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R G Beran

Publications and source records attributed to R G Beran.

At least 19 recordsLinked to original sources
PubMed2006

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.

Australia↗
PubMed2005

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.

Australia↗
PubMed2001

Pilot study of prevalence of Parkinson's disease in Australia.

Parkinson's disease is a common neurological disease and its prevalence increases with age. Because of an ageing population and changing environment compared to the last epidemiological study done in Australia over 30 years ago, we have conducted a door-to-door pilot survey which looked at the latest prevalence as well as putative risk factors in a random population. We used a two-phase investigation method (screening followed by detailed examination) in a random community sample of 2,820 households (with 527 individuals aged 55 and over) along with 203 residents in aged care facilities (single-phase examination for residents aged 55 and above) in the Randwick area of Sydney, New South Wales. We had a 75% participation rate in the community and a 94% in the aged care facilities. The results of the survey in this sample of 730 subjects indicated that the crude prevalence of Parkinson's disease was between 3.6 and 4.9% (higher in the aged care facilities). The putative risk factors positively identified using chi-square method were 'family history' (p < 0.01) and 'exposure to chemicals at work or in surrounding environment' (p < 0.05). The age-adjusted prevalence rate of Parkinson's disease revealed at least a 42.5% increase in the disease compared to 1966. We conclude that there may be an increase in the disease in Australia due to ageing and other risk factors.

Aged↗
PubMed2001

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?

Anticonvulsants↗
PubMed2001

Ethical dilemmas of potential adverse events.

Doctors should advise patients of recognised adverse events of proposed therapy. It remains unclear what responsibility attaches to suspected potential for adverse events if these have not been reported. Vigabatrin (VGB) is a gabaergic anti-epileptic medication (AEM) reported to produce tunnel vision with constricted fields. Tiagabine (TGB), also a gabaergic AEM recently approved for sale, has not been reported to cause field defects but raising GABA also raises concern. Doctors must decide what needs to be discussed with patients; should patients on TGB have field testing similar to those on VGB; what should be done if constricted fields are confirmed in asymptomatic patients; and what reporting procedures should be adopted.

Anticonvulsants↗
PubMed2001

The ethics of post-marketing surveillance of therapeutic agents.

Trials of new therapies have strict codes of conduct which expect the highest of ethical practice. Local ethics committees review protocols, patient information, consent. National research councils delineate guidelines for minimum standards regarding subjects in such trials. Once medications enter the market place, there is less definition of minimal codes of conduct. Clinical trials are designed to meet regulatory demands to access commercial markets. Prior to marketing, there is a usual drug trial exposure of less than 5,000 individuals which diminishes identification of rare adverse events. Australian case law has found negligence for not warning of a 1:14,000 risk of sympathetic ophthalmia and more recently, in Chappel v Hart, even a speculative risk was grounds for negligence. Recent reports of serious adverse events for conditions such as epilepsy or depression resulted in companies appearing to expend considerable effort to suppress concern rather than to seriously investigate these complications in the post marketing period. This paper will explore such cases and discuss approaches to improve post marketing surveillance and patient protection.

Adverse Drug Reaction Reporting Systems↗
PubMed2000

Facial pain as a presenting feature of intracerebral haemorrhage.

A literature review from 1966 using Medline with keywords 'cerebral haemorrhage' and 'facial pain' failed to reveal any cases in which facial pain was the initial feature of intracranial haemorrhage. The following case describes ipsilateral facial pain which is previously undescribed as a presentation of intracranial bleeding. A 53 year old female who was previously well, with no significant history of headache, developed right facial pain from the orbit to the maxilla. Ten to 15 min later she developed nausea and vomiting with unsteadiness and confusion. She had difficulty with left-hand fine finger movements, with normal sensation and reflexes but an extensor plantar response on the left. Facial pain persisted for 3 days. Initial imaging revealed a 4 x 3 cm right temporal lobe haemorrhage with mass effect and oedema extending into the subarachnoid space. Angiogram revealed a right temporal lobe arteriovenous malformation. The basis of the pain remains speculative but includes sensation from the torn vessel wall being referred to the face and subarachnoid blood irritation of the meninges in the middle cranial fossa. Another possibility is irritation of somatosensory cortex II, but why this should result in only ipsilateral pain is unclear. Facial pain should be an alerting symptom to the neurologist when it appears with no apparent cause.

Brain↗
PubMed2000

Conduct of trials in private clinical practice.

PURPOSE: Trials of antiepileptic medications are usually based in tertiary referral centers with teaching hospital resources. Epilepsy Research & Services (ERS) is part of a private outpatient neurological clinic that is involved in research as part of multicenter clinical trials, adhering to Good Clinical Research Practice. ERS is subject to external monitoring and auditing, but does so outside of the teaching hospital environment. METHODS: The clinic is operated by a neurologist supported by a research assistant, administrative and nursing staff and has no formal university attachment. Patients are recruited for trials from routine referrals for clinical care. The center has formal ties with the ethics committee of the local teaching hospital, but none of the team is formally attached to that hospital. RESULTS: The center conducted trials of zonisamide, oxcarbazepine, gabapentin, remacemide, tiagabine, vigabatrin, felbamate, and lamotrigine both as add-on trials in refractory seizure disorders and as monotherapy trials in de novo epilepsy. More than 200 patients have been recruited for trials at ERS (with some patients being involved in more than one trial). External review endorsed ERS as a superior environment for such research and as a model for other centers. CONCLUSIONS: Private practice is a viable alternative for the conduct of clincial trials and should be considered when establishing such protocols. Simplicity of administration and clinical practice, which more closely mirrors standard patient care, may enhance recruitment and management.

Ambulatory Care Facilities↗
PubMed2000

Validating a screening questionnaire for parkinsonism in Australia.

Parkinson's disease is a common neurodegenerative disorder in elderly people. Epidemiological studies of the disease can be labour intensive. A two phase design including a screening questionnaire as the first phase has become a popular method in prevalence studies of Parkinson's disease. Such a design has many advantages including less work for assessing physicians and enhanced recruitment of people to be screened. However, its wider application may be questioned because validation has been limited to samples that are drawn from hospitals (or clinics) and may be inappropriate for a community setting. This study assesses whether validating screening questionnaire by using a hospital sample yields the same result as a community based sample. Furthermore, it seeks to establish whether the screening instrument can be simplified to involve less questions. The findings show that some of the questions used in the screening phase yield different responses when comparing a hospital group with a community group. This study also provides a simplified model of questions that may be relevant for screening in the community setting.

Aged↗
PubMed2000

The ethics of clinical research and the conduct of clinical drug trials: international comparisons and codes of conduct.

Human research must respect most rigorous ethical standards to protect both the investigators and subjects. Codes of ethical practice relevant to such research are subjected to reviews around the world including The European Union (EU), the Canadian Tri-Council Policy Statement (including the Medical Research Council, the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council), the Finnish Parliament Research Act (April 1999) and the National Statement on Ethical Conduct in Research Involving Humans in accordance with the NHMRC Act 1992 (Cth) from the National Health and Medical Research Council of Australia. The Australian Statement was endorsed by the Australian Vice-Chancellors' Committee, the Australian Research Council, the Australian Academy of the Humanities, the Australian Academy of Science and the Academy of Social Sciences in Australia and supported by the Academy of Technological Sciences and Engineering. This reflects the extensive ramifications of human experimentation and the range of stack holders. Private organisations have also produced interpretations of minimum standards of good clinical practice. The paper that follows analyses approaches to human experimentation and the minimal ethical expectations in the conduct of such research.

Australia↗
PubMed1999

Interface of epilepsy and sleep disorders.

Obstructive sleep apnoea was first brought to prominence by Henri Gastaut, a French epileptologist. Since that time the interface between epilepsy and sleep disorders has received less attention than might be justified, recognizing that sleep deprivation is a poignant provocateur for seizures. Sleep deprivation is often used as a diagnostic procedure during electroencephalography (EEG) when waking EEG has failed to demonstrate abnormality. Patients referred to an outpatient neurological clinic for evaluation of possible seizures in whom sleep disorder was suspected, either due to snoring during the EEG or based on history, were evaluated with all-night diagnostic polysomnography (PSG) and appropriate intervention administered as indicated. Patient and seizure demography, sleep disorder and response to therapy were reviewed and the interface explored. Fifty patients aged between 10 and 83 years underwent PSG. Approximately half were diagnosed with epilepsy and almost three-quarters had sleep disorders sufficiently intrusive to require therapy (either continuous positive air pressure (CPAP) or medication). With co-existence of epilepsy and sleep disorders, proper management of sleep disorders provided significant benefit for seizure control. Snoring during EEG recordings could alert to the possibility of a sleep disorder even with epilepsy diagnosed. Where both epilepsy and sleep disorder coexist appropriate management of the sleep disorder improves control of the epilepsy.

Adult↗
PubMed1998

Confidentiality and the management of patients with epilepsy who fail to comply with doctor's advice not to drive: a survey of medical/legal opinions in Australia.

This study sought the opinions of a select group of professionals, trained in medicine and law concerning: professional privilege; management of patients who posed risks to society; and the legal charge to impose upon a patient with uncontrolled epilepsy who caused a fatality by driving contrary to medical advice. The second Academic Seminar of the Australian College of Legal Medicine was surveyed to define demographics and opinions. Of 23 respondents, 14 were trained in law and medicine, of whom eight had post graduate medical qualifications and seven had more than basic legal training; 20/23 supported professional privilege in medicine but 18/23 denied its absoluteness; 22/23 felt the doctor had a right to divulge information in the public interest. Only 14/23 (although still a majority opinion) felt this right was a duty and 6/23 refuted the same. When concerned regarding compliance not to drive, 7/23 would discuss it with family/friends in contravention of patient consent, 12/23 would report to the driving authorities where concern became fact, 13/23 would advise the patient that a report would be sent, 4/23 would report without the patient's knowledge and four would threaten but not send the report. In the case of a fatality consequent to non-compliance, 10/23 considered murder and 22/23 considered manslaughter charges to be appropriate. The majority supported professional privilege in the doctor/patient relationship but also supported the right or even a duty to report risks to society. Where a concern arose that a patient with epilepsy may drive contrary to advice, one-third of doctors would discuss with family/friends, without consent, one-half would report the patient to the driving authorities, while almost three-quarters would report the patient if concern was realised. Murder and manslaughter, serious charges, were deemed appropriate for patients who caused death by driving against medical advice.

Australia↗