Quality assurance experience with the randomized neuropathic bone pain trial (Trans-Tasman Radiation Oncology Group, 96.05)

Background and purpose: Trans-Tasman Radiation Oncology Group 96.05 is a prospective randomized controlled trial comparing a single 8 Gy with 20 Gy in five fractions of radiotherapy (RT) for neuropathic pain due to bone metastases. This paper summarizes the quality assurance (QA) activities for the first 234 patients (accrual target 270). Materials and methods: Independent audits to assess compliance with eligibility/exclusion criteria and appropriateness of treatment of the index site were conducted after each cohort of approximately 45 consecutive patients. Reported serious adverse events (SAEs) in the form of cord/cauda equina compression or pathological fracture developing at the index site were investigated and presented in batches to the Independent Data Monitoring Committee. Finally, source data verification of the RT prescription page and treatment records was undertaken for each of the first 234 patients to assess compliance with the protocol. Results: Only one patient was found conclusively not to have genuine neuropathic pain, and there were no detected 'geographical misses' with RT fields. The overall rate of detected infringements for other eligibility criteria over five audits (225 patients) was 8% with a dramatic improvement after the first audit. There has at no stage been a statistically significant difference in SAEs by randomization arm. There was a 22% rate of RT protocol variations involving ten of the 14 contributing centres, although the rate of major dose violations (more than +/- 10% from protocol dose) was only 6% with no statistically significant difference by randomization arm (P = 0.44). Conclusions: QA auditing is an essential but time-consuming component of RT trials, including those assessing palliative endpoints. Our experience confirms that all aspects should commence soon after study activation. Crown Copyright (C) 2003 Published by Elsevier Science Ltd. All rights reserved.

Unsafe driving behaviour and four wheel drive vehicles: observational study

Objective To assess the level of compliance with the new law in the United Kingdom mandating penalties for rising a hand held mobile phone while driving, to compare compliance with this law with the one on the use of seat belts, and to compare compliance with these laws between drivers of four wheel drive vehicles and drivers of normal cars. Design Observational study with two phases-one within the grace period, the other starting one week after penalties were imposed on drivers using such telephones. Setting Three busy sites in London. Participants Drivers of 38 182 normal cars and 2944 four wheel drive vehicles. Main outcome measures Proportions of drivers seen to be using hand held mobile phones and not using seat belts. Results Drivers of four wheel drive vehicles were more likely than drivers of other cars to be seen using hand held mobile phones (8.2% v 2.0%) and not complying with the law on seat belts (19.5% v 15.0%). Levels of non-compliance with both laws were slightly higher in the penalty phase of observation, and breaking one law was associated with increased likelihood of breaking the other. Conclusions The level of non-compliance with the law on the use of hand held mobile phones by drivers in London is high, as is non-compliance with the law on seat belts. Drivers of four wheel drive vehicles were four times more likely than drivers of other cars to be seen using hand held mobile phones and slightly more likely not to comply with the law on seat belts.

The impact of a reduction in drug supply on demand for and compliance with treatment for drug dependence

Background: In early 2001, Australia experienced a sudden, dramatic and;sustained decrease in heroin availability that was accompanied by sharp increases in price and decreases in street level purity-the so-called heroin shortage. These unprecedented changes occurred in a context of widespread treatment availability, which made it possible for the first time to examine the impact of a sharp reduction in heroin supply in New South Wales (NSW) on entry to and adherence with treatment for heroin dependence. Given the evidence of drug substitution by some users. the current paper also examines the effects of the shortage on entry to treatment for other forms of drug dependence. Methods: Interrupted time-series analysis of the number of persons entering opioid pharmacotherapy and other treatment modalities in NSW for heroin dependence and for the treatment for other types of drug dependence. Findings: The heroin shortage was associated with a reduction in the number of younger persons entering opioid pharmacotherapy. There was a dramatic decrease in the number of persons entering heroin withdrawal or assessment only treatment episodes. There appear to have been small improvements in adherence to and retention in heroin treatment after the reduction in heroin supply. Relatively small increases were observed in numbers being treated for cocaine dependence. Conclusions: In the context of good treatment provision, a reduction in heroin supply appeared to produce modest improvements in intermediate outcomes. Supply and demand reduction measures, when both are implemented successfully, may be complementary. (c) 2005 Elsevier Ireland Ltd. All rights reserved.

Lawyers and the third dimension : A Solicitor v Council of the Law Society of New South Wales

Casenote and comment on the High Court case of A Solicitor v Council of the Law Society of New South Wales which dealt with the issue of whether a solicitor, convicted of aggravated indecent assault, should be allowed to continue practicing law.

Myths and Truths: The "Law and Finance Theory" Revisited

The law and finance theory identifies two dominating legal traditions, a common law tradition inherited from England, and a civil law tradition that is going back to 19th century codifications in France, Germany and Scandinavia. Another key notion of the theory is the distinction between insiders (stakeholders, "the State") and outsiders (shareholders as well as creditors). The micro foundation of this approach is the willingness to invest. The innovative addition of the law and finance theory to these ideas lies in the way it combines them with its peculiar view on legal history. The innovative addition of the law and finance theory to these ideas lies in the way it combines them with its peculiar view on legal history. The major conclusion of this theory is that the common law system provides the best basis for financial development and economic growth, followed by Scandinavian and German origin civil law and finally French origin civil law.

Emerging Structures of Farmer Cooperatives in Vietnam: Case studies from the Mekong Delta

Four farmer groups for mango production and marketing were formed in 2002 in southern Vietnam in response to government support for the creation of market oriented farmer cooperatives. The role and structure of these groups is considered in terms of the degree to which they conform to internationally recognised principles for cooperative formation. Each of the farmer groups studied has evolved in different ways and their degree of compliance with the principles of cooperation varies widely. It is evident that state intervention and market forces may give rise to cooperative structures that differ from that intended under the principles surrounding cooperative law.

With the best of intentions: Is it possible to meet the CARI guidelines?

The CARI1 draft dialysis guidelines propose evidence based targets for biochemical and haematological parameters in ESRF. As part of a prospective randomised trial we investigated our ability to apply the CARI and National Heart Foundation of Australia targets to a representative dialysis population. All patients aged between 18–80 yrs were encouraged to enroll regardless of prior history of non-compliance or co-morbidity. Patients were randomised to either usual care (U;n = 44) or focussed care (F;n = 45). Usual care involved monthly blood tests and pysician review second monthly. In addition focus care patients had a monthly review in a physician supervised trial clinic run by nurses. The groups were comparable at baseline in terms of age, gender, dialysis modality, proportion of diabetics, time on dialysis, haemoglobin, ferritin, % saturation, parathyroid hormone, serum corrected calcium, serum phosphate, total cholesterol and LDL. At 6 months there had been significant improvements in PTH (p < 0.05), total cholesterol (p < 0.05) and LDL (p < 0.001), and a trend to better BP control. The proportion of patients meeting targets at 6 months were as follows: tot chol < 5 mmol/l-U 63%, F 82%; LDL < 3 mmol/l-U 75%, F 91%; phosphate < 1.8 mmol/l- U 42%, F 62%; PTH < 21 pmol/l-U 21%, F 40%; BP sys < 140 mmHg-U 41% F 46%; Hb > 11.5 g/dl U 58% F 64%. In spite of an intensive programme to maximise management of the haematological and biochemical parameters in patients with ESRF it appears that in a significant proportion of patients these targets could not be reached. 1The CARI Guidelines (Caring for Australians with Renal Impairment). Australian Kidney Foundation & Australia New Zealand Society of Nephrology, 2001.