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There is a rich literature on students' and teachers' intuitions and misconceptions about probability. However, less attention has been paid to the development of pre-service teachers' probabilistic thinking in teacher education. Based on this, the second author developed a lesson sequence for teaching probability. In particular, it demonstrates how a game context can be used to explore the relationship between experimental and theoretical probabilities in a collaborative learning setting. The lesson sequence integrates concepts and processes related to probability and is grounded in socio-cultural theory. We trialed the sequence with secondary pre-service teachers. This paper focuses on their understanding of the probability concepts embedded in the sequence. Video and audio data indicates that while teachers used a range of strategies and data displays to explain the ideas integrated in the lessons, some reverted to equiprobability bias. The findings also reveal that pre-service teachers can modify their thinking when engaged in rich teaching and learning tasks.

With online learning becoming a more viable option for teachers to develop their expertise, our report shares one such effort focused on improving the teaching of statistics. We share design principles and learning opportunities in an online course developed specifically to serve as a widescale online professional development opportunity for educators, thus deemed as a massive open online course for educators (MOOC-Ed). In this report we focus on a subset of 412 participants who identified themselves as classroom teachers. We use multiple data sources, quantitative and qualitative, to characterize changes in teachers' beliefs and perspectives about statistics and identify triggers in the course that appear to influence teachers' sense making about issues related to teaching statistics. Implications about specific course experiences that served as triggers for critical reflection and change are discussed.

This paper focuses on the use of home languages as a resource for Pasifika students who are learning about statistical methods. It is acknowledged that there are connections between language use and mathematics in mathematics learning and teaching, and the potential challenges this issue can pose have been investigated by researchers. Yet how the challenges of the use of home language versus teaching language might be overcome in statistics classrooms, where language is even more important as a medium of instruction, has received very little scrutiny. This article reports on research carried out in three New Zealand largely Pasifika dominated Year-12 classes. Data was collected from audio recordings of student group discussions and teacher reflections while students were carrying out an investigation of existing datasets. Findings from the teacher reflection aspect of the study indicate that teachers can struggle with how to use home language and real-life contexts to maximise learning in their classroom. Some strategies to incorporate students home language in their learning worked better than others. However, more in-depth research is needed to explore language issues and the barriers they might present in statistics education.

Preparing students to be critical thinkers and effective communicators is essential in today's multinational and technologically sophisticated environment. New electronic technologies provide opportunities for creating learning environments that extend the possibilities of "old" but still essential technologies: books, blackboards, and linear, one-way communication media. Such technologies contribute to engagement and meaningful learning in the higher education sector. Greater understanding in educational psychology and the effectiveness of educational interventions has motivated the development of various student-centred pedagogies (e.g. Problem-Based Learning [PBL]) addressing perceived shortcomings of traditional didactic instruction. PBL as a pedagogy promotes meaningful learning due largely to its power to stimulate critical, reflective and creative thinking. Can teaching staff, then, adopt technology-based approaches to create multi-disciplinary interactive PBL environments that enhance learning and excite students, inspiring them to take ownership of their own education? This paper presents a cross-case analysis of four cases that explore how classroom-based learning activities have been transferred to online formats in universities to improve critical thinking, problem-solving skills, and other learning attributes across a range of disciplines.

This paper examines the pedagogical and organisational changes three lead teachers made to their statistics teaching and learning programs. The lead teachers posed the research question: What would the effect of contextually integrating statistical investigations and literacies into other curriculum areas be on student achievement? By finding the significance of statistics nested within mathematics and other curriculum learning areas, the teachers increased their own value of statistical content and contexts and this impacted positively on the statistical achievement outcomes of their students. (Contains 6 tables and 2 figures.)

This paper describes a qualitative survey of professional statisticians carried out in New Zealand in 2014. The aim of the study was to find out if the issues this group faced were consistent with those identified in the literature. The issues identified were integrity, legitimacy, isolation, workforce shortage, communication, and marginalisation. They represent points of frustration for statisticians that may impact on the future of the profession as it responds to increasing demands and higher expectations. We found that these issues resonated for many of the statisticians included in our study and we have discussed a number of strategies to address them. They include raising our profile, attracting a broader range of people to the profession, increasing our communication skills, raising the statistical literacy of the people we work with, and a commitment to making it easy to engage with our colleagues.

In this paper, we report on the results of a series of e-mail interviews with statistics educators around the world, focusing on their views of the nature of teaching statistics as a "service" subject. What do they think are the important aspects of statistics to focus on in such servicing teaching? What do they think are the characteristics of good teachers? And how do they go about developing themselves as statistics teachers? We analyse their responses to these and other questions using a phenomenographic approach to identify an outcome space for their conceptions of teaching service statistics. We examine the centralities and tensions that emerged from their responses and discuss the implications--insights on agency and reflective practice. The study contributes to a research framework for understanding the nature of pedagogical awareness in contexts beyond the setting for this study and aims to stimulate discussion about teaching service courses.

Statistical literacy is complex and multifaceted. In every country, education and numeracy are a function of a multitude of factors including culture, history, and societal norms. Nevertheless, since the launch of the International Statistical Poster Competition (ISLP) in 1994, a number of patterns have emerged to suggest there are some common or universal success factors in running statistical literacy competitions involving schools, universities, statistical offices, and many other institutions. This paper outlines some of those factors, such as institutional cooperation, celebrating participation and success, improvement of statistical literacy in the local schools, support for teachers, the involvement of national statistics institutes, and use of technology. These factors have been identified from our own experience running the competition and from articles submitted to the ISLP newsletters. Statistical literacy is a complex phenomenon, and so this is neither an exhaustive list of key factors nor a formula for success, but rather an overview of recurring themes across countries participating in the competition around the world.

Statistical information pervades everyday life in the twenty-first century. Research shows, however, that the skills needed to be able to understand and critically evaluate statistical information must be specifically taught. In 2013, an externally assessed National Certificate in Educational Achievement standard in statistical literacy was introduced for the first time in New Zealand. A small exploratory study investigated a possible teaching approach designed to enable Year- 13 students (aged 17-18) to critically evaluate media reports. Findings suggest that the learning trajectory required several key components including media reports as both a motivational and conceptual development tool. In addition, computer visualizations and procedural scaffolds appeared valuable tools for facilitating conceptual understanding of the margin of error.

This article reports an analysis of the relationship between women's increased participation in higher education and other recent social changes over the last four decades. To date, women's increased involvement in higher education has been studied as either a force for or a consequence of other sociocultural changes. Drawing on data from key international data sets and with a focus on a range of Organisation for Economic Co-Operation and Development (OECD) countries, this article details an exploratory factor analysis of women's higher education participation and a range of other variables identified as indicators of or mediators for social change. This analysis reveals the existence of four underlying factors showing the structural interrelationship between the variables.

There exists considerable and rich literature on students' misconceptions about probability; less attention has been paid to the development of students' probabilistic thinking in the classroom. Grounded in an analysis of the literature, this article offers a lesson sequence for developing students' probabilistic understanding. In particular, a context familiar to teachers--exploring compound events that occur in a game of chance--is presented, and it is demonstrated how the context can be used to explore the relationship between experimental and theoretical probabilities in a classroom setting. The approach integrates both the content and the language of probability and is grounded in socio-cultural theory.

Because new learning technologies are enabling students to build and explore probability models, we believe that there is a need to determine the big enduring ideas that underpin probabilistic thinking and modeling. By uncovering the elements of the thinking modes of expert users of probability models we aim to provide a base for the setting of new and more relevant goals for probability education in the 21st century. We interviewed seven practitioners, whose professional lives are centered on probability modeling over a diverse range of fields including the development of probability theory. A thematic analysis approach produced four frameworks: (1) probability modeling approaches; (2) probabilistic thinking approaches to a problem; (3) a probability modeling cycle; and (4) core building blocks for probabilistic thinking and modeling. The main finding was that seeing structure and applying structure were important aspects of probability modeling. The implications of our findings for probability education are discussed.

For many years, students have been taught to visualise data by drawing graphs. Recently, there has been a growing trend to teach statistics, particularly statistical concepts, using interactive and dynamic visualisation tools. Free down-loadable teaching and simulation software designed specifically for schools, and more general data visualisation tools are increasingly being used in New Zealand classrooms. This paper discusses four examples: the use of GenStat for Teaching and Learning Schools and Undergraduate (GTL); Auckland University's iNZight and VIT (Visual Inference Tools) for teaching bootstrapping and randomisation; the CAST e-books, and the use of data visualisation tools to assist learning concepts in official statistics. All these tools are publically available and several are already being used internationally.

Many adults who need an understanding of statistical concepts have limited mathematical skills. They need a teaching approach that includes as little mathematical context as possible. Iterative participatory qualitative research (action research) was used to develop a statistical literacy course for adult learners informed by teaching in traditional first year university courses, workplace based training, teacher workshops and Masters of Public Policy courses. The latter learners in particular regularly come across confidence intervals and statistical significance in their everyday reading. The goal is to give them a conceptual rather than theoretical understanding of inferential concepts by developing inferential statistics logic through the introduction of exact probabilities in simple non-parametric tests (two-tailed coin tossing) and then contingency tables and parametric situations. The final course developed for the New Zealand Certificate of Official Statistics uses "hands-on" examples to reinforce concepts before proceeding to computer simulations. It emphasizes evaluation of the strength of statistical significance and its relationship to the possible cost of making an incorrect decision. Case studies that have influenced government policy reinforce inferential concepts and demonstrate the importance of statistics in complex real problems.

Over the past few decades there has been a large amount of research dedicated to the teaching of statistics. The impact of this research has started to change course content and structure, in both introductory and advanced courses for statisticians and those from other disciplines. In the light of these changes future directions in the teaching and learning of statistics must take into account new innovative pedagogical instructions, educational technologies and the abundance of Web resources that are now available. This article examines different aspects of currently identified challenges in the teaching and learning of statistics and gives an overview of useful strategies and innovations for developing research-based statistics courses in the context of recommendations for reforms, outlining the place of information technology within this framework. The article presents a review of the literature on the topic of statistics education and gives instructors a set of guidelines for generating new and effective teaching material. The summarised recommendations incorporate many innovations employed in a variety of successful statistics classes today. The review is complemented by a collection of statistics related online resources currently available on the Web. (Contains 3 tables.)

Computer simulations and animations for developing statistical concepts are often not understood by beginners. Hands-on physical simulations that morph into computer simulations are teaching approaches that can build students' concepts. In this paper we review the literature on visual and verbal cognitive processing and on the efficacy of animations in promoting learning. We describe an instructional sequence, from hands-on to animations, developed for 14 year-old students. The instruction focused on developing students' understanding of sampling variability and using samples to make inferences about populations. The learning trajectory from hands-on to animations is analyzed from the perspective of multimedia learning theories while the learning outcomes of about 100 students are explored, including images and reasoning processes used when comparing two box plots. The findings suggest that carefully designed learning trajectories can stimulate students to gain access to inferential concepts and reasoning processes. The role of verbal, visual, and sensory cues in developing students' reasoning is discussed and important questions for further research on these elements are identified. (Contains 12 figures and 1 table.)

This study seeks to describe the subject matter knowledge needed for teaching statistical association at the secondary level. Taking a practice-based qualitative approach, three experienced teachers were observed as they taught statistical association and interviewed immediately following each observation. Records of practice were assembled to create a compilation document to recreate each of the fifty observed class sessions along with related materials including textbook pages and student work. Analysis of the compilation documents focused on the demands upon teachers' subject matter knowledge involved in the practice of teaching. Findings regarding the knowledge required for teaching correlation coefficient are highlighted, including its computation, interpretation, sensitivity, estimation, and related terminology. (Contains 3 tables and 1 figure.)

Drawing conclusions from the comparison of datasets using informal statistical inference is a challenging task since the nature and type of reasoning expected is not fully understood. In this paper a secondary teacher's reasoning from the comparison of box plot distributions during the teaching of a Year 11 (15-year-old) class is analyzed. From the analysis a model incorporating ten distinguishable elements is established to describe her reasoning. The model highlights that reasoning in the sampling and referent elements is ill formed. The methods of instruction, and the difficulties and richness of verbalizing from the comparison of box plot distributions are discussed. Implications for research and educational practice are drawn. (Contains 3 figures.)

A postal survey was conducted regarding statistical techniques, research methods and software used in the workplace by 913 graduates with PhD and Masters degrees in the biological sciences, psychology, business, economics, and statistics. The study identified gaps between topics and techniques learned at university and those used in the workplace, and points to deficiencies in statistical preparation for employment. Courses requested include multivariate statistics, generalized linear models, research design and power analysis taught with minimal emphasis on probability and mathematics. Recommendations are presented, such as expanding statistical service courses to eliminate gaps, the development of intensive workshops for postgraduate students and for workplace retraining, or involving staff from other departments to provide context for statistics teaching. (Contains 7 tables.)

Evaluating the statistical process is considered a higher order skill and has received little emphasis in instruction. This study analyses thirty 15-year-old students' responses to two statistics assessment tasks, which required evaluation of a statistical investigation. The SOLO taxonomy is used as a framework to develop a hierarchy of responses. Focusing on the quality of response allowed insight into and suggestions for how instruction might be improved. The implications for teaching, assessment, and the curriculum are discussed. (Contains 3 tables and 2 figures.)

Objective: To compare clinical outcomes between patients for whom their participation in inpatient rehabilitation was and was not impacted by dementia through matching patients reporting dementia (dementia group) with those not reporting dementia (non‐dementia group). Methods: Prospectively collected data held by the Australasian Rehabilitation Outcome Centre (AROC) were analyzed for patients aged 65 years or older receiving inpatient rehabilitation in public hospitals in Australia following a hip fracture and discharged between July 1, 2014, and June 30, 2019. Patients reported as having dementia impacting their rehabilitation program were matched to patients not reporting dementia based on age, admission motor Functional Independence Measure (FIM) score, and accommodation prior to rehabilitation. The matched cohorts were compared in relation to clinical outcomes (motor and cognitive FIM improvement, FIM efficiency, length of stay, and discharge destination) following participation in hospital‐based rehabilitation using univariate analysis. Results: Patients with dementia had significantly lower cognitive FIM scores on commencing rehabilitation (17.6 and 26.9, respectively, P < 0.001) and their median length of stay was 2 days shorter than those without dementia (21 and 23 days, respectively, P < 0.001). Relative change in FIM score and FIM efficiency (per week) were lower in the dementia group [relative FIM score change of dementia vs non‐dementia, respectively, 26.2% vs. 44.0% (P < 0.001) and FIM efficiency, 6.5 vs. 8.9 (P < 0.001)]. Discharge destination between the two groups was statistically different, with 35.7% of patients with dementia being discharged to residential aged care facilities (RACFs) compared to 21.7% of those without dementia (P < 0.001). More patients with dementia had carers in their private residence in the post‐rehabilitation phase, 82.2% vs. 57.6% (P < 0.001). Conclusion: Patients with dementia who sustain a fractured hip benefit from inpatient rehabilitation, although their clinical outcomes are not as good as those without dementia. FIM change and FIM efficiency were lower in the dementia group. Length of stay in the hospital for patients with dementia was shorter due to earlier recognition for the need for placement in either an RACF or at home with carer support. The need for placement in an RACF or carer support in a private residence was significantly greater in the dementia group. [ABSTRACT FROM AUTHOR]

Background: Cardiometabolic disease (CMD) risk often begins early in life. Healthy lifestyle behaviors can mitigate risk, but the optimal combination of behaviors has not been determined. This cross-sectional study simultaneously examined the associations between lifestyle factors (fitness, activity behaviors, and dietary patterns) and CMD risk in preadolescent children. Methods: 1480 New Zealand children aged 8–10 years were recruited. Participants included 316 preadolescents (50% female, age: 9.5 ± 1.1 years, BMI: 17.9 ± 3.3 kg/m2). Fitness (cardiorespiratory fitness [CRF], muscular fitness), activity behaviors (physical activity, sedentary, sleep), and dietary patterns were measured. Factor analysis was used to derive a CMD risk score from 13 variables (adiposity, peripheral and central hemodynamics, glycemic control, and blood lipids). Results: Only CRF (β = −0.45, p < 0.001) and sedentary time (β = 0.12, p = 0.019) were associated with the CMD risk score in the adjusted multivariable analysis. CRF was found to be nonlinear (VO2 max ≤ ≈42 mL/kg/min associated with higher CMD risk score), and thus a CRF polynomial term was added, which was also associated (β = 0.19, p < 0.001) with the CMD risk score. Significant associations were not found with sleep or dietary variables. Conclusion: The findings indicate that increasing CRF and decreasing sedentary behavior may be important public health targets in preadolescent children. [ABSTRACT FROM AUTHOR]

Breast cancer is the most commonly diagnosed cancer worldwide, and its burden has been rising over the past decades. In this article, we examine and describe the global burden of breast cancer in 2020 and predictions for the year 2040. Estimates of new female breast cancer cases and deaths in 2020 were abstracted from the GLOBOCAN database. Age-standardized incidence and mortality rates were calculated per 100,000 females by country, world region, and level of human development. Predicted cases and deaths were computed based on global demographic projections for the year 2040. Over 2.3 million new cases and 685,000 deaths from breast cancer occurred in 2020. Large geographic variation across countries and world regions exists, with incidence rates ranging from <40 per 100,000 females in some Asian and African countries, to over 80 per 100,000 in Australia/New Zealand, Northern America, and parts of Europe. Smaller geographical variation was observed for mortality; however, transitioning countries continue to carry a disproportionate share of breast cancer deaths relative to transitioned countries. By 2040, the burden from breast cancer is predicted to increase to over 3 million new cases and 1 million deaths every year because of population growth and ageing alone. Breast cancer is the most common cancer worldwide and continues to have a large impact on the global number of cancer deaths. Global efforts are needed to counteract its growing burden, especially in transitioning countries where incidence is rising rapidly, and mortality rates remain high. • With over 2.3 million new cases and 685,000 deaths in 2020, breast cancer is the most commonly diagnosed cancer worldwide. • Most cases occur in transitioned countries yet transitioning countries have disproportionate share of breast cancer deaths. • The future burden of breast cancer is predicted to increase to over 3 million new cases and 1 million deaths in 2040. [ABSTRACT FROM AUTHOR]

Introduction. The Safer Prescribing and Care for the Elderly (SPACE) cluster randomised controlled trial in 39 general practices found that a search of the practice database to identify and generate for each general practitioner (GP) a list of patients with high-risk prescribing, pharmacist-delivered one-on-one feedback to GPs, and electronic tick-box for GPs to select action for each patient (Patient letter; No letter but possible medication review when patient next in; No action), prompted safer prescribing at 6 months but not at 1 year. Aim. This process evaluation explores research participation, intervention uptake and effect on GPs. Methods. Mixed methods were used including quantitative data (log of practice recruitment, demographic data, intervention delivery and GP responses including tick-box selections) and qualitative data (trial pharmacist reflective journal). Data were analysed using descriptive statistics and general inductive analysis, respectively. Results. Recruitment of general practices was challenging, with only 39% of eligible practices agreeing to participate. Those who declined were often 'too busy'. Engagement was also challenging, especially in larger practices, with the trial pharmacist managing to meet with only 64% of GPs in the intervention group. The GPs who did engage were positive about the intervention, but elected to send letters to only 23% of patients with high-risk prescribing, either because the high-risk prescribing had already stopped, the GP did not agree the prescribing was 'high-risk' or the GP was concerned a letter would upset the patient. Conclusions. Effectiveness of the SPACE cluster randomised controlled trial could be improved by changes including ensuring searches are current and relevant, repeating cycles of search and feedback, and integrating pharmacists into general practices. [ABSTRACT FROM AUTHOR]

Background: This paper describes the statistical analysis plan for a randomised controlled trial of a Healthy Lifestyle Program (HeLP) for low back pain targeting multiple health risks and behaviours, weight, physical activity, diet and smoking, to improve disability. We describe the methods for the main analyses and economic analysis of the trial.Methods and Design: The trial is a two-arm pragmatic randomised controlled trial comparing the effect of the HeLP intervention to usual care on low back pain disability at 26 weeks. A total of 346 adults with low back pain were recruited from the Newcastle and Hunter region between September 2017 and November 2019 and randomised to either HeLP or usual care. HeLP is a 6-month intervention with participant outcomes measured at weeks 6, 12, 26 and 52 post randomisation. This statistical analysis plan describes data integrity, handling and preparation of data for analyses and methods for analyses. The primary endpoint for the trial is disability at 26 weeks using the 24-item self-report Roland Morris Disability Questionnaire. The primary analysis will follow the intention-to-treat principle using linear mixed regression models.Discussion: The statistical analysis plan for this trial was produced to reduce outcome reporting bias arising from knowledge of the study findings. Any deviations will be described and justified in the final report.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12617001288314 . Registered on 6 September 2017. [ABSTRACT FROM AUTHOR]

Reliable and valid assessment of sports nutrition knowledge can inform athlete nutrition education to address knowledge gaps. This study aimed to test the reliability and validity of an electronically administered sports nutrition knowledge tool – Platform to Evaluate Athlete Knowledge of Sports Nutrition Questionnaire (PEAKS-NQ). A 94-item PEAKS-NQ was piloted to 149 developmental athletes (DA) in New Zealand, with a subset invited to complete the PEAKS-NQ again to assess reliability. Reliability was evaluated using sign test, intraclass correlation and Cronbach's α. Accredited sports dietitians (ASD; n 255) completed the PEAKS-NQ to establish construct validity via known-groups methodology and provided relevance scores to determine the scale content validity index (S-CVI). Rasch analysis was conducted to identify potentially problematic items and test reliability. Score differences between DA and ASD were analysed using independent t or non-parametric tests. DA (n 88) were 17·8 (sd 1·4) years, 61·4 % female and mostly in high school (94·3 %). ASD (n 45) were 37·8 (sd 7·6) years, 82·2 % female, with >5 years of dietetic experience (59·1 %). ASD scored higher than DA in all sections and overall (91·5 (sd 3·4) v. 67·1 (sd 10·5) %) (P < 0·001). There were no differences between retests (n 18; P = 0·14). Cronbach's α was 0·86. S-CVI indicated good content validity (0·88). Rasch analysis resulted in a fifty-item PEAKS-NQ with high item (0·91) and person (0·92) reliability. The PEAKS-NQ is reliable and valid for assessing sports nutrition knowledge which could assist practitioners effectively tailor and evaluate nutrition education. [ABSTRACT FROM AUTHOR]

Background: This a priori statistical analysis plan describes the analysis for CRISTAL.Methods: CRISTAL (cluster-randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study) aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic venous thromboembolism (VTE) following hip arthroplasty (HA) or knee arthroplasty (KA). The study is nested within the Australian Orthopaedic Association National Joint Replacement Registry. The trial was commenced in April 2019 and after an unplanned interim analysis, recruitment was stopped (December 2020), as the stopping rule was met for the primary outcome. The clusters comprised hospitals performing > 250 HA and/or KA procedures per annum, whereby all adults (> 18 years) undergoing HA or KA were recruited. Each hospital was randomised to commence with aspirin, orally, 85-150 mg daily or LMWH (enoxaparin), 40 mg, subcutaneously, daily within 24 h postoperatively, for 35 days after HA and 14 days after KA. Crossover was planned once the registration target was met for the first arm. The primary end point is symptomatic VTE within 90 days. Secondary outcomes include readmission, reoperation, major bleeding and death within 90 days, and reoperation and patient-reported pain, function and health status at 6 months. The main analyses will focus on the primary and secondary outcomes for patients undergoing elective primary total HA and KA for osteoarthritis. The analysis will use an intention-to-treat approach with cluster summary methods to compare treatment arms. As the trial stopped early, analyses will account for incomplete cluster crossover and unequal cluster sizes.Conclusions: This paper provides a detailed statistical analysis plan for CRISTAL.Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN12618001879257 . Registered on 19/11/2018. [ABSTRACT FROM AUTHOR]

Background: While high-quality meta-analyses have confirmed the effectiveness of aphasia therapy after stroke, there is limited evidence for the comparative effectiveness of different aphasia interventions. Two commonly used interventions, Constraint-induced Aphasia Therapy Plus (CIAT Plus) and Multi-modality Aphasia Therapy (M-MAT), are hypothesised to rely on diverse underlying neural mechanisms for recovery and may be differentially responsive to aphasia severity. COMPARE is a prospective randomised open-blinded end-point trial designed to determine whether, in people with chronic post-stroke aphasia living in the community, CIAT Plus and M-MAT provide greater therapeutic benefit compared to usual care, are differentially effective according to aphasia severity, and are cost-effective. This paper details the statistical analysis plan for the COMPARE trial developed prior to data analysis.Methods: Participants (n = 216) are randomised to one of three arms, CIAT Plus, M-MAT or usual care, and undertake therapy with a study trained speech pathologist in groups of three participants stratified by aphasia severity. Therapy occurs for 3 h blocks per day for 10 days across 2 weeks. The primary clinical outcome is aphasia severity as measured by the Western Aphasia Battery-Revised Aphasia Quotient (WAB-R-AQ) immediately post intervention. Secondary outcomes include WAB-R-AQ at 12-week follow-up, and functional communication, discourse efficiency, multimodal communication, and health-related quality of life immediately post intervention and at 12-week follow-up.Results: Linear mixed models (LMMs) will be used to analyse differences between M-MAT and UC, and CIAT-Plus and UC on each outcome measure immediately and at 12 weeks post-intervention. The LMM for WAB-R-AQ will assess the differences in efficacy between M-MAT and CIAT-Plus. All analyses will control for baseline aphasia severity (fixed effect) and for the clustering effect of treatment groups (random effect).Discussion: This trial will provide relative effectiveness data for two common interventions for people with chronic post-stroke aphasia, and highlight possible differential effects based on aphasia severity. Together with the health economic analysis data, the results will enable more informed personalised prescription for aphasia therapy after stroke.Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN 12615000618550 . Registered on 15 June 2016. [ABSTRACT FROM AUTHOR]

INTRODUCTION: Diabetes mellitus is common in primary care, yet little has been reported of its primary care prevalence or the clinical characteristics of patients with Type 2 diabetes mellitus (T2DM). AIM: To determine the prevalence of diabetes mellitus and clinical characteristics of diabetes patients in primary care in the Waikato region. METHODS: Primary care data were extracted from the electronic records of 15 general practices for patients aged >20 years with current diabetes mellitus at 20 June 2017. Diabetes mellitus was defined as having a glycated haemoglobin (HbA1c) of ≥50 mmol/mol (6.7%) or having being dispensed two or more anti-diabetic medications in the previous 12 months. Additional data collected included patients' ethnicity, age, sex and years since diagnosis. RESULTS: The overall prevalence of diabetes mellitus was 5.7% and was higher for Māori (8.6%), Asian (7.0%) and Pacific peoples (9.1%) than Europeans (5.0%; all P < 0.001). For patients with T2DM for whom current diabetes annual review data were available (n = 2227) the mean body mass index (BMI) was 32.8 ± 0.2 kg/m2, but BMI was higher in Māori, younger patients, females and patients diagnosed <2 years previously (all P < 0.001). Similarly, HbA1c levels were highest in Māori and younger patients (both P < 0.001), with 40% of patients overall having a HbA1c of ≤53 mmol/mol (7.0%). Approximately 70% of all patients had at least one measure of hypertension (systolic ≥130 or diastolic ≥80 mmHg), or dyslipidaemia. More than 85% of patients had completed a recent retinal screen and foot check. DISCUSSION: We found that management of T2DM was suboptimal, with measures for many patients not meeting clinical targets. Support should be provided to improve weight and glycaemic management, particularly for Māori, females and younger patients. [ABSTRACT FROM AUTHOR]

Background: Data from clinical registries may be linked to gain additional insights into disease processes, risk factors and outcomes. Identifying information varies from full names, addresses and unique identification codes to statistical linkage keys to no direct identifying information at all. A number of databases in Australia contain the statistical linkage key 581 (SLK-581). Our aim was to investigate the ability to link data using SLK-581 between two national databases, and to compare this linkage to that achieved with direct identifiers or other non-identifying variables.Methods: The Australian and New Zealand Society of Cardiothoracic Surgeons database (ANZSCTS-CSD) contains fully identified data. The Australian and New Zealand Intensive Care Society database (ANZICS-APD) contains non-identified data together with SLK-581. Identifying data is removed at participating hospitals prior to central collation and storage. We used the local hospital ANZICS-APD data at a large single tertiary centre prior to deidentification and linked this to ANZSCTS-CSD data. We compared linkage using SLK-581 to linkage using non-identifying variables (dates of admission and discharge, age and sex) and linkage using a complete set of unique identifiers. We compared the rate of match, rate of mismatch and clinical characteristics between unmatched patients using the different methods.Results: There were 1283 patients eligible for matching in the ANZSCTS-CSD. 1242 were matched using unique identifiers. Using non-identifying variables 1151/1242 (92.6%) patients were matched. Using SLK-581, 1202/1242 (96.7%) patients were matched. The addition of non-identifying data to SLK-581 provided few additional patients (1211/1242, 97.5%). Patients who did not match were younger, had a higher mortality risk and more non-standard procedures vs matched patients. The differences between unmatched patients using different matching strategies were small.Conclusion: All strategies provided an acceptable linkage. SLK-581 improved the linkage compared to non-identifying variables, but was not as successful as direct identifiers. SLK-581 may be used to improve linkage between national registries where identifying information is not available or cannot be released. [ABSTRACT FROM AUTHOR]

Background: The Census of Populations and Dwellings' is the five yearly population count of Aotearoa New Zealand. Best available populations (BAP) are subnational projections based on census data and demographic assumptions developed for healthcare planning and funding allocation but are also used as the denominator for health indicator monitoring. Pacific people are systematically undercounted, but the impact on health statistics is not well studied. For COVID-19 vaccination coverage, health service user (HSU) data were considered a more reliable denominator than BAP but introduced new biases. We aimed to understand how the choice of denominator population impacts estimates of population size and health system performance for Pacific people at a local level., Methods: We described how declining census response rates affected population data quality. We compared BAP and HSU data at district level. For the indicators 'access to primary care' and 'cervical cancer screening uptake' we replaced currently used BAP denominators with HSU and examined the impact for different ethnic groups in different geographic districts., Results: Overall Census 2018 response declined by 10%, but for Māori and Pacific people by 21% and 23%, respectively. This inequitably affected BAP accuracy. Census undercount was highest in the district with the largest Pacific populations, where HSU exceeded BAP most. Notably, 'access to primary care' for Pacific people in this district consistently exceeds 100%. Using BAP, both health indicators are currently estimated as highest for Pacific people compared to other ethnic groups, but when based on HSU, they dropped to lowest. Similar, but less pronounced trends occurred in other districts. Changes in trends over time for both indicators coincided mostly with adjustments in BAP, rather than changes in the numerators., Conclusions: The current use of BAP denominators for health statistics does not enable reliable monitoring of key health indicators for Pacific people. HSU denominators are also unsuitable for monitoring health. Exploring the feasibility of a real-time population register is strongly recommended as a new, transparent, way of obtaining more reliable, timely population data to guide policymaking and underpin a more equitable health system under the health reforms. Meanwhile, reporting of ethnic specific outcomes need to include a clear assessment of the potential for bias due to inaccurate population estimates., (© 2024. The Author(s).)

INTRODUCTION: Dabigatran etexilate has become widely used in New Zealand, but information relating to when renal function monitoring is being undertaken is lacking. AIM: To investigate if clinically appropriate renal function monitoring is being undertaken in New Zealand primary care for stroke prevention in non-valvular atrial fibrillation patients prescribed dabigatran etexilate. METHODS: New Zealand non-valvular atrial fibrillation patients' prescription and primary care health data were extracted from national administrative databases for the period 1 July 2011 to 31 December 2015. The proportion of patients who had serum creatinine measurements at close proximity to treatment initiation and 12-months post initiation were assessed with 95% confidence intervals (CIs) and compared with Fisher's exact test. Log-rank tests for univariate analysis (gender, age, ethnicity and deprivation) effects on serum creatinine testing at dabigatran etexilate treatment initiation and 12-months post initiation were performed. RESULTS: Overall, 1,948 patients who had been dispensed dabigatran etexilate with available primary care health data were identified. A total of 1,752 (89.9% [CI: 88.5–91.2]) patients had a renal function test at dabigatran etexilate initiation. There were 929 (72.8% [CI: 70.2–75.2]) patients who received ≥1 year supply of dabigatran etexilate and of these 207 (22.3% [CI: 19.6.6–25.1]) had a serum creatinine test 1 year after initiation. Demographic univariate analysis yielded insignificant log-rank tests for association with having serum creatinine measurements, except for Pacific Peoples. DISCUSSION: There appears to be sub-optimal adherence to renal function monitoring for non-valvular atrial fibrillation patients who receive more than 12-months' treatment with dabigatran etexilate in New Zealand primary care. [ABSTRACT FROM AUTHOR]

We test the hypothesis that ocean seafloor pressures impart stresses that alter the initiation or termination of transient slow slip events (SSEs) on shallow submarine and near‐coastal faults, using simulated seafloor pressures and a new catalog of SSEs in the Hikurangi subduction zone. We show that seafloor pressures may be represented by an average time history over the ~100‐km dimensions of the study area. We account for SSE uncertainties and the multiplicity of processes that affect SSEs statistically by estimating the probabilities of rejecting the null hypothesis that SSE initiation or termination pressures are those to be expected by chance sampling of known (modeled) seafloor pressures, with low probabilities indicating some causal connection. No impact of ocean pressure changes on SSE initiation is detectable, but a correlation with their terminations is suggested. SSE slip that weakens the fault and makes it more sensitive to small stress changes may explain results. Plain Language Summary: The ocean waters may impart stresses that change how shallow submarine and near‐coastal faults start or stop slipping, particularly when they slip slowly over days to months (in episodes called slow slip events or SSEs). We can now assess this possibility using new simulated seafloor pressures and a catalog of SSEs in the Hikurangi subduction zone, encompassing the onshore and offshore region of northeastern New Zealand. We only ask how probable this causal connection is because SSEs are difficult to measure precisely and many physical processes may change their behaviors. Our statistical analyses do not reveal any impact of ocean pressure changes on how or when SSEs start, but do indicate they may affect when SSEs end. One explanation of this result is that the slow slippage actually causes the fault to become weaker, making it more sensitive to the small stress changes imparted by the ocean. Key Points: Ocean water column changes may affect how and when Hikurangi shallow slow slip events end, but have no detectable impact on their startsTransient slow slip events may weaken faults, making them more sensitive to small stress changes (

Background: We are performing a combined randomised and observational study comparing internal fixation to non-surgical management for common wrist fractures in older patients. This paper describes the statistical analysis plan.Methods/design: A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE) is a randomised controlled trial comparing two types of usual care for treating wrist fractures in older patients, surgical fixation using volar locking plates and non-surgical treatment using closed reduction and plaster immobilisation. The primary aim of this comparative-effectiveness study is to determine whether surgery is superior to non-surgical treatment with respect to patient-reported wrist function at 12 months post treatment. The secondary outcomes include radiographic outcomes, complication rates and patient-reported outcomes including quality of life, pain, treatment success and cosmesis. Primary analysis will use a two-sample t test and an intention-to-treat analysis using the randomised arm of the study. Statistical analyses will be two-tailed and significance will be determined by p < 0.05. Sensitivity analyses will be conducted to assess for differences in intention-to-treat, per-protocol and as-treated analyses. Sensitivity analyses will also be conducted to assess selection bias by evaluating differences in participants between the randomised and observational study arms, and for bias relating to any missing data. An economic analysis will be conducted separately if surgery is shown to provide superior outcomes to a level of clinical significance.Discussion: This statistical analysis plan describes the analysis of the CROSSFIRE study which aims to provide evidence to aid clinical decision-making in the treatment of distal radius fractures in older patients.Trial Registration: CROSSFIRE was approved by The Hunter New England Human Research Ethics Committee (HNEHREC Reference No: 16/02/17/3.04). Registered on 22 July 2016 with The Australian and New Zealand Clinical Trials Registry (ANZCTR Number; ACTRN12616000969460 ). This manuscript is based on v.11 of the statistical analysis plan. A copy of v.11, signed by the chief investigator and the senior statistician is kept at the administering institution. [ABSTRACT FROM AUTHOR]

Background: The Melanoma Genomics Managing Your Risk Study is a randomised controlled trial that aims to evaluate the efficacy of providing information on personal genomic risk of melanoma in reducing ultraviolet radiation (UV) exposure, stratified by traditional risk group (low or high phenotypic risk) in the general population. The primary outcome is objectively measured total daily Standard Erythemal Doses at 12 months. Secondary outcomes include UV exposure at specific time periods, self-reported sun protection and skin-examination behaviours, psychosocial outcomes, and ethical considerations surrounding offering genomic testing at a population level. A within-trial and modelled economic evaluation will be undertaken from an Australian health system perspective to assess the cost-effectiveness of the intervention.Objective: To publish the pre-determined statistical analysis plan (SAP) before database lock and the start of analysis.Methods: This SAP describes the data synthesis, analysis principles and statistical procedures for analysing the outcomes from this trial. The SAP was approved after closure of recruitment and before completion of patient follow-up. It outlines the planned primary analyses and a range of subgroup and sensitivity analyses. Health economic outcomes are not included in this plan but will be analysed separately. The SAP will be adhered to for the final data analysis of this trial to avoid potential analysis bias that may arise from knowledge of the outcome data.Results: This SAP is consistent with best practice and should enable transparent reporting.Conclusion: This SAP has been developed for the Melanoma Genomics Managing Your Risk Study and will be followed to ensure high-quality standards of internal validity and to minimise analysis bias.Trial Registration: Prospectively registered with the Australian New Zealand Clinical Trials Registry, ID: ACTR N12617000691347 . Registered on 15 May 2017. [ABSTRACT FROM AUTHOR]

Background: The investigational medicinal product GKT137831 is a selective inhibitor of NOX 1 and 4 isoforms of the nicotinamide adenine dinucleotide phosphate (NADPH) oxidase family of enzymes, which has the potential to ameliorate diabetic kidney disease. An investigator-initiated, double-blind, randomised, placebo-controlled, multicentre phase 2 clinical trial started recruitment in December 2017, with the aim of evaluating the efficacy and safety of GKT13783, in adults with type 1 diabetes mellitus and persistently elevated urinary albumin excretion over a period of 48 weeks.Methods/design: The trial is currently recruiting in Australia and New Zealand, with recruitment expected to end on 30 June 2020. The primary outcome measure of the trial is the urinary albumin excretion level measured at 48 weeks of treatment. This statistical analysis plan presents an update to the published trial protocol and provides a comprehensive description of the statistical methods that will be used for the analysis of the data from this trial. In doing so, we follow the "Guidelines for the content of statistical analysis plans in clinical trials" to support transparency and reproducibility of the trial findings.Discussion: With the use of this prior statistical analysis plan, we aim to minimise bias in the reporting of the findings of this trial, which evaluates the investigational medicinal product GKT137831. The results of the trial are expected to be published in 2022.Trial Registration: ANZCTR registry: ACTRN12617001187336. Registered on 14 July 2017. Universal Trial Number: U1111-1187-2609; Protocol number: T1DGKT137831; Genkyotex trial number: GSN000241. [ABSTRACT FROM AUTHOR]