Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-seventh Congress, second session. Agency coordination study (pursuant to S. Res. 276, 87th Cong.). Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. ...

Pt. 4-5 titles vary: "Eighty-eighth Congress, first session. Agency Coordination Study (pursuant to S. Res. 27, 88th Cong., as amended). Review of cooperation on drug policies among (the) Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies.

Regulation of trade in drugs: hearings, Ninety-first Congress, second session, on S. 1575, to regulate trade in drugs and devices by prohibiting the dispensing of drugs or devices by medical practitioners and their participation in profits from the dispensing of such products, except under certain circumstances, and for other purposes, June 16 and 17, 1970.

"Serial no. 91-81."

Feel it and deal with it: mental health practitioners' experiences of exposure to the trauma of survivor clients

Empathic engagement by the trauma therapist with another person's traumatic experiences is believed to create risks for the helping professional. Much attention has been focused upon the mental health professional experiencing symptoms of distress as a result of their exposure to the material of clients who survive traumatic incidents. This thesis contains the findings of a qualitative study that centres on a group of male mental health professionals and their experiences of exposure to the trauma material of survivor clients. The participants of the study practise within an internal Employee Assistance Program that provides, among other duties, a 24 hour, 7 day response to critical incidents to a heavy transport industry. Using semi-structured, in-depth interviews, the effects on the trauma therapists are explored by analysing their reactions to their survivor clients' accounts, the impact of these experiences upon their psychological schema, the organisational culture in which they practise and its influence upon their experiences and the methods participants use to cope with the psychological effects of exposure to trauma material. Participants' experiences are closely examined for critical comparisons with vicarious traumatization. Therapists' responses reveal their continued ability and motivation to empathically engage with the trauma material of survivor clients despite the potential risks.

Understanding data collection behaviour of mental health practitioners

Failure to detect patients at risk of attempting suicide can result in tragic consequences. Identifying risks earlier and more accurately helps prevent serious incidents occurring and is the objective of the GRiST clinical decision support system (CDSS). One of the problems it faces is high variability in the type and quantity of data submitted for patients, who are assessed in multiple contexts along the care pathway. Although GRiST identifies up to 138 patient cues to collect, only about half of them are relevant for any one patient and their roles may not be for risk evaluation but more for risk management. This paper explores the data collection behaviour of clinicians using GRiST to see whether it can elucidate which variables are important for risk evaluations and when. The GRiST CDSS is based on a cognitive model of human expertise manifested by a sophisticated hierarchical knowledge structure or tree. This structure is used by the GRiST interface to provide top-down controlled access to the patient data. Our research explores relationships between the answers given to these higher-level 'branch' questions to see whether they can help direct assessors to the most important data, depending on the patient profile and assessment context. The outcome is a model for dynamic data collection driven by the knowledge hierarchy. It has potential for improving other clinical decision support systems operating in domains with high dimensional data that are only partially collected and in a variety of combinations.

Regulation of human stem cell research in Australia

Australia is currently well placed to contribute to the global growth of human stem cell research. However, as the science has progressed, authorities have had to deal with the ongoing challenges of regulating such a fast moving field of scientific endeavour. Australia’s past and current approach to regulating the use of embryos in human embryonic stem cell research provides an insight into how Australia may continue to adapt to future regulatory challenges presented by human stem cell research. In the broader context, a number of issues have been identified that may impact upon the success of future human stem cell research in Australia.

Views of general practitioners and benzodiazepine users on benzodiazepines : a qualitative analysis

Effectively assisting benzodiazepine users to cease use requires a greater understanding of general practitioners’ (GPs)and benzodiazepine users’ views on using and ceasing benzodiazepines. This paper reports the findings from a qualitative study that examined the views of 28 GPs and 23 benzodiazepine users (BUs) in Cairns, Australia. A semistructured interview was conducted with all participants and the information gained was analysed using the Consensual Qualitative Research Approach, which allowed comparisons to be made between the views of the two groups of interviewees. There was commonality between GPs and BUs on reasons for commencing benzodiazepines, the role of dependence in continued use, and the importance of lifestyle change in its cessation. However, several differences emerged regarding commencement of use and processes of cessation. In particular, users felt there was greater need for GPs to routinely advise patients about non-pharmacological management of their problems and potential adverse consequences of long-term use before commencing benzodiazepines. Cessation could be discussed with all patients who use benzodiazepines for longer than 3 months, strategies offered to assist in management of withdrawal and anxiety, and referral to other health service providers for additional support. Lifestyle change could receive greater focus at all stages of treatment.

The impact of health information technology on the quality of medical and health care : a systematic review

Objective: To systematically review the published evidence of the impact of health information technology (HIT) on the quality of medical and health care specifically clinicians’ adherence to evidence-based guidelines and the corresponding impact this had on patient clinical outcomes. In order to be as inclusive as possible the research examined literature discussing the use of health information technologies and systems in both medical care such as clinical and surgical, and other health care such as allied health and preventive services.----- Design: Systematic review----- Data Sources: Relevant literature was systematically searched on English language studies indexed in MEDLINE and CINAHL(1998 to 2008), Cochrane Library, PubMed, Database of Abstracts of Review of Effectiveness (DARE), Google scholar and other relevant electronic databases. A search for eligible studies (matching the inclusion criteria) was also performed by searching relevant conference proceedings available through internet and electronic databases, as well as using reference lists identified from cited papers.----- Selection criteria: Studies were included in the review if they examined the impact of Electronic Health Record (EHR), Computerised Provider Order-Entry (CPOE), or Decision Support System (DS); and if the primary outcomes of the studies were focused on the level of compliance with evidence-based guidelines among clinicians. Measures could be either changes in clinical processes resulting from a change of the providers’ behaviour or specific patient outcomes that demonstrated the effectiveness of a particular treatment given by providers. ----- Methods: Studies were reviewed and summarised in tabular and text form. Due to heterogeneity between studies, meta-analysis was not performed.----- Results: Out of 17 studies that assessed the impact of health information technology on health care practitioners’ performance, 14 studies revealed a positive improvement in relation to their compliance with evidence-based guidelines. The primary domain of improvement was evident from preventive care and drug ordering studies. Results from the studies that included an assessment for patient outcomes however, were insufficient to detect either clinically or statistically important improvements as only a small proportion of these studies found benefits. For instance, only 3 studies had shown positive improvement, while 5 studies revealed either no change or adverse outcomes.----- Conclusion: Although the number of included studies was relatively small for reaching a conclusive statement about the effectiveness of health information technologies and systems on clinical care, the results demonstrated consistency with other systematic reviews previously undertaken. Widescale use of HIT has been shown to increase clinician’s adherence to guidelines in this review. Therefore, it presents ongoing opportunities to maximise the uptake of research evidence into practice for health care organisations, policy makers and stakeholders.

The Capability of Nurse Practitioners may be Diminished by the Use of Controlling Protocols

Nurse practitioners will become a vital component of the health workforce because of the growing need to manage chronic illness, to deliver effective primary health services, and to manage workforce challenges effectively. In addition, the role of nurse practitioner is an excellent example of increased workforce flexibility and changes to occupational boundaries. This paper draws on an Australasian research project which defined the core role of nurse practitioners, and identified capability as the component of their level of practice that makes their service most useful. We argue that any tendency to write specific protocols to define the limits of nurse practitioner practice will reduce the efficacy of their contribution. The distinction we wish to make in this paper is between guidelines aiming to support practice, and protocols which aim to control practice.

Physical activity and regulation of food intake: current evidence

Objective: The evidence was reviewed on how physical activity could influence the regulation of food intake by either adjusting the sensitivity of appetite control mechanisms or by generating an energy deficit that could adjust the drive to eat. Design: Interventionist and correlational studies that had a significant influence on the relationship between physical activity and food intake were reviewed. Interventionist studies involve a deliberate imposition of physical activity with subsequent monitoring of the eating response. Correlational studies make use of naturally occurring differences in the levels of physical activity (between and within subjects) with simultaneous assessment of energy expenditure and intake. Subjects: Studies using lean, overweight, and obese men and women were included. Results: Only 19% of interventionist studies report an increase in energy intake after exercise; 65% show no change and 16% show a decrease in appetite. Of the correlational studies, approximately half show no relationship between energy expenditure and intake. These data indicate a rather loose coupling between energy expenditure and intake. A common sense view is that exercise is futile as a form of weight control because the energy deficit drives a compensatory increase in food intake. However, evidence shows that this is not generally true. One positive aspect of this is that raising energy expenditure through physical activity (or maintaining an active life style) can cause weight loss or prevent weight gain. A negative feature is that when people become sedentary after a period of high activity, food intake is not “down-regulated” to balance a reduced energy expenditure. Conclusion: Evidence suggests that a high level of physical activity can aid weight control either by improving the matching of food intake to energy expenditure (regulation) or by raising expenditure so that it is difficult for people to eat themselves into a positive energy balance.

The regulation of food intake in humans

Knowledge of the regulation of food intake is crucial to an understanding of body weight and obesity. Strictly speaking, we should refer to the control of food intake whose expression is modulated in the interests of the regulation of body weight. Food intake is controlled, body weight is regulated. However, this semantic distinction only serves to emphasize the importance of food intake. Traditionally food intake has been researched within the homeostatic approach to physiological systems pioneered by Claude Bernard, Walter Cannon and others; and because feeding is a form of behaviour, it forms part of what Curt Richter referred to as the behavioural regulation of body weight (or behavioural homeostasis). This approach views food intake as the vehicle for energy supply whose expression is modulated by a metabolic drive generated in response to a requirement for energy. The idea was that eating behaviour is stimulated and inhibited by internal signalling systems (for the drive and suppression of eating respectively) in order to regulate the internal environment (energy stores, tissue needs).