Do we need a law to help people try experimental drugs?

People with life-threatening or incurable diseases may be willing to try experimental drugs and unproven treatments, but they face the risk of exploitation. Is the law the best avenue to ensure that they are protected while medical innovation is encouraged? Protection of vulnerable people is a thread running through many laws, in Australia and elsewhere. In medical law, for instance, children and people with impaired decision-making capacity warrant special attention. But what of the ordinary person diagnosed with a life-threatening disease? Such people are vulnerable to harm and potential exploitation when they seek access to innovative, experimental or unproven treatments that depart from the existing range of accepted medicine.

A comparison between conductive and infrared devices for measuring mean skin temperature at rest, during exercise in the heat, and recovery

Purpose: Skin temperature assessment has historically been undertaken with conductive devices affixed to the skin. With the development of technology, infrared devices are increasingly utilised in the measurement of skin temperature. Therefore, our purpose was to evaluate the agreement between four skin temperature devices at rest, during exercise in the heat, and recovery. Methods: Mean skin temperature (T̅sk) was assessed in thirty healthy males during 30 min rest (24.0± 1.2°C, 56 ± 8%), 30 min cycle in the heat (38.0 ± 0.5°C, 41 ± 2%), and 45 min recovery(24.0 ± 1.3°C, 56 ± 9%). T̅sk was assessed at four sites using two conductive devices(thermistors, iButtons) and two infrared devices (infrared thermometer, infrared camera). Results: Bland–Altman plots demonstrated mean bias ± limits of agreement between the thermistors and iButtons as follows (rest, exercise, recovery): -0.01 ± 0.04, 0.26 ± 0.85, -0.37 ± 0.98°C; thermistors and infrared thermometer: 0.34 ± 0.44, -0.44 ± 1.23, -1.04 ± 1.75°C; thermistors and infrared camera (rest, recovery): 0.83 ± 0.77, 1.88 ± 1.87°C. Pairwise comparisons of T̅sk found significant differences (p < 0.05) between thermistors and both infrared devices during resting conditions, and significant differences between the thermistors and all other devices tested during exercise in the heat and recovery. Conclusions: These results indicate poor agreement between conductive and infrared devices at rest, during exercise in the heat, and subsequent recovery. Infrared devices may not be suitable for monitoring T̅sk in the presence of, or following, metabolic and environmental induced heat stress.

The safety of bicycles being overtaken by cars : what do we know and what do we need to know?

Many cyclist deaths and serious injuries result from rear-end or sideswipe collisions involving a car or heavy vehicle. As a consequence, minimum passing distance laws (often referred to as ‘one metre rules’) have been introduced in a number of U.S. states along with European countries such as France, Belgium and Spain. A two-year trial of a minimum passing distance rule is underway in Queensland. The international studies show that while the average passing distance is more than one metre, significant proportions of passes occur at less than this distance. Average passing distances are greater with wider lanes, when bicycle lanes are present, for cars rather than vans or trucks, and (possibly) at higher speed limits. Perceived characteristics of the cyclist (other than gender) appear to have little effect on passing distances. The research questions the ability to judge lateral distance and whether nominated distances predict on-road behaviour. Cyclists have strong concerns about drivers passing too close but the extent to which this behaviour reflects deliberate intimidation versus an inability to judge what is a safe passing distance is not clear. There has been no systematic evaluation of the road safety benefits of minimum passing distance laws. These laws have received little police enforcement but it is unclear whether enforcement is necessary for them to be effective.

Hydrotherapy as a recovery strategy after exercise: A pragmatic controlled trial

Background Our aim was to evaluate the recovery effects of hydrotherapy after aerobic exercise in cardiovascular, performance and perceived fatigue. Methods A pragmatic controlled repeated measures; single-blind trial was conducted. Thirty-four recreational sportspeople visited a Sport-Centre and were assigned to a Hydrotherapy group (experimental) or rest in a bed (control) after completing a spinning session. Main outcomes measures including blood pressure, heart rate, handgrip strength, vertical jump, self-perceived fatigue, and body temperature were assessed at baseline, immediately post-exercise and post-recovery. The hypothesis of interest was the session*time interaction. Results The analysis revealed significant session*time interactions for diastolic blood pressure (P=0.031), heart rate (P=0.041), self perceived fatigue (P=0.046), and body temperature (P=0.001); but not for vertical jump (P=0.437), handgrip (P=0.845) or systolic blood pressure (P=0.266). Post-hoc analysis revealed that hydrotherapy resulted in recovered heart rate and diastolic blood pressure similar to baseline values after the spinning session. Further, hydrotherapy resulted in decreased self-perceived fatigue after the spinning session. Conclusions Our results support that hydrotherapy is an adequate strategy to facilitate cardiovascular recovers and perceived fatigue, but not strength, after spinning exercise. Trial registration ClinicalTrials.gov Identifier: NCT01765387 Keywords: Hydrotherapy; Heart rate; Fatigue; Strength; Blood pressure; Body temperature

Research on injury compensation and health outcomes : ignoring the problem of reverse causality led to a biased conclusion

Objective This study highlights the serious consequences of ignoring reverse causality bias in studies on compensation-related factors and health outcomes and demonstrates a technique for resolving this problem of observational data. Study Design and Setting Data from an English longitudinal study on factors, including claims for compensation, associated with recovery from neck pain (whiplash) after rear-end collisions are used to demonstrate the potential for reverse causality bias. Although it is commonly believed that claiming compensation leads to worse recovery, it is also possible that poor recovery may lead to compensation claims—a point that is seldom considered and never addressed empirically. This pedagogical study compares the association between compensation claiming and recovery when reverse causality bias is ignored and when it is addressed, controlling for the same observable factors. Results When reverse causality is ignored, claimants appear to have a worse recovery than nonclaimants; however, when reverse causality bias is addressed, claiming compensation appears to have a beneficial effect on recovery, ceteris paribus. Conclusion To avert biased policy and judicial decisions that might inadvertently disadvantage people with compensable injuries, there is an urgent need for researchers to address reverse causality bias in studies on compensation-related factors and health.

Practical implementation of species' recovery plans - Lessons from the White-backed Woodpecker Action Plan in Sweden

Successful biodiversity conservation requires safeguarding viable populations of species. To work with this challenge Sweden has introduced a concept of Action Plans, which focus on the recovery of one or more species; while keeping in mind the philosophy of addressing ecosystems in a more comprehensive way, following the umbrella concept. In this paper we investigate the implementationprocess of the ActionPlanfor one umbrella species, the White-backed Woodpecker (WBW) Dendrocopos leucotos. We describe the plan's organisation and goals, and investigate its implementation and accomplishment of particular targets, based on interviewing and surveying the key actors. The achievement of the targets in 2005-2008 was on average much lower than planned, explained partially by the lack of knowledge/data, experienced workers, and administrative flexibility. Surprisingly, the perceived importance of particular conservation measures, the investment priority accorded to them, the money available and various practical obstacles all failed to kg? explain the target levels achieved. However qualitative data from both the interviews and the survey highlight possible implementation obstacles: competing interests with other conservation actions and the level of engagement of particular implementing actors. Therefore we suggest that for successful implementation of recovery plans, there is aneed for initial and inclusive scoping prior to embarking on the plan, where not only issues like ecological knowledge and practical resources are considered, but also possible conflicts and synergies with other conservation actions. An adaptive approach with regular review of the conservation process is essential, particularly in the case of such complex action plans as the one for the WBW.

Large-scale interlaboratory study to develop, analytically validate and apply highly multiplexed, quantitative peptide assays to measure cancer-relevant proteins in plasma

There is an increasing need in biology and clinical medicine to robustly and reliably measure tens-to-hundreds of peptides and proteins in clinical and biological samples with high sensitivity, specificity, reproducibility and repeatability. Previously, we demonstrated that LC-MRM-MS with isotope dilution has suitable performance for quantitative measurements of small numbers of relatively abundant proteins in human plasma, and that the resulting assays can be transferred across laboratories while maintaining high reproducibility and quantitative precision. Here we significantly extend that earlier work, demonstrating that 11 laboratories using 14 LC-MS systems can develop, determine analytical figures of merit, and apply highly multiplexed MRM-MS assays targeting 125 peptides derived from 27 cancer-relevant proteins and 7 control proteins to precisely and reproducibly measure the analytes in human plasma. To ensure consistent generation of high quality data we incorporated a system suitability protocol (SSP) into our experimental design. The SSP enabled real-time monitoring of LC-MRM-MS performance during assay development and implementation, facilitating early detection and correction of chromatographic and instrumental problems. Low to sub-nanogram/mL sensitivity for proteins in plasma was achieved by one-step immunoaffinity depletion of 14 abundant plasma proteins prior to analysis. Median intra- and inter-laboratory reproducibility was <20%, sufficient for most biological studies and candidate protein biomarker verification. Digestion recovery of peptides was assessed and quantitative accuracy improved using heavy isotope labeled versions of the proteins as internal standards. Using the highly multiplexed assay, participating laboratories were able to precisely and reproducibly determine the levels of a series of analytes in blinded samples used to simulate an inter-laboratory clinical study of patient samples. Our study further establishes that LC-MRM-MS using stable isotope dilution, with appropriate attention to analytical validation and appropriate quality c`ontrol measures, enables sensitive, specific, reproducible and quantitative measurements of proteins and peptides in complex biological matrices such as plasma.

Specificity and context in post-exercise recovery: It is not a one-size-fits-all approach

The concept of specificity of exercise prescription and training is a longstanding and widely accepted foundation of the exercise sciences. Simply, the principle holds that training adaptations are achieved relative to the stimulus applied. That is, the manipulation of training variables (e.g. intensity or loading, mode, volume and frequency) directly influences the acute training stimulus, and so the long-term adaptive response (Young et al., 2001; Bird et al., 2005). Translating this concept to practice then recommends that exercise be prescribed specific to the desired outcomes, and the more closely this is achieved, the greater the performance gain is likely to be. However, the cardiovascular and metabolic adaptations traditionally associated with long, slow distance training types, similarly achieved using high-intensity training methods (for a review see Gibala et al., 2012), highlights understanding of underlying physiology as paramount for effective training program design. Various other factors including illness, sleep and psychology also impact on the training stimulus (Halson, 2014) and must be managed collectively with appropriate post-exercise recovery to continue performance improvements and reduce overtraining and injury risks (Kenttä and Hassmén, 1998).

There and back again: Is there a need for GLAM education? (GLAM = Galleries, Libraries, Archives and Museums)

Conferences addressing emerging commonalities in the information professions were being held as far back as the early 1980s. At that time, there appeared to be two differing thoughts on the future of the information professions: one that saw the increasing diversification, the other favouring the professions’ convergence. Nearly thirty-five years later, we are still discussing the various advantages and disadvantages that a convergence of the information professions and professionals may bring; yet there has been very little empirical evidence gathered to enable us to move forward in this discussion. This conceptual paper uses existing literature to argue that the convergence of galleries, libraries, archives and museums is not a new concept to these institutions, but that they have been linked – philosophically and intellectually at least - for millennia. The intention of this paper is not to articulate what should be included in a GLAM curriculum, or to identify the skills and knowledge required of an information professional in a converged environment, but rather to demonstrate that this research is needed in order to provide an evidence base from which these may be developed.

"It broke our hearts": Understanding parents' lived experiences of their child's admission to an acute mental health care facility

This article reports the evaluative findings of an Early Psychosis Education Program (EPEP) designed to support parents caring for their child who was recently admitted to the psychiatric intensive care unit of an inpatient mental health care facility in Australia. The EPEP offered education on mental illness, treatment options, and medication, as well as information on the recovery model of care. The EPEP was facilitated by two RNs and was evaluated for educational effectiveness using a simple pre- and postevaluation questionnaire. The evaluation revealed two themes expressed by parents: "We didn't see it coming," and "Hopelessness and helplessness." The themes highlighted the parents' lack of mental health care knowledge prior to the EPEP, which had a significant impact on the parents' experiences and well-being. The evaluative findings highlighted a need for a nurse-led EPEP within the community. A community EPEP has the potential to strengthen the partnership between parents, families, and mental health service providers and to help with the provision of a recovery framework of care.

Effective communication during disasters: What effects community decision making & action?

Study/Objective This paper describes a program of research examining emergency messaging during the response and early recovery phases of natural disasters. The objective of this suite of studies is to develop message construction frameworks and channels that maximise community compliance with instructional messaging. The research has adopted a multi-hazard approach and considers the impact of formal emergency messages, as well as informal messages (e.g., social media posts), on community compliance. Background In recent years, media reports have consistently demonstrated highly variable community compliance to instructional messaging during natural disasters. Footage of individuals watching a tsunami approaching from the beach or being over-run by floodwaters are disturbing and indicate the need for a clearer understanding of decision making under stress. This project’s multi-hazard approach considers the time lag between knowledge of the event and desired action, as well as how factors such as message fatigue, message ambiguity, and the interplay of messaging from multiple media sources are likely to play a role in an individual’s compliance with an emergency instruction. Methods To examine effective messaging strategy, we conduct a critical analysis of the literature to develop a framework for community consultation and design experiments to test the potential for compliance improvement. Results Preliminary results indicate that there is, as yet, little published evidence on which to base decisions about emergency instructional messages to threatened communities. Conclusion The research described here will contribute improvements in emergency instructional message compliance by generating an evidence-based framework that takes into account behavioural compliance theory, the psychology of decision making under stress, and multiple channels of communication including social media.

Effective communication during disasters

This paper describes a program of research examining emergency messaging during the response and early recovery phases of natural disasters. The objective of this suite of studies is to develop message construction frameworks and channels that maximise community compliance with instructional messaging. The research has adopted a multi-hazard approach and considers the impact of formal emergency messages, as well as informal messages (e.g., social media posts), on community compliance. In recent years, media reports have consistently demonstrated highly variable community compliance to instructional messaging during natural disasters. Footage of individuals watching a tsunami approaching from the beach or being over-run by floodwaters are disturbing and indicate the need for a clearer understanding of decision making under stress. This project’s multi-hazard approach considers the time lag between knowledge of the event and desired action, as well as how factors such as message fatigue, message ambiguity, and the interplay of messaging from multiple media sources are likely to play a role in an individual’s compliance with an emergency instruction. To examine effective messaging strategy, we conduct a critical analysis of the literature to develop a framework for community consultation and design experiments to test the potential for compliance improvement. Preliminary results indicate that there is, as yet, little published evidence on which to base decisions about emergency instructional messages to threatened communities. The research described here will contribute improvements in emergency instructional message compliance by generating an evidence-based framework that takes into account behavioural compliance theory, the psychology of decision making under stress, and multiple channels of communication including social media.

Recovery from first episode psychosis: A dialogical perspective

This study aims to understand the process of change in self and its relationship to recovery in the first 3 months following first-episode psychosis (FEP). Because psychosis is understood as a disorder of self, theories of self are needed to consider how sense of self is affected and restored. The authors used semistructured interviews to explore the experiences of 12 young people who had been diagnosed with FEP. The interviews were conducted at two time points: during the first month following the onset of psychosis and 3 months later. The authors employed Interpretive Phenomenological Analysis to explicate interview data and explore the experience of change following FEP. Themes that emerged in the data came under two superordinate themes: loss of self and strengthening of self. Dialogical theory of self was used to interpret the findings and explore the relationship between sense of self and recovery for young people during this critical phase following FEP.

Recovery from first-episode psychosis and recovering self: A qualitative study

Objective The objective of this study was to explore the subjective factors associated with the experience of first-episode psychosis (FEP) and the very first stages of recovery to develop our understanding of this process and improve treatment outcomes. Method Interpretive Phenomenological Analysis was used to explore the experiences of 20 young people who had recently experienced FEP. Results Two broad superordinate themes captured essential thematic trends in the data: experiences of self-estrangement and self-consolidation. The concept of dialogical self was used to understand the effect of psychosis on self and the process of resuming familiar social positions to facilitate recovery. The concept of making meaning after traumatic events was also applied to the narratives of personal growth that participants formed. Those who reported subjective improvements in recovery were more likely to have developed a meaningful interpretation of their psychosis, strengthened relationships with others, and forged a stronger sense of self. Conclusions and Implications for Practice The experience of self-consolidation was strongly associated with the person’s resumption of familiar social roles and their ability to make meaning from their experience in a way that promoted personal growth. Although these processes are known to be part of personal recovery, this study highlights their importance in the very early stages of recovery immediately after the experience of FEP.