RLSP for each phantom material were compared to clinical carbon ion calibration curves. For absorbed dose comparison, ion chamber measurements were made in the center of a carbon ion spread-out Bragg peak (SOBP) in water and in the phantom material, evaluating whether the material perturbed the absorbed dose measurement beyond what was predicted by the HU-RLSP relationship. RESULTS: Polyethylene, solid water (Gammex and Sun Nuclear), Blue Water (Standard Imaging), and Techtron HPV had measured RLSP values that agreed within ±4.2% of RLSP values predicted by the clinical calibration curve. Measured RLSP for acrylic was 7.2% different from predicted. The agreement for balsa wood and cork varied between samples. Ion chamber measurements in the phantom materials were within 0.1% of ion chamber measurements in water for most materials (solid water, Blue Water, polyethylene, and acrylic), and within 1.9% for the rest of the materials (balsa wood, cork, and Techtron HPV). CONCLUSIONS: Several phantom materials (Blue Water, polyethylene, solid water [Gammex and Sun Nuclear], and Techtron HPV) are suitable for heterogeneous phantom measurements for carbon ion therapy. Low density materials should be carefully characterized due to inconsistencies between samples.

Scaling up search engine audits: Practical insights for algorithm auditing.

Algorithm audits have increased in recent years due to a growing need to independently assess the performance of automatically curated services that process, filter and rank the large and dynamic amount of information available on the Internet. Among several methodologies to perform such audits, virtual agents stand out because they offer the ability to perform systematic experiments, simulating human behaviour without the associated costs of recruiting participants. Motivated by the importance of research transparency and replicability of results, this article focuses on the challenges of such an approach. It provides methodological details, recommendations, lessons learned and limitations based on our experience of setting up experiments for eight search engines (including main, news, image and video sections) with hundreds of virtual agents placed in different regions. We demonstrate the successful performance of our research infrastructure across multiple data collections, with diverse experimental designs, and point to different changes and strategies that improve the quality of the method. We conclude that virtual agents are a promising venue for monitoring the performance of algorithms across long periods of time, and we hope that this article can serve as a basis for further research in this area.

OSLD nanoDot characterization for carbon radiotherapy dosimetry.

Objective. This study characterized optically-stimulated luminescent dosimeter (OSLD) nanoDots for use in a therapeutic carbon beam using the Imaging and Radiation Oncology Core (IROC) framework for remote output verification.Approach. The absorbed dose correction factors for OSLD (fading, linearity, beam quality, angularity, and depletion), as defined by AAPM TG 191, were characterized for carbon beams. For the various correction factors, the effect of linear energy transfer (LET) was examined by characterizing in both a low and high LET setting.Main results. Fading was not statistically different between reference photons and carbon, nor between low and high LET beams; thus, the standard IROC-defined exponential function could be used to characterize fading. Dose linearity was characterized with a linear fit; while low and high LET carbon linearity was different, these differences were small and could be rolled into the uncertainty budget if using a single linearity correction. A linear fit between beam quality and dose-averaged LET was determined. The OSLD response at various angles of incidence was not statistically different, thus a correction factor need not be applied. There was a difference in depletion between low and high LET irradiations in a primary carbon beam, but this difference was small over the standard five readings. The largest uncertainty associated with the use of OSLDs in carbon was because of thekQcorrection factor, with an uncertainty of 6.0%. The overall uncertainty budget was 6.3% for standard irradiation conditions.Significance. OSLD nanoDot response was characterized in a therapeutic carbon beam. The uncertainty was larger than for traditional photon applications. These findings enable the use of OSLDs for carbon absorbed dose measurements, but with less accuracy than conventional OSLD audit programs.

Causally estimating the effect of YouTube's recommender system using counterfactual bots.

In recent years, critics of online platforms have raised concerns about the ability of recommendation algorithms to amplify problematic content, with potentially radicalizing consequences. However, attempts to evaluate the effect of recommenders have suffered from a lack of appropriate counterfactuals-what a user would have viewed in the absence of algorithmic recommendations-and hence cannot disentangle the effects of the algorithm from a user's intentions. Here we propose a method that we call "counterfactual bots" to causally estimate the role of algorithmic recommendations on the consumption of highly partisan content on YouTube. By comparing bots that replicate real users' consumption patterns with "counterfactual" bots that follow rule-based trajectories, we show that, on average, relying exclusively on the YouTube recommender results in less partisan consumption, where the effect is most pronounced for heavy partisan consumers. Following a similar method, we also show that if partisan consumers switch to moderate content, YouTube's sidebar recommender "forgets" their partisan preference within roughly 30 videos regardless of their prior history, while homepage recommendations shift more gradually toward moderate content. Overall, our findings indicate that, at least since the algorithm changes that YouTube implemented in 2019, individual consumption patterns mostly reflect individual preferences, where algorithmic recommendations play, if anything, a moderating role.

Assessing the impact of real-time random safety audits through full propensity score matching on reliable data from the clinical information system.

BACKGROUND: Evidence-based care processes are not always applied at the bedside in critically ill patients. Numerous studies have assessed the impact of checklists and related strategies on the process of care and patient outcomes. We aimed to evaluate the effects of real-time random safety audits on process-of-care and outcome variables in critical care patients. METHODS: This prospective study used data from the clinical information system to evaluate the impact of real-time random safety audits targeting 32 safety measures in two intensive care units during a 9-month period. We compared endpoints between patients attended with safety audits and those not attended with safety audits. The primary endpoint was mortality, measured by Cox hazard regression after full propensity-score matching. Secondary endpoints were the impact on adherence to process-of-care measures and on quality indicators. RESULTS: We included 871 patients; 228 of these were attended in ≥ 1 real-time random safety audits. Safety audits were carried out on 390 patient-days; most improvements in the process of care were observed in safety measures related to mechanical ventilation, renal function and therapies, nutrition, and clinical information system. Although the group of patients attended in safety audits had more severe disease at ICU admission [APACHE II score 21 (16-27) vs. 20 (15-25), p = 0.023]; included a higher proportion of surgical patients [37.3 % vs. 26.4 %, p = 0.003] and a higher proportion of mechanically ventilated patients [72.8 % vs. 40.3 %, p < 0.001]; averaged more days on mechanical ventilation, central venous catheter, and urinary catheter; and had a longer ICU stay [12.5 (5.5-23.3) vs. 2.9 (1.7-5.9), p < 0.001], ICU mortality did not differ significantly between groups (19.3 % vs. 18.8 % in the group without safety rounds). After full propensity-score matching, Cox hazard regression analysis showed real-time random safety audits were associated with a lower risk of mortality throughout the ICU stay (HR 0.31; 95 %CI 0.20-0.47). CONCLUSIONS: Real-time random safety audits are associated with a reduction in the risk of ICU mortality. Exploiting data from the clinical information system is useful in assessing the impact of them on the care process, quality indicators, and mortality.

A Practical Guide to Clinical Studies in Veterinary Oncology.

This article explains the authors' experiences about opportunities, perspectives, and considerations required to initiate clinical studies in a veterinary oncology practice. These details include the infrastructure required for appropriate study training for all staff. Negotiation of scope of work and fees for service with study sponsors is also discussed. Finally, although generally similar, the article also describes management of clinical studies in academic and private practice settings.

Remote audit practice for inspection of structural and equipment standards for cell processing facilities under the act on the safety of regenerative medicine in Japan.

Introduction: The Act on the Safety of Regenerative Medicine enforced in Japan in 2014, regulates the manufacture of cellular processed products. However, with regards to the manufacturing facilities at medical institutions, only the submission of necessary documents is required for a license, and the need for third-party inspection has been highlighted. Remote activities are becoming more prominent with the spread of the Severe Acute Respiratory Syndrome Coronavirus 2 infection; therefore, the current assessment of compliance with structural facility standards was conducted remotely. Methods: The entire process, including start-up meetings, preparation of the survey schedule, submission and review of preliminary materials, audits, and reporting of results, was conducted via e-mail and web conferencing systems. The survey was conducted remotely, to minimize the risk of contamination of the cell processing facility (CPF) and reduce the burden on surveyors, while contributing to the establishment of suitable structural facilities by identifying and highlighting the areas or items that were considered to be non-compliant with the regulations. The series of audits were completed in ten weeks, with a period of six weeks between the start-up meeting and the audit implementation. The audit was completed in approximately 3 h on the day of the inspection. Results: The audit results were delivered in the report, with four items requiring improvement and several other recommended items listed as non-conformities. Conclusions: We believe that this remote method allows the effective inspection of regenerative medicine manufacturing facilities and assessment of more cell culture processing facilities than the current in-person audit method, with limited human resources.

Upcoding in medicare: where does it matter most?

Upcoding in Medicare has been a topic of interest to economists and policy makers for nearly 40 years. While upcoding is generally understood as "billing for services at higher level of complexity than the service actually pro- vided or documented," it has a wide range of definitions within the literature. This is largely because the financial incentives across programs and aspects under the coding control of billing specialists and providers are different, and have evolved substantially over time, as has the published literature. Arguably, the primary importance of analyzing upcoding in different parts of Medicare is to inform policy makers on the magnitude of the process and to suggest approaches to mitigate the level of upcoding. Financial estimates for upcoding in traditional Medicare (Medicare Parts A and B), are highly variable, in part reflecting differences in methodology for each of the services covered. To resolve this variability, we used summaries of audit data from the Comprehensive Error Rate Testing program for the period 2010-2019. This program uses the same methodology across all forms of service in Medicare Parts A and B, allowing direct comparisons of upcoding magnitude. On average, upcoding for hospitalization under Part A represents $656 million annually (or 0.53% of total Part A annual expenditures) during our sample period, while up- coding for physician services under Part B is $2.38 billion annually (or 2.43% of Part B annual expenditures). These numbers compare to the recent consistent estimates from multiple different entities putting upcoding in Medicare Part C at $10-15 billion annually (or approximately 2.8-4.2% of Part C annual expenditures). Upcoding for hospitalization under Medicare Part A is small, relative to overall upcoding expenditures.

Descriptive analysis of the most common types of food safety infractions at ready-to-eat meat processing plants in Ontario, Canada.

Food safety inspections of meat processing plants and abattoirs that process ready-to-eat (RTE) meats have identified a lack of compliance with good manufacturing practices. This study was undertaken to identify common food safety infractions in the RTE meat processing sector in Ontario through an analysis of historical audit records. A total of 376,457 audit item results were evaluated across 912 unique audits of 204 different RTE meat plants. A nearly two-thirds overall item pass rate (64.4%; n = 242,478) was identified. Across all other risk categories, the highest rates of infractions were observed in the "maintenance of premises, equipment and utensils" (56.7%; n = 750). The overall item pass rate was higher in free-standing meat processing plants than abattoirs, while pass rates gradually decreased across the study period. The results of this study have identified key areas for improvement in future inspection, audit and outreach with RTE meat processing plants.

Donor audits in deceased organ donation: a scoping review.

PURPOSE: We sought to collate and summarize existing literature on donor audits (DA) and how they have been used to guide deceased organ donation and transplantation system performance and quality assurance. SOURCE: We searched MEDLINE, Cumulative Index of Nursing and Allied Health Literature, and Web of Science supplemented by Google to identify grey literature on 6 May 2022, to locate studies in English, French, and Spanish. The data were screened, extracted, and analyzed independently by two reviewers. We grouped the results into five categories: 1) motivation for DA, 2) DA methodology, 3) potential and actual donors, 4) missed donation opportunities, and 5) quality improvement. PRINCIPAL FINDINGS: The search yielded 2,416 unique publications and 52 were included in this review. Most studies were from the UK (n = 13) and published between 2001 and 2006 (n = 15). The methodologies described for DA were diverse. Our findings showed that the primary motivation for conducting DA was to identify potential donors and the number of potential deceased organ donors is significantly higher than the number of actual donors. Among retrieved studies, the proportion of donation opportunities following neurologic determination of death was 95/222 (43%) compared with 25/181 (14%) for donation after cardiocirculatory death (DCD), suggesting that the missed donation rate is higher for DCD. CONCLUSION: Donor audits help identify missed donation opportunities along the deceased donation pathway and can help support the evaluation of quality improvement initiatives.

RéSUMé: OBJECTIF: Nous avons cherché à colliger et résumer la documentation existante sur les vérifications des donneuses et donneurs (VD) et la façon dont elles ont été utilisées pour guider la performance et l'assurance de la qualité des systèmes de don et de transplantation d'organes de personnes décédées. SOURCES: Le 6 mai 2022, nous avons effectué des recherches dans MEDLINE, CINAHL et Web of Science, complétées par des recherches sur Google afin d'identifier la littérature grise et de localiser les études en anglais, en français et en espagnol. Les données ont été examinées, extraites et analysées de manière indépendants par deux personnes. Nous avons regroupé les résultats en cinq catégories : 1) motivation pour la VD, 2) méthodologie de la VD, 3) donneurs et donneuses potentiel·les et réel·les, 4) occasions de dons manquées, et 5) amélioration de la qualité. CONSTATATIONS PRINCIPALES: Notre recherche nous a permis de découvrir 2416 publications uniques et 52 ont été incluses dans cette revue. La plupart des études provenaient du Royaume-Uni (n = 13) et avaient été publiées entre 2001 et 2006 (n = 15). Les méthodologies décrites pour la vérification des donneuses et donneurs étaient diverses. Nos résultats ont montré que la principale motivation pour mener une VD était d'identifier des donneurs et donneuses potentiel·les et que le nombre potentiel de donneuses et donneurs d'organes après le décès était significativement plus élevé que le nombre réel. Parmi les études retenues, la proportion d'occasions de dons après un diagnostic de décès neurologique était de 95/222 (43 %), comparativement à 25/181 (14 %) pour le don après un décès cardiocirculatoire (DDC), ce qui suggère que le taux de dons manqués est plus élevé pour le DDC. CONCLUSION: Les vérifications des donneuses et donneurs aident à identifier les occasions de dons manquées le long du parcours de don après un décès et peuvent aider à soutenir l'évaluation des initiatives d'amélioration de la qualité.

Three-phase generalized raking and multiple imputation estimators to address error-prone data.

Validation studies are often used to obtain more reliable information in settings with error-prone data. Validated data on a subsample of subjects can be used together with error-prone data on all subjects to improve estimation. In practice, more than one round of data validation may be required, and direct application of standard approaches for combining validation data into analyses may lead to inefficient estimators since the information available from intermediate validation steps is only partially considered or even completely ignored. In this paper, we present two novel extensions of multiple imputation and generalized raking estimators that make full use of all available data. We show through simulations that incorporating information from intermediate steps can lead to substantial gains in efficiency. This work is motivated by and illustrated in a study of contraceptive effectiveness among 83 671 women living with HIV, whose data were originally extracted from electronic medical records, of whom 4732 had their charts reviewed, and a subsequent 1210 also had a telephone interview to validate key study variables.

Auditorías: su impacto en los costos de evaluación del proceso innovación en la universidad médica de Matanzas

Introducción: Medir el desempeño de las actividades científicas y de innovación a través de las auditorías, obedece a la escasa disponibilidad de recursos y a la consecuente necesidad de concursar por ellos. Objetivo: Evaluar el impacto de las auditorias de calidad y académicas sobre los costos de evaluación en el proceso Gestión de la Innovación en la Universidad de Ciencias Médicas de Matanzas. Materiales y métodos: Se realizó una investigación científica, explicativa, que se fundamenta en el paradigma mixto, donde se aplicó el procedimiento para el cálculo de los costos de la calidad. Resultados: Se observó una disminución en los costos de prevención, de un 53 % a un 50 %. No así en los costos de evaluación, donde ascendieron de un 15 % a 31 %, por concepto de gastos incurridos en los procesos de auditorías. Conclusiones: El empleo de las auditorias académicas y de calidad como herramientas de control induce a un incremento en los costos de evaluación de la calidad, lo que favorece una mayor eficiencia en los resultados del proceso de gestión de la innovación de la Universidad de Ciencias Médicas de Matanzas.

Introduction: Measuring the performance of scientific and innovation activities through audits, is due to the limited availability of resources and the consequent need to compete for them. Objective: To assess the impact of quality and academic audits on evaluation costs in the Innovation Management process at the Matanzas University of Medical Sciences. Materials and methods: A scientific, explanatory investigation was carried out, based on the mixed paradigm, where the procedure for the calculation of quality costs was applied. Results: A decrease in prevention costs was observed, from 53% to 50%. Not so in the evaluation costs where they rose from 15% to 31% due to expenses incurred in the audit processes. Conclusions: The use of academic and quality audits as control tools induces an increase in the costs of quality evaluation, which favors greater efficiency in the results of the innovation management process of the Matanzas University of Medical Sciences.

Leading officials' audits of natural-resource assets and local environmental attention: evidence of word frequency analysis from Chinese local government work reports.

Drawing on the textual contents of the Chinese local government work reports, this paper focuses on the impact of leading officials' audits of natural-resource assets on the local environmental attention allocation. The study has found that during the pilot period of audits, compared with the non-pilot cities, the local government in the pilot cities has concentrated more on the ecological environment field and has placed greater emphasis on the actual environmental governance. The results of mechanism analysis show that differences in the personal and take-office characteristics of local officials, may lead to different promotion pressure and performance evaluation modes, and then have a different impact on local environmental attention. The test results of consequence analysis show that the environmental attention in the pilot cities can be further transformed into environmental administrative and financial governance behavior. The paper discusses the policy effect and internal mechanism of leading officials' audits of natural-resource assets from the perspective of local governments' environmental attention, providing empirical evidence for China to carry out the top-level design of environmental policy based on the idea of optimizing officials' performance evaluation mechanism.

Lessons learned from over a decade of data audits in international observational HIV cohorts in Latin America and East Africa.

Introduction: Routine patient care data are increasingly used for biomedical research, but such "secondary use" data have known limitations, including their quality. When leveraging routine care data for observational research, developing audit protocols that can maximize informational return and minimize costs is paramount. Methods: For more than a decade, the Latin America and East Africa regions of the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium have been auditing the observational data drawn from participating human immunodeficiency virus clinics. Since our earliest audits, where external auditors used paper forms to record audit findings from paper medical records, we have streamlined our protocols to obtain more efficient and informative audits that keep up with advancing technology while reducing travel obligations and associated costs. Results: We present five key lessons learned from conducting data audits of secondary-use data from resource-limited settings for more than 10 years and share eight recommendations for other consortia looking to implement data quality initiatives. Conclusion: After completing multiple audit cycles in both the Latin America and East Africa regions of the IeDEA consortium, we have established a rich reference for data quality in our cohorts, as well as large, audited analytical datasets that can be used to answer important clinical questions with confidence. By sharing our audit processes and how they have been adapted over time, we hope that others can develop protocols informed by our lessons learned from more than a decade of experience in these large, diverse cohorts.

audit_cc: A Stata command for the analysis of matched case-control audits of cervical cancer screening.

Background and objectives: Cervical screening programmes are crucial for the early diagnosis and prevention of cancer of the cervix. Regular auditing is vital for ensuring that these programmes achieve their full potential and meet their objectives in practice. Unfortunately, the time and skills required for the statistical analysis of the data collected are often important limiting factors. Comparisons across countries and over time have also been particularly difficult due to a lack of standardized definitions and methodology. We aimed to overcome these problems. Methods: Using the statistical software Stata, we developed a new command called audit_cc for the analysis of matched case-control audits of cervical cancer screening. Analyses are reported for two measures of screening history: time since last test and time since last negative test. Results: The command carries out the data manipulation which is required for the analysis and allows to save the resulting data set in an external file for further investigations. It promotes consistent evaluations of screening programmes over time and across studies and facilitates the creation of automatic publication-quality reports, which are especially useful in the context of routine audits. Conclusions: audit_cc is a valid tool that not only simplifies the analysis and reporting of cervical screening audits but also allows meaningful international comparisons. Although it is specific for cervical cancer, it can be seen as an example of how the standardisation of exposure definitions and key methodological issues can enable consistent and comparable evaluations of screening programmes across different countries and settings.

Good clinical practices in the bioanalytical laboratory.

Despite the existence of good clinical practice guidelines, the way in which they are applied to the bioanalytical laboratory remains unclear. Aspects of patient confidentiality, informed consent and subject withdrawal; addressing unblinding associated with sample analysis, including repeat analysis and incurred sample reanalysis; or the differences in responsibilities between the sponsor and contract research organization are not articulated by the US FDA within the bioanalytical setting, and for most bioanalytical laboratories this remains a gap in their standard operating procedures. The aim of this article is to identify and clarify the aspects of the good clinical practices that are applicable to the bioanalytical laboratory when conducting bioanalysis with clinical samples, and to address potential gaps in the bioanalytical laboratory when it comes to clinical sample bioanalysis.

Monitoring biosecurity in poultry production: an overview of databases reporting biosecurity compliance from seven European countries.

Compliance with required on-farm biosecurity practices reduces the risk of contamination and spread of zoonotic and economically important diseases. With repeating avian influenza epidemics in the poultry industry, the need to monitor and improve the overall level of biosecurity is increasing. In practice, biosecurity compliance is assessed by various actors (e.g., academic, private and public institutions), and the results of such assessments may be recorded and gathered in databases which are seldom shared or thoroughly analyzed. This study aimed to provide an inventory of databases related to the assessment of biosecurity in poultry farms in seven major poultry-producing European countries to highlight challenges and opportunities associated with biosecurity data collection, sharing, and use. The institutions in charge of these databases were contacted and interviewed using a structured questionnaire to gather information on the main characteristics of the databases and the context of their implementation. A total of 20 databases were identified, covering the gamut of poultry species and production types. Most databases were linked to veterinary health authorities or academia, and to a lesser extent interbranch organizations. Depending on the institutions in charge, the databases serve various purposes, from providing advice to enforcing regulations. The quality of the biosecurity data collected is believed to be quite reliable, as biosecurity is mostly assessed by trained farm advisors or official veterinarians and during a farm visit. Some of the databases are difficult to analyze and/or do not offer information concerning which biosecurity measures are most or least respected. Moreover, some key biosecurity practices are sometimes absent from certain databases. Although the databases serve a variety of purposes and cover different production types, each with specific biosecurity features, their analysis should help to improve the surveillance of biosecurity in the poultry sector and provide evidence on the benefits of biosecurity.