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A review of laboratory results across New Zealand for therapeutic drug monitoring (TDM) of infliximab and adalimumab concentrations and antidrug antibodies (ADAs) over 4 years was completed. Of 6591 results, the median serum concentration for infliximab was 5.7 mg/L and for adalimumab was 5.5 mg/L. Subtherapeutic drug concentrations (<7 mg/L) were measured in 54% of samples. Drug concentrations <2 mg/L were measured in 23% of samples, with ADAs detected in 51% of these. The high number of samples with subtherapeutic drug concentrations and common ADA detection is consistent with failing therapy but could also suggest that standard dosing is frequently too low for patients. These results reinforce the value of antitumour necrosis factor drug TDM in making decisions to adjust dosing or switch agents in patients taking infliximab and adalimumab. [ABSTRACT FROM AUTHOR]

Hoplodactylus delcourti is a presumably extinct species of diplodactylid gecko known only from a single specimen of unknown provenance. It is by far the largest known gekkotan, approximately 50% longer than the next largest-known species. It has been considered a member of the New Zealand endemic genus Hoplodactylus based on external morphological features including shared toe pad structure. We obtained DNA from a bone sample of the only known specimen to generate high-throughput sequence data suitable for phylogenetic analysis of its evolutionary history. Complementary sequence data were obtained from a broad sample of diplodactylid geckos. Our results indicate that the species is not most closely related to extant Hoplodactylus or any other New Zealand gecko. Instead, it is a member of a clade whose living species are endemic to New Caledonia. Phylogenetic comparative analyses indicate that the New Caledonian diplodactylid clade has evolved significantly more disparate body sizes than either the Australian or New Zealand clades. Toe pad structure has changed repeatedly across diplodactylids, including multiple times in the New Caledonia clade, partially explaining the convergence in form between H. delcourti and New Zealand Hoplodactylus. Based on the phylogenetic results, we place H. delcourti in a new genus. [ABSTRACT FROM AUTHOR]

Background: High-Intensity Interval Training (HIIT) involves bursts of high-intensity exercise interspersed with lower-intensity exercise recovery. HIIT may benefit cardiometabolic health in people with nonalcoholic steatohepatitis (NASH). Aims: We aimed to examine the safety, feasibility, and efficacy of 12-weeks of supervised HIIT compared with a sham-exercise control (CON) for improving aerobic fitness and peripheral insulin sensitivity in biopsy-proven NASH. Methods: Participants based in the community [(n = 14, 56 ± 10 years, BMI 39.2 ± 6.7 kg/m2, 64% male), NAFLD Activity Score 5 (range 3–7)] were randomized to 12-weeks of supervised HIIT (n = 8, 4 × 4 min at 85–95% maximal heart rate, interspersed with 3 min active recovery; 3 days/week) or CON (n = 6, stretching; 3 days/week). Safety (adverse events) and feasibility determined as ≥ 70% program completion and ≥ 70% global adherence (including session attendance, interval intensity adherence, and duration adherence) were assessed. Changes in cardiorespiratory fitness (V̇O2peak), exercise capacity (time-on-test) and peripheral insulin sensitivity (euglycemic hyperinsulinemic clamp) were assessed. Data were analysed using ANCOVA with baseline value as the covariate. Results: There were no HIIT-related adverse events and HIIT was globally feasible [program completion 75%, global adherence 100% (including adherence to session 95.4 ± 7.3%, interval intensity 95.3 ± 6.0% and duration 96.8 ± 2.4%)]. A large between-group effect was observed for exercise capacity [mean difference 134.2 s (95% CI 19.8, 248.6 s), ƞ2 0.44, p = 0.03], improving in HIIT (106.2 ± 97.5 s) but not CON (− 33.4 ± 43.3 s), and for peripheral insulin sensitivity [mean difference 3.4 mg/KgLegFFM/min (95% CI 0.9,6.8 mg/KgLegFFM/min), ƞ2 0.32, p = 0.046], improving in HIIT (1.0 ± 0.8 mg/KgLegFFM/min) but not CON (− 3.1 ± 1.2 mg/KgLegFFM/min). Conclusions: HIIT is safe, feasible and efficacious for improving exercise capacity and peripheral insulin sensitivity in people with NASH. Clinical Trial Registration Number: Australian New Zealand Clinical Trial Registry (anzctr.org.au) identifier ACTRN12616000305426 (09/03/2016). [ABSTRACT FROM AUTHOR]

Background: Acute low back pain is a common condition, has high burden, and there are evidence-to-practice gaps in the chiropractic and physiotherapy setting for imaging and giving advice to stay active. The aim of this cluster randomised trial was to estimate the effects of a theory- and evidence-based implementation intervention to increase chiropractors' and physiotherapists' adherence to a guideline for acute low back pain compared with the comparator (passive dissemination of the guideline). In particular, the primary aim of the intervention was to reduce inappropriate imaging referral and improve patient low back pain outcomes, and to determine whether this intervention was cost-effective.Methods: Physiotherapy and chiropractic practices in the state of Victoria, Australia, comprising at least one practising clinician who provided care to patients with acute low back pain, were invited to participate. Patients attending these practices were included if they had acute non-specific low back pain (duration less than 3 months), were 18 years of age or older, and were able to understand and read English. Practices were randomly assigned either to a tailored, multi-faceted intervention based on the guideline (interactive educational symposium plus academic detailing) or passive dissemination of the guideline (comparator). A statistician independent of the study team undertook stratified randomisation using computer-generated random numbers; four strata were defined by professional group and the rural or metropolitan location of the practice. Investigators not involved in intervention delivery were blinded to allocation. Primary outcomes were X-ray referral self-reported by clinicians using a checklist and patient low back pain-specific disability (at 3 months).Results: A total of 104 practices (43 chiropractors, 85 physiotherapists; 755 patients) were assigned to the intervention and 106 practices (45 chiropractors, 97 physiotherapists; 603 patients) to the comparator; 449 patients were available for the patient-level primary outcome. There was no important difference in the odds of patients being referred for X-ray (adjusted (Adj) OR: 1.40; 95% CI 0.51, 3.87; Adj risk difference (RD): 0.01; 95% CI - 0.02, 0.04) or patient low back pain-specific disability (Adj mean difference: 0.37; 95% CI - 0.48, 1.21, scale 0-24). The intervention did lead to improvement for some key secondary outcomes, including giving advice to stay active (Adj OR: 1.96; 95% CI 1.20, 3.22; Adj RD: 0.10; 95% CI 0.01, 0.19) and intending to adhere to the guideline recommendations (e.g. intention to refer for X-ray: Adj OR: 0.27; 95% CI 0.17, 0.44; intention to give advice to stay active: Adj OR: 2.37; 95% CI 1.51, 3.74).Conclusions: Intervention group clinicians were more likely to give advice to stay active and to intend to adhere to the guideline recommendations about X-ray referral. The intervention did not change the primary study outcomes, with no important differences in X-ray referral and patient disability between groups, implying that hypothesised reductions in health service utilisation and/or productivity gains are unlikely to offset the direct costs of the intervention. We report these results with the caveat that we enrolled less patients into the trial than our determined sample size. We cannot recommend this intervention as a cost-effective use of resources.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12609001022257 . Retrospectively registered on 25 November 2009. [ABSTRACT FROM AUTHOR]

Background: Scalable knee osteoarthritis programs are needed to deliver recommended education, exercise, and weight loss interventions.Objective: To evaluate two 6-month, telehealth-delivered exercise programs, 1 with and 1 without dietary intervention.Design: 3-group, parallel randomized (5:5:2) trial. (Australian New Zealand Clinical Trials Registry: ACTRN12618000930280).Setting: Australian private health insurance members.Participants: 415 persons with symptomatic knee osteoarthritis and a body mass index between 28 and 40 kg/m2 who were aged 45 to 80 years.Intervention: All groups received access to electronic osteoarthritis information (control). The exercise program comprised 6 physiotherapist consultations via videoconference for exercise, self-management advice, and behavioral counseling, plus exercise equipment and resources. The diet and exercise program included an additional 6 dietitian consultations for a ketogenic very-low-calorie diet (2 formulated meal replacements and a low-carbohydrate meal daily) followed by a transition to healthy eating, as well as nutrition and behavioral resources.Measurements: Primary outcomes were changes in knee pain (numerical rating scale [NRS] of 0 to 10, higher indicating worse) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]; scale, 0 to 68, higher indicating worse) at 6 months (primary time point) and 12 months. Secondary outcomes were weight, physical activity, quality of life, mental health, global change, satisfaction, willingness to have surgery, orthopedic appointments, and knee surgery.Results: A total of 379 participants (91%) provided 6-month primary outcomes, and 372 (90%) provided 12-month primary outcomes. At 6 months, both programs were superior to control for pain (between-group mean difference in change on NRS: diet and exercise, -1.5 [95% CI, -2.1 to -0.8]; exercise, -0.8 [CI, -1.5 to -0.2]) and function (between-group mean difference in change on WOMAC: diet and exercise, -9.8 [CI, -12.5 to -7.0]; exercise, -7.0 [CI, -9.7 to -4.2]). The diet and exercise program was superior to exercise (pain, -0.6 [CI, -1.1 to -0.2]; function, -2.8 [CI, -4.7 to -0.8]). Findings were similar at 12 months.Limitation: Participants and clinicians were unblinded.Conclusion: Telehealth-delivered exercise and diet programs improved pain and function in people with knee osteoarthritis and overweight or obesity. A dietary intervention conferred modest additional pain and function benefits over exercise.Primary Funding Source: Medibank, the Medibank Better Health Foundation Research Fund, and a National Health and Medical Research Council Centre of Research Excellence. [ABSTRACT FROM AUTHOR]

Background and objective: Chronic thromboembolic pulmonary hypertension (CTEPH) is a serious condition occurring in 2%–4% of patients after acute pulmonary embolism. Pulmonary endarterectomy (PEA) is a potential cure for technically operable disease. The epidemiology and long‐term outcomes of CTEPH have not been previously described in Australia and New Zealand. Methods: Data were extracted from the Pulmonary Hypertension Society of Australia and New Zealand (PHSANZ) registry for patients diagnosed with CTEPH between January 2004 and March 2020. Baseline characteristics, treatment strategies, outcome data and long‐term survival are reported. Results: A total of 386 patients were included with 146 (37.8%) undergoing PEA and 240 (62.2%) in the non‐PEA group. PEA patients were younger (55 ± 16 vs. 62 ± 16 years, p < 0.001) with higher baseline 6‐min walk distance (6MWD; 405 ± 122 vs. 323 ± 146 m, p = 0.021), whilst both groups had similar baseline pulmonary haemodynamics. Pulmonary hypertension‐specific therapy was used in 54% of patients post‐PEA and 88% in the non‐PEA group. The 1‐, 3‐ and 5‐year survival rates were 93%, 87% and 84% for the PEA group compared to 86%, 73% and 62%, respectively, for the non‐PEA group (p < 0.001). Multivariate survival analysis showed baseline 6MWD was an independent predictor of survival in both operated and medically managed patients. Conclusion: In this first multicentre report of CTEPH in Australia and New Zealand, long‐term survival is comparable to that in other contemporary CTEPH registries. However, PEA was only performed in a minority of CTEPH patients (37.8%) and significantly less than overseas reports. Greater awareness of PEA and improved patient access to experienced CTEPH centres are important priorities. Chronic thromboembolic pulmonary hypertension (CTEPH) is increasingly recognized as a prevalent cause of pulmonary hypertension, potentially curable with pulmonary endarterectomy (PEA) surgery. This analysis demonstrates that Australian and New Zealand patients display similar long‐term survival outcomes as internationally reported data. Strategies for improving access for Australian and New Zealand patients to PEA are an important step for advancing treatment of CTEPH in this region. [ABSTRACT FROM AUTHOR]

Background and objective: Early diagnosis of PAH is clinically challenging. Patterns of diagnostic delay in Australian and New Zealand PAH populations have not been explored in large‐scale studies. We aimed to evaluate the magnitude, risk factors and survival impact of diagnostic delay in Australian and New Zealand PAH patients. Methods: A cohort study of PAH patients from the PHSANZ Registry diagnosed from 2004 to 2017 was performed. Diagnostic interval was the time from symptom onset to diagnostic right heart catheterization as recorded in the registry. Factors associated with diagnostic delay were analysed in a multivariate logistic regression model. Survival rates were compared across patients based on the time to diagnosis using Kaplan–Meier method and Cox regression. Results: A total of 2044 patients were included in analysis. At diagnosis, median age was 58 years (IQR: 43–69), female‐to‐male ratio was 2.8:1 and majority of patients were in NYHA FC III–IV (82%). Median diagnostic interval was 1.2 years (IQR: 0.6–2.7). Age, CHD‐PAH, obstructive sleep apnoea and peripheral vascular disease were independently associated with diagnostic interval of ≥1 year. No improvement in diagnostic interval was seen during the study period. Longer diagnostic interval was associated with decreased 5‐year survival. Conclusion: PAH patients experience significant diagnostic interval, which has not improved despite increased community awareness. Age, cardiovascular and respiratory comorbidities are significantly associated with longer time to diagnosis. Mortality rates appear higher in patients who experience longer diagnostic interval. We examined diagnostic delay in a large binational cohort of PAH patients. Mean and median diagnostic intervals were 2.5+/–4.1 and 1.2 (IQR: 0.6–2.7) years, respectively. Age, cardiovascular and respiratory comorbidities were associated with longer diagnostic interval. Mortality was increased in patients with greater diagnostic interval. See relatedEditorial [ABSTRACT FROM AUTHOR]

Background: Although education, exercise, and weight loss are recommended for management of knee osteoarthritis, the additional benefits of incorporating weight loss strategies into exercise interventions have not been well investigated. The aim of this study is to compare, in a private health insurance setting, the clinical- and cost-effectiveness of a remotely-delivered, evidence- and theory-informed, behaviour change intervention targeting exercise and self-management (Exercise intervention), with the same intervention plus active weight management (Exercise plus weight management intervention), and with an information-only control group for people with knee osteoarthritis who are overweight or obese.Methods: Three-arm, pragmatic parallel-design randomised controlled trial involving 415 people aged ≥45 and ≤ 80 years, with body mass index ≥28 kg/m2 and < 41 kg/m2 and painful knee osteoarthritis. Recruitment is Australia-wide amongst Medibank private health insurance members. All three groups receive access to a bespoke website containing information about osteoarthritis and self-management. Participants in the Exercise group also receive six consultations with a physiotherapist via videoconferencing over 6 months, including prescription of a strengthening exercise and physical activity program, advice about management, and additional educational resources. The Exercise plus weight management group receive six consultations with a dietitian via videoconferencing over 6 months, which include a very low calorie ketogenic diet with meal replacements and resources to support behaviour change, in addition to the interventions of the Exercise group. Outcomes are measured at baseline, 6 and 12 months. Primary outcomes are self-reported knee pain and physical function at 6 months. Secondary outcomes include weight, physical activity levels, quality of life, global rating of change, satisfaction with care, knee surgery and/or appointments with an orthopaedic surgeon, and willingness to undergo surgery. Additional measures include adherence, adverse events, self-efficacy, and perceived usefulness of intervention components. Cost-effectiveness of each intervention will also be assessed.Discussion: This pragmatic study will determine whether a scalable remotely-delivered service combining weight management with exercise is more effective than a service with exercise alone, and with both compared to an information-only control group. Findings will inform development and implementation of future remotely-delivered services for people with knee osteoarthritis.Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12618000930280 (01/06/2018). [ABSTRACT FROM AUTHOR]

Background: Pulmonary arterial hypertension (PAH) prognosis has improved with targeted therapies; however, the long-term outlook remains poor. Objective multiparametric risk assessment is recommended to identify patients at risk of early morbidity and mortality, and for optimization of treatment. The US Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL) 2.0 risk score is a new model proposed for the follow-up of patients with PAH but has not been externally validated.Methods: The REVEAL 2.0 risk score was applied to a mixed prevalent and incident cohort of patients with PAH (n = 1,011) from the Pulmonary Hypertension Society of Australia and New Zealand (PHSANZ) Registry. Kaplan-Meier survival was estimated for each REVEAL 2.0 risk score strata and for a simplified three-category (low, intermediate, and high risk) model. Sensitivity analysis was performed on an incident-only cohort.Results: The REVEAL 2.0 model effectively discriminated risk in the large external PHSANZ Registry cohort, with a C statistic of 0.74 (both for full eight-tier and three-category models). When applied to incident cases only, the C statistic was 0.73. The three-category REVEAL 2.0 model demonstrated robust separation of 12- and 60-month survival estimates (all risk category comparisons P < .001). Although the full eight-tier REVEAL 2.0 model separated patients at low, intermediate, and high risk, survival estimates overlapped within some of the intermediate- and high-risk strata.Conclusions: The REVEAL 2.0 risk score was validated in a large external cohort from the PHSANZ Registry. The REVEAL 2.0 model can be applied for risk assessment of patients with PAH at follow-up. The simplified three-category model may be preferred for clinical use and for future comparison with other prognostic models. [ABSTRACT FROM AUTHOR]

Background: Therapeutic drug monitoring of anti‐tumour necrosis factor (TNF) drugs and anti‐drug antibodies (ADA) is now recommended in the treatment of inflammatory bowel disease. However, assay types and drug concentration thresholds are still debated. Aim: To correlate inflammatory bowel disease activity in a New Zealand cohort with trough concentrations of infliximab and adalimumab, and ADA using locally developed competitive‐binding enzyme‐linked immunosorbent assays (ELISA) to establish threshold concentrations. Methods: Patients with ulcerative colitis (UC) and Crohn disease (CD) from Christchurch and Dunedin on anti‐TNF drugs >12 weeks were enrolled. Trough blood samples were assayed for drug and ADA concentrations. Other data included quality of life, blood count, C‐reactive protein, albumin, renal function and disease activity indices. Results: Of 103 patients, 53 were on infliximab (36 CD, 15 UC and 2 unclassified) and 50 adalimumab (48 CD and 2 UC). Median (range) infliximab and adalimumab concentrations were 10.5 (0–41) and 9.61 mg/L (0–30). CD remission, Crohn Disease Activity Index <150, correlated with infliximab and adalimumab concentration in CD (infliximab, P = 0.03; adalimumab, P = 0.04), with too few UC patients for analysis. Receiver operator curve analysis suggested a threshold value of 5.1 mg/L for distinguishing active disease from remission for infliximab and 7.3 mg/L for adalimumab in CD. Of 13 patients with infliximab <2 mg/L, 10 were ADA positive by homogeneous mobility shift assay (HMSA), including five with neutralising antibodies using ELISA. Of six with adalimumab <2 mg/L, three were ADA positive using HMSA, including one with neutralising antibodies. Conclusion: Using the New Zealand ELISA assay, threshold concentrations of 5 mg/L for infliximab and 7 mg/L for adalimumab are suggested to aid dosing decisions, consistent with results internationally. Both neutralising (ELISA) and non‐neutralising ADA (HMSA) are associated with low drug concentrations. [ABSTRACT FROM AUTHOR]

While some primary care practices have found ways to deliver quality care more equitably to their Māori and Pacific patients, others have struggled to get started or be successful. Quality Symposium attendees shared their views on barriers and success factors, both within the practice and beyond. When practices have collaborated and used their own ethnic-specific data in quality improvement techniques, they have improved Māori and Pacific health and equity. Attendees asked for greater practical support and guidance from the profession and sector. They report a funding gap for services needed by their patients to enable primary care to deliver equitable services for Māori and Pacific people. [ABSTRACT FROM AUTHOR]

The article examines the raw statistics which records the disproportionate extent to which tax practice in New Zealand is weighted down to tax avoidance. It discusses why tax avoidance cases continue to be fought, despite repeated decisions at the highest level in favour of the Commissioner in Inland Revenue. It highlights factors that arouse further disputes to the detriment of the entire tax regime.

Statins are one of the most commonly prescribed drugs in New Zealand, with 525 772 or 16.5% of the adult New Zealand population prescribed a statin between June 2013 and July 2014. While generally well-tolerated, statins are known to cause a range of muscle-related side effects, ranging from myalgia to life-threatening rhabdomyolysis. Recently, it has been recognised that in rare instances, statins can induce an immune-mediated necrotising myositis with antibodies against 3-hydroxy-3-methylglutaryl-coenzyme A reductase ( HMGCR), the enzymatic target of statins. In 2014, anti- HMGCR antibody testing was introduced to Canterbury Health Laboratories ( CHL), with this being the only laboratory in New Zealand performing this test during the period of this case series. This article describes an index case and characterises the clinical features of a subsequent 12-month series. From this series, we estimated the yearly incidence of HMGCR-associated myositis at 1.7/million/year or ~1/90 000 New Zealand statin users. [ABSTRACT FROM AUTHOR]

Over the past decade, historians have situated feminist reformers’ efforts to dismantle the British imperial contagious diseases apparatus at the heart of the transnational turn in women's history. New Zealand was an early emulator of British prostitution regulations, which provoked an organised repeal campaign in the 1880s, yet the colony is seldom considered in these debates. Tracing the dialogue concerning the repeal of contagious diseases legislation between British and New Zealand feminists in the 1890s, this article reaffirms the salience of political developments in the settler colonies for metropolitan reformers. A close reading of these interactions, catalysed by the Auckland Women's Liberal League's endorsement of the Act in 1895, reveals recently enfranchised New Zealand women's desire to act as model citizens for the benefit of metropolitan suffragists. Furthermore, it highlights the asymmetries that remained characteristic of the relationship between British feminists and their enfranchised Antipodean counterparts. [ABSTRACT FROM PUBLISHER]

Background. Children report low back pain (LBP) as young as 8 years. Preventing LBP in children may prevent or delay adult incidence. Objectives. The purpose of this study was to determine whether education and daily exercise affect LBP episodes in children compared with education alone. Design. This was a prospective, multicenter cluster randomized controlled trial. Setting. The study was conducted at 7 New Zealand primary schools. Participants. Children (n=708), aged 8 to 11 years, from 7 schools stratified by sample size (36, 114, 151, 168, 113, 45, 83) were randomized and allocated to 2 masked groups: intervention (4 schools, n=469) or control (3 schools, n=239). Interventions. Participants in the intervention group were taught 4 spinal movements for daily practice. Both groups participated in education that emphasized “back awareness.” Measurements. Low back pain history at baseline was assessed. Children reported episodes of LBP during the previous week on trial days 7, 21, 49, 105, 161, and 270. Analysis was at the individual participant level, with adjustment for school clusters. There were no significant differences between groups in the odds of reporting no LBP in the previous week during the study period (odds ratio [OR] =0.72; 95% confidence interval [95% CI]=0.46, 1.14; P=.l6). The intervention group reported significantly fewer episodes of LBP (OR=0.54; 95% CI=0.39, 0.74; /p<.001) and significantly fewer lifetime first episodes of LBP (n=86 [34%]) compared with the control group (n=58 [47%]) (OR=0.60; 95% CI=0.39, 0.91; P=.02). The odds of an episode of LBP were greater in participants with a history of LBP (OR=4.21; 95% 0=3.07, 5.78; P<.001). Low back pain episodes decreased across the trial period for both groups (OR=0.89; 95% CI=0.84, 0.95; 7J<.001). Adherence to exercise was poor. Limitations. Replication in other settings is needed. Conclusions. Regular exercise and education appear to reduce LBP episodes in children aged 8 to 11 years compared with education alone. [ABSTRACT FROM AUTHOR]

Climate change is widely regarded as one of the most serious global health threats of the 21st century. Its impacts will be disproportionately borne by the most disadvantaged populations, including indigenous peoples. For Māori in Aotearoa/New Zealand, as with other indigenous peoples worldwide, colonization has led to dispossession of land, destabilization of cultural foundations, and social, economic, and political marginalization. Climate change threatens to exacerbate these processes, adding future insult to historical and contemporary injury. Yet the challenges posed by climate change are accompanied by considerable opportunities to advance indigenous rights and reduce health disparities. In this paper, we examine issues related to climate change and Māori health using a right to health analytical framework, which identifies obligations for the New Zealand government. [ABSTRACT FROM AUTHOR]

Mannitol dry powder for inhalation has been developed for the treatment of patients with cystic fibrosis. Two randomized, double-blind, multinational, 26-week, phase III trials (CF-301 and CF-302) examined the efficacy of inhaled dry powder mannitol in patients aged >6 years with cystic fibrosis who were receiving standard care (with a substantial proportion of patients receiving domase alfa and antibacterials at baseline). Good compliance was seen in both studies. A sustained, significant (p<0.001) improvement in forced expiratory volume in 1 second (FEV1) [mean absolute change from baseline over 26 weeks; primary endpoint] was seen in patients with cystic fibrosis who received inhaled mannitol, compared with the control group, in the CF-301 trial, but not in the CF-302 trial (p = 0.059). In both CF-301 and CF-302, the relative increase from baseline in percent predicted FEV1, and the improvement from baseline in forced vital capacity were significantly greater in patients receiving inhaled mannitol than in the control group. In a pooled analysis of the CF-301 and CF-302 trials, the relative risk of a pulmonary exacerbation requiring intravenous antibacterials was significantly reduced by 29% for inhaled mannitol recipients versus the control group (relative risk 0.71; 95% CI 0.51, 0.98) [p = 0.039]. Inhaled dry powder mannitol was generally well tolerated in adults with cystic fibrosis in the CF-301 and CF-302 studies, with most treatment-emergent adverse events being of mild to moderate severity. [ABSTRACT FROM AUTHOR]

The article discusses the New Zealand's General Anti-Avoidance Provisions (GAAR). It analyzes the similarities between New Zealand recent tax avoidance cases and the international transfer pricing regime. It focuses on domestic transfer pricing regime as a result of combination of economic analysis and market pricing. It informs that GAAR is used as proxy for avoiding the uncertainties for tax payers.

Plerixafor (Mozobil®) is a CXCR4 chemokine receptor antagonist that is indicated for use in combination with granulocyte colony-stimulating factor (G-CSF) to mobilize stem cells to the peripheral blood for collection and subsequent autologous stem-cell transplantation in patients who have non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) [US] and in patients who have lymphoma or MM and are poor mobilize (EU). This article reviews the clinical efficacy and tolerability of subcutaneous plerixafor for stem-cell mobilization in patients with lymphoma or MM, as well as summarizing its pharmacological properties. Pharmacoeconomic analyses of plerixafor and decision-making algorithms intended to optimize its use are also discussed. Plerixafor plus G-CSF mobilized stem cells more efficiently than placebo plus G-CSF in adults with NHL or MM, according to the results of two randomized, double-blind, multicentre trials. In these trials, significantly more plerixafor plus G-CSF recipients than placebo plus G-CSF recipients reached primary apheresis targets in significantly fewer apheresis days. In the trial in patients with NHL, significantly more plerixafor plus G-CSF than placebo plus G-CSF recipients proceeded to transplantation. Results of compassionate-use studies in patients with lymphoma or MM demonstrated that plerixafor plus G-CSF successfully mobilized stem cells in the majority of patients who were poor mobilizers (i.e. sufficient CD34+ cells had not been collected during apheresis or apheresis had not occurred because of low peripheral blood CD34+ cell counts). Results of compassionate-use studies and additional studies in patients with lymphoma or MM also demonstrated that plerixafor plus G-CSF successfully mobilized stem cells in predicted poor mobilizers, such as heavily pretreated patients considered to be at high risk of mobilization failure. In addition, a small study showed mobilization with preemptive plerixafor to be effective. Subcutaneous plerixafor was generally well tolerated during stem-cell mobilization in patients with NHL or MM; the most commonly occurring treatment- related adverse events in plerixafor plus G-CSF recipients included injection-site reactions and gastrointestinal adverse events. Preliminary results of a US cost-effectiveness analysis suggest that plerixafor plus G-CSF is a cost-saving option compared with cyclophosphamide plus G-CSF. A retrospective US cost analysis found no significant difference between plerixafor plus G-CSF and cyclophosphamide plus G-CSF recipients in the median total cost of initial mobilization, suggesting that the cost of plerixafor may be offset by increased utilization of other resources in patients receiving alternative mobilization regimens. Additional cost analyses examined the use of preemptive plerixafor; institutions have developed decision-making algorithms, mainly relating to the use of pre-emptive plerixafor, to help optimize its use. In conclusion, plerixafor is a valuable stem-cell mobilizer for use in combination with G-CSF in patients with lymphoma or MM, particularly in patients who are poor mobilizers or predicted poor mobilizers. [ABSTRACT FROM AUTHOR]

This article deals with the vexing question of the characterisation of supplies. In doing so it looks at two recent Australian cases on this issue -- Travelex Ltd v Commissioner of Taxation and Commissioner of Taxation v American Express Wholesale Currency Services Pty Limited. After reviewing the decisions and considering their implications from an Australian perspective, the paper describes how New Zealand would deal with identical fact scenarios. [ABSTRACT FROM AUTHOR]

Lenograstim (Granocyte®, Neutrogin®, Myelostim®) is a glycosylated recombinant human granulocyte colony-stimulating factor. This article reviews the pharmacological properties, therapeutic efficacy and tolerability of lenograstim, mainly focusing on its use in chemotherapy-induced neutropenia, acceleration of neutrophil recovery following haematopoietic stem cell transplantation (HSCT), and peripheral blood stem cell (PBSC) mobilization in patients with cancer and healthy donors. In randomized, multicentre trials in patients with solid tumours, lymphoma or multiple myeloma, the durations of chemotherapy-induced neutropenia, hospitalization for infection and intravenous antibacterial therapy were significantly shorter in patients receiving lenograstim prophylaxis than in those receiving placebo. The time to neutrophil recovery was also significantly shorter in patients with acute myeloid leukaemia or acute lymphoblastic leukaemia who received lenograstim than in those who received placebo or no treatment, according to the results of randomized, multicentre trials. In addition, lenograstim prophylaxis facilitated the administration of dose-intense or dose-dense chemotherapy regimens, with improved clinical outcomes seen in some trials. In patients with cancer undergoing HSCT, lenograstim accelerated neutrophil recovery post-HSCT and shortened the duration of hospitalization. according to the results of randomized, multicentre trials. Lenograstim effectively mobilized PBSCs in patients with cancer, demonstrating generally similar efficacy to filgrastim or molgramostim in five randomized trials (although lower dosages of lenograstim than filgrastim were administered in four of the trials). Lenograstim also provided effective PBSC mobilization in healthy donors and was more effective than filgrastim when both drugs were administered at a dosage of 10μg/kg/day. The efficacy and safety of lenograstim for PBSC mobilization in healthy donors was supported by the results of a prospective, longer-term study involving almost 4000 healthy donors. Lenograstim was generally well tolerated across a variety of treatment settings, including PBSC mobilization in healthy donors, with bone pain being one of the most commonly reported adverse events. In conclusion, lenograstim remains an important option for use in chemotherapy- induced neutropenia, acceleration of neutrophil recovery following HSCT, and PBSC mobilization. [ABSTRACT FROM AUTHOR]

The article discusses the difficulties that will arise from the implementation of the Tax Working Group's (TWG) recommendation that denies depreciation deductions for buildings that do not actually depreciate in value in New Zealand. It examines the consequences and the reasons behind the new legislation. The author mentions that TWG recommends the implemented tax reforms to include a nil rate of depreciation for all buildings and to rental and owner-occupied properties in the country.

The GST regime has now been operating in Australia for a decade. During that period there has been only one reported case on GST tax avoidance. The absence of other cases indicates either the GST regime is working as intended, and there is no avoidance of GST, or the ingenuity of taxpayers seeking GST benefits has simply not been detected by ATO. A New Tax System (Goods and Services Tax) Act 1999 ("GST Act") contains a number of measures to combat avoidance of GST. There are a range of specific anti-avoidance provisions to counter particular instances of tax avoidance. These specific rules are narrowly targeted provisions to prevent foreseeable instances where taxpayers may otherwise attempt to defeat the normal or expected operation of the relevant statute. More importantly, Div 165 GST Act contains a broad-ranging general anti-avoidance provision ("GAAR") to prevent abuse of the GST regime. Unlike the specific anti-avoidance rules, Div 165 is widely-worded with open-ended application. Such provisions are designed to apply to the unanticipated and unforeseen behaviour by taxpayers that, although contrary to neither the substantive provisions of the Act nor any applicable specific anti-avoidance provisions, nevertheless breach the scheme and purpose of the relevant statute. Despite the lack of case law, it can be presumed that tax avoidance is as much a part of the landscape of GST as it is for income tax. But while there have been many income tax avoidance cases litigated over the past decade, there is an understandable dearth of GST cases. The Australian Administration Appeals Tribunal heard the sole GST avoidance case under Div 165 in 2006. Following the enactment of a GST regime in New Zealand in 1986, it took 15 years for the first case to be considered by the courts under s 76 New Zealand Goods and Services Tax Act 1985 (NZGSTA). Those initial cases, involving fairly blatant schemes to obtain unwarranted tax benefits, were decided in favour of the Commissioners in both jurisdictions. It was not until 2007 that New Zealand's Court of Appeal heard two GST avoidance cases, upholding the Commissioner's assessment of tax avoidance in both instances. The decision in one of those cases was subsequently appealed to New Zealand's newly formed Supreme Court, which eventually upheld the assessment of tax avoidance. These New Zealand cases, involving very different schemes, are the first consideration of GST avoidance by higher courts in either jurisdiction. Accordingly the reasoning of those decisions provides a useful guide to the potential application of Div 165 in Australia. The cases demonstrate that, like the equivalent GAARs for income tax, Courts are willing to apply antiavoidance provisions wherever they believe taxpayers' conduct abuses the GST regime. The decisions give the antiavoidance provisions teeth and provided the Commissioner in both countries with a strong weapon against abusive conduct by taxpayers. This article examines the GST tax avoidance cases decided in both Australia and New Zealand. It compares them with the application of the income tax general anti-avoidance provisions. Finally the paper provides some guidance on when Div 165 may be applied to schemes, given the different requirements of the GST regime. [ABSTRACT FROM AUTHOR]

The secrecy of taxpayer in formation is a vital component of the tax system in both Australia and New Zealand. Strict limfits on the use of information are contained in tax legislation and harsh penalties are imposed for breaches of secrecy. However, the statutory restrictions are subject to a wide exception permitting disclosure of information for the purpose of carrying out the Commissioner's lawful duties. In a recent judgment, the New Zealand Supreme Court upheld the Commissioner's use of confidential information belonging to other taxpayers in litigation to defend an assessment, effectively overriding the secrecy of those other taxpayers. At the same time, courts in both Australia and New Zealand have consistently restricted taxpayers' access to confidential information about other taxpayers on the grounds of secrecy. The secrecy provisions and the right to disclose confidential information have therefore potentially become a tactical weapon for the Commissioner against which taxpayers have little defence. [ABSTRACT FROM AUTHOR]

This article outlines the decisions of the Supreme Court in December 2008 in the Ben Nevis Forestry Ventures Ltd and Ors v Commissioner of Inland Revenue (more colloquially known as the Trinity case) and Glenharrow Holdings Ltd v Commissioner of Inland Revenue tax avoidance cases. The article examines whether the decisions extend the reach of the general anti-avoidance provisions and predicts the future direction in anti-avoidance jurisprudence charted by the Court. Finally, the paper considers the first application of the Supreme Court's reasoning in the "surgeons' case" (Penny v Commissioner of Inland Revenue), decided on 19 March 2009. The writers conclude that whilst our highest court has completed the swing in favour of Inland Revenue, as shown in recent tax avoidance cases involving artificial and uncommercial arrangements, it has also brought some additional focus to how the general anti-avoidance rules work in tandem with the other "black letter" or specific provisions in the Act. [ABSTRACT FROM AUTHOR]

Objectives: Following the WHO 2015 policy framework, we tested the effects of older people's intrinsic capacity and their perceptions of their neighborhood environments on mental and physical health-related quality of life (QoL) outcomes across two years.Study Design: Participants (mean age = 66) were drawn from two waves of a longitudinal study of aging (n = 2910) in 2016 and 2018. Regression analyses tested the main and interaction effects of intrinsic capacity and neighborhood factors on health-related QoL at T2 (controlling for T1).Main Outcome Measures: Intrinsic capacity was assessed with number of chronic conditions. Neighborhood perceptions was assessed with measures of housing suitability, neighborhood satisfaction, and neighborhood social cohesion. Health-related QoL was assessed with SF12 physical and mental health component scores.Results: Perceptions of greater neighborhood accessibility and more trust among neighbours were associated with better mental health-related QoL two years later, but not to changes in physical health-related QoL. A significant interaction between intrinsic capacity and neighborhood access to facilities on physical health-related QoL over time showed that those reporting lower neighborhood access experienced a stronger impact of intrinsic capacity on physical health-related QoL.Conclusions: The neighborhood environment is important to the wellbeing of older people and is amenable to policy interventions. We need more work on the aspects of the immediate environment that support QoL in older age. This study points to the need for accessible facilities and cohesive neighborhoods to support health. [ABSTRACT FROM AUTHOR]

Background: Epidemiology and treatment strategies continue to evolve in pulmonary arterial hypertension (PAH). We sought to define the characteristics and survival of patients with idiopathic, heritable and drug-induced PAH in the current management era.Methods: Consecutive cases of idiopathic, heritable and drug-induced PAH were prospectively enrolled into an Australian and New Zealand Registry.Results: Between January 2012 and December 2016, a total of 220 incident cases were enrolled (mean age 57.2±18.7years, female 69.5%) and followed for a median duration of 26 months (IQR17-39). Co-morbidities were common such as obesity (34.1%), systemic hypertension (30.5%), coronary artery disease (16.4%) and diabetes mellitus (19.5%). Initial combination therapy was used in 54 patients (dual, n=50; triple, n=4). Estimated survival rates at 1-year, 2-years and 3-years were 95.6% (CI 92.8-98.5%), 87.3% (CI 82.5-92.4%) and 77.0% (CI 70.3-84.3%), respectively. Multivariate analysis showed that male sex and lower 6-minute distance at diagnosis independently predicted worse survival, whereas obesity was associated with improved survival. Co-morbidities other than obesity did not impact survival. Initial dual oral combination therapy was associated with a trend towards better survival compared with initial oral monotherapy (adjusted HR=0.27, CI 0.06-1.18, p=0.082) CONCLUSIONS: The epidemiology and survival of patients with idiopathic PAH in Australia and New Zealand are similar to contemporary registries reported in Europe and North America. Male sex and poorer exercise capacity are predictive of mortality whereas obesity appears to exert a protective effect. Despite current therapies, PAH remains a life-threatening disease associated with significant early mortality. [ABSTRACT FROM AUTHOR]

Our radiotherapy department is situated onsite at a university-affiliated hospital where medical students undertake clinical rotations. However, no formal programme for attachments to the radiation oncology service was previously in place. Student experience was limited to occasional classroom-based lectures and sporadic contact with cancer patients while rotating through other clinical services. Under-exposure to radiation oncology (RO) (and oncology generally) during medical school is common. A 2016 survey of medical students at two US universities found that only 4% of third year and 7% of fourth year students completed an RO rotation (Osvarak et al 2016). And 47% of Australian and New Zealand medical students recently reported that RO was not incorporated into their curriculum at all (Bravery et al 2020). We identified improving medical student involvement as a priority for our department. We collaborated with tutors at the University to arrange for medical students to have allocated RO rotations during their clinical attachments at the hospital. Agreed learning objectives fitted into three categories: -fundamental clinical skills in history taking and physical examination -care of cancer patients -an introduction to RO and its role in the care of cancer patients. A multidisciplinary effort with involvement of consultant and trainee radiation oncologists, radiation therapists, nurses, and university representatives allowed us to develop a programme to deliver these learning objectives. The programme began in January 2022. One radiation oncologist takes overall responsibility for day-to-day operations and acts as the primary point of contact for the students and other staff members in case of any issues. Students receive tutorials on oncological emergencies and are involved in academic sessions in the department. They are supervised as they spend time contouring organs at risk and clinical targets and also have dedicated sessions with radiation therapists where they observe the delivery of external beam radiotherapy. Clinical experience is gained via attendance at outpatient clinics and on the inpatient oncology ward. Feedback on history taking and clinical examination is provided via tutorials with radiation oncologists and trainees. Students provided feedback which indicated that they had enjoyed their experience of the specialty and found the rotation beneficial. The rotation has been well-received by students and the university tutors. The primary goal of incorporating RO rotations into the medical school curriculum was successful and these attachments will continue in future. Involvement of relevant stakeholders within the department and the university contributed to the successful implantation. [ABSTRACT FROM AUTHOR]

Chronic thromboembolic pulmonary hypertension (CTEPH) is defined as pulmonary hypertension resulting from non-resolving fibro-thrombotic obstructions of pulmonary arteries. Pulmonary endarterectomy (PEA) remains the treatment of choice for disease that is technically operable. The epidemiology and long-term outcomes of CTEPH has not been previously described in Australia and New Zealand. Using PHSANZ registry, data was extracted for all CTEPH patients diagnosed between January 2004 and March 2020. We analysed baseline characteristics, treatment strategies, outcome data, and long-term survival. A total of 404 patients were included with 146 (36.1%) undergoing PEA and 258 (63.9%) in the non-PEA group. PEA patients were younger (55±16yr vs. 62±16yr) with higher baseline 6MWD (405±122m vs. 323±146m), whilst both groups had similar baseline pulmonary haemodynamics. Pulmonary vasodilator therapy was used in 50% of patients post-PEA, and 76% in the non-PEA group. Actual 1, 5, and 10-yr transplant-free survivals were 93%, 84% and 74% for the PEA group compared to 87%, 63% and 42% for the non-PEA group (log rank test, p < 0.001). Similar survival trends were found in an incident-only cohort. Multivariate survival analysis is shown in Table 1 for a cohort of patients with full data available (total n=342). In this first multicentre report of CTEPH in Australia and New Zealand, long-term survival is comparable to other contemporary registries. However, PEA was only offered to a minority of CTEPH patients and significantly less than overseas reports. Greater awareness and improved patient access to experienced CTEPH surgical centres are important priorities. Multivariate survival analysis showed baseline 6MWD was an independent predictor of survival in both operated and medically managed patients. [ABSTRACT FROM AUTHOR]