Justification for conducting neurological clinical trials as part of patient care within private practice.

The aim of this review was to assess the benefits and drawbacks of conducting neurological clinical trials and research in private practice for the patients, clinician, Practice Manager, sponsors/Clinical Research Organisations (CROs) and Clinical Trial Coordinator (CTC) to determine if this is justified for all involved. A combination of literature reviews, original research articles and books were selected from 2005 to 2015. Provided that the practice has sufficient number of active trials to prevent financial loss, support staff, adequate facilities and equipment and time, the benefits outweigh the drawbacks. Clinical trials provide patients with more thorough monitoring, re-imbursement of trial-related expenses and the opportunity to try an innovative treatment at no charge when other options have failed. For the clinician, clinical trials provide more information to ensure better care for their patients and improved treatment methods, technical experience and global recognition. Trials collect detailed and up-to-date information on the benefits and risks of drugs, improving society's confidence in clinical research and pharmaceuticals, allow trial sponsors to explore new scientific questions and accelerate innovation. For the CTC, industry-sponsored clinical trials allow potential entry for a career in clinical research giving CTCs the opportunity to become Clinical Research Associates (CRAs), Study Start-Up Managers or Drug Safety Associates.

Mandatory notification of impaired doctors.

Mandatory reporting of impaired doctors is compulsory in Australasia. Australian Health Practitioner Regulation Agency guidelines for notification claim high benchmark though the Royal Australasian College of Surgeons and the Royal Australasian College of Physicians suggest they still obstruct doctors seeking help. Western Australia excludes mandatory reporting of practitioner-patients. This study examines reporting, consequences and international experiences with notification. Depressed doctors avoid diagnosis and treatment, fearing consequences, yet are more prone to marital problems, substance dependence and needing psychotherapy. South African research confirms isolation of impaired doctors and delayed seeking help with definable characteristics of those at risk. New Zealand data acknowledge: errors occur; questionable contribution from mandatory reporting; issues concerning competence assessment; favouring reporting to senior colleagues or self-intervention to compliance with mandatory reporting. UK found an anaesthetist guilty of professional misconduct for not reporting and sanctioned doctors regarding Harold Shipman. Australians are reluctant to report, fearing legalistic intrusion into care. Australian research confirmed definable characteristics for doctors with psychiatric illness or alcohol abuse. Exposure to legal medicine evokes personal disenchantment for doctors involved. Medicine poses barriers for impaired doctors. Spanish and UK doctors do not use general practitioners and may have suboptimal care. US and European doctors self-medicate using samples. US drug-dependent doctors also prescribe for spouses. Junior doctors are losing empathy with the profession. UK doctors favour private care, avoiding public scrutiny. NZ and Brazil created specific services for doctors, which appear effective. Mandatory reporting may be counterproductive requiring reappraisal.

Analysis of the latest Austroads guidelines for fitness to drive as promulgated in March 2012.

After 9 years, Austroads has published new guidelines for fitness to drive. The guidelines have a preamble, which includes a legal disclaimer denying any culpability for those who designed the guidelines. They also warn of the legal responsibility for health professionals to satisfy their obligations, the need to be current with both relevant medical and legal expectations and if in doubt to seek guidance from Medical Defence Organisations. The guidelines are divided into Parts A and B, with A providing broad overview and background information while B deals with specific entities, such as blackouts, epilepsy or sleep disorders. This paper examines the guidelines and offers an appraisal of their content, their relevance to health practitioners and an assessment of their role in assisting to improve road safety.

Low positive predictive value of the ABCD2 score in emergency department transient ischaemic attack diagnoses: the South Western Sydney transient ischaemic attack study.

BACKGROUND: The ABCD(2) stroke risk score is recommended in national guidelines for stratifying care in transient ischaemic attack (TIA) patients, based on its prediction of early stroke risk. We had become concerned about the score accuracy and its clinical value in modern TIA cohorts. METHODS: We identified emergency department-diagnosed TIA at two hospitals over 3 years (2004-2006). Cases were followed for stroke occurrence and ABCD(2) scores were determined from expert record review. Sensitivity, specificity and positive predictive values (PPV) of moderate-high ABCD(2) scores were determined. RESULTS: There were 827 indexed TIA diagnoses and record review was possible in 95.4%. Admitted patients had lower 30-day stroke risk (n = 0) than discharged patients (n = 7; 3.1%) (P < 0.0001). There was no significant difference in proportion of strokes between those with a low or moderate-high ABCD(2) score at 30 (1.2 vs 0.8%), 90 (2.0 vs 1.9%) and 365 days (2.4 vs 2.4%) respectively. At 30 days the sensitivity, specificity and PPV of a moderate-high score were 57% (95% confidence interval (CI) 25.0-84.2), 32.2% (95% CI 29.1-35.6) and 0.75% (95% CI 0.29-1.91) respectively. CONCLUSIONS: Early stroke risk was low after an emergency diagnosis of TIA and significantly lower in admitted patients. Moderate-high ABCD(2) scores did not predict early stroke risk. We suggest local validation of ABCD(2) before its clinical use and a review of its place in national guidelines.

Glyphosate-surfactant herbicide-induced reversible encephalopathy.

Glyphosate-surfactant (GlySH) is a commonly used herbicide that has been used in attempted suicide. Most reports of GlySH toxicity in patients have followed ingestion of the commercial product "Round-up" (Monsanto Ltd; Melbourne, Victoria, Australia), which consists of a mixture of glyphosate (as a isopropylanine salt) and a surfactant (polyoxyethyleneamine). Ingestion of Round-up is reported to cause significant toxicity including nausea, vomiting, oral and abdominal pain. Renal and hepatic impairment and pulmonary oedema may also occur. Impaired consciousness and encephalopathy have been reported as sequelae but there are limited data on the central nervous system (CNS) effects of Round-up toxicity. We report a 71-year-old male who attempted suicide with GlySH and developed a prolonged but reversible encephalopathy suggestive of acute CNS toxicity.

The law(s) of the rings: boxing and the law.

To threaten harm is to assault and to realise that threat is to batter. To do so intentionally for the purpose of producing injury amounts to causing harm with intent and one cannot consent to be the victim of such violence. Despite these clearly enunciated legal principles, such conduct is routinely practised in the name of sport. Boxing is widely accepted as a highly paid professional sporting activity in which the ultimate goal is to inflict a concussive head injury upon an opponent or at least cause sufficient damage to render an opponent incapable of further self-defence. Spectators pay to watch the anticipated systematic abuse of one human being by another in much the same way they delighted in gladiators who were forced to fight for the pleasure of others. This article reviews these concepts and challenges the legal ethics of authorised violence associated with these activities undertaken in the name of sport.

Association between ulcerative colitis and multiple sclerosis.

An association between inflammatory bowel disease (IBD) and multiple sclerosis (MS) has been described. The current study was undertaken to explore this association further. Personal records of patients with IBD and MS were reviewed. In addition, a search of medical records at a large tertiary teaching hospital in Sydney was carried out for the years 1996-2006. Four patients (three women and one man) with both ulcerative colitis and MS were identified. MS did not occur in any of our patients with Crohn's disease. The association between ulcerative colitis and MS appears to be real and may help identify common factors involved in the cause of these two diseases. No association was found in this study between MS and Crohn's disease, sparking consideration why such difference should occur. With the increasing use of biological therapies in IBD and their reported propensity to cause demyelination, recognition of an association is all the more important.

Road not taken: lessons to be learned from Queen v. Gillett.

Following the decision in the Gillet Case it may no longer be safe to rely on the Austroads guidelines when considering fitness to drive. This paper examines the case and its implications. Although the Guidelines claimed '... the identification and application of world best-practice...', they were disregarded by the court in Gillet. Both expert witnesses testified that on disclosure of epilepsy the accused would have been endorsed as fit for a licence application to the Roads & Traffic Authority, on the basis of 10 years of only nocturnal seizures, in accordance with the guidelines. The Court rejected this evidence and interpreted failure to disclose epilepsy as recognition of perceived risk and the previously undiagnosed sleep apnoea as the basis for that risk, despite being diagnosed after the accident. There needs to be greater certainty in the application of the guidelines, with legislative intervention and licenses should display a bold statement advising drivers of their responsibility to notify authorities of illnesses that could potentially affect driving.

Legal implications of public health guidelines.

Medical guidelines aim to provide stylised procedures to manage illnesses. Doctors might believe that conforming to guidelines provides protection within legal proceedings. Guidelines were deemed inadmissible evidence in Regina v Ross Gillett, raising some concerns. Gillett was a middle aged man who denied having epilepsy when applying for a driver's licence and was involved in a car crash which killed three people. He had confirmed epilepsy yet expert witnesses testified he was within AUSTROADS Guidelines for fitness to drive. The judge refused to admit these Guidelines into evidence, finding the defendant guilty of dangerous driving occasioning death. The Guidelines were endorsed by all Australian and New Zealand traffic authorities, seven medical colleges, two sub-specialty faculties, seventeen illness-related organisations plus the Australian Medical Association. Their purpose was to achieve "...best practice for the safe and effective management and use of the road system...". The judge rejected them when considering his verdict. Precedence demands the judiciary consider all relevant data although the Guidelines were deemed irrelevant and could not be admitted into evidence. Guidelines cannot bind the court unless enforced by legislation. It is difficult for doctors to comprehend how Guidelines, designed to determine optimal road usage, can be excluded when analysing a road accident. Doctors need to be circumspect about applying Guidelines in the wake of Gillett.

Opinions, attitudes and practices of Australian neurologists with regard to epilepsy and driving.

INTRODUCTION: Austroads Guidelines for fitness to drive were promulgated in 2003. Epilepsy was one of the conditions included and this paper reports results of a survey of Australian neurologists regarding opinions and practices relevant to the guidelines. METHODS: The survey was developed, piloted and Human Research Ethics Committee approved. Members of the Australian Association of Neurologists received three mailings and results were analysed. RESULTS: Almost 70% of 236 surveyed indicated assessment of epilepsy and driving with <9% not doing so--establishing approximately 77% response for eligible neurologists. Most questions achieved 90% response. Almost 90% respondents assessed epilepsy and 70% found the guidelines helpful. Seventy-seven per cent endorsed doctor assessors although half discounted General Practitioners as insufficiently knowledgeable and half advocated that only neurologists evaluate potential drivers with epilepsy. Most respondents supported reporting recalcitrant patients; yet only <30% did so. Three-quarters favoured licences carrying a warning to self-report and two-thirds felt that product information should identify driving implications. Although many questions attracted expected responses, the surprise was the large undecided numbers, which were greater than expected. Neurologists were more lenient than prescribed by the guidelines with neither consensus for controlled epilepsy nor mandatory driving restrictions. CONCLUSION: Respondents supplied predictable answers regarding ideal circumstances; yet most did not report recalcitrant patients. Most claimed to adhere to the guidelines and yet advocated more lenient driving restrictions that may allow preventable accidents. There was agreement between neurologists and guidelines for more rigorous restrictions for commercial drivers although again neurologists were more lenient. There is need for prospective research on epilepsy and driving.

Ethics in clinical drug trial research in private practice.

INTRODUCTION: Private clinics and clinicians have been involved in clinical drug trials for approximately two decades. This paper reviews the ethical consideration inherent in this process. METHODS: Involvement of a single community based, private, Australian neurological clinic in the conduct of trials was audited. Changes in ethical considerations were analysed. RESULTS: The clinic previously audited its clinical trial involvement, starting with pharmaceutical company orchestrated trials. These were vetted by hospital based ethics committees (ECs) which then refused to review private research. A private EC accommodating NH & MRC standards was formed to assess private research. Indemnity concerns forced return to institutional ECs with government guaranteed indemnification. Trials evolved to investigator initiated, company sponsored studies thence a company asking the clinic to devise, sponsor and manage a trial. The latter relegated trial co-ordination to the clinic which would control publication thereby creating new ethical standards. DISCUSSION: Private practice trial involvement evolved from reluctant inclusion to a pivotal role in privately sponsored studies. Access to ECs is government endorsed and publication is independent for investigator-sponsored trials. There has been modification of standard operating procedures and enhanced ethical standards.

Analysis and overview of the guidelines for assessing fitness to drive for commercial and private vehicle drivers.

Guidelines on fitness to drive were released by AUSTROADS and the National Road Transport Commission in September 2003. No recognised legal medical authority was cited. There are three parts in the document: (i) background information, (ii) specific medical conditions and (iii) appendices of relevant documents and contacts. This paper analyses the relevance of the guidelines for physicians and notes that the disclaimer exonerates its authors from potential repercussions. Guidelines for both private and commercial drivers are combined in the document and the basis for such delineation is defined. A lack of universal Australian standards with no State indicating the driver's responsibility to report changes in health standards on the issued licences is confirmed by the guidelines. Not all States indemnify physicians for reporting contrary to patients' wishes, while South Australia and the Northern Territory mandate reporting those at risk. Much of the language is patronizing, expecting '... conciliatory and supportive ...' behaviour even with recalcitrant patients. No allowance is made for patients who may not fulfil the guidelines but whom the doctor may consider fit to drive. Ambiguity regarding responsibility to report, as identified in the background section, may leave the doctor vulnerable for not reporting a patient who subsequently may cause injury. Attempt is made to differentiate the role of the specialist from the family general practitioner (GP), advocating specialists for commercial drivers, although this is largely left to the discretion of the GP. There is an implied onus on doctors to report all patients with the conditions under review. Some diagnoses, such as syncope, are discussed in different sections with application of conflicting limitations. Inappropriate language, such as reference to a seizure being '... an isolated non-epileptiform event ...', or withdrawal of medications failing to be restricted to anti-epileptic medications confounds interpretation. Some sections, such as that on sleep and epilepsy, are effectively analysed, while illnesses such as dementia are considered superficially. The guidelines are an attempt to assess fitness to drive, but contain serious flaws and provide limited information upon which to base decisions. Ambiguous language complicates application of the guidelines and places the health care professional at risk, despite a disclaimer protecting its authors.

Adverse events in medical management--vigabatrin as a paradigm of forensic responsibility with novel therapy.

The ethics of medical management are not always straightforward. There are many contributing factors: the condition treated; its effects on the patient; the required treatment; the effects of that treatment; and a cost/benefit ratio. Treatment of epilepsy with vigabatrin (VGB) exemplifies these problems. VGB has recently been reported to cause constricted visual fields. Formal testing of visual fields of patients attending an outpatient epilepsy service showed constriction with tunnel vision, even in patients who are asymptomatic. The ethical questions include: Should all reports of adverse events be subjected to tests of validity and subsequent quality assurance? Should treatment with VGB be stopped, risking recurrence of seizures? What are the legal consequences of continuing VGB? Does informed consent protect the doctor? After stopping VGB can the patient drive?